Augmented Care at Worksite for Diabetes Prevention

Impact of Augmented Care at the Worksite for Diabetes Prevention

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

Study Overview

• Status: Completed
• 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 participated in a standard lifestyle intervention (Group Lifestyle Balance) for diabetes prevention. Participants who did not achieve >2.5% weight loss at week 5 of the intervention were stratified to the augmented intervention (Group Lifestyle Balance Plus) at week 5. The impact of the augmented intervention compared to the standard intervention was determined at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helped participants achieve and maintain weight loss similar to those who received the standard intervention.

• Study Type: Interventional
• Enrollment (Actual): 208
• 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
      • The Ohio State University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Benefits-eligible Ohio State University (OSU) employee
2. Intend to be employed by OSU through the length of the follow-up phase
3. Body mass index: >24 kg/m^2 non-Asians; >22 kg/m^2 Asians
4. Fasting blood glucose of 100-125 mg/dL or an A1c of 5.7-6.4%
5. 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 indicating the potential for binge eating
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); Standard lifestyle intervention to promote weight loss	Behavioral: Group Lifestyle Balance (GLB); The intervention included the following key features: group-based sessions led by a lifestyle coach; a structured, state-of-the-art, 16-session core-curriculum that emphasized behavioral self-management strategies for weight loss and physical activity; 8-months of extended care with bimonthly or monthly sessions; self-monitoring of diet and physical activity.
Experimental: Group Lifestyle Balance Plus (GLB+); Augmented lifestyle intervention for early slow responders	Behavioral: Group Lifestyle Balance Plus (GLB+); The GLB+ intervention arm included participants who did not achieve the targeted percent weight loss by week 5 and incorporated enhanced training in values clarification, mindful decision making, planning, and problem solving. GLB+ included the same number of group-based sessions as GLB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Weight Change	Change in weight as measured in light clothing and shoes removed	baseline and 4-months
Percent Weight Change	Change in weight as measured in light clothing and shoes removed	baseline and 12-months
Percent Weight Change	Change in weight as measured in light clothing and shoes removed	12-months and 18-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Glucose	Fasting glucose from a fingerstick sample	baseline and 4-months
Fasting Glucose	Fasting glucose from a fingerstick sample	baseline and 12-months
Fasting Glucose	Fasting glucose from a fingerstick sample	12-months and 18-months

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Carla Miller, Ph.D., The Ohio State University (during study implementation)

Publications and helpful links

General Publications

• 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 (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

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): April 11, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

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