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Completed

NCT Number: NCT01730196

Lifestyle Change to Prevent Diabetes Via African-American Churches

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.

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Key information

Conditions

Diabetes Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fit Body and Soul

Behavioral

Wellness Education

Behavioral

Primary outcomes

  1. Weight change

    Time frame: 12-weeks post intervention

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: 12 week post intervention

  2. physical activity level

    Time frame: 12 week post-intervention

  3. quality of life measures

    Time frame: 12 week post-intervention

  4. cost-effectiveness

    Time frame: 12 week post-intervetnion

    Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®

  5. hemoglobin A1C

    Time frame: 12 week intervention

Other outcomes

  1. waist circumference

    Time frame: 12 weeks post-intervention

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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