Lifestyle Change to Prevent Diabetes Via African-American Churches
Primary Purpose
Diabetes, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit Body and Soul
Wellness Education
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes
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
Sites / Locations
- Georgia Health Sciences University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fit Body and Soul
Wellness education
Arm Description
Faith-based adaptation of the Group Life Style Program
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
Outcomes
Primary Outcome Measures
Weight change
Secondary Outcome Measures
Fasting plasma glucose
physical activity level
quality of life measures
cost-effectiveness
Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®
hemoglobin A1C
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01730196
Brief Title
Lifestyle Change to Prevent Diabetes Via African-American Churches
Official Title
Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Weight Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
604 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fit Body and Soul
Arm Type
Experimental
Arm Description
Faith-based adaptation of the Group Life Style Program
Arm Title
Wellness education
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Fit Body and Soul
Intervention Type
Behavioral
Intervention Name(s)
Wellness Education
Primary Outcome Measure Information:
Title
Weight change
Time Frame
12-weeks post intervention
Secondary Outcome Measure Information:
Title
Fasting plasma glucose
Time Frame
12 week post intervention
Title
physical activity level
Time Frame
12 week post-intervention
Title
quality of life measures
Time Frame
12 week post-intervention
Title
cost-effectiveness
Description
Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®
Time Frame
12 week post-intervetnion
Title
hemoglobin A1C
Time Frame
12 week intervention
Other Pre-specified Outcome Measures:
Title
waist circumference
Time Frame
12 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Sattin, MD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30273708
Citation
Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
Results Reference
derived
PubMed Identifier
26215167
Citation
Sattin RW, Williams LB, Dias J, Garvin JT, Marion L, Joshua TV, Kriska A, Kramer MK, Narayan KM. Community Trial of a Faith-Based Lifestyle Intervention to Prevent Diabetes Among African-Americans. J Community Health. 2016 Feb;41(1):87-96. doi: 10.1007/s10900-015-0071-8.
Results Reference
derived
Learn more about this trial
Lifestyle Change to Prevent Diabetes Via African-American Churches
We'll reach out to this number within 24 hrs