Lifestyle Change to Prevent Diabetes Via African-American Churches

Augusta University

Status: Completed

Conditions: Weight Loss; Diabetes

Treatments: Behavioral: Fit Body and Soul; Behavioral: Wellness Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01730196

R18DK082401

Details and patient eligibility

About

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.

Enrollment: 604 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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604 participants in 2 patient groups

Fit Body and Soul

Experimental group

Description:

Faith-based adaptation of the Group Life Style Program

Treatment:

Behavioral: Fit Body and Soul

Wellness education

Active Comparator group

Description:

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

Treatment:

Behavioral: Wellness Education