Augmented Care at Worksite for Diabetes Prevention

The Ohio State University

Status: Completed

Conditions: PreDiabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03382873

R01DK112930-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

208 participants in 2 patient groups

Group Lifestyle Balance (GLB)

Active Comparator group

Description:

Standard lifestyle intervention to promote weight loss

Treatment:

Behavioral: Group Lifestyle Balance (GLB)

Group Lifestyle Balance Plus (GLB+)

Experimental group

Description:

Augmented lifestyle intervention for early slow responders

Treatment:

Behavioral: Group Lifestyle Balance Plus (GLB+)