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Evaluation of a Lifestyle Intervention for Employees With Prediabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682954
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : October 23, 2014
Last Update Posted : October 30, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Carla Miller, Ohio State University

Brief Summary:
The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.

Condition or disease Intervention/treatment Phase
Prediabetes Overweight Obese Behavioral: Lifestyle counseling Not Applicable

Detailed Description:
The lifestyle intervention includes a 16-week group-based program which targets weight reduction through the adoption of a lower fat diet and greater physical activity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Study Start Date : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Lifestyle counseling
Diabetes Prevention Program lifestyle intervention
Behavioral: Lifestyle counseling
16-week nutrition, physical activity and behavioral intervention

No Intervention: Usual Care
Usual care from primary care physician

Primary Outcome Measures :
  1. Body Weight [ Time Frame: 4 months ]
    Change in body weight

  2. Body Weight [ Time Frame: 7 Months ]
    Change in body weight

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-65 years old
  • overweight or obese
  • prediabetes with elevated glucose value

Exclusion Criteria:

  • recent cardiovascular event
  • use of corticosteroids
  • concurrent participation in a structured weight loss program
  • pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01682954

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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Carla Miller, PhD Ohio State University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Carla Miller, Associate Professor, Ohio State University Identifier: NCT01682954    
Other Study ID Numbers: 2012H0149
1R34DK093907 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2012    Key Record Dates
Results First Posted: October 23, 2014
Last Update Posted: October 30, 2014
Last Verified: October 2014
Keywords provided by Carla Miller, Ohio State University:
lifestyle risk reduction
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases