N/A
Completed N=208
Augmented Care at Worksite for Diabetes Prevention
Source: ClinicalTrials.gov NCT03382873 ↗Enrolled (actual)
208
Serious AEs
2.4%
Results posted
Apr 2024
Primary outcomePrimary: Percent Weight Change — -8.13; -3.46 percent change — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Weight Change |
2.22; 2.28 | 0.9476 |
| PRIMARY Percent Weight Change |
2.22; 2.28 | 0.9476 |
| PRIMARY Percent Weight Change |
2.22; 2.28 | 0.9476 |
| SECONDARY Fasting Glucose |
-1.21; 2.71 | 0.2063 |
| SECONDARY Fasting Glucose |
-1.21; 2.71 | 0.2063 |
| SECONDARY Fasting Glucose |
-1.21; 2.71 | 0.2063 |
Eligibility Criteria
Inclusion Criteria
- Benefits-eligible Ohio State University (OSU) employee
- Intend to be employed by OSU through the length of the follow-up phase
- Body mass index: >24 kg/m^2 non-Asians; >22 kg/m^2 Asians
- Fasting blood glucose of 100-125 mg/dL or an A1c of 5.7-6.4%
- 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 indicating the potential for binge eating
- Unwilling to accept randomization
- Planning to move from the area or changing employment.
Data sourced from ClinicalTrials.gov (NCT03382873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.