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Impact of a Childhood Obesity Intervention for African American Families

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ClinicalTrials.gov Identifier: NCT02044731
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, Berkeley

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Active and Healthy Families Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Childhood Obesity Intervention for African American Families
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: Baseline and at week 10 ]
    Change in BMI will be calculated from measured height and weight


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline and at week 10 ]
    Change will be calculated based on measured blood pressure


Other Outcome Measures:
  1. Parent weight [ Time Frame: Baseline and at week 10 ]
    Change will be calculated based on measured weight of parent

  2. Parent reported behaviors [ Time Frame: Baseline and at 10 weeks ]
    Survey responses on parenting and child's dietary, physical activity, and screen time behaviors.

  3. Parent blood pressure [ Time Frame: Baseline and at week 10 ]


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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044731


Locations
United States, California
Parkside Elementary School
Pittsburg, California, United States, 94565
Sponsors and Collaborators
University of California, Berkeley
Investigators
Principal Investigator: Kristine A Madsen, MD University of California, Berkeley

Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT02044731     History of Changes
Other Study ID Numbers: 2012-07-4508 B
033728B ( Other Grant/Funding Number: Safeway Foundation )
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by University of California, Berkeley:
Schools
Pediatrics
Obesity
Overweight
Intervention Studies
African Americans
Family
Body mass index

Additional relevant MeSH terms:
Obesity
Overweight
Pediatric Obesity
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms