Augmented Care at Worksite for Diabetes Prevention

PreDiabetes Clinical Trial

Official title:

Impact of Augmented Care at the Worksite for Diabetes Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382873
• Other study ID #: R01DK112930-01A1
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: April 15, 2022

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Weight Change	Change in weight as measured in light clothing and shoes removed	baseline and 4-months
Primary	Percent Weight Change	Change in weight as measured in light clothing and shoes removed	baseline and 12-months
Primary	Percent Weight Change	Change in weight as measured in light clothing and shoes removed	12-months and 18-months
Secondary	Fasting Glucose	Fasting glucose from a fingerstick sample	baseline and 4-months
Secondary	Fasting Glucose	Fasting glucose from a fingerstick sample	baseline and 12-months
Secondary	Fasting Glucose	Fasting glucose from a fingerstick sample	12-months and 18-months