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A Trial of Two Family-based Childhood Obesity Treatment Programs

NCT03245775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2024-06-28

Study results available
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Summary

The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and 12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for implementation and sustainability, (3) relative impact on family eating/physical activity and parental weight, and (4) relative adherence and potential dose response relationships.

Conditions

  • Obesity, Childhood

Interventions

BEHAVIORAL

iChoose

12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only

BEHAVIORAL

Family Connections

2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only

Sponsors & Collaborators

  • University of Nebraska

    collaborator OTHER

  • Virginia Polytechnic Institute and State University

    collaborator OTHER

  • University of Virginia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-11-30
Completion
2020-06-30

Countries

  • United States

Study Locations

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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 NCT03245775 on ClinicalTrials.gov