NCT01682954

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 23, 2014

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

1.5 years

First QC Date

September 7, 2012

Results QC Date

October 16, 2014

Last Update Submit

October 22, 2014

Conditions

PrediabetesOverweightObese

Keywords

lifestyle risk reduction

Outcome Measures

Primary Outcomes (2)

  • Body Weight

    Change in body weight

    4 months

  • Body Weight

    Change in body weight

    7 Months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Diabetes Prevention Program lifestyle intervention

Behavioral: Lifestyle counseling

Usual Care

NO INTERVENTION

Usual care from primary care physician

Interventions

Lifestyle counselingBEHAVIORAL

16-week nutrition, physical activity and behavioral intervention

Lifestyle counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • overweight or obese
  • prediabetes with elevated glucose value

You may not qualify if:

  • recent cardiovascular event
  • use of corticosteroids
  • concurrent participation in a structured weight loss program
  • pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

  • 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.

    PMID: 26605710DERIVED

  • 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.

    PMID: 26095435DERIVED

  • 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.

    PMID: 25798374DERIVED

MeSH Terms

Conditions

Prediabetic StateOverweightObesityRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Dr. Carla Miller
Organization
Ohio State University
miller.4453@osu.edu
614-292-1391

Study Officials

  • Carla Miller, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 30, 2014

Results First Posted

October 23, 2014

Record last verified: 2014-10

Locations

US(1)