Lifestyle Change to Prevent Diabetes Via African-American Churches

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01730196

Enrollment

604

Registered

2012-11-21

Start date

2009-09-30

Completion date

2013-04-30

Last updated

2014-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Weight Loss

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.

Interventions

BEHAVIORALFit Body and Soul

BEHAVIORALWellness Education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Weight change	12-weeks post intervention

Secondary

Measure	Time frame	Description
Fasting plasma glucose	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	—
quality of life measures	12 week post-intervention	—

Other

Measure	Time frame
waist circumference	12 weeks post-intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026