Back to resultsImpact of a Childhood Obesity Intervention for African American Families
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active and Healthy Families
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Schools, Pediatrics, Obesity, Overweight, Intervention Studies, African Americans, Family, Body mass index
Eligibility 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:
-
Sites / Locations
- Parkside Elementary School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Family group sessions
Arm Description
Active and Healthy Families
Outcomes
Primary Outcome Measures
Body mass index (BMI)
Change in BMI will be calculated from measured height and weight
Secondary Outcome Measures
Blood pressure
Change will be calculated based on measured blood pressure
Full Information
NCT ID
NCT02044731
First Posted
January 22, 2014
Last Updated
December 8, 2014
Sponsor
University of California, Berkeley
1. Study Identification
Unique Protocol Identification Number
NCT02044731
Brief Title
Impact of a Childhood Obesity Intervention for African American Families
Official Title
Impact of a Childhood Obesity Intervention for African American Families
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Schools, Pediatrics, Obesity, Overweight, Intervention Studies, African Americans, Family, Body mass index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family group sessions
Arm Type
Experimental
Arm Description
Active and Healthy Families
Intervention Type
Behavioral
Intervention Name(s)
Active and Healthy Families
Intervention Description
A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.
Primary Outcome Measure Information:
Title
Body mass index (BMI)
Description
Change in BMI will be calculated from measured height and weight
Time Frame
Baseline and at week 10
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change will be calculated based on measured blood pressure
Time Frame
Baseline and at week 10
Other Pre-specified Outcome Measures:
Title
Parent weight
Description
Change will be calculated based on measured weight of parent
Time Frame
Baseline and at week 10
Title
Parent reported behaviors
Description
Survey responses on parenting and child's dietary, physical activity, and screen time behaviors.
Time Frame
Baseline and at 10 weeks
Title
Parent blood pressure
Time Frame
Baseline and at week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine A Madsen, MD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkside Elementary School
City
Pittsburg
State/Province
California
ZIP/Postal Code
94565
Country
United States
12. IPD Sharing Statement
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Impact of a Childhood Obesity Intervention for African American Families
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