Lifestyle Change to Prevent Diabetes Via African-American Churches

Not Applicable

Completed

• Conditions: Diabetes; Weight Loss
• Interventions: Behavioral: Wellness Education; Behavioral: Fit Body and Soul

• Registration Number: NCT01730196
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-04
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Study Completion: 2013-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wellness education	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
Fit Body and Soul	Fit Body and Soul	Faith-based adaptation of the Group Life Style Program

Primary Outcome Measures

Name	Time	Method
Weight change	12-weeks post intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Georgia Health Sciences University; 🇺🇸 Augusta, Georgia, United States