Augmented Care at Worksite for Diabetes Prevention

February 23, 2021 updated by: Carla Miller, Ohio State University

Impact of Augmented Care at the Worksite for Diabetes Prevention

The purpose of the study is to evaluate the impact of augmented care at the worksite through a lifestyle intervention for diabetes prevention among employees with prediabetes who are slower to respond to a standard diabetes prevention intervention.

Study Overview

Detailed Description

Employees at The Ohio State University (OSU) with prediabetes will participate in a standard lifestyle intervention for diabetes prevention. Participants who do not achieve >2.5% weight loss by week 5 of the intervention will transition into augmented care with an enhanced training program that addresses values clarification, decision making, planning, and problem solving. The impact of the enhanced intervention will be evaluated at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helps participants achieve and maintain weight loss similar to those who received the standard intervention.

Study Type


Enrollment (Anticipated)



  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
          • Carla Miller, Ph.D.
          • Phone Number: 614-292-1391

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers


Genders Eligible for Study



Inclusion Criteria:

  1. Benefits-eligible Ohio State University employee
  2. Intend to be employed by OSU through the length of the follow-up phase
  3. Body mass index: >24 kg/m2 non-Asians; >22 kg/m2 Asians
  4. American Diabetes Association risk score of ≥ 5
  5. Fasting blood glucose of 100-125 mg/dL
  6. Blood glucose of 110-199 (if non-fasting in previous 2 hours)

Exclusion Criteria:

  1. Blood glucose level of ≥ 200 mg/dL
  2. Conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension)
  3. Chronic use of medications that affect blood glucose levels (i.e., corticosteroids)
  4. Concurrent participation in a structured weight loss program or counseling for bariatric surgery
  5. Pregnant or breastfeeding
  6. Score of ≥ 10 on the Patient Health Questionnaire-8 indicating moderate to severe depressive symptoms
  7. Score of ≥ 27 on the Binge Eating Scale
  8. Unwilling to accept randomization
  9. Planning to move from the area or changing employment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Lifestyle Balance (GLB)
Implement the first 4-sessions of the core 16-session phase of the GLB intervention for diabetes prevention to all participants. Determine percent weight change at week 5. Those who achieve >2.5% weight loss at week 5 will remain in the GLB arm.
The intervention includes the following key features: 1) individual case managers or "lifestyle coaches;" 2) frequent contact with participants; 3) a structured, state-of-the-art, 16-session core-curriculum that teaches behavioral self-management strategies for weight loss and physical activity; 4) a more flexible maintenance intervention, combining group and individual approaches and motivational campaigns; 6) individualization through a "toolbox" of adherence strategies; and 7) tailoring of materials and strategies utilizing a network of training, feedback, and support.
Experimental: Group Lifestyle Balance Plus (GLB+)
Implement the first 4-sessions of the core 16-session phase of the GLB intervention for diabetes prevention to all participants. Determine percent weight change at week 5. Those who fail to achieve >2.5% weight loss at week 5 will transfer to the GLB+ arm.
The GLB+ intervention arm will include participants who did not achieve the targeted percentage of weight loss by week 5, and will add enhanced training to the program that will focus on values clarification, mindful decision making, planning, and problem solving.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: Weight will be taken at baseline, 4 months (mos), 12 months, and 18 months
Weight will be used to calculate percentage change in body weight.
Weight will be taken at baseline, 4 months (mos), 12 months, and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased Glycemia
Time Frame: Glucose will be taken at baseline, 4 mos, 12 mos, and 18 mos.
Glucose level will be assessed from a fingerstick capillary blood sample.
Glucose will be taken at baseline, 4 mos, 12 mos, and 18 mos.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


  • Principal Investigator: Carla Miller, Ph.D., Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • R01DK112930-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?


IPD Plan Description

De-identified data will be released to other researchers using a data-sharing agreement that specifies that the data will be used only for research purposes and only by the specified individuals to whom the data are released. Documentation of Institutional Review Board approval for the proposed use must be provided in advance to the PI. The data must be either destroyed or returned to the PI after all analyses are completed.

IPD Sharing Time Frame

The data will be available following all analyses and publication of primary and secondary study results. The data will be available upon request.

IPD Sharing Access Criteria

To be developed

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


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