Clinical trial NCT06137963: Digital Diabetes Prevention Program Study
Official title: Effectiveness of an Augmented Digital Diabetes Prevention Program for Adults With Prediabetes Having Elective Total Hip Arthroplasty: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PreDiabetes
Keywords: prediabetes
hemoglobin a1c
hba1c
total hip arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized control trial
Primary purpose: PREVENTION

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 (BMI) in prediabetic individuals undergoing total hip arthroplasty (THA) procedure.

As part of the standard procedure of the Centers for Disease Control (CDC)-approved DPP program, all study participants will report their active minutes and weight via the Transform10 website throughout the 6 month-long program. In addition, participants will have a repeat Hba1c test ordered at the end of the program by the medical director as part of routine procedures. The main questions it aims to answer are:

1. Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty?
2. Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty?
3. Is an augmented digital diabetes prevention program an effective strategy to improve postoperative outcomes and patient satisfaction in adults with prediabetes undergoing elective total hip arthroplasty?

Participants will be randomized to get the DPP on their day of surgery (intervention group) or get their DPP 6 months after their day of surgery (control group).

Comparing the intervention group to the control group, the researcher's primary outcome is change in percent of body weight before and after a 6-month intervention period.

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 glycemic control has become an increasingly relevant indicator of postoperative complications. Glycemic control is commonly measured and referred to through the medical term hemoglobin A1c (HbA1c). Each percentage increase in HbA1c has been shown to be associated with increased complications around the time of surgery, intensive care unit admission, and hospital length of stay.

The aim of this study is to determine if completion of the Diabetes Prevention Program (DPP) via the Transform 10 website can significantly decrease HbA1c levels and Body Mass Index (BMI) in prediabetic individuals undergoing THA surgery. The main questions it aims to answer are:

1. Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty?
2. Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty?
3. Is an augmented digital diabetes prevention program an effective strategy to improve postoperative outcomes and patient satisfaction in adults with prediabetes undergoing elective total hip arthroplasty?

Participants will be randomized to get the DPP on their day of surgery (intervention group) or get their DPP 6 months after their day of surgery (control group).

Comparing the intervention group to the control group, the researcher's primary outcome is change in percent of body weight before and after a 6-month intervention period.

As part of the standard procedure of the Centers for Disease Control (CDC)-approved DPP program, all study participants will report their active minutes and weight via the Transform10 website throughout the 6 month-long program. In addition, participants will have a repeat Hba1c test ordered at the end of the program by the medical director as part of routine procedures.

The self-paced curriculum and optional video content covers:

* Strategies to overcome emotional eating using cognitive behavioral therapy principles.
* Improving cardiovascular function with capacity-matched training programs using participants' estimated cardio scores.
* An introductory-level course for increasing muscle and bone density foundation via strength training.
* Education regarding physical therapy and expectations for patients.

Participants will also have access to lifestyle coaches who discuss evidence-based information regarding hunger and insulin, macronutrient strategies, time-restricted intermittent fasting, and inflammation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in percent of body weight before and after a 6 month intervention period.
timeFrame: Pre-surgical screening to 12 months post-operation
Secondary outcomes:
measure: Change in percent Hgb A1C after a 6 month intervention period.
timeFrame: Pre-surgical screening to 12 months post-operation
measure: Patient satisfaction.
timeFrame: 12 months post-operation
measure: Patient readiness assessment
timeFrame: day of surgery to 6 months prior to surgery
measure: Health related quality of life (HRQOL)
timeFrame: 12 months post-operation
measure: Possible postoperative complications
timeFrame: PACU arrival time to 12 months post-operation
measure: Possible ICU Admission
timeFrame: PACU arrival time to 12 months post-operation
measure: Possible patient readmission
timeFrame: PACU arrival time to 12 months post-operation
measure: Postoperative length of stay
timeFrame: PACU arrival time to 12 months post-operation
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, Department of Anesthesiology
name: Jashvant Poeran, MD/PhD
role: STUDY_DIRECTOR
affiliation: Hospital for Special Surgery, Department of Anesthesiology
name: Stephanie Cheng, MD
role: PRINCIPAL_INVESTIGATOR
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