Impact of Active and Healthy Families (AHF)

April 9, 2015 updated by: University of California, Berkeley

Impact of Active and Healthy Families (Familias Activas y Saludables): A Family-Based Group Medical Appointment Model for Childhood Obesity in Federally Qualified Health Centers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

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
        • Pittsburg Health Center
      • San Pablo, California, United States, 94806
        • West County Health Center

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

No

Genders Eligible for Study

All

Description

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 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: Randomized
  • Interventional Model: Parallel 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
Pediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions).
No Intervention: Wait-list control
Controls may participate in Active and Healthy Families after the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in body mass index (BMI)
Time Frame: Baseline and at week 10
Change from baseline are assessed from measured height and weight
Baseline and at week 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in blood glucose
Time Frame: Baseline and week 10
Baseline and week 10
Changes from baseline in fasting lipids
Time Frame: Baseline and week 10
Baseline and week 10
Change from baseline in insulin resistance
Time Frame: Baseline and week 10
Baseline and week 10
Change from baseline in blood pressure
Time Frame: Baseline and week 10
Baseline and week 10

Other Outcome Measures

Outcome Measure
Time Frame
Change in parent weight
Time Frame: Baseline and week 10
Baseline and 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

September 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 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)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-07-4508 A
  • 033728 (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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