Family-based Outcome Results

NCT ID: NCT04132245

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

Brief Summary

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Many obesity related risk factors are strikingly apparent in minority populations. Mexican-American children have the highest rates of overweight. The goals of this study are to: 1) test the acceptability of a 14-week family-based intervention with 3-5 year old children and their parents; 2) Estimate the effectiveness of a 14-week family-based intervention designed to show smaller changes, on average, in BMI appropriate for growth; 3) estimate the effectiveness of a 14-week family-based intervention designed to produce changes in television viewing, physical activity, fat, fiber, and fruit and vegetable intake in 3-5 year old Latino children and their parents at post-intervention and Year 1 follow-up.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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obesity prevention

Families were randomized to an obesity prevention intervention arm or a general health control arm.

Group Type EXPERIMENTAL

Obesity prevention intervention trial

Intervention Type BEHAVIORAL

Families were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention

behavioral intervention

there are two arms in this study. An active intervention arm and a control arm

Group Type EXPERIMENTAL

behavioral intervention

Intervention Type BEHAVIORAL

Families were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention

Interventions

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behavioral intervention

Families were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention

Intervention Type BEHAVIORAL

Obesity prevention intervention trial

Families were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* have received an annual physical
* parent or guardian willing to give consent
* parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child

Exclusion Criteria

* requires a specialized diet outside of that served by the Chicago Public Schools
* has a chronic physical or behavioral disorder that requyires participant to be under close emdical psychologicagl supervision and routinely absent from the study
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fitzgibbon

Professor, Dept. of Medicine and School of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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R21CA121423

Identifier Type: NIH

Identifier Source: org_study_id

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