Augmented Care at Worksite for Diabetes Prevention

Not Applicable

Completed

• Conditions: PreDiabetes
• Interventions: Behavioral: Group Lifestyle Balance Plus (GLB+); Behavioral: Group Lifestyle Balance (GLB)

• Registration Number: NCT03382873
• Lead Sponsor: Ohio State University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Study Start: 2018-02-08
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Results First Submitted: 2024-02-09
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Results First Posted: 2024-04-11
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Lifestyle Balance Plus (GLB+)	Group Lifestyle Balance Plus (GLB+)	Augmented lifestyle intervention for early slow responders
Group Lifestyle Balance (GLB)	Group Lifestyle Balance (GLB)	Standard lifestyle intervention to promote weight loss

Primary Outcome Measures

Name	Time	Method
Percent Weight Change	12-months and 18-months	Change in weight as measured in light clothing and shoes removed

Secondary Outcome Measures

Name	Time	Method
Fasting Glucose	12-months and 18-months	Fasting glucose from a fingerstick sample

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States