NCT00379925

Brief Summary

Obese African Americans are at risk for diseases such as diabetes, cancer, and heart disease. Church-based interventions have the potential to positively influence the health habits and behaviors of a large percentage of African Americans. The purpose of this study is to evaluate the effectiveness of a church-based program that emphasizes increased physical activity and healthy dietary habits among members of predominately African American churches in South Carolina.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

5.1 years

First QC Date

September 22, 2006

Last Update Submit

April 26, 2021

Conditions

Keywords

Physical ActivityExerciseDietary Habits

Outcome Measures

Primary Outcomes (3)

  • Blood pressure

    Systolic and diastolic blood pressure

    15 months

  • Physical activity (measured with the Community Healthy Activities Model Program For Seniors [CHAMPS] questionnaire)

    Self-report measure of physical activity

    15 months

  • Fruit and vegetable consumption (measured with NCI screener & 2-item measure)

    self-report measure of physical activity

    15 months

Secondary Outcomes (3)

  • Physical activity (measured with an accelerometer)

    15 months

  • Fat consumption

    15 months

  • Fiber consumption

    15 months

Study Arms (2)

Behavioral

EXPERIMENTAL

Participants will take part in the Physical Activity and Dietary Health Promotion Program.

Behavioral: Physical Activity and Dietary Health Promotion Program

Delayed intervention

NO INTERVENTION

Participants are assigned to a delayed intervention group and serve as a no-intervention control group.

Interventions

Churches within the intervention group will receive a committee training and church cook training designed to teach them how to do a self-assessment of current practices and develop a plan for their program. The intervention is based on the structural model of health behavior and targets opportunities, mass media (within the church), guidelines and policies, and church environment. Intervention churches also receive monthly intervention mailings to support intervention implementation.

Behavioral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of a church in the Palmetto Conference of the 7th Episcopal District of the AME Church
  • Attends church services or events at least once per month

You may not qualify if:

  • Planning to move in the 18 months following study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

African Methodist Episcopal Churches in South Carolina

Lane, South Carolina, 29564, United States

Location

Related Publications (3)

  • Kyryliuk R, Baruth M, Wilcox S. Predictors of Weight Loss for African-American Women in the Faith, Activity, and Nutrition (FAN) Study. J Phys Act Health. 2015 May;12(5):659-65. doi: 10.1123/jpah.2013-0220. Epub 2014 Jun 4.

  • Saunders RP, Wilcox S, Baruth M, Dowda M. Process evaluation methods, implementation fidelity results and relationship to physical activity and healthy eating in the Faith, Activity, and Nutrition (FAN) study. Eval Program Plann. 2014 Apr;43:93-102. doi: 10.1016/j.evalprogplan.2013.11.003. Epub 2013 Dec 10.

  • Wilcox S, Parrott A, Baruth M, Laken M, Condrasky M, Saunders R, Dowda M, Evans R, Addy C, Warren TY, Kinnard D, Zimmerman L. The Faith, Activity, and Nutrition program: a randomized controlled trial in African-American churches. Am J Prev Med. 2013 Feb;44(2):122-31. doi: 10.1016/j.amepre.2012.09.062.

MeSH Terms

Conditions

ObesityMotor ActivityFeeding Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavior, Animal

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sara Wilcox, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 25, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations