Lifestyle Change to Prevent Diabetes Via African-American Churches

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Sattin, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01730196
First received: November 15, 2012
Last updated: April 8, 2014
Last verified: April 2014
  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:


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
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
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: 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 Regents University
ClinicalTrials.gov Identifier: NCT01730196     History of Changes
Other Study ID Numbers: R18DK082401
Study First Received: November 15, 2012
Last Updated: April 8, 2014
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 July 31, 2014