Ideas Moving Parents and Adolescents to Change Together (IMPACT)
Ideas Moving Parents and Adolescents to Change Together (IMPACT)
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.
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.
Inclusion Criteria:

 -  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 Criteria:

 -  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)