Evaluation of a Lifestyle Intervention for Employees With Prediabetes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Ohio State University
Sponsor:
Collaborator:
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 July 23, 2014