A Program to Increase Physical Activity Among Blacks

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Gramercy Research Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Montana State University
Kaiser Permanente
Information provided by:
Gramercy Research Group
ClinicalTrials.gov Identifier:
NCT00991731
First received: October 6, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

The purpose of this research study is to evaluate three different approaches for increasing physical activity in African American women who are not currently doing enough physical activity. One approach will teach people about physical activity, in groups, using general principles (general physical activity program). The second approach will teach people about physical activity, in groups, using principles from the bible (faith-based physical activity program). The third approach will teach people about physical activity by giving them written materials created at the National Institutes of Health (control group). Control groups are used in research studies to see if the program being studied really does have an effect on physical activity. At the end of the study, people in the control group will also participate in either the general physical activity program or the faith-based physical activity program.


Condition Intervention
Physical Activity
Behavioral: Faith Based
Behavioral: Non-Faith Based

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: A Faith-Based Intervention to Increase Physical Activity Among Blacks

Further study details as provided by Gramercy Research Group:

Primary Outcome Measures:
  • Comparing the efficacy of faith-based vs non-faith-based to a control condition in increasing daily physical activity measured as steps/day. [ Time Frame: baseline, 10 months, and 22 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: July 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Faith-based curriculum
Faith-based interventions incorporate tenets of the faith-based organization (e.g., religious beliefs, scriptural references) and involve the faith-based organization in the planning of the intervention from beginning to end
Behavioral: Faith Based
24 group sessions. Sessions 1 - 16 will occur weekly, sessions 17 - 20 will occur bi-weekly, and sessions 21 - 24 will occur monthly. Sessions will be scheduled to last for 90 minutes each. This will include a 30-minute physical activity session (led by a trained exercise leader) and 60 minutes of group discussion (led by a Community Health Worker trained in group facilitation, familiarity with theology and health ministry education, and experience implementing group-based activities in faith settings). Group discussion content will be standardized to ensure consistent delivery. All items will be delivered with biblical references to further guide the participants.
Active Comparator: Non-faith-based curriculum
A curriculum designed for delivery without biblical references. In the traditional teachings of how to increase physical activity.
Behavioral: Non-Faith Based
24 group sessions. Sessions 1 - 16 will occur weekly, sessions 17 - 20 will occur bi-weekly, and sessions 21 - 24 will occur monthly. Sessions will be scheduled to last for 90 minutes each. This will include a 30-minute physical activity session (led by a trained exercise leader) and 60 minutes of group discussion (led by a Community Health Worker trained in group facilitation, familiarity with theology and health ministry education, and experience implementing group-based activities in faith settings). Group discussion content will be standardized to ensure consistent delivery. All items will be delivered without biblical references as in the faith-based intervention.
No Intervention: Uncontrolled
This group will receive a printed pamphlet "Energize Yourself! Stay Physically Active", published by the National Heart Lung and Blood Institute, that encourages participation in at least 30 minutes of daily physical activity all at once or in bouts lasting 10 minutes at a time.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American women > 18 years of age who report that they are not currently meeting the guidelines for regular moderate or vigorous physical activity.
  • No physical limitations or disabilities that would limit physical activity participation.
  • No contraindications for increasing daily physical activity, such as recent myocardial infarction or congestive heart failure, and should be willing to participate in a two-year study.

Exclusion Criteria:

  • Individuals <18 years of age will be ineligible for participation.
  • Those with walking aids (e.g., walkers, canes).
  • Those who may need additional medical clearance (e.g., severe obesity) will be asked to obtain clearance prior to formal enrollment into the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991731

Locations
United States, North Carolina
Gramercy Research Group
Winston Salem, North Carolina, United States, 27101
Sponsors and Collaborators
Gramercy Research Group
University of North Carolina, Chapel Hill
Montana State University
Kaiser Permanente
Investigators
Principal Investigator: Melicia C Whitt-Glover, Ph.D. Gramercy Research Group
  More Information

No publications provided by Gramercy Research Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Melicia Whitt-Glover, Gramercy Research Group
ClinicalTrials.gov Identifier: NCT00991731     History of Changes
Other Study ID Numbers: REE1-09-063, 1R01HL094580-01A1
Study First Received: October 6, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Gramercy Research Group:
Physical Activity
Faith based
Non faith based
African American
Female
Pedometers

ClinicalTrials.gov processed this record on August 28, 2014