Ideas Moving Parents and Adolescents to Change Together (IMPACT)

Completed · Not applicable

Conditions studied: Overweight, Obese

In brief

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.

Key facts

Study ID

NCT01514279

Run by

Case Western Reserve University

People needed

360

Starts

2011-02-01

Expected to finish

2017-01-31

Last updated by the study team

2020-08-25

Who can join

Age: 11 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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