Ideas Moving Parents and Adolescents to Change Together (IMPACT)
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional

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.
    

Intervention name(s): HealthyCHANGE; SystemCHANGE
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overweight; Obese; Over Nutrition; Nutrition Disorders; Body weight; Signs and Symptoms