- Email: [email protected]
Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups
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Contents lists available at ScienceDirect
Primary Care Diabetes journal homepage: http://www.elsevier.com/locate/pcd
Original research
Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups Sarah M. Brokaw, Diane Arave, Derek N. Emerson, Marcene K. Butcher, Steven D. Helgerson, Todd S. Harwell ∗ , the Montana Cardiovascular Disease and Diabetes Prevention Workgroup1 Montana Department of Public Health and Human Services, Helena, MT, United States
a r t i c l e
i n f o
a b s t r a c t
Article history:
Objective: The purpose of this study was to assess if group size is associated with weight loss
Received 29 July 2013
outcomes among participants in an adapted diabetes prevention program.
Received in revised form
Methods: Adults at high-risk (N = 841) for CVD and diabetes were enrolled in the lifestyle
14 February 2014
intervention in 2011. Multiple logistic regression analyses were used to identify if group size
Accepted 16 February 2014
(smaller group < 16 participants; larger group ≥16 participants) was independently associ-
Available online xxx
ated with weight loss outcomes among participants.
Keywords:
the larger groups were significantly more likely to have a higher baseline body mass index,
Type 2 diabetes mellitus
to attend fewer intervention sessions, and less likely to self-monitor their fat intake for
Results: In the bivariate analyses, participants in the smaller groups compared to those in
Diabetes prevention
≥14 weeks, and to have lost less weight during the core intervention (5.1 kg [SD 4.7] versus
Group size
5.8 kg [4.5]). However, analysis adjusting for age, sex, baseline BMI, achievement of the phys-
Intervention studies
ical activity goal, number of weeks self-monitoring fat intake, and group size, found only
Cardiovascular disease related risk
two factors to be independently associated with achievement of the 7% weight loss goal:
factors
frequency of self-monitoring of fat intake and achievement of the physical activity goal.
Montana
Conclusions: Our findings indicate that intensive lifestyle intervention goals can be achieved
Pre-diabetes
as effectively with large or small groups.
Weight loss
1.
© 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
Introduction
The prevalence of type 2 diabetes continues to increase in the US, and it is estimated that one in three individuals
born in 2000 will develop type 2 diabetes in their lifetime [1]. The Finnish Diabetes Prevention Study (DPS) and the National Institutes of Health Diabetes Prevention Programs (DPP) both demonstrated that the incidence of type 2 diabetes mellitus among adults at high-risk for diabetes can be
∗ Corresponding author at: Montana Department of Public Health and Human Services, Cogswell Building, C-314, P.O. Box 202951, Helena, MT 59620-2951, United States. Tel.: +1 406 444 1437; fax: +1 406 444 7465. E-mail address: [email protected] (T.S. Harwell). 1 Members of the Montana Cardiovascular Disease and Diabetes Prevention Workgroup are identified in Appendix.
http://dx.doi.org/10.1016/j.pcd.2014.02.002 1751-9918/© 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: S.M. Brokaw, et al., Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.02.002
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significantly reduced through an intensive lifestyle intervention [2,3]. The lifestyle interventions in both the DPS and the DPP studies were delivered one-on-one to participants [2,3]. Since the publication of these landmark studies, a number of translation studies have shown that it is feasible to deliver the lifestyle intervention in a group setting and achieve similar weight loss outcomes [4–13]. Delivering the DPP lifestyle intervention in a group setting has a number of potential benefits including increasing the number of persons that can participate and enhancing the cost effectiveness of the intervention. Additionally, one of the key skills that participants are taught in the DPP curriculum is problem solving. Using a group setting to deliver the DPP can potentially enhance the learning process of individual participants through shared learning, feedback, and support from their peers. However, optimal group size to deliver the DPP or other weight loss related lifestyle interventions has not been documented nor has whether or not group size affects participant achievement of the targeted weight loss goals. In 2008, the Montana Department of Public Health and Human Services (DPHHS) implemented an adapted groupbased cardiovascular disease (CVD) and diabetes prevention program, resulting in similar weight loss outcomes as those in the NIH DPP [5,6]. This report uses the experience of 841 participants in 2011 to assess if group size was associated with weight loss outcomes for these participants.
2.3.
Data collection
Height, weight, blood pressure, fasting blood glucose and lipid values were collected at enrolment, at completion of the core (four months), and after core (10 months). Participants were weighed at each session and submitted weekly selfmonitoring booklets. Participants attended the same group throughout the study. Participants were assigned daily fat and calorie intake goals based on their baseline weight. Participants were offered a minimum of twice-weekly supervised physical activity opportunities. Following DPP guidelines, participants began self-monitoring daily fat gram intake starting after session two, physical activity after session five and calories, if necessary, after session seven [14]. Participants submitted completed weekly self-monitoring booklets beginning at session three to be reviewed by the lifestyle coaches. Weekly dietary self-monitoring and weight data were recorded for each participant. Self-reported fat gram and calorie intake were reported as a daily average, and physical activity minutes as a weekly total. The lifestyle coaches measured participant weight at each session. The goals for this lifestyle intervention are the same as the original DPP [14]. These goals include: (1) daily selfmonitoring of fat intake and reduction in fat intake, (2) achieving ≥150 min weekly of moderately vigorous physical activity, and (3) achieving weight loss of ≥7% of participant’s baseline weight by completion of the core sessions.
2.
Methods
2.4.
2.1.
Intervention sites and intervention design
Participant data for 2011 were analyzed using SPSS version 15.0 (Chicago, IL). Participants were categorized into two group sizes (<16 vs. ≥16 participants) based on the number of participants that attended each of the weekly core sessions. The median group size was 16 (range 8–38), and the quartiles were ≤11, 12–15, 16–19, and ≥20. Participants weekly selfmonitoring of fat intake was categorized into three groups: 0–6 weeks, 7–13 weeks, and ≥14 weeks. Participants mean weekly physical activity minutes over the 16 sessions were categorized into three groups: met the physical activity goal, did not meet the physical activity goal, and unknown. The proportion of participants enrolled in the core intervention that met the 7% weight goal was calculated. The proportion of participants who achieved ≥5% weight loss was also calculated, because previous studies suggest that this level of weight loss is associated with significant health-related outcomes. Independent t-tests and Chi-square tests were used to compare the baseline characteristics, session attendance, weekly self-monitoring of fat intake, achievement of the physical activity goal, and weight loss among participants in the smaller (<16) versus larger group (≥16). Intention-to-treat analyses were performed using the last observed weight of participants enrolled in the program to calculate weight loss measures, achievement of the 7% weight loss goal, and the ≥5% weight loss outcome. Multiple logistic regression analyses were used to indentify variables independently associated with participant achievement of the 7% weight loss goal and the ≥5% weight loss outcome. Adjusted odds ratios and 95% confidence intervals were calculated.
A description of this intervention has been published previously [5,6]. Briefly, the Montana DPHHS began implementing an adapted DPP in a group setting in 2008 and currently supports fifteen health care facilities to implement this intervention. These facilities included ten diabetes self-management education (DSME) programs, two DSME programs in collaboration with their local YMCA, one cardiac rehabilitation program, one rural health clinic, and one local health department. Sites used trained health professionals as lifestyle coaches to provide the 16 core sessions followed by six monthly after-core sessions. These sessions were based on the original DPP curriculum (intervention length of 10 months) [14].
2.2.
Participant eligibility criteria
Overweight (BMI ≥ 25.0 kg/m2 ) adults with medical clearance from their referring physician and one or more of the following CVD and diabetes risk factors were eligible: a previous diagnosis of pre-diabetes, impaired glucose tolerance or impaired fasting glucose, hemoglobin A1C between 5.7% and 6.4%, high blood pressure (≥130/85 mmHg or treatment), dyslipidemia (triglycerides > 150 mg/dl, LDL-cholesterol > 130 mg/dl or treatment, or HDL-cholesterol < 40 mg/dl men and <50 mg/dl women), a history of gestational diabetes (GDM), or had given birth to a baby weighing >9 pounds.
Data analysis
Please cite this article in press as: S.M. Brokaw, et al., Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.02.002
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Table 1 – Characteristics, physical activity levels, and self-monitoring of fat intake among participants in the Montana Cardiovascular Disease and Diabetes Prevention Program, by group size, 2011. Group size <16 Participants (n = 420)
≥16 Participants (n = 421)
Mean (SD)
Mean (SD)
Demographic characteristics Age (years) BMI (kg/m2 ) at intake
54.0 (12.3) 36.3 (7.3)a
53.9 (11.3) 35.1 (7.0)
Sex (female)
% (n) 84 (351)
% (n) 80 (337)
Mean (SD)
Mean (SD)
190.1 (110.4)
181.5 (107.8)
% (n)
% (n)
43 (181) 43 (182) 14 (57)
30 (126) 51 (215) 19 (80)b
51 (214) 49 (206)
53 (221) 47 (200)
Outcome measures Mean minutes of physical activity achieved (weekly)
Self-monitoring fat intake (weeks) 0–6 7–13 14+ Physical activity goalc Met Unmet/unknown a b c
P = 0.03 (independent t-test). P = 0.01 (Chi-square test). Participant achieved ≥150 min of moderately intense physical activity per week.
Institutional review board approval for this project was not required by the Montana DPHHS as previous research has established the safety and efficacy of the lifestyle intervention and only de-identified data were utilized for analyses.
3.
Results
3.1.
Participant characteristics
In 2011, 841 participants were enrolled in the program. The mean age of these participants was 53.4 years (SD 12.1), 82% were female, and the mean number of core sessions attended was 13.0 (SD 4.4). There were no statistically significant differences in age or gender among participants in the smaller compared to those in larger groups (Table 1). Participants in the smaller groups had a significantly higher BMI at baseline compared to participants in the larger groups. Participants in the larger groups attended significantly more of the 16 weekly core sessions (mean 13.8, SD 3.8) compared to participants in the smaller groups (mean 12.5, SD 4.6, P ≤ 0.001).
3.2. Level of physical activity achieved and self-monitoring of fat intake among participants Participants in the larger groups were significantly more likely than those in smaller groups to self-monitor their weekly fat intake (Table 1). There were no significant differences in the mean minutes of physical activity achieved, or the proportion of participants who achieved the weekly physical activity goal
of ≥150 min between participants in the smaller compared to those in the larger group.
3.3.
Participant weight loss outcomes
There were no significant differences in weight loss, change in BMI, achievement of the 7% weight loss goal or achievement of ≥5% weight loss outcome between groups (Table 2).
3.4.
Factors associated with weight loss
Analysis by multiple logistic regression found only two factors independently associated with achievement of the 7%
Table 2 – Weight loss outcomes among participants in the Montana Cardiovascular Disease and Diabetes Prevention Program, by group size, 2011. Group size
Weight loss (kg) Change in BMI (kg/m2 ) Achieved ≥5% weight loss Achieved 7% weight loss goal
<16 Participants (n = 420)
≥16 Participants (n = 421)
Mean (SD) 5.1 (4.7) 2.4 (1.6)
Mean (SD) 5.8 (4.5) 2.4 (1.6)
% (n) 48 (202)
% (n) 54 (229)
33 (140)
39 (166)
Please cite this article in press as: S.M. Brokaw, et al., Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.02.002
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Table 3 – Factors assessed by multiple logistic regression for independent association with achieving the 7% weight loss goal, and achieving ≥5% weight loss among participants in the Montana Cardiovascular Disease and Diabetes Prevention Program, 2011. Achieved 7% weight loss goal AOR (95% Age (years) ≥65 45–64 18–44 (Referent) Sex Male Female (Referent) BMI (kg/m2 ) at intake ≥35.0 30.0–34.9 25.0–29.9 (Referent) Physical activity goal Met Unmet/unknown (Referent) Self-monitored fat intake (weeks) ≥14 7–13 0–6 (Referent) Group size <16 ≥16 (Referent) a
CI)a
AOR (95% CI)
P
0.95 (0.55–1.65) 1.13 (0.73–1.73) 1.0
0.86 0.59
0.99 (0.57–1.71) 1.26 (0.83–1.91) 1.0
0.97 0.27
1.53 (0.98–2.39) 1.0
0.06
1.54 (0.96–2.46) 1.0
0.07
1.33 (0.84–2.09) 1.21 (0.76–1.92) 1.0
0.23 0.43
1.13 (0.72–1.76) 1.46 (0.91–2.34) 1.0
0.60 0.11
1.58 (1.10–2.26) 1.0
0.01
1.91 (1.34–2.73) 1.0
≤0.001
23.83 (12.30–46.19) 9.91 (5.62–17.48) 1.0
≤0.001 ≤0.001
15.83 (8.65–28.97) 7.47 (4.84–11.55) 1.0
≤0.001 ≤0.001
1.03 (0.73–1.44) 1.0
0.73
0.98 (0.69–1.38) 1.0
0.90
Adjusted odds ratio (95% confidence interval).
weight loss goal or achievement of ≥5% weight loss outcome: increased weekly self-monitoring of fat intake, and achievement of the physical activity goal (Table 3). Group size was not independently associated with the achievement of the 7% weight loss goal or achievement of ≥5% weight loss outcome.
4.
P
Achieved ≥5% weight loss
Discussion
The adapted DPP approach in Montana has achieved intensive lifestyle intervention goals very similar to those achieved in the NIH DPP [5,6]. Our findings suggest that 7% weight loss and 5% weight loss goals can be achieved by participants in both large and small group settings. Group size as defined in this assessment was not independently associated with the achievement of the weight loss goals. The only variables associated with achievement of these weight loss goals were more frequent weekly self-monitoring of fat intake and achievement of the physical activity goal. These independent associations are consistent with findings from both the original NIH DPP and our previous work, which indicate more frequent self-monitoring of fat intake and achievement of the physical activity goal are the most important factors associated with the achievement of the 7% weight loss goal [15,16]. There are a number of limitations to our study. First, this was not a randomized controlled trial and participants were not randomly assigned to groups. Second, self-reported physical activity measures were utilized and a participant’s level of physical activity may be overestimated. Third, we did not collect or adjust for additional demographic (e.g., household income) and psychosocial-related (e.g., depression) information from participants, which may be associated with the
participant achievement of the weight loss goal. However, the NIH DPP found that these variables were not independently associated with the achievement of the weight loss goal among participants [15]. Additionally we were not able to adjust for within group (e.g., peers characteristics) or within site (e.g., coach characteristics) effects. Fourth, we categorized participants into two group sizes based on the median number of group participants attending the 16 weekly core sessions. An alternative strategy would have been to categorize participants into two group sizes based on the group size at the first core session. We chose to categorize group size based on the former because we believe this more accurately reflects the group size experience across the 16 weekly core sessions. Finally, we categorized participants into groups to assess the impact of group size on the weight loss outcomes. It is possible that finer graduation in group size could be associated with participant weight loss outcomes. To address this potential issue we categorized participants into four groups based on the quartile sizes (≤11, 12–15, 16–19, ≥20). We included this variable into the same multiple logistic regression models and found that none of these group sizes were independently associated with the weight loss outcomes. The weight loss among participants in the small (5.1 kg) and larger groups (5.8 kg) was similar to other group based translation studies where the reported weight loss ranged from 0.5 to 6.7 kg [17]. However, the weight loss outcomes among participants in our group-based program were somewhat lower than those achieved in the one-on-one delivered lifestyle interventions in US DPP and the Finnish Diabetes Prevention Study [2,3]. A number of previous studies that have translated the DPP by providing the lifestyle intervention in a group setting have
Please cite this article in press as: S.M. Brokaw, et al., Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.02.002
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reported the group size. Four studies reported group sizes ranging from 6 to 12 participants per group [7–9]. Two studies had had somewhat larger group sizes ranging from 7 to 16, 8 to 21 [5,11]. One recent translation study of the DPP in American Indian and Alaska Native communities reported a mean group size of 4 [18]. The original DPP lifestyle intervention was delivered individually to participants and not in a group setting [3]. An economic analysis of the DPP found that the one-on-one delivered lifestyle intervention cost approximately $1400 per participant and was cost effective [19]. Some of the DPP translation studies have reported the estimated cost to provide the lifestyle intervention in a group setting; these costs have ranged from $275 to $800 per participant and are significantly lower than the costs associated with delivering the intervention one-on-one [5,10,13,18]. Further research is needed to determine the extent to which delivery of the DPP in group settings can be used to maximize use of limited resources to achieve the extraordinary benefits of the DPP.
5.
Conclusions
By enrolling a larger number of participants into adapted DPP lifestyle interventions, the number of persons who can participate in the service is increased, and the cost per participant is reduced. This enhances the cost effectiveness of the service. There are a number of logistical challenges that one should consider when enrolling a larger number of participants into group-based DPP interventions. These challenges include the time it takes to weigh participants at each session, reviewing each participant’s self-monitoring logs weekly, providing individual feedback to participants, as well as having sufficient meeting space for larger groups. Finally, our findings reinforce the importance of supporting participants in DPP lifestyle interventions to initiate and maintain dietary selfmonitoring and increased levels of physical activity in order to achieve the weight loss goal.
Conflict of interest statement The authors declare that they have no conflict of interest in connection with this article.
Authors’ contribution SMB, DNE, SDH, and TSH participated in the design of the study. SMB, DA, and DNE participated in the acquisition of the data. DNE performed the statistical analyses. TSH drafted the manuscript. SMB, DA, DNE, MKB, and SDH had substantial contributions to the conception and design of the study and they helped draft the manuscript. All authors read and approved the final manuscript.
Acknowledgements This project was funded by the State of Montana and supported through a cooperative agreement with the Centers for Disease Control and Prevention (CDC), Division of
5
Diabetes Translation (5U58DP001977-03) in Atlanta, Georgia. The contents of this report are solely the responsibility of the authors and do not necessarily represent the views of the CDC.
Appendix A. The following persons were members of the Montana Cardiovascular Disease and Diabetes Prevention Program Workgroup. Community Medical Center, Missoula, Montana: Nancy R. Eyler, MD, FACP, Marjorie J. Samsoe, MA, CDE, Shirley K. Schneiter, RD, CDE, Susan Schmidt, RD, Julie Bauer, MA. Holy Rosary Healthcare, Miles City, Montana: Darcy R. Kassner, BS, Carla McPherson, BS, Liane M. Vadheim, RD, LN, CDE, Tracy A. Vosler, MS, PT. Montana Department of Public Health and Human Services, Helena, Montana: Diane Arave, BS, Sarah M. Brokaw, MPH, Marcene K. Butcher, RD, CDE, Derek N. Emerson, MA, Todd S. Harwell, MPH, and Steven D. Helgerson, MD, MPH, Mark L. Niebylski, PhD. Saint Vincent Healthcare, Billings, Montana: Beverly McHugh RD, LN, CNSD, Jane Fitch Meszaros, RN, BSN, CDE, Doris Biersdorf, RD LN CDE, Charles R. McClave, II MD, FACP, Justen Rudolph, MD. Saint Peter’s Hospital, Helena, Montana: Yvonne B. Tapper-Gardzina, MS, RD, Tolly J. Patten, RD, Julie Abramson, CPT Kalispell Regional Medical Center, Kalispell, Montana: Leslie Coates, MS, RD. Benefis Health System, Great Falls, Montana: Susan A. Garnic, RN, BSN, CDE, Deb K. Bjorsness MPH, RD, BC-ADM, CDE, Christina Skinner, RD and Jamey Galbraith, CSCS. Barrett Hospital and HealthCare, Dillon, Montana: Jill Pulaski, RD, CDE Deanna Nelson, RN, and Sandra McIntyre MD. Billings Clinic, Billings Montana: Therese Hrncirik, RD, Lisa Ranes, RD, CDE St. Patrick Hospital, Missoula, Montana: Christine Bond, MS, RD, HFS, Sara Engberg, RD, LN, CDE, Jennifer Troupe, MS, RD, CDE. Teton Medical Center, Choteau, Montana: Heather Hodgskiss, DPT, Cathy Sessions. Missoula City-County Health Department, Missoula, Montana: Heather Lucas Sauro, MS, RD, CYT, Mary Pittaway, MS, RD. St. James Healthcare and the Butte Family YMCA, Butte, Montana: Holly McCamant, ACSM, Ida Reighard, RN, CDE. St. John’s Lutheran Hospital, Libby, Montana: Becky Brundin, MPH, RD, CDE, Matt Larsen, RD. Bozeman Deaconess Hospital, Bozeman, Montana: Arlene Eliason, RD, CDE, Lindsay Kordick, RD, Paige Reddan, MS, RD, CDE.
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Contents lists available at ScienceDirect
Primary Care Diabetes journal homepage: http://www.elsevier.com/locate/pcd
Original research
Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups Sarah M. Brokaw, Diane Arave, Derek N. Emerson, Marcene K. Butcher, Steven D. Helgerson, Todd S. Harwell ∗ , the Montana Cardiovascular Disease and Diabetes Prevention Workgroup1 Montana Department of Public Health and Human Services, Helena, MT, United States
a r t i c l e
i n f o
a b s t r a c t
Article history:
Objective: The purpose of this study was to assess if group size is associated with weight loss
Received 29 July 2013
outcomes among participants in an adapted diabetes prevention program.
Received in revised form
Methods: Adults at high-risk (N = 841) for CVD and diabetes were enrolled in the lifestyle
14 February 2014
intervention in 2011. Multiple logistic regression analyses were used to identify if group size
Accepted 16 February 2014
(smaller group < 16 participants; larger group ≥16 participants) was independently associ-
Available online xxx
ated with weight loss outcomes among participants.
Keywords:
the larger groups were significantly more likely to have a higher baseline body mass index,
Type 2 diabetes mellitus
to attend fewer intervention sessions, and less likely to self-monitor their fat intake for
Results: In the bivariate analyses, participants in the smaller groups compared to those in
Diabetes prevention
≥14 weeks, and to have lost less weight during the core intervention (5.1 kg [SD 4.7] versus
Group size
5.8 kg [4.5]). However, analysis adjusting for age, sex, baseline BMI, achievement of the phys-
Intervention studies
ical activity goal, number of weeks self-monitoring fat intake, and group size, found only
Cardiovascular disease related risk
two factors to be independently associated with achievement of the 7% weight loss goal:
factors
frequency of self-monitoring of fat intake and achievement of the physical activity goal.
Montana
Conclusions: Our findings indicate that intensive lifestyle intervention goals can be achieved
Pre-diabetes
as effectively with large or small groups.
Weight loss
1.
© 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
Introduction
The prevalence of type 2 diabetes continues to increase in the US, and it is estimated that one in three individuals
born in 2000 will develop type 2 diabetes in their lifetime [1]. The Finnish Diabetes Prevention Study (DPS) and the National Institutes of Health Diabetes Prevention Programs (DPP) both demonstrated that the incidence of type 2 diabetes mellitus among adults at high-risk for diabetes can be
∗ Corresponding author at: Montana Department of Public Health and Human Services, Cogswell Building, C-314, P.O. Box 202951, Helena, MT 59620-2951, United States. Tel.: +1 406 444 1437; fax: +1 406 444 7465. E-mail address: [email protected] (T.S. Harwell). 1 Members of the Montana Cardiovascular Disease and Diabetes Prevention Workgroup are identified in Appendix.
http://dx.doi.org/10.1016/j.pcd.2014.02.002 1751-9918/© 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: S.M. Brokaw, et al., Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.02.002
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significantly reduced through an intensive lifestyle intervention [2,3]. The lifestyle interventions in both the DPS and the DPP studies were delivered one-on-one to participants [2,3]. Since the publication of these landmark studies, a number of translation studies have shown that it is feasible to deliver the lifestyle intervention in a group setting and achieve similar weight loss outcomes [4–13]. Delivering the DPP lifestyle intervention in a group setting has a number of potential benefits including increasing the number of persons that can participate and enhancing the cost effectiveness of the intervention. Additionally, one of the key skills that participants are taught in the DPP curriculum is problem solving. Using a group setting to deliver the DPP can potentially enhance the learning process of individual participants through shared learning, feedback, and support from their peers. However, optimal group size to deliver the DPP or other weight loss related lifestyle interventions has not been documented nor has whether or not group size affects participant achievement of the targeted weight loss goals. In 2008, the Montana Department of Public Health and Human Services (DPHHS) implemented an adapted groupbased cardiovascular disease (CVD) and diabetes prevention program, resulting in similar weight loss outcomes as those in the NIH DPP [5,6]. This report uses the experience of 841 participants in 2011 to assess if group size was associated with weight loss outcomes for these participants.
2.3.
Data collection
Height, weight, blood pressure, fasting blood glucose and lipid values were collected at enrolment, at completion of the core (four months), and after core (10 months). Participants were weighed at each session and submitted weekly selfmonitoring booklets. Participants attended the same group throughout the study. Participants were assigned daily fat and calorie intake goals based on their baseline weight. Participants were offered a minimum of twice-weekly supervised physical activity opportunities. Following DPP guidelines, participants began self-monitoring daily fat gram intake starting after session two, physical activity after session five and calories, if necessary, after session seven [14]. Participants submitted completed weekly self-monitoring booklets beginning at session three to be reviewed by the lifestyle coaches. Weekly dietary self-monitoring and weight data were recorded for each participant. Self-reported fat gram and calorie intake were reported as a daily average, and physical activity minutes as a weekly total. The lifestyle coaches measured participant weight at each session. The goals for this lifestyle intervention are the same as the original DPP [14]. These goals include: (1) daily selfmonitoring of fat intake and reduction in fat intake, (2) achieving ≥150 min weekly of moderately vigorous physical activity, and (3) achieving weight loss of ≥7% of participant’s baseline weight by completion of the core sessions.
2.
Methods
2.4.
2.1.
Intervention sites and intervention design
Participant data for 2011 were analyzed using SPSS version 15.0 (Chicago, IL). Participants were categorized into two group sizes (<16 vs. ≥16 participants) based on the number of participants that attended each of the weekly core sessions. The median group size was 16 (range 8–38), and the quartiles were ≤11, 12–15, 16–19, and ≥20. Participants weekly selfmonitoring of fat intake was categorized into three groups: 0–6 weeks, 7–13 weeks, and ≥14 weeks. Participants mean weekly physical activity minutes over the 16 sessions were categorized into three groups: met the physical activity goal, did not meet the physical activity goal, and unknown. The proportion of participants enrolled in the core intervention that met the 7% weight goal was calculated. The proportion of participants who achieved ≥5% weight loss was also calculated, because previous studies suggest that this level of weight loss is associated with significant health-related outcomes. Independent t-tests and Chi-square tests were used to compare the baseline characteristics, session attendance, weekly self-monitoring of fat intake, achievement of the physical activity goal, and weight loss among participants in the smaller (<16) versus larger group (≥16). Intention-to-treat analyses were performed using the last observed weight of participants enrolled in the program to calculate weight loss measures, achievement of the 7% weight loss goal, and the ≥5% weight loss outcome. Multiple logistic regression analyses were used to indentify variables independently associated with participant achievement of the 7% weight loss goal and the ≥5% weight loss outcome. Adjusted odds ratios and 95% confidence intervals were calculated.
A description of this intervention has been published previously [5,6]. Briefly, the Montana DPHHS began implementing an adapted DPP in a group setting in 2008 and currently supports fifteen health care facilities to implement this intervention. These facilities included ten diabetes self-management education (DSME) programs, two DSME programs in collaboration with their local YMCA, one cardiac rehabilitation program, one rural health clinic, and one local health department. Sites used trained health professionals as lifestyle coaches to provide the 16 core sessions followed by six monthly after-core sessions. These sessions were based on the original DPP curriculum (intervention length of 10 months) [14].
2.2.
Participant eligibility criteria
Overweight (BMI ≥ 25.0 kg/m2 ) adults with medical clearance from their referring physician and one or more of the following CVD and diabetes risk factors were eligible: a previous diagnosis of pre-diabetes, impaired glucose tolerance or impaired fasting glucose, hemoglobin A1C between 5.7% and 6.4%, high blood pressure (≥130/85 mmHg or treatment), dyslipidemia (triglycerides > 150 mg/dl, LDL-cholesterol > 130 mg/dl or treatment, or HDL-cholesterol < 40 mg/dl men and <50 mg/dl women), a history of gestational diabetes (GDM), or had given birth to a baby weighing >9 pounds.
Data analysis
Please cite this article in press as: S.M. Brokaw, et al., Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.02.002
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Table 1 – Characteristics, physical activity levels, and self-monitoring of fat intake among participants in the Montana Cardiovascular Disease and Diabetes Prevention Program, by group size, 2011. Group size <16 Participants (n = 420)
≥16 Participants (n = 421)
Mean (SD)
Mean (SD)
Demographic characteristics Age (years) BMI (kg/m2 ) at intake
54.0 (12.3) 36.3 (7.3)a
53.9 (11.3) 35.1 (7.0)
Sex (female)
% (n) 84 (351)
% (n) 80 (337)
Mean (SD)
Mean (SD)
190.1 (110.4)
181.5 (107.8)
% (n)
% (n)
43 (181) 43 (182) 14 (57)
30 (126) 51 (215) 19 (80)b
51 (214) 49 (206)
53 (221) 47 (200)
Outcome measures Mean minutes of physical activity achieved (weekly)
Self-monitoring fat intake (weeks) 0–6 7–13 14+ Physical activity goalc Met Unmet/unknown a b c
P = 0.03 (independent t-test). P = 0.01 (Chi-square test). Participant achieved ≥150 min of moderately intense physical activity per week.
Institutional review board approval for this project was not required by the Montana DPHHS as previous research has established the safety and efficacy of the lifestyle intervention and only de-identified data were utilized for analyses.
3.
Results
3.1.
Participant characteristics
In 2011, 841 participants were enrolled in the program. The mean age of these participants was 53.4 years (SD 12.1), 82% were female, and the mean number of core sessions attended was 13.0 (SD 4.4). There were no statistically significant differences in age or gender among participants in the smaller compared to those in larger groups (Table 1). Participants in the smaller groups had a significantly higher BMI at baseline compared to participants in the larger groups. Participants in the larger groups attended significantly more of the 16 weekly core sessions (mean 13.8, SD 3.8) compared to participants in the smaller groups (mean 12.5, SD 4.6, P ≤ 0.001).
3.2. Level of physical activity achieved and self-monitoring of fat intake among participants Participants in the larger groups were significantly more likely than those in smaller groups to self-monitor their weekly fat intake (Table 1). There were no significant differences in the mean minutes of physical activity achieved, or the proportion of participants who achieved the weekly physical activity goal
of ≥150 min between participants in the smaller compared to those in the larger group.
3.3.
Participant weight loss outcomes
There were no significant differences in weight loss, change in BMI, achievement of the 7% weight loss goal or achievement of ≥5% weight loss outcome between groups (Table 2).
3.4.
Factors associated with weight loss
Analysis by multiple logistic regression found only two factors independently associated with achievement of the 7%
Table 2 – Weight loss outcomes among participants in the Montana Cardiovascular Disease and Diabetes Prevention Program, by group size, 2011. Group size
Weight loss (kg) Change in BMI (kg/m2 ) Achieved ≥5% weight loss Achieved 7% weight loss goal
<16 Participants (n = 420)
≥16 Participants (n = 421)
Mean (SD) 5.1 (4.7) 2.4 (1.6)
Mean (SD) 5.8 (4.5) 2.4 (1.6)
% (n) 48 (202)
% (n) 54 (229)
33 (140)
39 (166)
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Table 3 – Factors assessed by multiple logistic regression for independent association with achieving the 7% weight loss goal, and achieving ≥5% weight loss among participants in the Montana Cardiovascular Disease and Diabetes Prevention Program, 2011. Achieved 7% weight loss goal AOR (95% Age (years) ≥65 45–64 18–44 (Referent) Sex Male Female (Referent) BMI (kg/m2 ) at intake ≥35.0 30.0–34.9 25.0–29.9 (Referent) Physical activity goal Met Unmet/unknown (Referent) Self-monitored fat intake (weeks) ≥14 7–13 0–6 (Referent) Group size <16 ≥16 (Referent) a
CI)a
AOR (95% CI)
P
0.95 (0.55–1.65) 1.13 (0.73–1.73) 1.0
0.86 0.59
0.99 (0.57–1.71) 1.26 (0.83–1.91) 1.0
0.97 0.27
1.53 (0.98–2.39) 1.0
0.06
1.54 (0.96–2.46) 1.0
0.07
1.33 (0.84–2.09) 1.21 (0.76–1.92) 1.0
0.23 0.43
1.13 (0.72–1.76) 1.46 (0.91–2.34) 1.0
0.60 0.11
1.58 (1.10–2.26) 1.0
0.01
1.91 (1.34–2.73) 1.0
≤0.001
23.83 (12.30–46.19) 9.91 (5.62–17.48) 1.0
≤0.001 ≤0.001
15.83 (8.65–28.97) 7.47 (4.84–11.55) 1.0
≤0.001 ≤0.001
1.03 (0.73–1.44) 1.0
0.73
0.98 (0.69–1.38) 1.0
0.90
Adjusted odds ratio (95% confidence interval).
weight loss goal or achievement of ≥5% weight loss outcome: increased weekly self-monitoring of fat intake, and achievement of the physical activity goal (Table 3). Group size was not independently associated with the achievement of the 7% weight loss goal or achievement of ≥5% weight loss outcome.
4.
P
Achieved ≥5% weight loss
Discussion
The adapted DPP approach in Montana has achieved intensive lifestyle intervention goals very similar to those achieved in the NIH DPP [5,6]. Our findings suggest that 7% weight loss and 5% weight loss goals can be achieved by participants in both large and small group settings. Group size as defined in this assessment was not independently associated with the achievement of the weight loss goals. The only variables associated with achievement of these weight loss goals were more frequent weekly self-monitoring of fat intake and achievement of the physical activity goal. These independent associations are consistent with findings from both the original NIH DPP and our previous work, which indicate more frequent self-monitoring of fat intake and achievement of the physical activity goal are the most important factors associated with the achievement of the 7% weight loss goal [15,16]. There are a number of limitations to our study. First, this was not a randomized controlled trial and participants were not randomly assigned to groups. Second, self-reported physical activity measures were utilized and a participant’s level of physical activity may be overestimated. Third, we did not collect or adjust for additional demographic (e.g., household income) and psychosocial-related (e.g., depression) information from participants, which may be associated with the
participant achievement of the weight loss goal. However, the NIH DPP found that these variables were not independently associated with the achievement of the weight loss goal among participants [15]. Additionally we were not able to adjust for within group (e.g., peers characteristics) or within site (e.g., coach characteristics) effects. Fourth, we categorized participants into two group sizes based on the median number of group participants attending the 16 weekly core sessions. An alternative strategy would have been to categorize participants into two group sizes based on the group size at the first core session. We chose to categorize group size based on the former because we believe this more accurately reflects the group size experience across the 16 weekly core sessions. Finally, we categorized participants into groups to assess the impact of group size on the weight loss outcomes. It is possible that finer graduation in group size could be associated with participant weight loss outcomes. To address this potential issue we categorized participants into four groups based on the quartile sizes (≤11, 12–15, 16–19, ≥20). We included this variable into the same multiple logistic regression models and found that none of these group sizes were independently associated with the weight loss outcomes. The weight loss among participants in the small (5.1 kg) and larger groups (5.8 kg) was similar to other group based translation studies where the reported weight loss ranged from 0.5 to 6.7 kg [17]. However, the weight loss outcomes among participants in our group-based program were somewhat lower than those achieved in the one-on-one delivered lifestyle interventions in US DPP and the Finnish Diabetes Prevention Study [2,3]. A number of previous studies that have translated the DPP by providing the lifestyle intervention in a group setting have
Please cite this article in press as: S.M. Brokaw, et al., Intensive lifestyle intervention goals can be achieved as effectively with large groups as with small groups, Prim. Care Diab. (2014), http://dx.doi.org/10.1016/j.pcd.2014.02.002
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reported the group size. Four studies reported group sizes ranging from 6 to 12 participants per group [7–9]. Two studies had had somewhat larger group sizes ranging from 7 to 16, 8 to 21 [5,11]. One recent translation study of the DPP in American Indian and Alaska Native communities reported a mean group size of 4 [18]. The original DPP lifestyle intervention was delivered individually to participants and not in a group setting [3]. An economic analysis of the DPP found that the one-on-one delivered lifestyle intervention cost approximately $1400 per participant and was cost effective [19]. Some of the DPP translation studies have reported the estimated cost to provide the lifestyle intervention in a group setting; these costs have ranged from $275 to $800 per participant and are significantly lower than the costs associated with delivering the intervention one-on-one [5,10,13,18]. Further research is needed to determine the extent to which delivery of the DPP in group settings can be used to maximize use of limited resources to achieve the extraordinary benefits of the DPP.
5.
Conclusions
By enrolling a larger number of participants into adapted DPP lifestyle interventions, the number of persons who can participate in the service is increased, and the cost per participant is reduced. This enhances the cost effectiveness of the service. There are a number of logistical challenges that one should consider when enrolling a larger number of participants into group-based DPP interventions. These challenges include the time it takes to weigh participants at each session, reviewing each participant’s self-monitoring logs weekly, providing individual feedback to participants, as well as having sufficient meeting space for larger groups. Finally, our findings reinforce the importance of supporting participants in DPP lifestyle interventions to initiate and maintain dietary selfmonitoring and increased levels of physical activity in order to achieve the weight loss goal.
Conflict of interest statement The authors declare that they have no conflict of interest in connection with this article.
Authors’ contribution SMB, DNE, SDH, and TSH participated in the design of the study. SMB, DA, and DNE participated in the acquisition of the data. DNE performed the statistical analyses. TSH drafted the manuscript. SMB, DA, DNE, MKB, and SDH had substantial contributions to the conception and design of the study and they helped draft the manuscript. All authors read and approved the final manuscript.
Acknowledgements This project was funded by the State of Montana and supported through a cooperative agreement with the Centers for Disease Control and Prevention (CDC), Division of
5
Diabetes Translation (5U58DP001977-03) in Atlanta, Georgia. The contents of this report are solely the responsibility of the authors and do not necessarily represent the views of the CDC.
Appendix A. The following persons were members of the Montana Cardiovascular Disease and Diabetes Prevention Program Workgroup. Community Medical Center, Missoula, Montana: Nancy R. Eyler, MD, FACP, Marjorie J. Samsoe, MA, CDE, Shirley K. Schneiter, RD, CDE, Susan Schmidt, RD, Julie Bauer, MA. Holy Rosary Healthcare, Miles City, Montana: Darcy R. Kassner, BS, Carla McPherson, BS, Liane M. Vadheim, RD, LN, CDE, Tracy A. Vosler, MS, PT. Montana Department of Public Health and Human Services, Helena, Montana: Diane Arave, BS, Sarah M. Brokaw, MPH, Marcene K. Butcher, RD, CDE, Derek N. Emerson, MA, Todd S. Harwell, MPH, and Steven D. Helgerson, MD, MPH, Mark L. Niebylski, PhD. Saint Vincent Healthcare, Billings, Montana: Beverly McHugh RD, LN, CNSD, Jane Fitch Meszaros, RN, BSN, CDE, Doris Biersdorf, RD LN CDE, Charles R. McClave, II MD, FACP, Justen Rudolph, MD. Saint Peter’s Hospital, Helena, Montana: Yvonne B. Tapper-Gardzina, MS, RD, Tolly J. Patten, RD, Julie Abramson, CPT Kalispell Regional Medical Center, Kalispell, Montana: Leslie Coates, MS, RD. Benefis Health System, Great Falls, Montana: Susan A. Garnic, RN, BSN, CDE, Deb K. Bjorsness MPH, RD, BC-ADM, CDE, Christina Skinner, RD and Jamey Galbraith, CSCS. Barrett Hospital and HealthCare, Dillon, Montana: Jill Pulaski, RD, CDE Deanna Nelson, RN, and Sandra McIntyre MD. Billings Clinic, Billings Montana: Therese Hrncirik, RD, Lisa Ranes, RD, CDE St. Patrick Hospital, Missoula, Montana: Christine Bond, MS, RD, HFS, Sara Engberg, RD, LN, CDE, Jennifer Troupe, MS, RD, CDE. Teton Medical Center, Choteau, Montana: Heather Hodgskiss, DPT, Cathy Sessions. Missoula City-County Health Department, Missoula, Montana: Heather Lucas Sauro, MS, RD, CYT, Mary Pittaway, MS, RD. St. James Healthcare and the Butte Family YMCA, Butte, Montana: Holly McCamant, ACSM, Ida Reighard, RN, CDE. St. John’s Lutheran Hospital, Libby, Montana: Becky Brundin, MPH, RD, CDE, Matt Larsen, RD. Bozeman Deaconess Hospital, Bozeman, Montana: Arlene Eliason, RD, CDE, Lindsay Kordick, RD, Paige Reddan, MS, RD, CDE.
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