Lifestyle Change to Prevent Diabetes Via African-American Churches

Study Overview
=================
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.

Official Title
-----------------
Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches

Conditions
-----------------
Diabetes, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: Fit Body and Soul
* Behavioral: Wellness Education


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fit Body and Soul<br>Faith-based adaptation of the Group Life Style Program | Behavioral: Fit Body and Soul<br> <br> |
| Active Comparator: Wellness education<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 12-weeks post intervention | 

Secondary Outcome Measures

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