Lifestyle Change to Prevent Diabetes Via African-American Churches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01730196
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : April 9, 2014
Information provided by (Responsible Party):
Richard Sattin, Augusta University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Weight Loss Behavioral: Fit Body and Soul Behavioral: Wellness Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches
Study Start Date : September 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Weight change [ Time Frame: 12-weeks post intervention ]

Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: 12 week post intervention ]
  2. physical activity level [ Time Frame: 12 week post-intervention ]
  3. quality of life measures [ Time Frame: 12 week post-intervention ]
  4. 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®

  5. hemoglobin A1C [ Time Frame: 12 week intervention ]

Other Outcome Measures:
  1. waist circumference [ Time Frame: 12 weeks post-intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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%
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01730196

United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Principal Investigator: Richard W Sattin, MD Augusta University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard Sattin, Professor and Research Director, Department of Emergency Medicine, Augusta University Identifier: NCT01730196     History of Changes
Other Study ID Numbers: R18DK082401 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms