- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132245
Family-based Outcome Results
October 16, 2019 updated by: Dr. Fitzgibbon, University of Illinois at Chicago
Famil-based Obesity Prevention Trial in Latino Families
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: obesity prevention
Families were randomized to an obesity prevention intervention arm or a general health control arm.
|
Families were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention
|
Experimental: behavioral intervention
there are two arms in this study.
An active intervention arm and a control arm
|
Families were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: 1 year
|
we measured the change in BMI of the children at baseline and post-intervention
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
May 16, 2016
First Submitted That Met QC Criteria
October 16, 2019
First Posted (Actual)
October 18, 2019
Study Record Updates
Last Update Posted (Actual)
October 18, 2019
Last Update Submitted That Met QC Criteria
October 16, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21CA121423 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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