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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
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesAccepts 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

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

First Posted
November 15, 2012
Last Updated
April 8, 2014
Sponsor
Augusta University
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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

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Lifestyle Change to Prevent Diabetes Via African-American Churches

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