Evaluation of a Lifestyle Intervention for Employees With Prediabetes

NCT ID: NCT01682954

Last Updated: 2014-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prediabetes Overweight Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lifestyle counseling

Diabetes Prevention Program lifestyle intervention

Group Type EXPERIMENTAL

Lifestyle counseling

Intervention Type BEHAVIORAL

16-week nutrition, physical activity and behavioral intervention

Usual Care

Usual care from primary care physician

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle counseling

16-week nutrition, physical activity and behavioral intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Carla Miller

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carla Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26605710 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26095435 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25798374 (View on PubMed)

Other Identifiers

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1R34DK093907

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012H0149

Identifier Type: -

Identifier Source: org_study_id

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