Family-based Outcome Results

NCT04132245 | Completed DMC

• 1 other identifier: R21CA121423
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity

Keywords

childhood obesity; minorities; diet; physical activity; parents

Outcome Measures

Primary Outcomes (1)

• Body mass index

  we measured the change in BMI of the children at baseline and post-intervention

  1 year

Study Arms (2)

obesity prevention

EXPERIMENTAL

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

Behavioral: Obesity prevention intervention trial

behavioral intervention

EXPERIMENTAL

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

Behavioral: behavioral intervention

Interventions

behavioral intervention BEHAVIORAL

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

behavioral intervention

Obesity prevention intervention trial BEHAVIORAL

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

obesity prevention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Motor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept. of Medicine and School of Public Health

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: October 18, 2019
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2011
• Last Updated: October 18, 2019

Record last verified: 2019-10