A family-based lifestyle intervention that aims to prevent childhood obesity by teaching inner-city kids, teens, and their families about healthy weight management through nutrition education, behavior modification, and exercise.
Blueprints: Promising
Mary Savoye
Yale University School of Medicine
2 Church St. South, Suite 201
New Haven, CT 06520
(203) 737-4384
mary.savoye@yale.edu
www.brightbodies.org
Curriculum: www.smartmovesforkids.com
Mary Savoye
Yale University School of Medicine
The Yale Bright Bodies Weight Management Program is a family-based, intensive lifestyle intervention that uses nutrition education, behavior modification and exercise to address weight and weight-related issues in children and adolescents. The program is designed for ethnically diverse, obese, inner-city youth. Participants and caregivers are provided nutrition education and behavior modification techniques in 40-minute sessions, once per week, for six months, followed by every other week for the next six months. The exercise component, facilitated by exercise physiologists, is provided in two 50-minute sessions once per week for the first 6 months and two 50-minute sessions twice per month for the next 6 months.
The Yale Bright Bodies Weight Management Program is a family-based, intensive lifestyle intervention that is designed for ethnically diverse, obese, inner-city youth. The program uses nutrition education, behavior modification and exercise and requires a significant time commitment of participants.
Nutrition education is provided by a registered dietician using the 'Smart Moves Workbook' (a curriculum developed for overweight children) and emphasizes food choice and portion control. Participants and caregivers attend these sessions once per week for 40 minutes for the first 6 months, followed by once every other week for the next 6 months.
The behavior modification component of the program also uses the 'Smart Moves Workbook' and teaches techniques such as self-awareness and goal setting, and uses coping skills training, cognitive behavioral skills training and contingency management as modalities. Behavior modification classes are also provided to the caregivers of the children enrolled in the program and topics focus on challenges that the caregivers are experiencing with the children with the overall goal of empowering the caregiver. Participants and caregivers attend these sessions once per week for 40 minutes for the first 6 months, followed by once every other week for the next 6 months.
The exercise component, facilitated by exercise physiologists, consists of a warm up, high-intensity aerobic exercise (e.g., obstacle courses, games, sprints, dance), and a cool down. Participants wear heart monitors as well as report their level of perceived exertion. The minimum requirement of this component is two 50-minute sessions per week for the first 6 months and two 50-minute sessions twice per month for the next 6 months.
Primary Evidence Base for Certification
Study 1
Savoye et al. (2007, 2011) and Shaw et al. (2009) found that, relative to control participants, intervention participants experienced:
A subsample of participants was also measured on glucose and insulin sensitivity and participants in the treatment group experienced the following outcomes after 12 months:
Study 2
Savoye et al. (2014) found at the six-month posttest that the intervention group, relative to the control group, had:
Primary Evidence Base for Certification
Of the two studies Blueprints has reviewed, both studies (Study 1 and Study 2) meet Blueprints evidentiary standards (specificity, evaluation quality, impact, dissemination readiness) and were done by the developer.
Study 1
Savoye et al. (2007, 2011) and Shaw et al. (2009) used a parallel group, randomized control trial to examine 209 youths aged 8 and 16 with a body mass index (BMI) above 95th percentile. Participants were randomly assigned to the treatment group or a traditional clinical weight management control group. However, due to discontinuation of a part of the program, 105 participants ended up in the treatment group and 69 participants in the control group. Measures collected at baseline, six months, 12 months and 24 months examined body weight, blood pressure, and glucose levels.
Study 2
Savoye et al. (2014) used a randomized controlled trial to examine 75 youths ages 10-16 with prediabetes (but not diabetes or other serious medical conditions). After assignment to the intervention or standard clinical care control group, the youths completed a six-month assessment of glucose and insulin levels, weight and body mass, and cardiovascular health.
Study 1
Savoye, M., Shaw, M., Dziura, J., Tamborlane, W., Rose, P., Guandalini, C., . . . Caprio, S. (2007). Effects of a weight management program on body composition and metabolic parameters in overweight children: A randomized control trial. Journal of the American Medical Association, 297(24), 2697-2704.
Study 2
Savoye, M., Caprio, S., Dziura, J., Camp, A., Germain, G., Summers, C. . . . & Tamborlane, W. V. (2014). Reversal of early abnormalities in glucose metabolism in obese youth: Results of an intensive lifestyle randomized controlled trial. Diabetes Care, 37(2):317-24. doi: 10.2337/dc13-1571.
Individual: Poor Diet
Family: Low socioeconomic status
Individual: Coping Skills, Exercise
Family: Parent social support
*
Risk/Protective Factor was significantly impacted by the program
Sample demographics including race, ethnicity, and gender for Blueprints-certified studies:
17 hour training of all disciplines - coordinator/director (C/D)
11 hour training for exercise (EX), nutrition (N), and parent class (P) staff
Day 1 - 5 hrs.*
Overview of Program - 1.5 hrs (ALL)
Exercise Physiologist training - 3 hrs (EX, C/D)
Day 2 - 6 hrs.
Overview of Obesity & Clinical
Day 3 - 6 hrs.
Nutrition/Behavior Modification Training - 2 hrs. (C/D,N,P)
Parent Class Training - 1 hr.(C/D, N, P)
Observe Program - 3 hrs.
Training Cost
Cost $1,200 for 3 staff members ($300 for each additional staff)
Travel, hotel, and food costs are responsibility of trainees.
Module Modification
*If a third day of training is not possible, overview and exercise training could be incorporated on Wed and Thurs. Program overview would take place 12-2 on Wednesday and exercise training would occur one hour before program at 4:30 Thursday. This module, however, does not allow for cross-training of disciplines between exercise and nutrition staff.
Source: Washington State Institute for Public Policy
All benefit-cost ratios are the most recent estimates published by The Washington State Institute for Public Policy for Blueprint programs implemented in Washington State. These ratios are based on a) meta-analysis estimates of effect size and b) monetized benefits and calculated costs for programs as delivered in the State of Washington. Caution is recommended in applying these estimates of the benefit-cost ratio to any other state or local area. They are provided as an illustration of the benefit-cost ratio found in one specific state. When feasible, local costs and monetized benefits should be used to calculate expected local benefit-cost ratios. The formula for this calculation can be found on the WSIPP website.
Training will cost $1,200 beginning January 2013. Additionally, trainees must pay for travel, hotel, and food while training.
Equipment represents a one-time investment of $3,650, which covers items such as physical education equipment, a body fat analyzer, heart rate monitors and games. The Smart Moves curriculum is utilized. A start-up manual and an exercise and behavioral/nutrition curriculum and an initial supply of 80 student workbooks costs $4,230.
Materials Available in Other Language: Student workbooks are available in Spanish at no additional cost; facilitator manual has not been translated.
None.
Generally there is a sponsoring organization of a Bright Bodies initiative. That organization raises the funding and employs the staff. There may be some overhead cost incurred for this support.
The curriculum is updated every two years. After two years, an institution might decide to purchase updated workbooks and instructor's manuals at its discretion.
Each program would employ hourly staff with the following qualifications:
The program director and/or coordinator should be in the fields of nutrition, exercise, or social work/psychology so that they have a deep understanding of one of the disciplines and can provide training.
Youth incentives are budgeted at $300 per year. The sponsoring organization may incur some overhead costs to support the program. Students can be used to supplement the professional staff. The program is based in schools, eliminating the cost of space rental.
Formal 2-3 day training is provided, if desired. To purchase the nutrition/behavior modification curriculum, at minimum, staff from the nutrition and behavioral sciences must be utilized to deliver its contents. Likewise, to purchase the exercise curriculum, at minimum, staff from the exercise or physical therapy science must be utilized. Smart Moves staff is available via telephone for ongoing consultation regarding delivery of curriculum.
Evaluation tools cost $700 annually.
None.
No information is available
No information is available
This example will include the cost for one site to offer Bright Bodies to a group of 80-90 youth/families during Year 1 implementation.
| Compensation and travel for 4-5 staff to be trained at purveyor site | $6,500.00 |
| Compensation for Program Director | $22,500.00 |
| Compensation for Program Coordinator | $11,000.00 |
| Compensation for Exercise Physiologist | $4,500.00 |
| Compensation for Dietitian | $2,500.00 |
| Compensation for Social Worker | $1,250.00 |
| Equipment | $3,560.00 |
| Education Materials | $4,230.00 |
| Incentives for Participants | $300.00 |
| Evaluation Materials | $700.00 |
| Overhead for Sponsor Organization | $10,000.00 |
| Total One Year Cost | $67,040.00 |
If the program serves 80 youth during Year 1, the cost per youth would be $838.
This program has been funded by a combination of sliding scale fees, grants and insurance. In order to minimize the amount parents are expected to contribute to the cost of Bright Bodies, the developers suggest diligent attempts be made to secure grant funding.
Funding from state and local health departments in the form of grants for obesity prevention should be considered sources of funding for Bright Bodies.
Discretionary Grants: Discretionary grants from the Department of Health and Human Services, especially those with a focus on obesity, should be explored for Bright Bodies funding. The National Institutes of Health have provided funding for the evaluation of Bright Bodies.
Grant funding, especially from foundations and corporations interested in obesity prevention and child health, may provide sources of support for Bright Bodies.
Bright Bodies programs lacking in grant funding may be forced to consider charging families fees for participation. These are commonly structured on a sliding scale to make the program affordable to as many families as possible. Families are not charged when programs are supported by NIH grants.
All information comes from the responses to a questionnaire submitted by the developers of Bright Bodies to the Annie E. Casey Foundation.
Mary SavoyeYale University School of Medicine2 Church Street South, Suite 201New Haven, CT 6520USA(203) 737-4384mary.savoye@yale.edu www.brightbodies.org
A family-based lifestyle intervention that aims to prevent childhood obesity by teaching inner-city kids, teens, and their families about healthy weight management through nutrition education, behavior modification, and exercise.
Bright Bodies targets overweight children (body mass index > 95th percentile for age and sex) ages 8-16.
Sample demographics including race, ethnicity, and gender for Blueprints-certified studies:
Poor diet and lack of exercise are likely risk factors for health outcomes.
Individual: Poor Diet
Family: Low socioeconomic status
Individual: Coping Skills, Exercise
Family: Parent social support
*Risk/Protective Factor was significantly impacted by the program
The Yale Bright Bodies Weight Management Program is a family-based, intensive lifestyle intervention that uses nutrition education, behavior modification and exercise to address weight and weight-related issues in children and adolescents. The program is designed for ethnically diverse, obese, inner-city youth. Participants and caregivers are provided nutrition education and behavior modification techniques in 40-minute sessions, once per week, for six months, followed by every other week for the next six months. The exercise component, facilitated by exercise physiologists, is provided in two 50-minute sessions once per week for the first 6 months and two 50-minute sessions twice per month for the next 6 months.
The Yale Bright Bodies Weight Management Program is a family-based, intensive lifestyle intervention that is designed for ethnically diverse, obese, inner-city youth. The program uses nutrition education, behavior modification and exercise and requires a significant time commitment of participants.
Nutrition education is provided by a registered dietician using the 'Smart Moves Workbook' (a curriculum developed for overweight children) and emphasizes food choice and portion control. Participants and caregivers attend these sessions once per week for 40 minutes for the first 6 months, followed by once every other week for the next 6 months.
The behavior modification component of the program also uses the 'Smart Moves Workbook' and teaches techniques such as self-awareness and goal setting, and uses coping skills training, cognitive behavioral skills training and contingency management as modalities. Behavior modification classes are also provided to the caregivers of the children enrolled in the program and topics focus on challenges that the caregivers are experiencing with the children with the overall goal of empowering the caregiver. Participants and caregivers attend these sessions once per week for 40 minutes for the first 6 months, followed by once every other week for the next 6 months.
The exercise component, facilitated by exercise physiologists, consists of a warm up, high-intensity aerobic exercise (e.g., obstacle courses, games, sprints, dance), and a cool down. Participants wear heart monitors as well as report their level of perceived exertion. The minimum requirement of this component is two 50-minute sessions per week for the first 6 months and two 50-minute sessions twice per month for the next 6 months.
The program uses an education and skill-building theoretical rationale which highlights the importance of (1) actively engaging the participants and caregivers in learning new skills; (2) using incentives to reinforce positive behavior; and, (3) emphasizing coping skills training to increase the participants' and caregivers' efficacy at managing difficult situations.
Primary Evidence Base for Certification
Of the two studies Blueprints has reviewed, both studies (Study 1 and Study 2) meet Blueprints evidentiary standards (specificity, evaluation quality, impact, dissemination readiness) and were done by the developer.
Study 1
Savoye et al. (2007, 2011) and Shaw et al. (2009) used a parallel group, randomized control trial to examine 209 youths aged 8 and 16 with a body mass index (BMI) above 95th percentile. Participants were randomly assigned to the treatment group or a traditional clinical weight management control group. However, due to discontinuation of a part of the program, 105 participants ended up in the treatment group and 69 participants in the control group. Measures collected at baseline, six months, 12 months and 24 months examined body weight, blood pressure, and glucose levels.
Study 2
Savoye et al. (2014) used a randomized controlled trial to examine 75 youths ages 10-16 with prediabetes (but not diabetes or other serious medical conditions). After assignment to the intervention or standard clinical care control group, the youths completed a six-month assessment of glucose and insulin levels, weight and body mass, and cardiovascular health.
Primary Evidence Base for Certification
Study 1
Savoye et al. (2007, 2011) and Shaw et al. (2009) found sustained treatment effects up to 24 months when compared with standard clinical care on outcome measures such as weight, BMI, body fat, lipid panels and insulin sensitivity.
Study 2
Savoye et al. (2014) found at the six-month posttest that the intervention group, relative to the control group, had lower glucose and insulin levels, lower weight and body mass, and better cardiovascular health.
Primary Evidence Base for Certification
Study 1
Savoye et al. (2007, 2011) and Shaw et al. (2009) found that, relative to control participants, intervention participants experienced:
A subsample of participants was also measured on glucose and insulin sensitivity and participants in the treatment group experienced the following outcomes after 12 months:
Study 2
Savoye et al. (2014) found at the six-month posttest that the intervention group, relative to the control group, had:
Study 2 (Savoye et al., 2014) found that improvements in body mass due to the program mediated changes in glucose and insulin levels and cardiovascular health.
Not presented.
Two studies meet Blueprints standards for high quality methods with strong evidence of program impact (i.e., "certified" by Blueprints): Study 1 (Savoye et al., 2007) and Study 2 (Savoye et al., 2014). The samples for these studies included low-income inner-city youths who were overweight but did not have other serious medical conditions.
Blueprints: Promising
Mary Savoye
Yale University School of Medicine
2 Church St. South, Suite 201
New Haven, CT 06520
(203) 737-4384
mary.savoye@yale.edu
www.brightbodies.org
Curriculum: www.smartmovesforkids.com
Savoye, M., Nowicka, P., Shaw, M., Yu, S., Dziura, J., Chavent, G., . . . Caprio, S. (2011). Long-term results of an obesity program in an ethnically diverse pediatric population. Pediatrics, 127(3), 1-9.
Certified Savoye, M., Shaw, M., Dziura, J., Tamborlane, W., Rose, P., Guandalini, C., . . . Caprio, S. (2007). Effects of a weight management program on body composition and metabolic parameters in overweight children: A randomized control trial. Journal of the American Medical Association, 297(24), 2697-2704.
Shaw, M., Savoye, M., Cali, A., Dziura, J., Tamborlane, W., & Caprio, S. (2009). Effect of a successful intensive lifestyle program on insulin sensitivity and glucose tolerance in obese youth. Diabetes Care, 32(1), 45-47.
Certified
Savoye, M., Caprio, S., Dziura, J., Camp, A., Germain, G., Summers, C. . . . & Tamborlane, W. V. (2014). Reversal of early abnormalities in glucose metabolism in obese youth: Results of an intensive lifestyle randomized controlled trial. Diabetes Care, 37(2):317-24. doi: 10.2337/dc13-1571.
Summary
Savoye et al. (2007, 2011) and Shaw et al. (2009) used a parallel group, randomized control trial to examine 209 youths aged 8 and 16 with a body mass index (BMI) above 95th percentile. Participants were randomly assigned to the treatment group or a traditional clinical weight management control group. However, due to discontinuation of a part of the program, 105 participants ended up in the treatment group and 69 participants in the control group. Measures collected at baseline, six months, 12 months and 24 months examined body weight, blood pressure, and glucose levels.
Savoye et al. (2007, 2011) and Shaw et al. (2009) found that, relative to control participants, intervention participants experienced:
A subsample of participants was also measured on glucose and insulin sensitivity and participants in the treatment group experienced the following outcomes after 12 months:
Evaluation Methodology
Design: Bright Bodies was evaluated using a parallel group, randomized control trial that recruited participants from a Pediatric Obesity Clinic who met the following criteria: body mass index (BMI) above 95th percentile based on the Center for Disease Control growth chart; between the ages of 8 and 16; able to speak English; caregiver willing to participate in the educational component of the program; did not have a major mental illness or serious medical condition; were not taking medication that could potentially cause weight gain.
A total of 284 participants were assessed for eligibility; 62 declined to participate and 13 did not meet criteria. Therefore, 209 participants were randomly assigned to a weight management group and a control group at a 2:1 ratio and then within the weight management group were randomly assigned at a 1:1 ratio to Bright Bodies using a structured meal plan and Bright Bodies using better food choices as part of the nutritional component. However, due to an 83% dropout rate by 6 months from the structured meal plan group (n=35), this portion of the program was discontinued and randomization to control and Bright Bodies continued at the 2:1 ratio. Therefore, a total of 174 participants remained in the study, 105 participants in the treatment group and 69 participants in the control group. Control group participants and their caregivers received diet and exercise counseling by dieticians and physicians once every 6 months at a pediatric obesity clinic. They also received brief psychosocial counseling by a social worker at these appointments.
A subset of 34 participants was further randomized to undergo an oral glucose tolerance test (OGTT) to evaluate the program's impact on glucose metabolism and insulin sensitivity, however, only 23 participants (13 in the treatment group and 10 in the control group) completed these measures at baseline and 12 months.
By the end of the 12 month program, 29% of the participants in the treatment group and 33% of the participants in the control group dropped out. At 24-month follow up, 57% of the treatment group and 55% of the control group had dropped out.
The program was delivered for one year; measures were collected at baseline, 6 months, 12 months and 24 months for both the treatment and control groups at the same facility using the same scales and instruments.
Sample: Of the 174 participants in the study, 61% were female, 37% were White, 38% were Black and 24% were Hispanic. The average age was 12 years old.
Measures: Measures included weight, body fat, body mass index, and blood pressure. Blood samples were also taken to determine lipid and insulin levels. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) was used to measure insulin sensitivity and was calculated using fasting plasma and glucose levels from the blood samples. All of these measures were collected at baseline, 6 months, 12 months and 24 months for both the treatment and control groups at the same facility using the same scales and instruments. The additional measure for the subsample was an oral glucose tolerance test (OGTT) which measures glucose and insulin sensitivity. From this test, whole body insulin sensitivity index is also calculated.
Analysis: Procedures were consistent with an intent-to-treat analysis. Baseline characteristics were compared using t-tests and chi-square tests. Changes in weight, body fat, BMI, blood pressure, lipid and insulin levels were compared between treatment and control groups using mixed model repeated measures analysis. Savoye et al. (2007) imputed missing data using a multiple imputation method; however, separate analyses were also conducted on models without multiple imputation and no differences were found on the treatment estimates between models with and without multiple imputation of missing data. Therefore, the study only presented results from the multiple imputation analyses.
Savoye et al. (2009) used mixed model repeated measures analysis incorporating all available data. Prior to analyses, missing data patterns were examined with simple graphical and tabular methods. The authors state that missing levels of outcomes were not related to observed previous levels of outcomes or any baseline covariates for either the treatment group or control group. Additionally, using pattern mixture models with dropout as a covariate, no effect of dropout was found on estimates of treatment, time, and treatment by time.
Outcomes
Implementation Fidelity: No information on fidelity measures was provided in the study.
Baseline Equivalence: Baseline characteristics were compared using t-tests and chi-square tests. Control and treatment groups were statistically equivalent at baseline on all demographic and outcome variables.
Differential Attrition: At the 24-month follow-up, no significant differences were found in dropout rates among ethnic groups, although minority participants had a somewhat greater retention than white participants. Further, no baseline difference in demographic or outcome measures (with the exception of diastolic blood pressure) was found for those who dropped out versus those who didn't. The most common reasons for dropping out were similar for the treatment and control groups - moved with no forwarding address and lost interest in the program. The percentage of participants lost to follow-up was substantial, overall, but similar between groups (57% in the treatment group and 55% in the control group).
Posttest (Savoye et al., 2007): Differences between the two groups in changes in BMI, weight, and body fat at 6 and 12 months were all significant (p<0.001). Specifically, while both groups had equivalent increases in height in the 12-month period, the treatment group gained an average of 0.66 pounds versus the control group that gained an average of 16.94 pounds. The treatment group lost an average of 4% body fat, whereas the control group gained an average of 2% body fat. Differences in total cholesterol measures and changes in insulin sensitivity as measured by the HOMA-IR were also statistically significant at 6 (p=.05 and p<0.001 respectively) and 12 months (p=.005 and p<0.001 respectively). However, there were no significant differences in changes in other lipid levels or blood pressure between treatment and control groups.
Long-term (Savoye et al., 2011): Bright Bodies demonstrated sustained treatment effects on all measures that were significant at post-test. Specifically, differences between the two groups in changes in BMI, weight, and body fat were significant at 24-months (p<0.002). While both groups had equivalent increases in height in the 24-month period, the treatment group gained an average of 13 pounds versus the control group that gained an average of 26.4 pounds. The treatment group lost an average of 3.6% body fat, whereas the control group gained an average of 0.6% body fat. Differences in changes in total cholesterol measures and changes in insulin sensitivity as measured by the HOMA-IR were also statistically significant at 24 months (p=.004 and p<0.001 respectively).
Subsample Outcomes (Shaw et al., 2009): A report on the subsample comparison between treatment and control groups was reported in a third article. Treatment group participants had a 53% reduction in insulin levels and a 42% increase in whole body insulin sensitivity index (derived from glucose and insulin levels tested using OGTT) compared to the control group (p=.0025 and 0.007 respectively). There was also a small, but statistically significant, decrease in glucose levels in the treatment group (p=0.042). Further, in three participants in the treatment group who had pre-diabetes (impaired glucose tolerance or impaired fasting glucose), their levels normalized, whereas the number of pre-diabetic participants in the control group increased from one to five at 12 months (p=0.04).
The program had participants attend sessions twice per week for six months.
Summary
Savoye et al. (2014) used a randomized controlled trial to examine 75 youths ages 10-16 with prediabetes (but not diabetes or other serious medical conditions). After assignment to an intervention or standard clinical care control group, the youths completed a six-month assessment of glucose and insulin levels, weight and body mass, and cardiovascular health.
Savoye et al. (2014) found at the six-month posttest that the intervention group, relative to the control group, had:
Evaluation Methodology
Design:
Recruitment: The sample came from youths ages 10-16 who had prediabetes and were recruited from the Yale Pediatric Obesity Clinic. Those having diabetes or other serious medical conditions, taking medications that affect weight, insulin sensitivity, or glucose metabolism, participating in another lifestyle program, or planning to move within the next six months were not eligible. Of 577 assessed, 92 met eligibility criteria and 75 consented.
Assignment: The randomized controlled trial used permuted blocks to randomly assign the 75 participants to the intervention group (n = 38) or a control group (n = 37) that received diet and exercise instruction from the Obesity Clinic and standard clinician care every 2-3 months.
Assessments/Attrition: Assessments occurred at baseline and posttest (i.e., six months later). Six-month posttest data were missing for 23% of the participants.
Sample:
The randomized sample averaged 13.0 years of age and included 65% females. By race, the sample had 28% Blacks, 36% Hispanic Whites, and 33% non-Hispanic Whites. About 80% of children lived in homes with incomes of less than $30,000.
Measures:
The study examined 22 outcome measures that were grouped according to three primary categories: 1) glucose and insulin metabolism, 2) anthropomorphic characteristics (height, weight, body mass), and 3) cardiovascular health. All measures related to physical health or obesity. Change in two-hour plasma glucose was the primary outcome. The measures appear to have been obtained independently with well-validated instruments and procedures.
Analysis:
Changes in outcomes were compared between groups using ANCOVA with adjustment for the baseline outcome and body weight. Analyses also adjusted for baseline factors associated with dropping out.
Missing Data Method: The analysis used multiple imputation for missing data at baseline and posttest, including the posttest outcomes. An additional complete case analysis had little effect on treatment estimates and was not presented.
Intent-to-Treat: The analysis used all randomized participants in their originally assigned condition. Five control participants "were withdrawn from the study because their clinicians started them on metformin," but they were included in the analysis with multiple imputation.
Outcomes
Implementation Fidelity:
Figure 1 in the supplementary document indicated that 95% of the intervention group received the intervention, but the authors offered no details on implementation of the program.
Baseline Equivalence:
Tests in Table 1 for condition differences among the full randomization sample "produced similar distributions of baseline characteristics in both groups," but the authors did not explicitly state that all the differences were non-significant. In addition, the difference between the means for one outcome (2-hour insulin) appears large relative to the standard deviations.
Differential Attrition:
Attrition rates were 18% for the intervention group and 27% for the control group. Dropping out was associated with several baseline measures, but according to the text (p. 320), tests for baseline equivalence using the analysis sample in Table 1 showed no significant differences. Note again that the difference between the means for one outcome (2-hour insulin) appears large relative to the standard deviations.
Posttest:
Of the 22 tests listed in Table 2, 12 reached statistical significance. The intervention group had significantly better outcomes for five of nine measures of glucose and insulin metabolism, five of six measures of weight and body mass, and two of seven measures of cardiovascular health. These effects were the same across gender.
Mediation analysis revealed that from 11-38% of the treatment-related changes in glucose, insulin, and triglycerides were explained by changes in body weight.
Long-Term:
Not examined.