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NCT01682954 Clinical Trial

Evaluation of a Lifestyle Intervention for Employees With Prediabetes

Overweight Clinical Trial

Official title:
Evaluation of a Lifestyle Intervention for Employees With Prediabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01682954
Other study ID # 2012H0149
Secondary ID 1R34DK093907
Status Completed
Phase N/A
First received September 7, 2012
Last updated October 22, 2014
Start date November 2012
Est. completion date May 2014

Study information
Verified date October 2014
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle counseling
16-week nutrition, physical activity and behavioral intervention

Locations
Country Name City State
United States Ohio State University Columbus Ohio

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body Weight Change in body weight 4 months No
Primary Body Weight Change in body weight 7 Months No
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