Ideas Moving Parents and Adolescents to Change Together (IMPACT)

Study Overview
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Brief Summary
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The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled Targeting Obesity and Blood Pressure in Urban Youth. The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together). The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes. The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years.

Detailed Description
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The IMPACT trial will involve a 3-arm randomized controlled trial of three behavioral and educational interventions: (1) HealthyCHANGE, a behavioral approach focusing on building skills and increasing intrinsic motivation (based on cognitive-behavioral theory with motivational interviewing components); (2) SystemCHANGE, an innovative behavioral approach focusing on system re-design of the family environment and daily routines (based on social-ecological and personal process improvement theories); and (3) education-only (representing usual care, called Tools4CHANGE). In the main trial, approximately half of the children will also be in schools that take part in the We Run This City (WRTC)Marathon program, a school-based fitness program administered by the YMCA, and half will be in schools that do not take part in the WRTC program. This study will assess the impact of the interventions on the main trial's (1) primary outcome, Change in Body Mass Index (BMI). (2) secondary outcomes including diet, physical activity, sedentary behavior, sleep, blood pressure, cardiovascular risk, body composition, fitness, and quality of life (3) mediators including : child's self-efficacy, social support, motivation, family problem solving ability, systems thinking, and self-regulation;(4) moderators including: socioeconomic status, demographic factors, environmental factors, personal and psychosocial characteristics of child and parent.

Official Title
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Targeting Obesity and Blood Pressure in Urban Youth(Consortium Title: Childhood Obesity Prevention and Treatment Research [COPTR] and Site Project Name IMPACT (Ideas Moving Parents and Adolescents to Change Together).

Conditions
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Overweight, Obese

Intervention / Treatment
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* Behavioral: HealthyCHANGE
* Behavioral: SystemCHANGE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Students entering the 6th grade who are found at the standard school screenings to be overweight or obese (BMI 85th- 94th percentile or > 95th percentile for age/sex respectively) Exclusion Criteria: Taking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones) Inability to understand English Stage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria) Severe behavioral problems that preclude group participation (as reported by parent/guardian) Child involvement in another weight management program Family expectation to move from the region within 1 year The presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HealthyCHANGE<br>Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. | Behavioral: HealthyCHANGE<br>* Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.<br>|
| Experimental: SystemCHANGE<br>Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines | Behavioral: SystemCHANGE<br>* Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.<br>|
| No Intervention: Tools4CHANGE<br>In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slope of Body Mass Index (BMI) | BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Intake- Calories Per Day | Annualized change in calories per day. Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos | 
| Blood Pressure | Annualized change in blood pressure measures using the slope of 3 year trajectory. Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos | 
| Physical Activity | Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer. Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | [Baseline, 12 mos, 24 mos and 36 mos] | 
| Sleep | The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome. Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | [Baseline, 12 mos, 24 mos and 36 mos] | 
| Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported. | Baseline, 12 mos, 24 mos and 36 mos | 
| Body Composition- BMI Percentile | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of BMI percentile over time reported. | Baseline, 12 mos, 24 mos and 36 mos | 
| Fitness | The annualized change in pacer laps completed during PACER test over 3 years. PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos | 
| Quality of Life- Perceived Stress | The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months). The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | [Baseline, 12 mos, 24 mos and 36 mos] | 
| Dietary Intake- Percent Calories From Fat | The annualized change of percent of calories from fat over 3 years. Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 months, 24 months, 36 months | 
| Dietary Intake- Fruit and Vegetable Servings | The annualized change in the number of fruit and vegetable servings per day over 3 years. Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 months, 24 months, 36 months | 
| Dietary Intake- Sodium | The annualized change in sodium intake (mg) per day over 3 years. Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 months, 24 months, 36 months | 
| Cardiometabolic Factors- Hemoglobin A1c | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of glycated Hemoglobin A1c over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] | 
| Cardiometabolic Factors- High-sensitivity C-reactive Protein | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of high-sensitivity C-reactive protein over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] | 
| Cardiometabolic Factors- Insulin | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of insulin over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] | 
| Cardiometabolic Factors- HOMA-IR | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of HOMA-IR over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] | 
| Body Composition- Waist-to-height Ratio | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm). | [Baseline, 12 mos, 24 mos, 36 mos] | 
| Body Composition- Waist Circumference | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist circumference (cm) over time reported. | [Baseline, 12 mos, 24 mos, 36 mos] | 
| Body Composition- Percent Body Fat | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation. | [Baseline, 12 mos, 24 mos, 36 mos] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Over Nutrition, Overweight, Obese, Nutrition Disorders, Body weight, Signs and Symptoms