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Evaluation of a Lifestyle Intervention for Employees With Prediabetes

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ClinicalTrials.gov Identifier: NCT01682954
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : October 23, 2014
Last Update Posted : October 30, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Prediabetes Overweight Obese Behavioral: Lifestyle counseling

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.

Study Design

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
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01682954


Locations
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)
Investigators
Principal Investigator: Carla Miller, PhD Ohio State University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carla Miller, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01682954     History of Changes
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:
Overweight
Prediabetic State
Glucose Intolerance
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia