CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 267 enrolled
Drug / intervention
iChoose +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/NCT03245775
NCT03245775N/ACompleted
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A Randomized-controlled Trial to Compare the Reach, Effectiveness and Maintenance of Two Family-based Childhood Obesity Treatment Programs in a Medically Underserved Region

University of Virginia·interventional·Posted Aug 10, 2017·Updated Jun 28, 2024

In Brief

A clinical study evaluating iChoose and Family Connections for Obesity, Childhood. Completed, enrolled 267 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Childhood
CountriesUnited States
CollaboratorsUniversity of Nebraska, Virginia Polytechnic Institute and State University

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 10, 2017
Enrollment StartJun 1, 2017
Primary CompletionNov 30, 2019
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.9 years ago

Interventions

iChoosebehavioral

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

Family Connectionsbehavioral

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