Impact of a Childhood Obesity Intervention for African American Families

December 8, 2014 updated by: University of California, Berkeley
The purpose of this study is to evaluate the impact on body mass index (BMI) of a 5-session childhood obesity intervention for African American families among children aged 5-12 years. We hypothesize that children participating in the program will experience a reduction in BMI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pittsburg, California, United States, 94565
        • Parkside Elementary School

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

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI greater than or equal to the 85th percentile for age and sex
  • Attends an elementary school in the Pittsburg Unified School District in California
  • Parent of child meeting above criteria

Exclusion Criteria:

-

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family group sessions
Active and Healthy Families
Behavioral: Active and Healthy Families
A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: Baseline and at week 10
Change in BMI will be calculated from measured height and weight
Baseline and at week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Baseline and at week 10
Change will be calculated based on measured blood pressure
Baseline and at week 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent weight
Time Frame: Baseline and at week 10
Change will be calculated based on measured weight of parent
Baseline and at week 10
Parent reported behaviors
Time Frame: Baseline and at 10 weeks
Survey responses on parenting and child's dietary, physical activity, and screen time behaviors.
Baseline and at 10 weeks
Parent blood pressure
Time Frame: Baseline and at week 10
Baseline and at week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Investigators

  • Principal Investigator: Kristine A Madsen, MD, University of California, Berkeley

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

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-07-4508 B
  • 033728B (Other Grant/Funding Number: Safeway Foundation)

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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