Augmented Care at Worksite for Diabetes Prevention

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

• Status: Recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: Group Lifestyle Balance (GLB); Behavioral: Group Lifestyle Balance Plus (GLB+)

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: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla Miller, Ph.D.; Phone Number: 614-292-1391; Email: miller.4453@osu.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	Behavioral: Group Lifestyle Balance (GLB); 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.	Behavioral: Group Lifestyle Balance Plus (GLB+); 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	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	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

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

Publications and helpful links

General Publications

• 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.
• 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.
• Miller CK, Nagaraja HN, Cheavens J, Fujita K, Lazarus S. Impact of a Novel Diabetes Prevention Intervention for Early Slow Weight Loss Responders Among Adults With Prediabetes: An Adaptive Trial. Diabetes Care. 2022 Oct 1;45(10):2452-2455. doi: 10.2337/dc22-0824.

Study record dates

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

• Keywords: Overweight; Obese; Hyperglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: R01DK112930-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• 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: No
• Studies a U.S. FDA-regulated device product: No