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Lifestyle Change to Prevent Diabetes Via African-American Churches

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Sattin, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01730196
First received: November 15, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Diabetes
Weight Loss
 Behavioral: Fit Body and Soul
Behavioral: Wellness Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Weight change [ Time Frame: 12-weeks post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose [ Time Frame: 12 week post intervention ] [ Designated as safety issue: No ]
  • physical activity level [ Time Frame: 12 week post-intervention ] [ Designated as safety issue: No ]
  • quality of life measures [ Time Frame: 12 week post-intervention ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: 12 week post-intervetnion ] [ Designated as safety issue: No ]
    Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®

  • hemoglobin A1C [ Time Frame: 12 week intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • waist circumference [ Time Frame: 12 weeks post-intervention ] [ Designated as safety issue: No ]

Enrollment: 604
Study Start Date: September 2009
Estimated Study Completion Date: April 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730196

Locations
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Richard W Sattin, MD Georgia Regents University
  More Information

No publications provided

Responsible Party: Richard Sattin, Professor and Research Director, Department of Emergency Medicine, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01730196     History of Changes
Other Study ID Numbers: R18DK082401
Study First Received: November 15, 2012
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013