Augmented Care at Worksite for Diabetes Prevention

NCT ID: NCT03382873

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2022-04-15

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.

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group Lifestyle Balance (GLB)

Standard lifestyle intervention to promote weight loss

Group Type: ACTIVE_COMPARATOR

Group Lifestyle Balance (GLB)

Intervention Type: BEHAVIORAL

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.

Group Lifestyle Balance Plus (GLB+)

Augmented lifestyle intervention for early slow responders

Group Type: EXPERIMENTAL

Group Lifestyle Balance Plus (GLB+)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Carla Miller

Professor (current affiliation at Indiana University)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla Miller, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University (during study implementation)

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Miller CK, Nagaraja HN, Cheavens JS, Fujita K, Lazarus SA, Brunette DS. Sex Differences in Early Weight Loss Success During a Diabetes Prevention Intervention. Am J Health Behav. 2023 Apr 30;47(2):337-348. doi: 10.5993/AJHB.47.2.13.

Reference Type: DERIVED

PMID: 37226352 (View on PubMed)

Miller CK, King D, Nagaraja HN, Fujita K, Cheavens J, Focht BC. Impact of an augmented intervention on self-regulatory, dietary and physical activity outcomes in a diabetes prevention trial among adults with prediabetes. J Behav Med. 2023 Oct;46(5):770-780. doi: 10.1007/s10865-023-00406-w. Epub 2023 Mar 18.

Reference Type: DERIVED

PMID: 36933057 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36041053 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK112930-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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