Ideas Moving Parents and Adolescents to Change Together (IMPACT)
NCT01514279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2020-08-25
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.
Conditions
Interventions
- BEHAVIORAL
-
HealthyCHANGE
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.
- BEHAVIORAL
-
SystemCHANGE
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.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Case Western Reserve University
lead OTHER
Principal Investigators
-
Elaine A Borawski, PhD · Case Western Reserve University
-
Shirley M Moore, RN, PhD · Case Western Reserve University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 11 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-01
- Primary Completion
- 2017-01-21
- Completion
- 2017-01-31
Countries
- United States
Study Locations
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