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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04132245
Other study ID # R21CA121423
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2008
Est. completion date April 2011

Study information

Verified date October 2019
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date April 2011
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
behavioral intervention
Families were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention
Obesity prevention intervention trial
Families were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Chicago

Outcome

Type Measure Description Time frame Safety issue
Primary Body mass index we measured the change in BMI of the children at baseline and post-intervention 1 year
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