Lifestyle Change to Prevent Diabetes Via African-American Churches

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730196
• Other study ID #: R18DK082401
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: April 8, 2014
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Weight Loss

Intervention

Behavioral:
• Fit Body and Soul

• Wellness Education

Locations

Country	Name	City	State
United States	Georgia Health Sciences University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia Regents University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	waist circumference		12 weeks post-intervention	No
Primary	Weight change		12-weeks post intervention	No
Secondary	Fasting plasma glucose		12 week post intervention	No
Secondary	physical activity level		12 week post-intervention	No
Secondary	quality of life measures		12 week post-intervention	No
Secondary	cost-effectiveness	Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®	12 week post-intervetnion	No
Secondary	hemoglobin A1C		12 week intervention	No