Lifestyle Change to Prevent Diabetes Via African-American Churches

NCT ID: NCT01730196

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

604 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fit Body and Soul

Faith-based adaptation of the Group Life Style Program

Group Type EXPERIMENTAL

Fit Body and Soul

Intervention Type BEHAVIORAL

Wellness education

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

Group Type ACTIVE_COMPARATOR

Wellness Education

Intervention Type BEHAVIORAL

Interventions

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Fit Body and Soul

Intervention Type BEHAVIORAL

Wellness Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Richard Sattin

Professor and Research Director, Department of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard W Sattin, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Georgia Health Sciences University

Augusta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30273708 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26215167 (View on PubMed)

Other Identifiers

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R18DK082401

Identifier Type: NIH

Identifier Source: org_study_id

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