NCT00535704

Brief Summary

The Rural African American Families Health (RAAFH) Project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural African American families. One program, FUEL, helps teens develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The sessions deal with goal setting, peer pressure, and staying in school.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 11, 2017

Status Verified

April 1, 2014

Enrollment Period

5.1 years

First QC Date

September 24, 2007

Last Update Submit

January 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sexual behavior

    3 months

Secondary Outcomes (1)

  • Substance Use

    3 months

Study Arms (2)

1

EXPERIMENTAL

The Strong AFrican American FAmilies-Teen program is a five part educational program has been designed to help teens and their parents create successful futures and avoid the risky behaviors that sometimes keep teens from reaching their goals.

Behavioral: Strong African American Families-Teen Program

2

OTHER

The FUEL program is a family-based adaptation of a curriculum designed to assist teens to develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress.

Behavioral: FUEL

Interventions

5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours.

1
FUELBEHAVIORAL

5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours

2

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • African American student in 10th grade
  • Agree to randomization and assessment
  • Resides in targeted county
  • Target and parent speak English

You may not qualify if:

  • Active psychoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Family Research

Athens, Georgia, 30605, United States

Location

Study Officials

  • Gene H Brody

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 11, 2017

Record last verified: 2014-04

Locations