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Evaluation of a Lifestyle Intervention for Employees With Prediabetes

This study is not yet open for participant recruitment.
Verified September 2012 by Ohio State University
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Carla Miller, Ohio State University
ClinicalTrials.gov Identifier:
NCT01682954
First received: September 7, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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


Condition Intervention
Prediabetes
Overweight
Obese
 Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of a Lifestyle Intervention for Employees With Prediabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Body Weight [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in body weight

  • Body Weight [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
    Change in body weight


Estimated Enrollment: 76
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682954

Contacts
Contact: Carla Miller, PhD 614-292-4772 miller.4453@osu.edu

Locations
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Kellie Weinhold, BS     614-292-4772     weinhold.8@osu.edu    
Principal Investigator: Carla Miller, PhD            
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

No publications provided

Responsible Party: Carla Miller, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01682954     History of Changes
Other Study ID Numbers: 2012H0149, 1R34DK093907
Study First Received: September 7, 2012
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
lifestyle risk reduction

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Overweight
Hyperglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013