Outcomes of comprehensive lifestyle modification in inpatient setting

Patient Education and Counseling 62 (2006) 95–103 www.elsevier.com/locate/pateducou

Outcomes of comprehensive lifestyle modification in inpatient setting Gunnar Kaati a,*, Lars-Olov Bygren b, Monica Vester b, AnnBrith Karlsson b, Michael Sjo¨stro¨m c b

a Department of Public Health and Clinical Medicine, University of Umea˚, S-90185 Umea˚, Sweden Department of Community Medicine and Rehabilitation, Social Medicine, University of Umea˚, Umea˚, Sweden c Department of Biosciences, Preventive Nutrition, Karolinska Institute, Stockholm, Sweden

Received 10 November 2004; received in revised form 20 June 2005; accepted 27 June 2005

Abstract Objective: To examine the effectiveness of a 4-week inpatient non-pharmacological risk factor modification programme for individuals with the metabolic syndrome. The aim of the program was to reduce patients’ over risks for stroke and myocardial infarction. Methods: A prospective clinical study including 2468 patients – 1096 men and 1372 women – with and average age of 50  10 years. The patients were referred to the programme from primary care units and hospitals where treatment options were exhausted. Results: All risk factor levels for stroke and myocardial infarction decreased. The reduction of weight among men was 4.7  2.6 kg and 3.8  1.8 kg among women from an initial weight of 96  17 kg and 85  16 kg, respectively. The patients systolic and diastolic blood pressure decreased by15/10 mm Hg for men and 14/9 mm Hg among women from initial average for the whole population of 148/90  19/ 11 mm Hg and 146/87  19/12 mm Hg, respectively. The greatest decrease in weight and blood pressure occurred in men and women with an initial body mass index of 30 and with a diastolic blood pressure of 90; in this group, the average reductions in weight were 5.8  2.4 kg for men and 4.4  1.7 kg for women; the reductions in systolisk/diastolisk blood pressure were 22/15  16/9 mm Hg ( p < 0.001) for both men and women. A reduction of medication (DDD) although not a goal was also achieved. Conclusion: The results prove the value of a comprehensive and highly structured inpatient approach to lifestyle modification. Practice implications: The results should give cause to trials with half-way strategies integrating features from the inpatient programme into the design of risk factor interventions. # 2005 Elsevier Ireland Ltd. All rights reserved. Keywords: Health education; Prevention; Obesity; Hypertension; Nutrition

1. Introduction Lifestyle risk reduction programmes have shown that atherosclerotic processes, with or without medical therapy, can be retarded, arrested, and even reversed [1–8]; this is also achieved in interventions that have not used lipidlowering drugs [9–14]. And several recent non-drug lifestyle interventions have successfully controlled blood pressure [15–20]. On the other hand, the effectiveness of community interventions has been questioned [21,22]. * Corresponding author. E-mail address: [email protected] (G. Kaati).

Although both pharmacological and non-pharmacological strategies appear to be effective, research suggest that patient compliance with these therapies (short and long term) is lacking [23]. Non-pharmacological interventions in residential settings aiming at coronary risk factor reduction are rare; among them are the Pritikin Longevity Centre programme [24], the McDougall Wellness Centre programme [25], and the Fo¨llinge programme [26]. Although all three have been successful in lowering coronary risk factor, the results achieved are difficult to interpret because of the varying nature of the programmes; each programme, for example, appealed to and attracted different types of individuals.

0738-3991/$ – see front matter # 2005 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2005.06.012

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The results of a unique non-pharmacological inpatient programme will be presented here. It owed its uniqueness primarily to the facts that it was established as an integral component in the public medical care system, and designed to be a complimentary treatment modality for patients suffering from what is today designated as the metabolic syndrome [27]. The patients were admitted to the programme only be referral from primary care and hospitals where the treatment of these patients had not particularly successful; the programme was seen as the last remaining major treatment options available for these patients. The programme was launched in the County of Va¨sterbotten in Sweden in mid-1980s. The main question posed in this study is whether this alternative treatment modality could significantly improve the health status of individuals burdened by a broad array of risk factors for cardiovascular disease.

specific goal of caring for this special group of individuals. Each month a new cohort of 30 individuals was admitted— eight to nine groups per year. They all arrived at the same time (Monday, first week) to the Centre and stayed for nearly 4 weeks (Thursday–Friday, fourth week). The drop out rate from the programme was practically non-existent. The Health Centre was purpose built for its mission with a broad range of facilities: gymnasium, bath, kitchens, group rooms, lecture-hall, outdoor equipment, and trails. The staff consisted of 17 people: a physician, an administrator, a nurse, a dietician, two physiotherapists, a physical fitness therapist, a psychologist, kitchen staff, and administrative and technical staff. The budget was about SEK 5 million per year (E = 9.15 SEK), which is about SEK 20,000 per patient. The treatment was free for all participants (except a small patient fee that applied to all medical care); those in employment were sick-listed for rehabilitation, and received normal sickness benefits.

2. Methods

2.3. The intervention

2.1. Design

The main components of programme are shown in Fig. 1. The design of the programme was derived from a broad eclectic theoretical foundation [28]. In this framework, the development of a capable and safe environment within which the patients could tackle their health problems was considered to be especially important; an environment enabling the patients to develop a deeper sense of connection and community, a safe place to let go of their emotional defences, freeing them from the constraints and pressures of their home environments. The staff was trained to develop a secure and positive atmosphere. This setting, in turn, provided the backbone for the development of a comprehensive, highly structured, and intensive treatment system consisting of a broad array of subprogrammes. To counteract the traditionally passive role of patients in medical care, a problem-based learning perspective was established as the main vehicle in all problem-solving; the responsibility of planning and execution of the programme activities was thus

A prospective clinical study encompassing 2468 patients admitted to the Vindeln Health Centre between 1984 and 1996. Clinical trials were not implemented owing chiefly to practical reasons. The patients admitted were referred from primary care centre and hospitals in the county; the referral criteria required patients to manifest one or more risk factors, such as hypertension or diabetes, for cardiovascular disease. The patients were primarily individuals the referring physicians had not been able to cope successfully with. The patients were actively motivated to be referred to the Centre by their physicians, and by the families. 2.2. The Centre The Health Centre was established as an integrated component in the county’s medical care system with the

Fig. 1. The main component of the program.

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shared between patients and staff. Theory and evidencebased principles of learning and behavioural or lifestyle change as synthesised and reflected in the Precede–Proceed Model of health promotion planning was applied [29,30]. The goal was to empower the patients to define their problems, and think about strategies to master the risk factors associated with the diseases. Much attention was also devoted to the development of functioning groups. It was both an objective in itself and a means through which changes could be achieved. Thus, the group played several roles: (1) as a resource, in that success would require group ownership and authentic participation; (2) as an agent, in that the group reinforced the adaptive, supportive, and developmental capacities of the group to achieve changes; (3) as a setting for individual interventions. A consistent daily feedback system was an integral feature in the programme. The daily schedule run from 7:00 h to 19:00 h, most of the time patients worked in small groups of 5–10 individuals addressing ‘‘health’’ problems with the goal of establishing ‘‘good’’ health habits. Active participation in all activities was obligatory. The diet was a diabetes diet that included salt restrictions and moderate calorie restrictions. In accordance with Nordic nutrition recommendations [31], breakfast provided 25% of a person’s daily energy intake, 30% at lunch and dinner, and 15% between meals. The recommended portion sizes amounted to 1800 kcal/day for overweight individuals. Use of alcohol was not permitted and smokers were strongly encouraged to quit smoking. Physical activities of moderate intensity were scheduled for 2 h/day. Half an hour a day was devoted to autogenous relaxation. Towards the end of the residential period, patients prepared (with the support of the staff) a plan or contract for further improvement after they return home. At some weekends, the patients’ families were invited to the Centre. 2.4. Measurements Blood pressure, arterial pulse, and body weight, blood and urine tests were recorded on the second day after arriving and each consecutive week using a standardised routine. Average time between first and last measurements was 23 days. Blood pressure was determined using the same semi-automatic machine, which was operated by a trained nurse, for every patient. The same scale was used throughout the study. Blood pressure and resting pulse were measured with the patient in a supine position and after five minutes of rest. Patients were tested using a cycle ergometer test the day they arrived and during the last residential week. Oxygen uptake was estimated using the linear relationship between heart rate, workload, and oxygen uptake and by using ageadjusted gender-specific tables [32]. The test-cycle was made by Monark. Heart rate was measured using a Cardiomix Cardiometer 275.

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Cholesterol and triglycerides were measured using commercial kits and using an enzymatic method, Boehringer Mannheim GmbH, Germany, or Vitros, USA. 2.5. Data analysis The data analysis for this paper was generated using SAS Software. The main procedures used were proc reg, proc means, proc ttest (mainly two paired t-test), and proc gplot procedures [33].

3. Results 3.1. Baseline measurements Of the 2468 patients admitted between 1984 and 1996 the majority were women. The educational level of the patient population was lower than the average for the country. The patients suffered from multiple health problems. Nearly half of the patients had two diagnoses at admission, 11% had three or more diagnoses; 64% were diagnosed as hypertensive, 19% as diabetics, and hyperlipidemia or ischemic heart disease (IHD) were diagnosed in 12%. Three quarters of the patients had a diastolic blood pressure of 90 or were using anti-hypertensive medication; of these patients more than 40% had a diastolic blood pressure (DBP) of 100 mm Hg or higher. Obesity was common (although not one of the admission criteria); at admission, 77% had a body mass index (BMI) over 27 kg/m, 55% had a BMI over 30 kg/ m2 (Table 1). In summary, the majority of the patients exhibited what is now defined as the metabolic syndrome [27]. 3.2. The outcomes Considerable reductions in blood pressure, weight, and blood lipids were achieved during the residential weeks for both men and women. Positive changes, for example, occurred as oxygen uptake increased and heart rate decreased (Table 2). In general, participants who exhibited the highest levels of the risk factors achieved the greatest improvements. 3.2.1. Blood pressure The DBP decreased from the average baseline level of 88.4 mm Hg to 79.0 mm Hg, or by 10% ( p < 0.001), and the systolic blood pressure (SBP) decreased from 146.8 mm Hg to 132.4 mm Hg, or by 9% ( p < 0.001) (Table 2). The reductions were greatest the first week but continued steadily throughout the whole period. The achieved reductions were more pronounced in hypertensive patients whose blood pressure was not controlled (DBP  90 and SDP  140), namely 15 mm Hg DBP and 22 mm Hg SBP in both men and women ( p < 0.001) (Table 3).

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Table 1 Physical and social characteristicsa

Table 2 Values at baseline and changes at 3 weeks by gender

Male (n = 1096)

Female (n = 1372)

Total (n = 2468)a

Age (years) Weight (kg)

50.3  9.4 95.7  17

49.7  10.6 84.5  16

50.0  10.1b 89.5  18b

BMI (kg/m2) <25 kg/m2 25–30 kg/m2 30 kg/m2

30.7  4.9 96 (9%) 431 (39%) 569 (52%)

31.5  5.6 170 (12%) 399 (29%) 803 (59%)

31.1  5.3b 66 (11%) 830 (33%) 1372 (56%)

DBP (mm Hg) <90 >90 or medication

89.7  11 233 (22%) 810 (78%)

87.5  12 363 (27%) 961 (73%)

88.5  12 596 (25%) 1771 (75%)

SBP (mm Hg) Smokers Non-smokers

148.2  19 241 (22%) 847 (78%)

145.7  19 271 (20%) 1096 (80%)

Family Single Cohabiting With children

193 (22%) 681 (78%) 706 (82%)

225 (20%) 882 (80%) 955 (87%)

84.5  16 3.8 4

89.5  18 4.2 5

BMI (kg/m2) Baseline 30.7  5 Change 1.5 Change (%) 5

31.5  6 1.4 4

31.1  5 1.5 5

146.8  19 512 (21%) 1943 (79%)

DBP (mm Hg) Baseline 89.7  11 Change 10.0 Change (%) 10

87.4  12 8.9 9

88.4  12 9.4 10

418 (21%) 1563 (79%) 1661 (84%)

SBP (mm Hg)a Baseline 148.2  19 Change 15.0 Change (%) 9

145.7  19 13.9 9

146.8  19 14.4 9

S-Chol (mmol/L)a Baseline 6.7  1 Change 1.4 Change (%) 19

6.6  1 1.1 16

6.7  1 1.2 18

STG (mmol/L)a Baseline 2.8  2 Change 1.0 Change (%) 36

2.2  2 0.4 18

2.5  2 0.7 28

Pulse (HR/min)a Baseline 72.0  13 Change 6.6 Change (%) 9

73.8  12 4.8 7

730  12 5.6 8

Physical Fitness (mL/(kg min))b Baseline 27.4  7 Change +5.6 Change (%) 20

25.9  +5.0 19

26.5  7 +5.2 20

531 (66%)

703 (69 %)

1234 (67 %)

338 (42%) 193 (24%)

460 (45%) 243 (24%)

798 (44%) 436 (23%)

Secondary school College/university

165 (21%) 102 (13%)

204 (20%) 123 (12%)

369 (21%) 245 (12%)

a

Males (n = 1096) Females (n = 1372) Total (n = 2468) Weight (kg) Baseline 95.7  17 Change 4.7 Change (%) 5

Education Primary school 9 years of which 7 years 9 years

b

Mean S.D.

The total and the partitions do not always match owing to missing data. S.D.

More than three out of four of the patients having hypertension left the programme with DBP 90 mm Hg or less. Anti-hypertensive medication was common; 57% of the patients were on anti-hypertensive medication; slightly more than half of these patients had, in spite of medication, an elevated blood pressure (DBP  90 mm Hg) at admission. At discharge, 4% of non-medicated and 14% of medicated participants still suffered from elevated DBP  90 mm Hg. The non-medicated patients reduced their systolic and diastolic blood pressure 2–4 mm Hg more than medicated patients did. No systematic attempt was made to reduce the anti-hypertensive medication during their stay. The reduction in defined daily doses (DDD) was 0.33 (29%) for 1412 individuals on anti-hypertensive medication (19 patients increased their DDD). 3.2.2. Weight Weight reduction was not a primary goal in treatment but seen as a means to achieve blood pressure reduction, the target for weight reduction was 0.5 kg per week. The reductions achieved were above the target: from 96 kg to 91 kg in men and from 85 kg to 81 kg in women, or 5% ( p < 0.001). At arrival, 91% of the men and 88% of the women were overweight (BMI  25 kg/m2), and 56% of the participants were obese (BMI  30 kg/m2) (Table 1). Men

a

Missing values SBP 2, S-chol 209, STG 235, Pu 317. n = 1181. Patients medicated with betablockers or missing medicine value are excluded. b

and women with BMI 25–29 kg/m2 reduced their weight by 4.0 kg from 86 kg and by 3.2 kg from 75 kg among men and women, respectively ( p < 0.001). Obese men and women reduced their weight with 5.8 kg and 4.4 kg, respectively (Table 3). Their BMI declined 1.9 kg/m2 and 1.7 kg/m2, respectively, against 0.6 kg/m2 for men and 0.4 kg/m2 for women with moderate overweight. Practically, all of the moderate overweight or obese participants reduced their weight, and 95% of obese men and women reduced their weight by 2 kg or more. The mean weight reduction for the first week was 2.7 kg for men and 2.0 kg for women; for the second week, weight loss was 1.5 kg for men and 1.2 kg for women; for the third week, weight loss was 1.4 kg for men and 1.2 kg for women. Weight reduction was correlated with positive changes in blood lipids, serum cholesterol, triglycerids, and high density lipoprotein. In men, weight loss was associated with lower blood pressure and improved physical fitness; in women, the positive changes were

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Table 3 Body mass index (BMI), diastolic and systolic blood pressure (DBP and SBP) and anti-hypertensive medication (mean  S.D.) at arrival and changes during the residential period among obese patients, with BMI > 30, or patients with arterial hypertension, i.e., with DBP  90, with or without anti-hypertensive medication or patients with anti-hyperintensive medication 2

BMI at arrival (kg/m ) S.D. (n) Changes in BMI after 1 week 2 weeks 3 weeks

Males

Females

Total

34.2  3.9 (569)

35.1  4.2 (803)

34.7  4.1 (1372)

0.9 1.3 1.9

Weight at arrival (kg) (n)

106.9  15 (569)

Changes in Weight after 1 week 2 weeks 3 weeks

2.7 4.2 5.8

DBP at arrival (mm Hg) (n)

98.3  7 (581)

Changes in DBP after 1 week 2 weeks 3 weeks SBP at arrival (mm Hg) (n) Changes in SDP after 1 week 2 weeks 3 weeks Medication at arrival (DDD) Changes after 3 weeks a b

10 14 15 160.4  14 (581) 15 20 22 1.2  0.8 (631) 0.4

0.8 1.2 1.7 94.0  13 (803) 2.0 3.2 4.4 97.8  7(631) 11 13 15 160.4  13 (631) 15 20 22 1.2  0.8 (781) 0.3

0.8 1.3 1.7 99.3  15 (1372) 2.3 3.6 5.1 98.0  7 (1212)a 10 13 15 160.4  14 (1212)a 15 20 22 1.2  0.8 (1412)b 0.3

Six hundred and sixty nine of these used anti-hypertensive medication. Every anti-hypertensive medicated patients. One hundred and seventy-one missing values are excluded.

associated with serum cholesterol, high density lipoprotein ( p =0.01), triglycerides, lower blood pressure, and improved physical fitness ( p = 0.05). 3.2.3. Blood lipids Total serum cholesterol decreased by 1.4 mmol/L from 6.7 mmol/L in men, and 1.1 mmol/L from 6.6 mmol/L in women. Serum triglycerides (STG) decreased with 1.0 mmol/L from 2.8 mmol/L in men, and 0.4 mmol/L from 2.2 mmol/L in women ( p < 0.001). High density lipoprotein increased by 4.0% units from 17.9% of serum cholesterol in men and by 2.5% units from 22.3% in women. 3.2.4. Physical fitness The target in relation to physical fitness was set as 10% improvement: 1353 of the participants that were not medicated with beta-blockers improved by 20%, or 6 mL/ (kg min) from 27 mL/(kg min) for men, and 5 mL/(kg min) from 26 mL/(kg min) for women ( p < 0.001). Resting heart rate decreased in the same group by 9 beats/min from 76 for men and 6 beats/min from 77 for women ( p < 0.001). 3.3. Regression towards the mean Could the effects in the programme be due to a regression towards the mean? It is obvious that patients with highly

elevated risk levels had a greater potential to achieve improvements than those with moderately elevated risk levels. Some of these patients had this elevated risk only by coincidence; conversely, some patients with the lowest level of risk had this low risk only by chance. A regression towards the mean among the latter may indicate the magnitude of the regression towards the mean [22]. It was calculated that this could be at most 5%, which corresponds to 0.4 mm Hg DBP on average, leaving 3.9 mm Hg as real change (Fig. 2). An analysis of the extent of convergence of ‘‘extreme’’ percentiles to the average in relation to other outcome variables (i.e., weight and serum cholesterol) shows no such convergence. Therefore, regression towards the mean was probably extremely small or non-existent.

4. Discussion and conclusions The inpatient programme presented here, although undoubtedly an effective systemic component in treatment of individuals with the metabolic syndrome the programme was closed down after 10 years. In retrospect, however, the programme has to be judged as an imaginative health policy innovation. In the decision processes leading to the closure of the programme, it was evident that knowledge played a

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Fig. 2. Diastolic blood pressure development during intervention. Mean values mm Hg at baseline and after 1–3 weeks (N = 2468). (&) Those 10% of the patients with a DBP > 104 mm Hg (90–99 percentile); (~) those 10% of the patients with a DBP between 87 mm Hg and 90 mm Hg (45–55 percentile); (^) those 10% of the patients with a DBP < 74 mm Hg (1–9 percentile).

minor role, highlighting the obscure role of knowledge in medical care policy processes [34]. 4.1. Discussion A striking result was that normal level blood pressure was achieved both among males and females although at admission only 25% the participants had a diastolic blood pressure less than 90 mm Hg; at discharge, almost 90% had achieved this level. Almost 60% of those admitted to the programme were individuals who were resistant to any of the traditional therapeutic efforts. Of the medicated participants, almost 60% had an elevated blood pressure level at the time of admission. This may be a result of the widespread poor adherence to drug treatment as shown by Ren et al. [35] and Gryfe and Gryfe [36] and/or because hypertension in these patients was difficult to control. Practically, every one of the overweight or obese participants reduced their weight. The real reduction of body fat was probably even more pronounced because some of the fat tissue was probably replaced by muscle tissue; the measurements of O2 L/(kg min) support this proposition. In addition, the patients improved their body shape image. The weight decreases were correlated to most of the other risk factor changes. This finding strengthens the proposition that weight reduction is a strategic factor in risk factor modifications. A large number of controlled trials have also reported that weight loss is followed by reductions by blood pressure or the need for medication in hypertensive patients [37]. The improvements in total serum cholesterol, serum triglycerides, and high density lipoprotein levels were significant. The target for improvements in relation to physical fitness was set rather low (10% improvement) but the results exceeded the target. Considerable improvements were also achieved in regard to serum levels of calcium, albumin, urat, gammag, lutamyltransferas, alaninminotransferas (ALAT), asparatatominotransferas (ASAT), serum urate, serum glucosoe, and serum phosphate (data not shown).

The residential programmes have also been rather successful. The Pritikin and the McDougall programmes, both basically commercial weight loss programmes, succeeded in lowering serum cholesterol levels and other risk factors. In the Pritikin programme, dramatic improvements in BP, oxidative stress, NO availability, and the metabolic profile were obtained after 3 weeks of treatment [38]. The programme was also very effective in controlling non-insulin-dependent diabetes mellitus and reducing risk factors associated with macrovascular complications [39]. The McDougall program achieved moderate reduction of blood pressure and weight loss [25]. The Fo¨llinge programme, on the other hand, was a 4week residential programme followed by a maintenance programme, targeting individuals with coronary artery disease, such as acute myocardial infarction, coronary bypass surgery, and percutaneous coronary angioplasty (AMI, CABG, and PTCA). Several risk indicators were significantly improved in 292 consecutive patients, 51  6 years old patients, 79 of them males. BMI was reduced from 27 kg/m2 to 26 kg/m2 and S-Chol from 6.4 kg/m2 to 5.4 mmol/L. Exercise capacity increased from 153 W to 173 W ( p < 001) [26]. Although all three programmes are residential they differ considerably in other ways. The term ‘‘residential’’ in connection with these programmes is a vague description of their real structures, especially when compared with the term ‘‘inpatient’’ as the designation of the structure of the Vindeln programme. Furthermore, the programmes both appealed to and attracted different types of individuals. These programmes are thus really neither comparable with each other nor with the Vindeln programme. Hence, comparisons between these programmes and between residential and inpatient programmes is fraught with problems. The DASH studies [15–18] provide, however, some indications about the effectiveness of community based interventions. The Dietary Approaches to Stop Hypertension (The DASH) reinvigorated enthusiasm among proponents of non-drug lifestyle modification interventions in community settings by showing that a substantial reduction of the blood pressure was obtained in this 11week diet intervention that focused on a diet rich in fruit, vegetables, and low-fat diary products and with reduced saturated and total fat. In participants with an average blood pressure of 160/80–95 mm Hg, this diet lowered systolic blood pressure by 5.5 mm Hg and diastolic blood pressure by 3.0 mm Hg more than participants on the control diet; the lowering began within 2 weeks and was maintained for the remaining 6 weeks of the study [15]. In the DASH sodium study, in which a DASH diet was combined with sodium restrictions, the blood pressure was reduced by 7.1 mm Hg in participants without hypertension, and 11.5 mm Hg in participants with hypertension [16]. The Diet Exercise and Weight Loss Intervention Trial (DEW-IT) – a low-calorie version of the DASH diet – in combination with weight loss among overweight hypertensive individuals who had been

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treated with drugs reduction, resulted in net reductions in SBP and DBP of 9.5 mm Hg and 5.3 mm Hg, respectively [17]. In the PREMIER Clinical Trial, which lasted 6 months, the DASH approach was combined with efforts to lose weight, reduce sodium, increase physical activity, and limit alcohol intake. This was somewhat more effective in reducing systolic blood pressure than DASH although the differences were only 0.6 mm Hg [18]. Of interest in this context are also the studies conducted by Ornish et al. [9–13] because they contain features that were integral in the Vindeln programme. Ornish was interested whether ambulatory patients could be motivated to make and sustain comprehensive lifestyle changes, and, if so, whether the progression of coronary arteriosclerosis could be stopped or reversed without using lipid-lowering drugs. Patients in the experimental group were prescribed an intensive lifestyle programme including a 10% fat vegetarian diet, moderate aerobic exercise, stress management training, smoking cessation, and group psychosocial support. They were also encouraged to avoid simple sugars and to consume complex carbohydrates and whole foods. The majority of the experimental group participants (20 out of 28) were able to make and maintain an intensive lifestyle changes for 4 years; the adherence to all aspects of the programme was good after 5 years. The patient lost 10.9 kg at 1 year (baseline mean weight 91.4 kg) and sustained weight loss of 5.8 kg at 5 years. The control group had increased weight by 1.4 kg after 5 years. Blood pressures were slightly lowered, but SBP and DBP were low already when the baseline data were collected. There were more than twice as many cardiac events in the control group. The importance of the study was the demonstration that coronary artery lumen widened. The varieties of intervention reviewed above have varying strengths and weaknesses. To discuss problems in the design of residential/inpatient/outpatient interventions requires, first of all, that the logical premises of the ‘‘classical’’ scientific laboratory’’ are unfolded. The resulting model provides then the standard against which the intervention can be judged. The design of control in this model is based on the postulate that the ‘‘dependent’’ variable(s) is a function of a set of variables which can be carefully controlled; these ‘‘independent’’ variables account for all changes in the dependent variable, except for random fluctuations. The system is designed to keep out of investigation all nuisance variables that would cloud the issue; the environment of the ‘‘laboratory’’ is assumed to be a sufficiently closed system, that is, the only important variables are the ones that are being observed by the scientist. It is only in a such closed environment that the scientist can begin to vary the variables under his control and ‘‘test’’ whether the ‘‘experimental’’ variables are changing in a way that his hypothesis indicate they should [40]. Especially, two questions are pertinent in this context: (1) What produces the effects? and (2) How durable are the

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changes? More factors are obviously ‘‘controlled’’ in an inpatient intervention than in an outpatient intervention, although not all ‘‘important’’ factors are controlled. It is also very difficult to specify which component(s) will be/are/ were effective. The second question reminds of the findings of the Hawthorne studies. Roethlisberger and Dickson [41] found that paying attention to workers raised their levels of productivity and motivation notwithstanding whether the change was improvement or deterioration. Only to be observed or be in spotlight induced positive changes in the behaviour of individuals. This mechanism, thoroughly established, probably explain many of the observed changes in interventions. Hence, the task ahead is to ascertain longterm effects and impacts. But how can the factors that will influence and impact on the persons when they return (in this case) to their families, workplaces, local communities, and other social systems be controlled? It was realized very early that an ‘‘optimal treatment system’’ should include, or at least be involved, in these systems. But such ‘‘comprehensive’’ approach was not feasible. The highly structured treatment system in which the patient had lived for some weeks was thus replaced by the ‘‘old’’ risk generating systems. Although the families (and employers) were positive to the ‘‘new’’ lifestyle it is unlikely that they endured in their support in the absence of structural support. The general problem of compliance has to be considered in this perspective. The analyzes of the durability of the achieved changes are not completed, but it is shown in a study of a subsample of 100 consecutive patients in the programme that the reductions in weight and blood pressure were pronounced also after 1 year. After 5 years, the total mean weight with initial BMI  30/m2 was still 5 kg lower and diastolic and systolic BP among those with hypertension was 15 mm Hg and 20 mm Hg lower, respectively, than before the programme [42]. Ultimately, this intervention must be judged in terms of improvements to the health of the patients, the durability of the obtained improvements, and the comparative effectiveness of the intervention. The ultimate measure of success would be a reduction in death rates. An analysis of the longterm effects along these lines is in progress. 4.2. Conclusions The changes achieved covered a broad spectrum of variables. The achievements were probably related to the programme’s basic principles of design which, among other things, contributed to high levels of compliance which in turn presumably was a prerequisite for changes, especially long-term changes. The evidence of the durability of the changes is still weak, a problem afflicting all interventions studies. The knowledge about comparative effectiveness of pharmacological versus non-pharmacological as well as inpatient versus outpatient interventions is also lacking.

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4.3. Practice implications For most physicians, helping patients modifying their high-risk behaviours is frustrating; they do not believe that they can do it nor do they believe that their patients can do it [43]. Many physicians, in addition, do not believe in the efficacy of lifestyle changes as means to reduce LDC levels [44]. Obviously lifestyle changes to reduce risk factors and premature death would be better than drugs if they could accomplish the same goals as drugs [45]. The results achieved in the Vindeln programme show that inpatient lifestyle modification programmes are more successful than outpatient programmes especially when controlling for patient characteristics. However, such inpatient programmes are presumably not conceivable policy alternatives in today’s health policy environments [34]. Interest should by paid to ‘‘half-way’’ strategies incorporating features from inpatient programmes into the design of risk factor interventions as exemplified by the intervention carried out by Sartorio et al. [46].

[11]

[12]

[13]

[14]

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