NCT01514279

Ideas Moving Parents and Adolescents to Change Together (IMPACT)

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).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 11 Years – 15 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Overweight
• Obese

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-02-01
• Primary completion: 2017-01-21
• Completion: 2017-01-31
• First posted: 2012-01-23
• Last updated: 2020-08-25
• Results posted: 2020-08-25

Locations

1 site across 1 country: United States