Ideas Moving Parents and Adolescents to Change Together (IMPACT)

NCT01514279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-08-25

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514279 on ClinicalTrials.gov