NCT01730196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
604

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

2.6 years

First QC Date

November 15, 2012

Last Update Submit

April 8, 2014

Conditions

DiabetesWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight change

    12-weeks post intervention

Secondary Outcomes (5)

  • Fasting plasma glucose

    12 week post intervention

  • physical activity level

    12 week post-intervention

  • quality of life measures

    12 week post-intervention

  • cost-effectiveness

    12 week post-intervetnion

  • hemoglobin A1C

    12 week intervention

Other Outcomes (1)

  • waist circumference

    12 weeks post-intervention

Study Arms (2)

Fit Body and Soul

EXPERIMENTAL

Faith-based adaptation of the Group Life Style Program

Behavioral: Fit Body and Soul

Wellness education

ACTIVE COMPARATOR

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

Behavioral: Wellness Education

Interventions

Fit Body and SoulBEHAVIORAL
Fit Body and Soul
Wellness EducationBEHAVIORAL
Wellness education

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-described African American
  • BMI ≥25kg/m2
  • Planning to remain within the community for 1 year
  • Non-diabetic

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Related Publications (2)

  • 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.

    PMID: 30273708DERIVED

  • 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.

    PMID: 26215167DERIVED

MeSH Terms

Conditions

Diabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard W Sattin, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Research Director, Department of Emergency Medicine

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

September 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2013

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

US(1)