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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02044705
Other study ID # 2012-07-4508 A
Secondary ID 033728
Status Completed
Phase N/A
First received January 22, 2014
Last updated April 9, 2015
Start date September 2012
Est. completion date May 2014

Study information

Verified date April 2015
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 of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date May 2014
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- Aged 5-12 years

- Body mass index greater than or equal to the 85th percentile for age and sex

- Patients seen at Contra Costa County clinics participating in Active and Healthy Families

- Spanish speaking

- Parent of participant

Exclusion Criteria:

- Previous participation in Active and Healthy Families

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Active and Healthy Families
Pediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions).

Locations

Country Name City State
United States Pittsburg Health Center Pittsburg California
United States West County Health Center San Pablo 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 Change in parent weight Baseline and week 10 No
Primary Changes from baseline in body mass index (BMI) Change from baseline are assessed from measured height and weight Baseline and at week 10 No
Secondary Change from baseline in blood glucose Baseline and week 10 No
Secondary Changes from baseline in fasting lipids Baseline and week 10 No
Secondary Change from baseline in insulin resistance Baseline and week 10 No
Secondary Change from baseline in blood pressure Baseline and week 10 No
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