Status:
COMPLETED
Ideas Moving Parents and Adolescents to Change Together (IMPACT)
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Overweight
Obese
Eligibility:
All Genders
11-15 years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2017
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01514279
Start Date
February 1 2011
End Date
January 31 2017
Last Update
August 25 2020
Active Locations (1)
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1
Case Western Reserve University
Cleveland, Ohio, United States, 44106