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Application of telemedicine in obesity management
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European Research in Telemedicine/La Recherche Européenne en Télémédecine (2017) xxx, xxx.e1—xxx.e10
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ORIGINAL ARTICLE /Remote Medical Assistance
Application of telemedicine in obesity management L’application de la télémédecine dans la prise en charge de l’obésité M.L. Tarraga Marcos a, J.M. Panisello Royo b, J.A. Carbayo-Herencia c, N. Rosich Domenech d, J. Alins Presas e, E. Castell Panisello f, P.J. Tárraga López g,∗ a
Geriatric Residency Nurse, Albacete, Spain Internal Medicine, Barcelona, Spain c Lipids Unit, Quironsalud Hospital, Albacete, Spain d Nutrition Unit — Igualada, Barcelona, Spain e Family and Community Medicine, ABS ABRERA, Barcelona, Spain f FUFOSA Health Foundation, Madrid, Spain g Family and Community Medicine, EAP 5, University of Castilla-La Mancha, Albacete, Spain b
Received 28 December 2016; accepted 12 February 2017
KEYWORDS Telemedicine; Obesity; Health care
∗
Summary Introduction. — To evaluate the effectiveness of obesity intervention with telemedicine support technology in patients who have been recently diagnosed as overweight or obese, in comparison to usual protocols currently implemented in our area. Material and methods. — Randomized, controlled, double-blind, parallel clinical trial comparing 2 arms, multicentre study in overweight or obese patients with a 12-month follow-up. Patients were randomized into two groups: Intervention in primary care centres with a telematic platform support (G1) and a control group provided constantly with guidelines to lose weight and follow-up in primary care centres (G2). Variables were collected: weight, height, BMI, waist circumference, lipid parameters, blood pressure and glycaemia. After the interventions were conducted, indicators of clinical relevance were studied, i.e. relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT) both by intention-to-treat and by biological efficacy.
Corresponding author. C/Angel 53.1E, CP 02002 Albacete, Spain. E-mail address: [email protected] (P.J. Tárraga López).
http://dx.doi.org/10.1016/j.eurtel.2017.02.041 2212-764X/© 2017 Elsevier Masson SAS. All rights reserved.
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M.L. Tarraga Marcos et al. Results. — One hundred and sixteen patients were included in the study where 61 were randomized to group 1 and 55 to group 2. Of the study population, 58.6% were women and 41.4% were men. Patients’ weight in both groups descended in each of the visits, observing an overall average weight reduction at the end of the study of 3.06 kg, being 4.3 kg in group 1 and 1.8 kg in the control group. It also was noted that cholesterol levels in both groups were reduced. On the other hand, the triglycerides levels were significantly reduced only in the study group G1, and HDL was increased in both groups, but more in G1. Regarding of clinically relevant parameters were G1 versus G2: RR: 1.21 to 3.57; RRR: 21.3 to 256.8; ARR: 8.7 to 42.4, and NNT: 3 to 12. Discussion and conclusions. — Both groups were able to reduce the weight while the group with the telemedicine support based on Medtep digital platform showed significant differences. © 2017 Elsevier Masson SAS. All rights reserved.
MOTS CLÉS Télémédecine ; Obésité ; Soins de santé
Résumé Introduction. — Évaluer l’efficacité de l’intervention sur l’obésité avec la télémédecine chez les patients qui ont été récemment diagnostiqués comme en surpoids ou obèses, par rapport aux protocoles habituels actuellement mis en œuvre dans notre région. Matériel et méthodes. — Essai clinique randomisé, contrôlé, en double aveugle, parallèle comparant 2 bras avec une étude multicentrique chez les patients en surpoids ou obèses avec un suivi à 12 mois. Les patients ont été randomisés dans deux groupes : une intervention dans des centres de soins primaires avec un soutien de plate-forme télématique (G1) et un groupe témoin fourni constamment avec des lignes directrices pour perdre du poids et un suivi dans des centres de soins primaires (G2). Les variables suivantes ont été recueillies : poids, taille, indice de masse corporelle, tour de taille, paramètres lipidiques, tension artérielle et glycémie. Après la réalisation des interventions, des indicateurs de pertinence clinique ont été étudiés, à savoir le risque relatif (RR), la réduction absolue du risque (ARR), la réduction du risque relatif (RRR) et le nombre de sujets à traiter (NNT) — à la fois par l’intention de traiter et par l’efficacité biologique. Résultats. — Cent seize patients ont été inclus dans l’étude, dont 61 qui ont été randomisés dans le groupe 1 et 55 dans le groupe 2. Parmi la population étudiée, 58,6 % étaient des femmes et 41,4 % étaient des hommes. Le poids des patients dans les deux groupes a baissé à chacune des visites, observant ainsi une réduction de poids moyenne globale à la fin de l’étude de 3,06 kg, soit 4,3 kg dans le groupe 1 et 1,8 kg dans le groupe témoin. Il a été également noté que les taux de cholestérol dans les deux groupes ont été réduits. D’autre part, les taux de triglycérides ont été réduits de manière significative seulement dans le groupe d’étude G1 et le HDL a été augmenté dans les deux groupes, mais de manière plus importante dans G1. En ce qui concerne les paramètres cliniques pertinents chez G1 par rapport à G2 : RR : 1,21—3,57 ; RRR : 21,3—256,8 ; ARR : 8,7—42,4, et NNT : 3—12. Discussion et conclusions. — Les deux groupes ont été en mesure de réduire leur poids tandis que le groupe avec le soutien par télémédecine basé sur la plate-forme numérique Medtep montrait des différences significatives. © 2017 Elsevier Masson SAS. Tous droits r´ eserv´ es.
Introduction Obesity is a growing global pandemic [1,2] and prevalence rates of obesity worldwide have been duplicated since 1980. An estimated 205 million men and 297 million women are obese—–a total of more than half a billion adults worldwide [3]. Spain, corroborating this trend [4], is reaching obesity prevalence rates that indicate that we are facing a serious public health problem given the associated comorbidities that excess body weight involves [5], besides demonstrating its independent effect on mortality [6,7]. According to
recent data, 60.9% of the adult population between 25 and 64 years [4] and 41.3% of children [8] were overweight or obese. While it is evident that treatments based on the Mediterranean diet side by side with cognitive-behavioural intervention and physical exercise are effective in treatment of obesity and its associated diseases [9—14], Spanish society is gradually moving away from the traditional Mediterranean diet [14—16]. Thus, in 2011, the consumption of fruit, vegetables, oils, legumes, fish and traditional Mediterranean food has fallen in relation to previous years, while consumption of pre-prepared meals has increased
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Application of telemedicine in obesity management considerably [17], which may explain the increase of obesity prevalence rates observed in our population. There are diverse experiences with weight loss treatments based on the Mediterranean diet. Since 1993, weight loss treatment based on the Mediterranean diet along with exercise and conductive therapy is being implemented and has proven to be effective in treating obesity and its associated diseases [18,19]. Similarly, in the SUN study [20] on adherence to the Mediterranean diet and weight change on the long-term that included more than 10,000 subjects during two years of follow-up, it was observed that the group with high adherence levels to the Mediterranean diet showed a lower risk of regaining the lost weight. Interventions that focus on changing eating habits and increasing daily physical activity in order to promote a healthy lifestyle are the best options to address overweight and obesity. In addition, other components of cognitiveconductive therapy from the behavioural perspective have shown to be relevant in a way that makes it recommended to include it in the interventions targeting overweight and obesity problems in order to improve their effectiveness and promote the maintenance of the obtained results. Moreover, regarding the effectiveness of these interventions to reduce weight, scientific evidence has reached satisfactory results, achieving weight reductions between 5% and 10% of the initial weight [14,15]. But when considering the maintenance of the weight loss over time, the results are less encouraging. Scientific evidence indicates weight regain between 30% and 35% in patients during the first year after concluding the intervention. Even more, weight regain is over 50% in the follow-up conducted during the following 5 years [16]. In fact, all of the interventions that have proven useful need to be intensive, well-structured and address multiple aspects. This entails a significant investment in time and human resources in our health system [19—21], and that is why we need to find strategies that allow us to use effective approaches on the short term as well as the medium and the long ones that consume fewer resources so as to allow us to intervene on a larger population. Moreover, information and communications technologies (ICTs), especially the Internet, are emerging as a new strategy with different potentials, able to cope with the limitations of the traditional programmes, in order not only to achieve weight loss but also to maintain the results after concluding the intervention. Technology-based health services, enhanced or delivered by the Internet (i.e. e-health technologies) [22] and, in particular, mobile technologies, offer great potential to increase the reach of public health initiatives and to improve public health [23,24]. This potential can be enhanced by promoting the use of mobile and Internet technologies. In 2014, there were 6.5 billion mobile users of the entire world population [25], with mobile phone penetration rates reaching over 70% of the population of many European and North American countries, such as Spain (83%) [26], Canada (78%), the United Kingdom (75%), the United States (73%), and Italy (71%). ICT, being available for a large number of the general population, allow people to access them from home or other places, and to receive treatment with an intervention adjustable to their personal needs reducing the costs associated with the traditional protocols [22]. Furthermore, the Internet can be used in all of the phases of treatment and during the
xxx.e3 follow-up after concluding the intervention. Another advantage of the Internet and computer programmes is the ability to adapt to the personal characteristics and the specific needs of the studied target groups. As we mentioned above, the use of ICT-based interventions not only makes it possible to reach more people, but it also makes it possible to access them at any time throughout the intervention process. This allows us to adjust the requirements to the needs and demands of each individual, therefore facilitating the achievement of optimal results during the intervention. It also allows us to extend the follow-up period in a way that helps us maintain the success of achieving a healthy lifestyle during a larger period [27,28]. An increasing number of systematic reviews and metaanalysis on weight management e-health interventions are available [24,29,30]. However, most of them focus on mobile technologies alone [31—34] and do not provide a comprehensive picture of the research involving both Web 2.0 and mobile phone technologies for weight management in particular. In fact, although numerous wearable technologies directed at the control of physical activity and diet are available, it is yet unclear if these technologies are effective at improving weight loss. In that way, studies are needed in our environment to confirm the effectiveness and the feasibility of such interventions in overweight and obese patients, and to figure out if it is worthwhile to implement their application in the primary care system as a tool to address this health problem. Therefore, the main objective was a comparison between a standard behavioural weight loss intervention (standard intervention) and a technology-enhanced weight loss intervention (enhanced intervention) in order to confirm which one of them would result in greater weight loss, and assess if results (losing more than 5% of the initial weight) can be maintained after one year of follow-up.
Material and methods Study design and participants We performed a randomized, controlled, double-blind, parallel clinical trial with 2 arms and a 12-month follow-up. The trial was conducted from March 2015 to June 2016, with all overweight or obese men and women aged between 30 and 70 years. Subjects were confirmed to have no participations in diet reduction programmes within the last 12 months and they completed a personal health and medical history questionnaire, which served as a screening tool. Exclusion criteria were type 2 diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140—200 mg/dL [7.8—11.1 mmol/L] 2 hours after a 75 — g oral glucose load), hypertension (blood pressure > 140/90 mmHg or if the participant was taking antihypertensive medication), cardiovascular disease, psychiatric problems, history of alcohol abuse (intake of ≥ 500 g/wk in the last year), current smoking, and any medicine consumption. No patient was pregnant or became pregnant during the study. The study was approved by the institutional committee of ethical practice and all the study participants provided written informed consent. Participants were individually assigned to
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either the intervention or the control group by a computergenerated number. Neither nurses nor physicians who visited the participants had access to the randomization list.
Interventions Patients were randomized into two intervention groups: (G1) intervention in primary care with the support of a telematic platform and another group receiving guidelines to lose weight and follow-up in primary care centres (G2). The Medtep platform offered the participants in the intervention group (G1) access to the Mediterranean Diet Adherence Screener (MEDAS) and kept track of their adherence level. Adherence to the Mediterranean diet was assessed using the validated 14-point MEDAS [34], an adaptation of a previously validated 9-item index [35]. The MEDAS was developed within the PREDIMED study group [34,35]. The MEDAS can rapidly estimate Mediterranean diet adherence and it may be useful in the clinic. The 14-item screener includes 12 questions about food consumption frequency and two questions about food intake habits characteristic of the Spanish Mediterranean diet (Table 1). Participants knew their initial level of adherence prior to starting the intervention. After that, a health professional asked them to answer the test every day (self-monitoring food diary) and the platform showed the participant their adherence level weekly. In that way this tool was useful in evaluating the compliance with the Mediterranean diet, allowing personalized dietary advice provided automatically by the platform. At the same time, in cases of low compliance, the platform offered personalized advice and
Table 1 Test of adherence to the Mediterranean Diet in adultsa . Test d’adhésion au régime méditerranéen chez les adultesa . 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
Using olive oil as the principal source of fat for cooking ≥ 4 spoons (1 = 13.5 g) of olive oil/d (e.g. used in frying, salads, meals eaten away from home) 2 or more servings of vegetables/day 3 or more pieces of fruit/day 1 serving of red meat or sausages/day 1 serving of animal fat/day 1 cup (1 cup = 100 mL) of sugar-sweetened beverages/day ≥ 7 servings of red wine/week ≥ 3 servings of legumes/week ≥ 3 servings of fish/week < 2 commercial pastries/week ≥ 3 servings of nuts/week Preferring white meat or red meat? ≥ 2 servings/week of a dish with a traditional sauce of tomatoes, garlic, onion, or leeks sautéed in olive oil
a If the condition was not met, 0 points were recorded for the category and if the condition was met, 1 point was recorded for the category. Values are expressed as number.
suggestions (such as recipes, etc.) to the participant as a way to improve results. The protocol applied in G1 after the first visit was: visits scheduled at 15 days, one month, 3 months, 6 months and 12 months. At each visit, anthropometric data were collected, physical activity level was reviewed, adhesion to the Mediterranean diet using the data recorded by the patient in the Medtep platform was reviewed and the patient was encouraged to improve the adherence level to the Mediterranean diet. The G2 received guidelines and recommendations to lose weight. Participants in the G2 were given general oral and written information about healthy food choices based on the Mediterranean diet and exercises on the first visit and subsequent visits. Those recommendations included information on three different concepts offering the patient self-monitoring instruments. With the first concept (‘‘the weight monitoring can be helpful in terms of achieving the goal of weight loss’’), in order to achieve this objective, the patient was offered the opportunity to record his weight in primary care centres periodically with the same frequency as in the G1 group. The second concept was as follows: ‘‘following a Mediterranean dietary pattern promotes the acquisition and maintenance of a proper body weight’’. The third concept stated that ‘‘following a Mediterranean dietary pattern involves adherence to diet guidelines and maintaining an active lifestyle’’.
Variables and measurements Weight in kilograms (kg) wearing very light clothes was measured using a digital scale (range from 0.1 to 150 kg and precision of 0.1 kg), height in metres (m) with the subject barefoot using Harpenden Digital Stadiometer (range from 0.7 to 2.05 m and precision of 1 mm) and body mass index (BMI) was calculated (kg/m2 ). Waist circumference was measured in the horizontal plane midway between the lowest rib and the iliac crest. Analysis for serum total and high-density lipoprotein cholesterol, triglyceride, and glucose levels were performed in the chemistry laboratory.
Sample size To assess the statistical power of this study ‘‘a posteriori’’, it was assumed, with a confidence level of 95%, a proportion of 30% would reach the objective in the control group and 70% in the experimental group. The total number of participants was 116. The study power to detect a relative risk other than 1 was 99.69%.
Statistical analysis All calculations were performed using the SPSS v19.0 statistics programme. Quantitative variables are presented as mean and standard deviation (SD), qualitative ones as exact amount and percentage. To verify that randomization was successful among the two compared groups, Student’s ttest was used in the comparison of means for independent groups and the Chi2 test (Pearson or Fisher) in the qualitative variables. The comparison of means during the follow-up has been performed by analysing the variance of repeated
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Randomized (n=120)
G1
G2
(n=61)
(n=59)
Lost to follow-up
Lost to follow-up
(n=0)
(n=4)
Analysed
Analysed (intenon to treat) (n=55)
(n=61)
4 withdrew from study
Figure 1. Study flowchart. G1: intervention group (consultations in primary care and digital platform); G2: control group (follow the general advice established to lose weight in their primary care centres). Diagramme de l’étude. G1 : groupe d’intervention (consultations de soins primaires et sur la plate-forme numérique) ; G2 : groupe témoin (suivre les recommandations générales pour perdre du poids dans leurs centres de soins primaires).
measures. When the criteria of normality and specificity were not met, the non-parametric Friedman test was applied. A comparison between the groups after concluding the interventions was performed with indicators of clinical relevance, i.e. relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT). The results between both groups are presented by both intention-to-treat analysis and by biological efficacy analysis. Significant values were considered those whose comparisons have reached a value of P ≤ 0.05.
When assessing all participants (61 in G1 and 55 in G2) in both the initial and final examinations, a decrease in all parameters related to body weight can be observed on Fig. 3, being more intense in the G1 than in G2, except in the waist circumference (WC) per year in the G2 in which no significant changes were observed (P = 0.317). Fig. 4 shows that G1 reached the goal of reducing weight by more than 5% in 30 individuals (49.2%) versus 9 subjects (16.4%) in G2 (P < 0.001). Therefore, the G1 significantly reached the year with a greater number of individuals with weight losses equal to or greater than 5%.
Results
Analytical parameters
One hundred and twenty participants were randomly assigned to the intervention (n = 61) or control group (n = 59). Fig. 1 shows the number of participants and their evolution. During the follow-up, four individuals of the control group left the study for personal reasons, leaving at the end 55 people in this group. Because participants were screened for exclusion criteria, both groups were comparable. Table 2 shows this comparison, without observing significant differences between the considered variables, which supports a correct randomization. It can be seen globally and in both groups that, on average, the participants were obese and presented high values of total cholesterol (TC) and triglycerides (TG). Fig. 2 shows the evolution of BMI between these two groups. An analysis of the variance of repeated measures showed that both groups decreased in weight throughout the study, but more in G1, except in the last 6 months where it increased in both groups.
Reduction in lipid parameters was detected (Table 3). It is observed that total cholesterol was reduced in both groups. On the other hand, triglycerides were significantly reduced more in the study group, without achieving significant differences in the control group (P = 0.710). HDL cholesterol was increased in both groups. Table 4 shows the analysis of clinical relevance after the 12-month follow-up in patients who achieved the 5% weight reduction. This table also presents the biological efficacy analysis, i.e. those patients who followed the strict recommendations in each of their assigned group (61 in G1 and 47 in G2). If the results in this analysis follow the same direction as the intention-to-treat analysis, it implies a strength in the conclusions of the study. More than the double of the RR (4.62) can be observed in the biological efficacy analysis than in the intention-to-treat analysis (RR = 2.08). In both cases, the comparison between the experimental group and
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Table 2 Sample groups baseline data. Données de base pour les groupes échantillons. Baseline variables
Global(n = 116)
G1 (n = 61)
G2 (n = 55)
P
Men (n; %) Age (years) Baseline weight (kg) BMI (kg/m2 ) Waist circumference (cm) Total cholesterol (mg/dL) Triglycerides (mg/dL) HDL cholesterol (mg/dL)
48 49.8 86.4 30.8 86.4 246.0 165.1 46.9
26 49.7 88.2 30.8 85.2 242.1 172.3 48.1
22 49.8 84.4 30.7 87.7 250.3 157.2 45.7
0.775 0.925 0.150 0.841 0.131 0.170 0.263 0.224
(41.4) (6.4) (14.3) (3.5) (8.9) (32.8) (71.9) (10.7)
(42.6) (6.4) (14.5) (3.6) (9.6) (38.0) (73.0) (11.6)
(40.0) (6.6) (14.0) (3.4) (7.9) (25.3) (70.6) (9.5)
Data are reported as mean and (standard deviation) or number y (percentage). G1: doctor’s visit + telemedicine group; G2: group receiving weight loss guidelines only; Kg: kilograms; BMI: body mass index; Cm: centimetres; kg/m2 : kg divided by height in meters squared; Mg/dL: milligrams per decilitre. HDL: high-density lipoprotein. The comparison between means was performed with Student’s t-test for independent groups.
33
32
p<0.001 31
BMI (kg/m2)
31
p=0.001 30.5
p<0.001 30.4
30.8 30
p<0.001
30.1
30.2
p<0.001 30.4
30
30
p=0.087
29
p<0.001
G1 (n=61) 29.4
29.3
G2 (n=47)
29
p<0.001
p<0.001 28
p<0.001
27 Basal
15 days
30 days
three
6 months
1 year
Figure 2. Body mass index (BMI) evolution in the two groups. The comparison between the means (each level of each group with the previous one) has been made through the analysis of the variance of repeated measures. The overall comparison in each group with the Friedman test (P < 0.001). L’évolution de l’indice de masse corporelle dans les deux groupes.
the control group showed significant differences in all variables (RR, RRR, ARR and NNT), with a very low NNT, requiring only 4 patients to achieve weight loss maintenance of more than 5% during a year.
Discussion In this study, we tested the hypothesis that a technologyenhanced weight loss intervention aimed at reducing body weight by 5% or more was effective at 1 year. The physiological rationale underlying this hypothesis is that obesity is a difficult problem, such that at most, only 10% of
people going on a diet manage to keep the weight off in the long-term. In this study, the addition of telemedicine intervention was most effective in the 12-month weight loss plan. This was thought to be as a result of the technology being effective in changing diet or physical activity behaviours compared to what was achieved with standard intervention; however, the study found no significant differences in these concepts between standard intervention and technologyenhanced intervention groups. Thus, the reason for this difference in weight loss between the standard intervention and technology-enhanced intervention groups should draw our attention to further investigation in the future. The results obtained from our study show that the intervention
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p=0.317
p<0.001 88.2 83.9
84.4
87.7 87
85.2
82.6
81.7
80 70 60
Initial
50
Final (1 year)
40 30.8
30
30.7 30.1
29.3
Figure 3. Evolution of the anthropometric measurements at the beginning and at the end of the study. G1 (n = 61): doctor’s visit + telemedicine group; G2 (n = 55): group receiving weigh loss guidelines only; BMI: body mass index; WC: waist circumference. Significant differences were observed between the 2 groups at 12-month follow-up with Student’s t-test for paired groups (P < 0.001). L’évolution des mesures anthropométriques au début et à la fin de l’étude.
Table 3 Lipid parameters evolution for both groups and by group, both at baseline and at the year of follow-up. L’évolution des paramètres lipidiques pour les deux groupes et chaque groupe, au départ et après un an de suivi. Groups
Initial TC
Final TC
P
Initial TG
Final TG
P
Initial HDL-c
Final HDL-c
P
Global (n = 116) G1 (n = 61) G2 (n = 55)
246.0 (32.8) 242.1 (38.0) 250.3 (25.3)
240.5 (30.5) 237.4 (33.6) 244.0 (26.4)
< 0.001
165.1 (71.9) 172.3 (72.9) 157.2 (70.6)
154.3 (59.8) 153.0 (58.6) 155.8 (61.5)
0.005
46.9 (10.7) 48.1 (11.6) 45.7 (9.5)
47.8 (10.6) 48.7 (11.6) 46.9 (9.4)
< 0.001
0.027 0.007
0.003 0.710
0.017 < 0.001
Data are reported as mean and (standard deviation). TC: total cholesterol; TG: triglycerides; HDL-c: high-density lipoprotein cholesterol; G1: intervention group (consultation and use of the digital platform); G2: control group (habitual tips for losing weight in their primary care centres). The comparison of means was done with Student’s t-test for paired data.
with telemedicine support implemented in the study group (G1) got better results where almost 50% of patients achieved the goal of reducing 5% of their initial weight. The effect of intervention with telemedicine support with 49.2% success is higher than the usual care protocols
used in G2. In group G1, where monitoring is less intensive and results are better, monitoring the adherence level to the Mediterranean diet and physical activity (recorded by a pedometer) was carried out. The use of ICTs, such as the Internet, mobile devices, virtual reality, etc., has been
Table 4 Analysis of patients who could achieve the goal of 5% weight loss after a year of follow-up. Analyse des patients qui ont pu atteindre l’objectif d’une perte de poids de 5 % après un an de suivi. Comparison groups
RR (95% CI)
RRR (95% CI)
ARR (95% CI)
Consultation + TM/control (intention-to-treat analysis) Consultation + TM/control (biological efficacy analysis)
2.08 (1.21 to 3.57)
108.1 (21.3 to 256.8)
25.5 (8.7 to 42.4)
4 (3 to 12)
4.62 (1.94 to 11.0)
362.3 (94.3 to 1000.1)
38.5 (23.2 to 53.9)
3 (2 to 5)
NNT (95% CI)
RR: relative risk; CI: confidence interval; RRR: relative risk reduction; ARR: absolute risk reduction; NNT: number needed to treat; TM: telemedicine.
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60
50
49.2
40
G1
30
G2 20
16.4
10
0 objectives achieved at 12 months
Figure 4. Percentage of patients achieving at least a 5% weight loss in each of the intervention groups at 12 months follow-ups. G1: doctor’s visit + telemedicine group; G2: group receiving weigh loss guidelines only. Significant differences were observed between the 2 groups, at 12 months (Chi2 test: P < 0.001). Pourcentage des patients ayant atteint au moins une perte de poids de 5 % dans chaque groupe au suivi de 12 mois.
increasing significantly over recent years. ICTs can provide additional resources to traditional programmes and improve their quality, raising the effectiveness and the efficiency of interventions in chronic problems such as obesity [22—24]. In the control group G2, weight loss is less than in G1, being 19.1% at the 6-month follow-up and 10.6% at the 12-month follow-up, accompanied by a reduction of waist circumference of 0.21 cm at the 12-month follow-up. Comparing the two groups together, a significant difference (P < 0.0001) was observed. Data analysis shows that the NNT in the first group is 4, i.e. we should treat three patients to achieve effectiveness in at least one of them, while in the second group NNT is 7—9 patients. Patients in the G2 group after being diagnosed as overweight or obese were advised to lose weight. While this recommendation should be given to all patients suffering from excess weight [22,23], several studies have shown that this does not happen and in most of the cases, it only happens in 20%—36% [24—27] although, in the study of Phelan et al., a proportion of 75.5% was reached. This lack of systematic recommendations exists despite being widely proved that patients receiving these recommendations from their family doctors are twice as likely to achieve the abovementioned weight loss versus those who have not received it [25,26]. There is no clear consensus [27] on the barriers that explain this phenomenon, but perhaps the most reliable reasons are financial management, lack of motivation by the patient and lack of time and training of the health providers [26,27]. It is important to point out that the use of resources in this second intervention group was minimal given that the patient was only advised to lose weight, informing him that regular weight recording could be done in Primary Care Centres. They were also informed that the more they adhered to the Mediterranean diet the better optimal weight maintenance could be achieved, and that those with a lifestyle
that included keeping a good level of physical activity could achieve better weight maintenance. While the tendency in adult patients is to gradually regain the lost body weight, in the group G1, it was almost the contrary since 24% of patients stabilized their weight and 19% reduced their weight. Twenty-one percent of patients achieved a reduction of 5% or higher as an effectiveness objective. This study does not allow us to know the weight control factor (whether weight was recorded by health professionals or by digital tools). By analysing the study, it is clear that patients started from an adherence level of 8.3 at the beginning of the study and improved their adherence level over time in a way that they reached an adherence level at the end of the study of 9.9. On one hand, numerous studies have shown that simple weight monitoring can facilitate weight loss and/or maintenance after loss. On the other hand, it is known that better adherence to the Mediterranean diet is followed by weight optimization. In the SUN study on adherence to the Mediterranean diet and long-term weight changes, it was observed that the group with improved adherence to the Mediterranean diet showed a lower risk of weight regain. Thus, the results of this control group lead us to propose using new technologies to measure adherence to the Mediterranean diet and then use them to improve adherence levels. Further research will be needed to compare different programmes for this purpose, programmes that include different processes and smart monitoring that can adapt to the user profile and include gamification [31—38]. Strengths and limitations: the main strength of our study is that it is a clinical trial, with two randomized and homogeneous groups, thus minimizing systematic errors. Regarding the limitations, it is noteworthy that the four losses described corresponded to the same group, representing 6.8%, thus believing that it did not invalidate the results. The RR when comparing the two groups for biological efficacy was 4.6 in favour of G1. RR that fell to 2 when the comparison between the two groups was done by intentionto-treat, which demonstrates the strength of the association in favour of the group that used the telematic platform.
Conclusion The intervention with telemedicine support yields better results in terms of both weight reduction and its maintenance, the results of the two protocols have presented sufficient clinical impact and even more considering the limited resources they use. So we believe it is essential to further explore the role that new technologies can have in the treatment of overweight and obesity.
Disclosure of interest The authors declare that they have no competing interest.
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ORIGINAL ARTICLE /Remote Medical Assistance
Application of telemedicine in obesity management L’application de la télémédecine dans la prise en charge de l’obésité M.L. Tarraga Marcos a, J.M. Panisello Royo b, J.A. Carbayo-Herencia c, N. Rosich Domenech d, J. Alins Presas e, E. Castell Panisello f, P.J. Tárraga López g,∗ a
Geriatric Residency Nurse, Albacete, Spain Internal Medicine, Barcelona, Spain c Lipids Unit, Quironsalud Hospital, Albacete, Spain d Nutrition Unit — Igualada, Barcelona, Spain e Family and Community Medicine, ABS ABRERA, Barcelona, Spain f FUFOSA Health Foundation, Madrid, Spain g Family and Community Medicine, EAP 5, University of Castilla-La Mancha, Albacete, Spain b
Received 28 December 2016; accepted 12 February 2017
KEYWORDS Telemedicine; Obesity; Health care
∗
Summary Introduction. — To evaluate the effectiveness of obesity intervention with telemedicine support technology in patients who have been recently diagnosed as overweight or obese, in comparison to usual protocols currently implemented in our area. Material and methods. — Randomized, controlled, double-blind, parallel clinical trial comparing 2 arms, multicentre study in overweight or obese patients with a 12-month follow-up. Patients were randomized into two groups: Intervention in primary care centres with a telematic platform support (G1) and a control group provided constantly with guidelines to lose weight and follow-up in primary care centres (G2). Variables were collected: weight, height, BMI, waist circumference, lipid parameters, blood pressure and glycaemia. After the interventions were conducted, indicators of clinical relevance were studied, i.e. relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT) both by intention-to-treat and by biological efficacy.
Corresponding author. C/Angel 53.1E, CP 02002 Albacete, Spain. E-mail address: [email protected] (P.J. Tárraga López).
http://dx.doi.org/10.1016/j.eurtel.2017.02.041 2212-764X/© 2017 Elsevier Masson SAS. All rights reserved.
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M.L. Tarraga Marcos et al. Results. — One hundred and sixteen patients were included in the study where 61 were randomized to group 1 and 55 to group 2. Of the study population, 58.6% were women and 41.4% were men. Patients’ weight in both groups descended in each of the visits, observing an overall average weight reduction at the end of the study of 3.06 kg, being 4.3 kg in group 1 and 1.8 kg in the control group. It also was noted that cholesterol levels in both groups were reduced. On the other hand, the triglycerides levels were significantly reduced only in the study group G1, and HDL was increased in both groups, but more in G1. Regarding of clinically relevant parameters were G1 versus G2: RR: 1.21 to 3.57; RRR: 21.3 to 256.8; ARR: 8.7 to 42.4, and NNT: 3 to 12. Discussion and conclusions. — Both groups were able to reduce the weight while the group with the telemedicine support based on Medtep digital platform showed significant differences. © 2017 Elsevier Masson SAS. All rights reserved.
MOTS CLÉS Télémédecine ; Obésité ; Soins de santé
Résumé Introduction. — Évaluer l’efficacité de l’intervention sur l’obésité avec la télémédecine chez les patients qui ont été récemment diagnostiqués comme en surpoids ou obèses, par rapport aux protocoles habituels actuellement mis en œuvre dans notre région. Matériel et méthodes. — Essai clinique randomisé, contrôlé, en double aveugle, parallèle comparant 2 bras avec une étude multicentrique chez les patients en surpoids ou obèses avec un suivi à 12 mois. Les patients ont été randomisés dans deux groupes : une intervention dans des centres de soins primaires avec un soutien de plate-forme télématique (G1) et un groupe témoin fourni constamment avec des lignes directrices pour perdre du poids et un suivi dans des centres de soins primaires (G2). Les variables suivantes ont été recueillies : poids, taille, indice de masse corporelle, tour de taille, paramètres lipidiques, tension artérielle et glycémie. Après la réalisation des interventions, des indicateurs de pertinence clinique ont été étudiés, à savoir le risque relatif (RR), la réduction absolue du risque (ARR), la réduction du risque relatif (RRR) et le nombre de sujets à traiter (NNT) — à la fois par l’intention de traiter et par l’efficacité biologique. Résultats. — Cent seize patients ont été inclus dans l’étude, dont 61 qui ont été randomisés dans le groupe 1 et 55 dans le groupe 2. Parmi la population étudiée, 58,6 % étaient des femmes et 41,4 % étaient des hommes. Le poids des patients dans les deux groupes a baissé à chacune des visites, observant ainsi une réduction de poids moyenne globale à la fin de l’étude de 3,06 kg, soit 4,3 kg dans le groupe 1 et 1,8 kg dans le groupe témoin. Il a été également noté que les taux de cholestérol dans les deux groupes ont été réduits. D’autre part, les taux de triglycérides ont été réduits de manière significative seulement dans le groupe d’étude G1 et le HDL a été augmenté dans les deux groupes, mais de manière plus importante dans G1. En ce qui concerne les paramètres cliniques pertinents chez G1 par rapport à G2 : RR : 1,21—3,57 ; RRR : 21,3—256,8 ; ARR : 8,7—42,4, et NNT : 3—12. Discussion et conclusions. — Les deux groupes ont été en mesure de réduire leur poids tandis que le groupe avec le soutien par télémédecine basé sur la plate-forme numérique Medtep montrait des différences significatives. © 2017 Elsevier Masson SAS. Tous droits r´ eserv´ es.
Introduction Obesity is a growing global pandemic [1,2] and prevalence rates of obesity worldwide have been duplicated since 1980. An estimated 205 million men and 297 million women are obese—–a total of more than half a billion adults worldwide [3]. Spain, corroborating this trend [4], is reaching obesity prevalence rates that indicate that we are facing a serious public health problem given the associated comorbidities that excess body weight involves [5], besides demonstrating its independent effect on mortality [6,7]. According to
recent data, 60.9% of the adult population between 25 and 64 years [4] and 41.3% of children [8] were overweight or obese. While it is evident that treatments based on the Mediterranean diet side by side with cognitive-behavioural intervention and physical exercise are effective in treatment of obesity and its associated diseases [9—14], Spanish society is gradually moving away from the traditional Mediterranean diet [14—16]. Thus, in 2011, the consumption of fruit, vegetables, oils, legumes, fish and traditional Mediterranean food has fallen in relation to previous years, while consumption of pre-prepared meals has increased
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Application of telemedicine in obesity management considerably [17], which may explain the increase of obesity prevalence rates observed in our population. There are diverse experiences with weight loss treatments based on the Mediterranean diet. Since 1993, weight loss treatment based on the Mediterranean diet along with exercise and conductive therapy is being implemented and has proven to be effective in treating obesity and its associated diseases [18,19]. Similarly, in the SUN study [20] on adherence to the Mediterranean diet and weight change on the long-term that included more than 10,000 subjects during two years of follow-up, it was observed that the group with high adherence levels to the Mediterranean diet showed a lower risk of regaining the lost weight. Interventions that focus on changing eating habits and increasing daily physical activity in order to promote a healthy lifestyle are the best options to address overweight and obesity. In addition, other components of cognitiveconductive therapy from the behavioural perspective have shown to be relevant in a way that makes it recommended to include it in the interventions targeting overweight and obesity problems in order to improve their effectiveness and promote the maintenance of the obtained results. Moreover, regarding the effectiveness of these interventions to reduce weight, scientific evidence has reached satisfactory results, achieving weight reductions between 5% and 10% of the initial weight [14,15]. But when considering the maintenance of the weight loss over time, the results are less encouraging. Scientific evidence indicates weight regain between 30% and 35% in patients during the first year after concluding the intervention. Even more, weight regain is over 50% in the follow-up conducted during the following 5 years [16]. In fact, all of the interventions that have proven useful need to be intensive, well-structured and address multiple aspects. This entails a significant investment in time and human resources in our health system [19—21], and that is why we need to find strategies that allow us to use effective approaches on the short term as well as the medium and the long ones that consume fewer resources so as to allow us to intervene on a larger population. Moreover, information and communications technologies (ICTs), especially the Internet, are emerging as a new strategy with different potentials, able to cope with the limitations of the traditional programmes, in order not only to achieve weight loss but also to maintain the results after concluding the intervention. Technology-based health services, enhanced or delivered by the Internet (i.e. e-health technologies) [22] and, in particular, mobile technologies, offer great potential to increase the reach of public health initiatives and to improve public health [23,24]. This potential can be enhanced by promoting the use of mobile and Internet technologies. In 2014, there were 6.5 billion mobile users of the entire world population [25], with mobile phone penetration rates reaching over 70% of the population of many European and North American countries, such as Spain (83%) [26], Canada (78%), the United Kingdom (75%), the United States (73%), and Italy (71%). ICT, being available for a large number of the general population, allow people to access them from home or other places, and to receive treatment with an intervention adjustable to their personal needs reducing the costs associated with the traditional protocols [22]. Furthermore, the Internet can be used in all of the phases of treatment and during the
xxx.e3 follow-up after concluding the intervention. Another advantage of the Internet and computer programmes is the ability to adapt to the personal characteristics and the specific needs of the studied target groups. As we mentioned above, the use of ICT-based interventions not only makes it possible to reach more people, but it also makes it possible to access them at any time throughout the intervention process. This allows us to adjust the requirements to the needs and demands of each individual, therefore facilitating the achievement of optimal results during the intervention. It also allows us to extend the follow-up period in a way that helps us maintain the success of achieving a healthy lifestyle during a larger period [27,28]. An increasing number of systematic reviews and metaanalysis on weight management e-health interventions are available [24,29,30]. However, most of them focus on mobile technologies alone [31—34] and do not provide a comprehensive picture of the research involving both Web 2.0 and mobile phone technologies for weight management in particular. In fact, although numerous wearable technologies directed at the control of physical activity and diet are available, it is yet unclear if these technologies are effective at improving weight loss. In that way, studies are needed in our environment to confirm the effectiveness and the feasibility of such interventions in overweight and obese patients, and to figure out if it is worthwhile to implement their application in the primary care system as a tool to address this health problem. Therefore, the main objective was a comparison between a standard behavioural weight loss intervention (standard intervention) and a technology-enhanced weight loss intervention (enhanced intervention) in order to confirm which one of them would result in greater weight loss, and assess if results (losing more than 5% of the initial weight) can be maintained after one year of follow-up.
Material and methods Study design and participants We performed a randomized, controlled, double-blind, parallel clinical trial with 2 arms and a 12-month follow-up. The trial was conducted from March 2015 to June 2016, with all overweight or obese men and women aged between 30 and 70 years. Subjects were confirmed to have no participations in diet reduction programmes within the last 12 months and they completed a personal health and medical history questionnaire, which served as a screening tool. Exclusion criteria were type 2 diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140—200 mg/dL [7.8—11.1 mmol/L] 2 hours after a 75 — g oral glucose load), hypertension (blood pressure > 140/90 mmHg or if the participant was taking antihypertensive medication), cardiovascular disease, psychiatric problems, history of alcohol abuse (intake of ≥ 500 g/wk in the last year), current smoking, and any medicine consumption. No patient was pregnant or became pregnant during the study. The study was approved by the institutional committee of ethical practice and all the study participants provided written informed consent. Participants were individually assigned to
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either the intervention or the control group by a computergenerated number. Neither nurses nor physicians who visited the participants had access to the randomization list.
Interventions Patients were randomized into two intervention groups: (G1) intervention in primary care with the support of a telematic platform and another group receiving guidelines to lose weight and follow-up in primary care centres (G2). The Medtep platform offered the participants in the intervention group (G1) access to the Mediterranean Diet Adherence Screener (MEDAS) and kept track of their adherence level. Adherence to the Mediterranean diet was assessed using the validated 14-point MEDAS [34], an adaptation of a previously validated 9-item index [35]. The MEDAS was developed within the PREDIMED study group [34,35]. The MEDAS can rapidly estimate Mediterranean diet adherence and it may be useful in the clinic. The 14-item screener includes 12 questions about food consumption frequency and two questions about food intake habits characteristic of the Spanish Mediterranean diet (Table 1). Participants knew their initial level of adherence prior to starting the intervention. After that, a health professional asked them to answer the test every day (self-monitoring food diary) and the platform showed the participant their adherence level weekly. In that way this tool was useful in evaluating the compliance with the Mediterranean diet, allowing personalized dietary advice provided automatically by the platform. At the same time, in cases of low compliance, the platform offered personalized advice and
Table 1 Test of adherence to the Mediterranean Diet in adultsa . Test d’adhésion au régime méditerranéen chez les adultesa . 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
Using olive oil as the principal source of fat for cooking ≥ 4 spoons (1 = 13.5 g) of olive oil/d (e.g. used in frying, salads, meals eaten away from home) 2 or more servings of vegetables/day 3 or more pieces of fruit/day 1 serving of red meat or sausages/day 1 serving of animal fat/day 1 cup (1 cup = 100 mL) of sugar-sweetened beverages/day ≥ 7 servings of red wine/week ≥ 3 servings of legumes/week ≥ 3 servings of fish/week < 2 commercial pastries/week ≥ 3 servings of nuts/week Preferring white meat or red meat? ≥ 2 servings/week of a dish with a traditional sauce of tomatoes, garlic, onion, or leeks sautéed in olive oil
a If the condition was not met, 0 points were recorded for the category and if the condition was met, 1 point was recorded for the category. Values are expressed as number.
suggestions (such as recipes, etc.) to the participant as a way to improve results. The protocol applied in G1 after the first visit was: visits scheduled at 15 days, one month, 3 months, 6 months and 12 months. At each visit, anthropometric data were collected, physical activity level was reviewed, adhesion to the Mediterranean diet using the data recorded by the patient in the Medtep platform was reviewed and the patient was encouraged to improve the adherence level to the Mediterranean diet. The G2 received guidelines and recommendations to lose weight. Participants in the G2 were given general oral and written information about healthy food choices based on the Mediterranean diet and exercises on the first visit and subsequent visits. Those recommendations included information on three different concepts offering the patient self-monitoring instruments. With the first concept (‘‘the weight monitoring can be helpful in terms of achieving the goal of weight loss’’), in order to achieve this objective, the patient was offered the opportunity to record his weight in primary care centres periodically with the same frequency as in the G1 group. The second concept was as follows: ‘‘following a Mediterranean dietary pattern promotes the acquisition and maintenance of a proper body weight’’. The third concept stated that ‘‘following a Mediterranean dietary pattern involves adherence to diet guidelines and maintaining an active lifestyle’’.
Variables and measurements Weight in kilograms (kg) wearing very light clothes was measured using a digital scale (range from 0.1 to 150 kg and precision of 0.1 kg), height in metres (m) with the subject barefoot using Harpenden Digital Stadiometer (range from 0.7 to 2.05 m and precision of 1 mm) and body mass index (BMI) was calculated (kg/m2 ). Waist circumference was measured in the horizontal plane midway between the lowest rib and the iliac crest. Analysis for serum total and high-density lipoprotein cholesterol, triglyceride, and glucose levels were performed in the chemistry laboratory.
Sample size To assess the statistical power of this study ‘‘a posteriori’’, it was assumed, with a confidence level of 95%, a proportion of 30% would reach the objective in the control group and 70% in the experimental group. The total number of participants was 116. The study power to detect a relative risk other than 1 was 99.69%.
Statistical analysis All calculations were performed using the SPSS v19.0 statistics programme. Quantitative variables are presented as mean and standard deviation (SD), qualitative ones as exact amount and percentage. To verify that randomization was successful among the two compared groups, Student’s ttest was used in the comparison of means for independent groups and the Chi2 test (Pearson or Fisher) in the qualitative variables. The comparison of means during the follow-up has been performed by analysing the variance of repeated
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Randomized (n=120)
G1
G2
(n=61)
(n=59)
Lost to follow-up
Lost to follow-up
(n=0)
(n=4)
Analysed
Analysed (intenon to treat) (n=55)
(n=61)
4 withdrew from study
Figure 1. Study flowchart. G1: intervention group (consultations in primary care and digital platform); G2: control group (follow the general advice established to lose weight in their primary care centres). Diagramme de l’étude. G1 : groupe d’intervention (consultations de soins primaires et sur la plate-forme numérique) ; G2 : groupe témoin (suivre les recommandations générales pour perdre du poids dans leurs centres de soins primaires).
measures. When the criteria of normality and specificity were not met, the non-parametric Friedman test was applied. A comparison between the groups after concluding the interventions was performed with indicators of clinical relevance, i.e. relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT). The results between both groups are presented by both intention-to-treat analysis and by biological efficacy analysis. Significant values were considered those whose comparisons have reached a value of P ≤ 0.05.
When assessing all participants (61 in G1 and 55 in G2) in both the initial and final examinations, a decrease in all parameters related to body weight can be observed on Fig. 3, being more intense in the G1 than in G2, except in the waist circumference (WC) per year in the G2 in which no significant changes were observed (P = 0.317). Fig. 4 shows that G1 reached the goal of reducing weight by more than 5% in 30 individuals (49.2%) versus 9 subjects (16.4%) in G2 (P < 0.001). Therefore, the G1 significantly reached the year with a greater number of individuals with weight losses equal to or greater than 5%.
Results
Analytical parameters
One hundred and twenty participants were randomly assigned to the intervention (n = 61) or control group (n = 59). Fig. 1 shows the number of participants and their evolution. During the follow-up, four individuals of the control group left the study for personal reasons, leaving at the end 55 people in this group. Because participants were screened for exclusion criteria, both groups were comparable. Table 2 shows this comparison, without observing significant differences between the considered variables, which supports a correct randomization. It can be seen globally and in both groups that, on average, the participants were obese and presented high values of total cholesterol (TC) and triglycerides (TG). Fig. 2 shows the evolution of BMI between these two groups. An analysis of the variance of repeated measures showed that both groups decreased in weight throughout the study, but more in G1, except in the last 6 months where it increased in both groups.
Reduction in lipid parameters was detected (Table 3). It is observed that total cholesterol was reduced in both groups. On the other hand, triglycerides were significantly reduced more in the study group, without achieving significant differences in the control group (P = 0.710). HDL cholesterol was increased in both groups. Table 4 shows the analysis of clinical relevance after the 12-month follow-up in patients who achieved the 5% weight reduction. This table also presents the biological efficacy analysis, i.e. those patients who followed the strict recommendations in each of their assigned group (61 in G1 and 47 in G2). If the results in this analysis follow the same direction as the intention-to-treat analysis, it implies a strength in the conclusions of the study. More than the double of the RR (4.62) can be observed in the biological efficacy analysis than in the intention-to-treat analysis (RR = 2.08). In both cases, the comparison between the experimental group and
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Table 2 Sample groups baseline data. Données de base pour les groupes échantillons. Baseline variables
Global(n = 116)
G1 (n = 61)
G2 (n = 55)
P
Men (n; %) Age (years) Baseline weight (kg) BMI (kg/m2 ) Waist circumference (cm) Total cholesterol (mg/dL) Triglycerides (mg/dL) HDL cholesterol (mg/dL)
48 49.8 86.4 30.8 86.4 246.0 165.1 46.9
26 49.7 88.2 30.8 85.2 242.1 172.3 48.1
22 49.8 84.4 30.7 87.7 250.3 157.2 45.7
0.775 0.925 0.150 0.841 0.131 0.170 0.263 0.224
(41.4) (6.4) (14.3) (3.5) (8.9) (32.8) (71.9) (10.7)
(42.6) (6.4) (14.5) (3.6) (9.6) (38.0) (73.0) (11.6)
(40.0) (6.6) (14.0) (3.4) (7.9) (25.3) (70.6) (9.5)
Data are reported as mean and (standard deviation) or number y (percentage). G1: doctor’s visit + telemedicine group; G2: group receiving weight loss guidelines only; Kg: kilograms; BMI: body mass index; Cm: centimetres; kg/m2 : kg divided by height in meters squared; Mg/dL: milligrams per decilitre. HDL: high-density lipoprotein. The comparison between means was performed with Student’s t-test for independent groups.
33
32
p<0.001 31
BMI (kg/m2)
31
p=0.001 30.5
p<0.001 30.4
30.8 30
p<0.001
30.1
30.2
p<0.001 30.4
30
30
p=0.087
29
p<0.001
G1 (n=61) 29.4
29.3
G2 (n=47)
29
p<0.001
p<0.001 28
p<0.001
27 Basal
15 days
30 days
three
6 months
1 year
Figure 2. Body mass index (BMI) evolution in the two groups. The comparison between the means (each level of each group with the previous one) has been made through the analysis of the variance of repeated measures. The overall comparison in each group with the Friedman test (P < 0.001). L’évolution de l’indice de masse corporelle dans les deux groupes.
the control group showed significant differences in all variables (RR, RRR, ARR and NNT), with a very low NNT, requiring only 4 patients to achieve weight loss maintenance of more than 5% during a year.
Discussion In this study, we tested the hypothesis that a technologyenhanced weight loss intervention aimed at reducing body weight by 5% or more was effective at 1 year. The physiological rationale underlying this hypothesis is that obesity is a difficult problem, such that at most, only 10% of
people going on a diet manage to keep the weight off in the long-term. In this study, the addition of telemedicine intervention was most effective in the 12-month weight loss plan. This was thought to be as a result of the technology being effective in changing diet or physical activity behaviours compared to what was achieved with standard intervention; however, the study found no significant differences in these concepts between standard intervention and technologyenhanced intervention groups. Thus, the reason for this difference in weight loss between the standard intervention and technology-enhanced intervention groups should draw our attention to further investigation in the future. The results obtained from our study show that the intervention
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p=0.317
p<0.001 88.2 83.9
84.4
87.7 87
85.2
82.6
81.7
80 70 60
Initial
50
Final (1 year)
40 30.8
30
30.7 30.1
29.3
Figure 3. Evolution of the anthropometric measurements at the beginning and at the end of the study. G1 (n = 61): doctor’s visit + telemedicine group; G2 (n = 55): group receiving weigh loss guidelines only; BMI: body mass index; WC: waist circumference. Significant differences were observed between the 2 groups at 12-month follow-up with Student’s t-test for paired groups (P < 0.001). L’évolution des mesures anthropométriques au début et à la fin de l’étude.
Table 3 Lipid parameters evolution for both groups and by group, both at baseline and at the year of follow-up. L’évolution des paramètres lipidiques pour les deux groupes et chaque groupe, au départ et après un an de suivi. Groups
Initial TC
Final TC
P
Initial TG
Final TG
P
Initial HDL-c
Final HDL-c
P
Global (n = 116) G1 (n = 61) G2 (n = 55)
246.0 (32.8) 242.1 (38.0) 250.3 (25.3)
240.5 (30.5) 237.4 (33.6) 244.0 (26.4)
< 0.001
165.1 (71.9) 172.3 (72.9) 157.2 (70.6)
154.3 (59.8) 153.0 (58.6) 155.8 (61.5)
0.005
46.9 (10.7) 48.1 (11.6) 45.7 (9.5)
47.8 (10.6) 48.7 (11.6) 46.9 (9.4)
< 0.001
0.027 0.007
0.003 0.710
0.017 < 0.001
Data are reported as mean and (standard deviation). TC: total cholesterol; TG: triglycerides; HDL-c: high-density lipoprotein cholesterol; G1: intervention group (consultation and use of the digital platform); G2: control group (habitual tips for losing weight in their primary care centres). The comparison of means was done with Student’s t-test for paired data.
with telemedicine support implemented in the study group (G1) got better results where almost 50% of patients achieved the goal of reducing 5% of their initial weight. The effect of intervention with telemedicine support with 49.2% success is higher than the usual care protocols
used in G2. In group G1, where monitoring is less intensive and results are better, monitoring the adherence level to the Mediterranean diet and physical activity (recorded by a pedometer) was carried out. The use of ICTs, such as the Internet, mobile devices, virtual reality, etc., has been
Table 4 Analysis of patients who could achieve the goal of 5% weight loss after a year of follow-up. Analyse des patients qui ont pu atteindre l’objectif d’une perte de poids de 5 % après un an de suivi. Comparison groups
RR (95% CI)
RRR (95% CI)
ARR (95% CI)
Consultation + TM/control (intention-to-treat analysis) Consultation + TM/control (biological efficacy analysis)
2.08 (1.21 to 3.57)
108.1 (21.3 to 256.8)
25.5 (8.7 to 42.4)
4 (3 to 12)
4.62 (1.94 to 11.0)
362.3 (94.3 to 1000.1)
38.5 (23.2 to 53.9)
3 (2 to 5)
NNT (95% CI)
RR: relative risk; CI: confidence interval; RRR: relative risk reduction; ARR: absolute risk reduction; NNT: number needed to treat; TM: telemedicine.
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60
50
49.2
40
G1
30
G2 20
16.4
10
0 objectives achieved at 12 months
Figure 4. Percentage of patients achieving at least a 5% weight loss in each of the intervention groups at 12 months follow-ups. G1: doctor’s visit + telemedicine group; G2: group receiving weigh loss guidelines only. Significant differences were observed between the 2 groups, at 12 months (Chi2 test: P < 0.001). Pourcentage des patients ayant atteint au moins une perte de poids de 5 % dans chaque groupe au suivi de 12 mois.
increasing significantly over recent years. ICTs can provide additional resources to traditional programmes and improve their quality, raising the effectiveness and the efficiency of interventions in chronic problems such as obesity [22—24]. In the control group G2, weight loss is less than in G1, being 19.1% at the 6-month follow-up and 10.6% at the 12-month follow-up, accompanied by a reduction of waist circumference of 0.21 cm at the 12-month follow-up. Comparing the two groups together, a significant difference (P < 0.0001) was observed. Data analysis shows that the NNT in the first group is 4, i.e. we should treat three patients to achieve effectiveness in at least one of them, while in the second group NNT is 7—9 patients. Patients in the G2 group after being diagnosed as overweight or obese were advised to lose weight. While this recommendation should be given to all patients suffering from excess weight [22,23], several studies have shown that this does not happen and in most of the cases, it only happens in 20%—36% [24—27] although, in the study of Phelan et al., a proportion of 75.5% was reached. This lack of systematic recommendations exists despite being widely proved that patients receiving these recommendations from their family doctors are twice as likely to achieve the abovementioned weight loss versus those who have not received it [25,26]. There is no clear consensus [27] on the barriers that explain this phenomenon, but perhaps the most reliable reasons are financial management, lack of motivation by the patient and lack of time and training of the health providers [26,27]. It is important to point out that the use of resources in this second intervention group was minimal given that the patient was only advised to lose weight, informing him that regular weight recording could be done in Primary Care Centres. They were also informed that the more they adhered to the Mediterranean diet the better optimal weight maintenance could be achieved, and that those with a lifestyle
that included keeping a good level of physical activity could achieve better weight maintenance. While the tendency in adult patients is to gradually regain the lost body weight, in the group G1, it was almost the contrary since 24% of patients stabilized their weight and 19% reduced their weight. Twenty-one percent of patients achieved a reduction of 5% or higher as an effectiveness objective. This study does not allow us to know the weight control factor (whether weight was recorded by health professionals or by digital tools). By analysing the study, it is clear that patients started from an adherence level of 8.3 at the beginning of the study and improved their adherence level over time in a way that they reached an adherence level at the end of the study of 9.9. On one hand, numerous studies have shown that simple weight monitoring can facilitate weight loss and/or maintenance after loss. On the other hand, it is known that better adherence to the Mediterranean diet is followed by weight optimization. In the SUN study on adherence to the Mediterranean diet and long-term weight changes, it was observed that the group with improved adherence to the Mediterranean diet showed a lower risk of weight regain. Thus, the results of this control group lead us to propose using new technologies to measure adherence to the Mediterranean diet and then use them to improve adherence levels. Further research will be needed to compare different programmes for this purpose, programmes that include different processes and smart monitoring that can adapt to the user profile and include gamification [31—38]. Strengths and limitations: the main strength of our study is that it is a clinical trial, with two randomized and homogeneous groups, thus minimizing systematic errors. Regarding the limitations, it is noteworthy that the four losses described corresponded to the same group, representing 6.8%, thus believing that it did not invalidate the results. The RR when comparing the two groups for biological efficacy was 4.6 in favour of G1. RR that fell to 2 when the comparison between the two groups was done by intentionto-treat, which demonstrates the strength of the association in favour of the group that used the telematic platform.
Conclusion The intervention with telemedicine support yields better results in terms of both weight reduction and its maintenance, the results of the two protocols have presented sufficient clinical impact and even more considering the limited resources they use. So we believe it is essential to further explore the role that new technologies can have in the treatment of overweight and obesity.
Disclosure of interest The authors declare that they have no competing interest.
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