NCT00991731

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

5.4 years

First QC Date

October 6, 2009

Last Update Submit

August 10, 2015

Conditions

Physical Activity

Keywords

Physical ActivityFaith basedNon faith basedAfrican AmericanFemalePedometers

Outcome Measures

Primary Outcomes (1)

  • Comparing the efficacy of faith-based vs non-faith-based to a control condition in increasing daily physical activity measured as steps/day.

    baseline, 10 months, and 22 months

Study Arms (3)

Faith-based

ACTIVE COMPARATOR

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

Non-faith-based

ACTIVE COMPARATOR

A curriculum designed for delivery without biblical references. In the traditional teachings of how to increase physical activity.

Behavioral: Non-faith-based

Control

NO INTERVENTION

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.

Interventions

Faith-basedBEHAVIORAL

The faith-based intervention will include 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.

Faith-based
Non-faith-basedBEHAVIORAL

The non-faith based intervention will include 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.

Non-faith-based

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gramercy Research Group

Winston-Salem, North Carolina, 27101, United States

Location

Related Publications (3)

  • Story CR, Gross TT, Harvey IS, Whitt-Glover MC. Pastoral perceptions of the learning and developing individual exercise skills (L.A.D.I.E.S.) intervention: a qualitative study. Health Educ Res. 2017 Feb 1;32(1):81-95. doi: 10.1093/her/cyw054.

    PMID: 28052931DERIVED

  • Harvey IS, Story CR, Knutson D, Whitt-Glover MC. Exploring the Relationship of Religiosity, Religious Support, and Social Support Among African American Women in a Physical Activity Intervention Program. J Relig Health. 2016 Apr;55(2):495-509. doi: 10.1007/s10943-015-0017-6.

    PMID: 25673181DERIVED

  • Whitt-Glover MC, Goldmon MV, Karanja N, Heil DP, Gizlice Z. Learning and Developing Individual Exercise Skills (L.A.D.I.E.S.) for a better life: a physical activity intervention for black women. Contemp Clin Trials. 2012 Nov;33(6):1159-71. doi: 10.1016/j.cct.2012.08.003. Epub 2012 Aug 11.

    PMID: 22917598DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Faith-Based Organizations

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Melicia C Whitt-Glover, Ph.D.

    Gramercy Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President & CEO

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 8, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(1)