Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. (2007). Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. Journal of the American Medical Association, 297 (24), 2697-2704.
Designed to improve dietary habits and increase physical activity to reduce obesity in children and adolescents, this manual-driven, family-based intervention consists of four sequential, 12-week learning phases with sessions focusing on exercise, nutrition education, and cognitive behavioral skills as well as a peer support maintenance phase. The study showed decreases in weight, body mass index (BMI), percent body fat, total estimated body fat mass, total fasting cholesterol, fasting insulin, and insulin resistance.
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From 1980 to 2008, the rate of obesity tripled for children in the United States, and by 2011, 17 percent of American children were considered obese, according to the Centers for Disease Control and Prevention (CDC). Obesity increases the risk of many chronic health conditions in adulthood, including coronary heart disease, stroke, high blood pressure, type 2 diabetes, high total cholesterol, certain cancers, liver and gallbladder disease, and sleep apnea. Medical care costs related to obesity for U.S. adults were estimated at $147 billion in 2008. American society has become characterized by lifestyles and environments that promote physical inactivity and increased consumption of less-healthy food. Maintaining a healthy weight decreases an individual's risk of developing endometrial (uterine), breast, prostate, and colorectal cancers in adulthood.
Smart Moves/Bright Bodies is a manual-driven, family-based weight management program that offers periodic exercise and nutrition education or cognitive behavioral skill training to obese children and adolescents (aged 8-18 years) and their caregivers. Delivered over a 12-month period, the curriculum consists of four sequential, 12-week learning phases to achieve a goal weight, each separated by a 2-week break. During each learning phase, participants receive two exercise sessions per week and one nutrition education or cognitive behavioral skill session per week. Once a goal weight has been achieved, youth move into a bimonthly maintenance phase, which consists mostly of peer support to maintain their goal weight. Parents do not participate in the exercise component of the program and attend separate cognitive behavioral skill sessions from their children.
The exercise component of Smart Moves/Bright Bodies is provided to groups of youth of similar ages (e.g., 8-10 or 14-16 years old). Each session begins with a warm-up activity followed by high-intensity aerobic exercise and a cool-down activity. The high-intensity exercise consists of games, obstacle courses, basketball, flag football, sprinting, and sport drills that are designed to sustain 65-80 percent of the age-adjusted maximal heart rate for the duration of the exercise. Youth are encouraged to exercise an additional 3 days at home weekly and to decrease sedentary behaviors.
The cognitive behavioral skill sessions for youth address self-awareness, goal setting, stimulus control, coping skills training, and cognitive behavior strategies. The sessions include topics such as "Ready, Set, Goal!", "Risky Business: Identifying High-Risk Situations", "Mirror, Mirror on the Wall", "Bullies, Teasers, and Other Annoying People", and "Oops I Slipped: Understanding a Relapse". The cognitive behavioral skill sessions for parents include topics that reflect the challenges parents verbalize during the sessions and emphasize the importance of the parents' role in modeling healthy behavior change. For example, parents learn about good food choices for the entire family and how to be better role models and communicators-all factors considered to be associated with the youth's weight management success.
The nutrition education component is attended by both youth and parents. It uses a lifestyle modification approach that emphasizes low-fat, nutrient-dense foods of moderate portions. Session topics include "Determining Portion Sizes", "Better Food Choices: A NonDiet Approach", Making Sense of a Food Label", and "Bag It! Pros to Bringing Lunch to School". For another topic, "Recipes Dear to the Heart", participants are invited to share traditional family recipes and work together as a team to modify these recipes to be healthier.
Ideally, staffing for the program includes a registered dietician to facilitate the nutrition sessions, a social worker with training in cognitive behavioral therapy to facilitate the cognitive behavioral skill sessions, and one or two exercise physiologists trained in pediatric CPR to facilitate the exercise classes. One exercise physiologist is recommended to facilitate classes of 6-10 youth at one time; two exercise physiologists may be needed for group activities such as basketball games, kickball, and relay races. A psychologist or social worker may also serve as a facilitator for the parent cognitive behavioral skill sessions.
An award system for maintaining or reducing one's weight (for example, monthly or bimonthly gift certificates) helps to retain participants in the program. A small enrollment fee can be used to fund the award system. Smart Moves/Bright Bodies can be delivered in a school (as an afterschool program), hospital, doctor's office, fitness center, community educational center, or YMCA/YMHA.
In the randomized clinical trial of Smart Moves/Bright Bodies, the active component of the program was delivered over 6 months, rather than the 12-month period that is now recommended. At the end of the 6 months, students entered a 6-month maintenance phase during which they attended either one session every other week or two sessions per month. Students were not required to meet their goal weight before entering the maintenance phase.
- 15 hours per week of clerical/secretarial support for 60-80 youth participants
- 45-50 minutes twice weekly for the exercise class
- 40 minutes per class once weekly for the nutrition education or cognitive behavioral skill class (30 minutes for 8- to 10-year old children)
- 1-2 hours per evening/day of services for special topics, parent groups, or individual meetings with youth as needed
The intervention targets youth aged 8-18 years old and at least one caregiver (for example, mother, father, or grandparent) willing to participate in the program.
The intervention is delivered in a hospital, doctor's office, fitness center, after school program, school, community educational center, or YMCA/YMHA.
Materials required for implementation include:
- Smart Moves Curriculum Start-up Package (20 workbooks, 2 instructor's manuals); workbooks are available in English and Spanish
Recommended but not required:
-Smart Moves Start-up Manual (step-by-step instructions for starting a program, with electronic copies of brochure, schedules, newsletters, etc.)
- Smart Moves Exercise Curriculum
- On-site training by the Bright Bodies Program staff at the Yale Center for Clinical Investigating and Pediatric Endocrinology, Yale School of Medicine
All materials can be ordered from the Smart Moves/Bright Bodies Web site. For information on costs associated with the program, please contact the program developer: Mary Savoye-DeSanti.
About the Study
A randomized clinical study evaluated the effects of an intensive, family-based weight management program for obese youth (aged 8-16 years) on body composition, cholesterol, and insulin sensitivity at 6- and 12-month follow-ups. Obese youth with a body mass index (BMI) above the 95th percentile for age, based on CDC growth charts, were recruited from a university-based pediatric obesity clinic.
A total of 209 volunteer youth were randomized from 284 youth assessed for eligibility, yielding a recruitment rate of 73.6 percent. A second randomization of 35 youth to a structured meal plan occurred within the intervention group, but this study arm was discontinued after 6 months because of an 83 percent dropout rate. These 35 youth were not included in any of the analyses. The resulting dataset of 174 youth (plus parents/caregivers who agreed to participate) were randomly assigned to either the intervention group (n=105) or a control group receiving traditional, clinical weight management counseling (n=69). The control group was seen in a pediatric obesity clinic every 6 months and received diet and exercise counseling from registered dieticians and physicians, along with brief psychosocial counseling from a social worker. Youth in the control group were guaranteed participation in the intervention after completion of the 12-month randomized study period. The mean age of participating youth was 11.9 years in the intervention group and 12.4 years in the control group; 60.9 percent of the randomized sample was female, 36.8 percent was White, 38.5 percent was Black, and 24.7 percent was Hispanic.
During the high-intensity exercise sessions, youth wore a heart rate monitor to confirm they sustained 65-80 percent of the age-adjusted maximal heart rate. Youth also self-reported their level of exertion using the Borg Perceived Exertion Scale. The minimum activity completed by each youth was 100 minutes per week (two 50-minute sessions) for the first 6 months and 100 minutes twice per month for the last 6 months. Motivational tools were used to encourage regular exercise attendance, and youth were encouraged to decrease sedentary behaviors and exercise an additional 3 days weekly at home.
The study measured body composition, blood pressure, and fasting blood total cholesterol, triglycerides, glucose, insulin, and insulin resistance at baseline and at 6 and 12 months after baseline. For the body composition outcome, weight was measured using a medical scale zeroed and calibrated before each weight, with youth wearing socks and a light gown; BMI was assessed by dividing the weight (in kilograms) by height in meters squared, measured in 0.1 centimeter intervals using a stadiometer. Percent body fat was estimated by a Tanita TBF 300 Body Composition Analyzer/Scale. Total body fat mass was calculated by multiplying the percent body fat by actual weight in kilograms. Blood pressure was measured automatically with a sphygmomanometer, with three measures taken after the youth sat still for at least 5 minutes; the second and third measurements were averaged for analysis. Blood samples were obtained after a 10-hour, overnight fast for the measurement of plasma glucose, insulin, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride levels. Plasma glucose levels were measured with a chemistry analyzer, and plasma insulin levels were measured by radioimmunoassay. Plasma lipid levels were measured with an autoanalyzer. The homeostasis model assessment of insulin resistance (HOMA-IR) was used to measure change in insulin sensitivity. HOMA-IR was calculated using the following formula: fasting plasma insulin plus fasting plasma glucose divided by 22.5.
There were no significant differences between the intervention and control groups at baseline on demographic or outcome characteristics. Follow-up rates across the entire sample were 78 percent and 68 percent at 6 and 12 months, respectively. Missing data were imputed in an intent-to-treat analysis approach that incorporated all randomized youth (except for those in the second randomization, who were excluded from analyses).
- From baseline to 6-month follow-up, participants in the intervention group had a significant decrease in body weight compared with participants in the control group, who increased in body weight (-2.6 kg vs. +5.0 kg, p<.001). From baseline to 12-month follow-up, participants in the intervention group gained less weight compared with participants in the control group (+0.3 kg vs. +7.7 kg, p<.001).
- For both follow-up periods (baseline to 6-months and baseline to 12-months), participants in the intervention group had a significant decrease in BMI, whereas participants in the control group increased in BMI (-2.1 BMI vs. +1.1 BMI at 6 months, p<.001, and -1.7 BMI vs. +1.6 BMI at 12 months, p<.001).
- From baseline to 6-month and 12-month follow-ups, participants in the intervention group had decreases in percent body fat compared with participants in the control group, whose percent body fat increased (-3.2 percent vs. +2.0 percent at 6 months, p<.001, and -4.0 percent vs. +2.0 percent at 12 months, p<.001). Similarly, for both follow-up periods, participants in the intervention group had decreases in total estimated body fat mass compared with participants in the control group, who had increases in body fat mass (-4.1 kg vs. +4.4 kg at 6 months, p<.001, and -3.7 kg vs. +5.5 kg at 12 months, p<.001).
- From baseline to 6-month and 12-month follow-ups, participants in the intervention group had decreases in total fasting cholesterol compared with participants in the control group, who had increases in total fasting cholesterol (-7.5 mg/dL vs. +1.5 mg/dL at 6 months, p=.05, and -9.2 mg/dL vs. +3.7 mg/dL at 12 months, p=.005).
- From baseline to 6-month and 12-month follow-ups, participants in the intervention group had decreases in fasting insulin compared with participants in the control group, whose fasting insulin increased (-6.5 μIU/mL vs. +1.7 μIU/mL at 6 months, p<.001, and -6.1 μIU/mL vs. +4.5 μIU/mL at 12 months, p<.001). For both follow-up periods, participants in the intervention group also had decreases in the HOMA-IR measure of insulin resistance, while participants in the control group had increases in HOMA-IR (-1.51 HOMA-IR vs. +0.33 HOMA-IR at 6 months, p<.001, and -1.52 HOMA-IR vs. +0.9 HOMA-IR at 12 months, p<.001).
Matthews, D. R., Hosker, J. P., Rudenski, A. S., Naylor, B. A., Treacher, D. F., & Turner, R. C. (1985). Homeostasis model assessment: Insulin resistance and beta cell function from fasting plasma glucose and insulin concentration in man. Diabetologia, 28 (7), 412-419.
Savoye, M., Berry, D., Dziura, J., Shaw, M., Serrecchia, J. B., Barbetta, G., Rose, P., Lavietes, S., & Caprio, S. (2005). Anthropometric and psychosocial changes in obese adolescents enrolled in a weight management program. Journal of the American Dietetic Association , 105 (3), 364-370.
Savoye, M., Nowicka, P., Shaw, M., Yu, S., Dziura, J., Chavent, G., O'Malley, G., Serrecchia, J. B., Tamborlane, W. W., & Caprio, S. (2011). Long-term results of an obesity program in an ethnically diverse pediatric population. Pediatrics, 127 (3), 402-410.
Shaw, M., Savoye, M., Cali, A., Dziura, J., Tamborlane, W. V., & 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.
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