Lifestyle Change to Prevent Diabetes Via African-American Churches

April 8, 2014 updated by: Richard Sattin, Augusta University

Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches

Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program compared with a health education intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

604

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Self-described African American
  • BMI ≥25kg/m2
  • Planning to remain within the community for 1 year
  • Non-diabetic

Exclusion Criteria:

  • Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
  • HIV/AIDS
  • Active tuberculosis
  • Cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis
  • Stroke within the past 6 months
  • Cirrhosis of the liver
  • Currently pregnant or planning pregnancy within the study period
  • Gastric weight-loss surgery
  • Weight loss > 10% in past three months for any reason other than childbirth
  • Anti-diabetic medications
  • Prescription weight- loss medications
  • Anti-neoplastic agents
  • Anti-psychotic agents that have gluco-corticoid effect
  • Oral corticosteroid use >6 weeks
  • Unwilling or unable to give informed consent
  • Unable to communicate with the church team or research group
  • Participation in another research study that would interfere with FBAS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fit Body and Soul
Faith-based adaptation of the Group Life Style Program
Behavioral: Fit Body and Soul
Active Comparator: Wellness education
A health education program developed from the list of topics provided by the Centers for Disease Control and Prevention (CDC) Guide to Community Prevention Services
Behavioral: Wellness Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change
Time Frame: 12-weeks post intervention
12-weeks post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting plasma glucose
Time Frame: 12 week post intervention
12 week post intervention
physical activity level
Time Frame: 12 week post-intervention
12 week post-intervention
quality of life measures
Time Frame: 12 week post-intervention
12 week post-intervention
cost-effectiveness
Time Frame: 12 week post-intervetnion
Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®
12 week post-intervetnion
hemoglobin A1C
Time Frame: 12 week intervention
12 week intervention

Other Outcome Measures

Outcome Measure
Time Frame
waist circumference
Time Frame: 12 weeks post-intervention
12 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Investigators

  • Principal Investigator: Richard W Sattin, MD, Augusta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18DK082401 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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