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Impact of Active and Healthy Families (AHF)

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active and Healthy Families

About this trial

This is an interventional treatment trial for Overweight focused on measuring Primary Health Care, Pediatrics, Obesity, Overweight, Clinical trial, Hispanic Americans, Family, Body mass index

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Pittsburg Health Center
West County Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family group sessions

Wait-list control

Arm Description

Active and Healthy Families

Controls may participate in Active and Healthy Families after the study

Outcomes

Primary Outcome Measures

Changes from baseline in body mass index (BMI)

Change from baseline are assessed from measured height and weight

Secondary Outcome Measures

Change from baseline in blood glucose

Changes from baseline in fasting lipids

Change from baseline in insulin resistance

Change from baseline in blood pressure

Full Information

NCT ID

NCT02044705

First Posted

January 22, 2014

Last Updated

April 9, 2015

Sponsor

University of California, Berkeley

1. Study Identification

Unique Protocol Identification Number

NCT02044705

Brief Title

Impact of Active and Healthy Families

Acronym

AHF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Berkeley

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

Primary Health Care, Pediatrics, Obesity, Overweight, Clinical trial, Hispanic Americans, Family, Body mass index

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Family group sessions

Arm Type

Experimental

Arm Description

Active and Healthy Families

Arm Title

Wait-list control

Arm Type

No Intervention

Arm Description

Controls may participate in Active and Healthy Families after the study

Intervention Type

Behavioral

Intervention Name(s)

Active and Healthy Families

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes from baseline in body mass index (BMI)

Description

Change from baseline are assessed from measured height and weight

Time Frame

Baseline and at week 10

Secondary Outcome Measure Information:

Title

Change from baseline in blood glucose

Time Frame

Baseline and week 10

Title

Changes from baseline in fasting lipids

Time Frame

Baseline and week 10

Title

Change from baseline in insulin resistance

Time Frame

Baseline and week 10

Title

Change from baseline in blood pressure

Time Frame

Baseline and week 10

Other Pre-specified Outcome Measures:

Title

Change in parent weight

Time Frame

Baseline and week 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

Pittsburg Health Center

City

Pittsburg

State/Province

California

ZIP/Postal Code

94565

Country

United States

Facility Name

West County Health Center

City

San Pablo

State/Province

California

ZIP/Postal Code

94806

Country

United States

12. IPD Sharing Statement

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