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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02044731
Other study ID # 2012-07-4508 B
Secondary ID 033728B
Status Completed
Phase N/A
First received January 22, 2014
Last updated December 8, 2014
Start date January 2014
Est. completion date July 2014

Study information

Verified date December 2014
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date July 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 12 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Active and Healthy Families
A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.

Locations

Country Name City State
United States Parkside Elementary School Pittsburg California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Parent weight Change will be calculated based on measured weight of parent Baseline and at week 10 No
Other Parent reported behaviors Survey responses on parenting and child's dietary, physical activity, and screen time behaviors. Baseline and at 10 weeks No
Other Parent blood pressure Baseline and at week 10 No
Primary Body mass index (BMI) Change in BMI will be calculated from measured height and weight Baseline and at week 10 No
Secondary Blood pressure Change will be calculated based on measured blood pressure Baseline and at week 10 No
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