Status:
WITHDRAWN
Digital Diabetes Prevention Program Study
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
PreDiabetes
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The aim of this study is to determine if completion of the Diabetes Prevention Program (DPP) via the Transform 10 website can significantly decrease hemoglobin A1c (HbA1c) levels and Body Mass Index (...
Detailed Description
Glycemic, or blood sugar, control is an important factor associated with improved outcomes for patients after surgery. With one in three adults in the United States living with prediabetes, poor glyce...
Eligibility Criteria
Inclusion
- Planned primary total hip arthroplasty for the indication of osteoarthritis at facility
- Age 18 - 64
- Overweight (BMI 25+ or 22+ if Asian)
- HbA1c 5.7%-6.4%
- Predicted ability to walk following procedure
- English or Spanish speaking
- Able to provide informed consent
- Willing to accept a random assignment
- Readiness for change
- ASA 1 or 2
Exclusion
- Not meeting all inclusion criteria
- Diagnosed with Type I or II diabetes
- Diagnosed with congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, pulmonary hypertension
- Diagnosed with dementia or probable Alzheimer's disease
- Taking oral hypoglycemic agents other than Metformin
- Participating in a concurrent weight management program outside of HSS current protocol
- Unable to engage in walking as physical activity post-procedure
- Had bariatric surgery within the past 3 years or planning surgery within the next 12 months
- Anti-obesity or diabetes therapy within the preceding 4 months
- Any mental health condition, including eating disorders or alcohol/substance use, which would preclude full participation
- Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)
- Unstable cardiac disease (i.e. heart attack/failure or stroke in the last 6 months, or currently in cardiac rehabilitation)
- On dialysis or an active organ transplant list
- Chronic kidney disease
- Untreated thyroid disease
- Cancer within the last 5 years unless skin cancer (i.e. currently or within the last 5 years in chemotherapy or radiation treatment)
- Unwilling to accept random assignment
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06137963
Start Date
January 24 2024
End Date
April 4 2024
Last Update
December 27 2024
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021