CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 360 enrolled
Drug / intervention
HealthyCHANGE +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01514279
NCT01514279N/ACompleted

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).

Case Western Reserve University·interventional·Posted Jan 23, 2012·Updated Aug 25, 2020

In Brief

A clinical study evaluating HealthyCHANGE and SystemCHANGE for Overweight and Obese. Completed, enrolled 360 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obese
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2012
Enrollment StartFeb 1, 2011
Primary CompletionJan 21, 2017
Study CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 14.4 years ago

Interventions

HealthyCHANGEbehavioral

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.

SystemCHANGEbehavioral

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.