N/A
Completed N=360
Ideas Moving Parents and Adolescents to Change Together (IMPACT)
Overweight · Obese
Source: ClinicalTrials.gov NCT01514279 ↗
Enrolled (actual)
360
Serious AEs
24.2%
Results posted
Aug 2020
Primary outcomePrimary: Slope of Body Mass Index (BMI) — 0.821; 1.083; 0.952 kg/m^2/year
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slope of Body Mass Index (BMI) |
0.821; 1.083; 0.952 | — |
| SECONDARY Dietary Intake- Calories Per Day |
12.49; 6.99; 24.03 | — |
| SECONDARY Blood Pressure |
1.245; 1.130; 0.886; -0.136; -0.074; -0.162 | — |
| SECONDARY Physical Activity |
-3.370; -4.619; -3.523; 10.501; 13.052; 11.022 | — |
| SECONDARY Sleep |
-1.061; -1.552; -1.184; -0.239; -0.361; -0.273 | — |
| SECONDARY Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol |
-0.146; -0.520; -0490; -0.300; -0.600; -0.385 | — |
| SECONDARY Body Composition- BMI Percentile |
-1.375; -0.258; -1.082 | — |
| SECONDARY Fitness |
1.084; 0.533; 1.715 | — |
| SECONDARY Quality of Life- Perceived Stress |
0.313; -0.049; -0.026 | — |
| SECONDARY Dietary Intake- Percent Calories From Fat |
0.139; -0.050; -0.055 | — |
| SECONDARY Dietary Intake- Fruit and Vegetable Servings |
-0.061; -0.050; -0.055; 0.013; 0.008; -0.008 | — |
| SECONDARY Dietary Intake- Sodium |
-0.42; 26.46; 39.15 | — |
| SECONDARY Cardiometabolic Factors- Hemoglobin A1c |
-0.040; -0.021; -0.017 | — |
| SECONDARY Cardiometabolic Factors- High-sensitivity C-reactive Protein |
-0.013; -0.002; -0.0185 | — |
| SECONDARY Cardiometabolic Factors- Insulin |
0.772; 0.406; 0.228 | — |
| SECONDARY Cardiometabolic Factors- HOMA-IR |
0.032; 0.037; 0.004 | — |
| SECONDARY Body Composition- Waist-to-height Ratio |
-0.003; 0.002; -0.001 | — |
| SECONDARY Body Composition- Waist Circumference |
1.814; 2.339; 2.200 | — |
| SECONDARY Body Composition- Percent Body Fat |
-0.246; 0.299; -0.044 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01514279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.