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Evaluation of a Lifestyle Intervention for Employees With Prediabetes

Primary Purpose

Prediabetes, Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring lifestyle risk reduction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle counseling

Usual Care

Arm Description

Diabetes Prevention Program lifestyle intervention

Usual care from primary care physician

Outcomes

Primary Outcome Measures

Body Weight
Change in body weight
Body Weight
Change in body weight

Secondary Outcome Measures

Full Information

First Posted
September 7, 2012
Last Updated
October 22, 2014
Sponsor
Ohio State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01682954
Brief Title
Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Official Title
Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Overweight, Obese
Keywords
lifestyle risk reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Diabetes Prevention Program lifestyle intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care from primary care physician
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
16-week nutrition, physical activity and behavioral intervention
Primary Outcome Measure Information:
Title
Body Weight
Description
Change in body weight
Time Frame
4 months
Title
Body Weight
Description
Change in body weight
Time Frame
7 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Miller, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26605710
Citation
Weinhold KR, Miller CK, Marrero DG, Nagaraja HN, Focht BC, Gascon GM. A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012-2014. Prev Chronic Dis. 2015 Nov 25;12:E210. doi: 10.5888/pcd12.150301.
Results Reference
derived
PubMed Identifier
26095435
Citation
Miller CK, Nagaraja HN, Weinhold KR. Early weight-loss success identifies nonresponders after a lifestyle intervention in a worksite diabetes prevention trial. J Acad Nutr Diet. 2015 Sep;115(9):1464-71. doi: 10.1016/j.jand.2015.04.022. Epub 2015 Jun 19.
Results Reference
derived
PubMed Identifier
25798374
Citation
Miller CK, Weinhold K, Marrero DG, Nagaraja HN, Focht BC. A Translational Worksite Diabetes Prevention Trial Improves Psychosocial Status, Dietary Intake, and Step Counts among Employees with Prediabetes: A Randomized Controlled Trial. Prev Med Rep. 2015;2:118-126. doi: 10.1016/j.pmedr.2015.02.003.
Results Reference
derived

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Evaluation of a Lifestyle Intervention for Employees With Prediabetes

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