Augmented Care at Worksite for Diabetes Prevention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Augmented Care at the Worksite for Diabetes Prevention

Conditions
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PreDiabetes

Intervention / Treatment
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* Behavioral: Group Lifestyle Balance (GLB)
* Behavioral: Group Lifestyle Balance Plus (GLB+)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Benefits-eligible Ohio State University employee Intend to be employed by OSU through the length of the follow-up phase Body mass index: >24 kg/m2 non-Asians; >22 kg/m2 Asians American Diabetes Association risk score of ≥ 5 Fasting blood glucose of 100-125 mg/dL Blood glucose of 110-199 (if non-fasting in previous 2 hours) Exclusion Criteria: Blood glucose level of ≥ 200 mg/dL Conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension) Chronic use of medications that affect blood glucose levels (i.e., corticosteroids) Concurrent participation in a structured weight loss program or counseling for bariatric surgery Pregnant or breastfeeding Score of ≥ 10 on the Patient Health Questionnaire-8 indicating moderate to severe depressive symptoms Score of ≥ 27 on the Binge Eating Scale Unwilling to accept randomization Planning to move from the area or changing employment.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed translational study applies an innovative experimental approach, an adaptive design, to optimize treatment for weight loss and weight loss maintenance in individuals with prediabetes. All participants will begin a standard lifestyle intervention to promote weight loss. Those who do not achieve >2.5% weight loss during the first month of the intervention will transition to augmented care to enhance weight loss during the intensive intervention phase. Following the intensive phase, participants will be randomly assigned to either the standard intervention or the enhanced intervention for the maintenance study phase. By randomly assigning participants to either the standard maintenance phase of the intervention or the innovative maintenance phase of the intervention following the initial core phase, the impact of extended training in self-regulation for weight loss maintenance will be evaluated.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Lifestyle Balance (GLB)<br>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)<br>* 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.<br>|
| Experimental: Group Lifestyle Balance Plus (GLB+)<br>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+)<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperglycemia, Obese, Overweight