Digital Diabetes Prevention Program Study

Study Overview
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Brief Summary
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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: Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty? Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty? 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
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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: Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty? Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty? 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.

Official Title
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Effectiveness of an Augmented Digital Diabetes Prevention Program for Adults With Prediabetes Having Elective Total Hip Arthroplasty: A Randomized Control Trial

Conditions
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PreDiabetes

Intervention / Treatment
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* Other: Transform10 Diabetes Prevention Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transform10 Waitlist<br>The control group will receive access to the Transform10 website at 6 months. Patients in this group will report their active minutes and weight via the Transform10 website throughout the 6 month-long programs. In addition, participants will take an Hba1c blood test at pre surgical screening, 6 months after their day of surgery and 1 year after their day of surgery as part of routine procedures. | Other: Transform10 Diabetes Prevention Program<br>* The Transform10 app includes a Centers for Disease Control (CDC)-approved diabetes prevention program. 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. The Transform10 app also provides access to lifestyle coaches who discuss evidence-based information regarding hunger and insulin, macronutrient strategies, time-restricted intermittent fasting, and inflammation.<br>|
| Experimental: Transform10<br>Patients in this group will get access to the Transform10 website on their day of surgery. Patients in this group 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 6 months after their day of surgery and 1 year after their day of surgery as part of routine procedures. | Other: Transform10 Diabetes Prevention Program<br>* The Transform10 app includes a Centers for Disease Control (CDC)-approved diabetes prevention program. 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. The Transform10 app also provides access to lifestyle coaches who discuss evidence-based information regarding hunger and insulin, macronutrient strategies, time-restricted intermittent fasting, and inflammation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent of body weight before and after a 6 month intervention period. | body mass index will be measured at pre-surgical screening and again after a 6 month and 12-month period. The percent change in body weight will be recorded at program completion and at 6 months prior to program completion. | Pre-surgical screening to 12 months post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent Hgb A1C after a 6 month intervention period. | hemoglobin a1c levels will be measured at pre-surgical screening and again after a 6 month and 12-month period. The percent change in hba1c level will be recorded. | Pre-surgical screening to 12 months post-operation | 
| Patient satisfaction. | Patient satisfaction will be a questionnaire that is asked by the Transform10 website 1 year after surgery. This questionnaire assesses how satisfied patients have been with their post operative pain management. This is reported on a scale from 0-10 with 0 being strongly dissatisfied and 10 being strongly satisfied. | 12 months post-operation | 
| Patient readiness assessment | Patients will be asked 8 questions upon access to the Transform10 program to assess their level of readiness for change. Each question asks if the patient is capable of a task and the responses range from Sure I can, Think I can, Not sure I can, Don't think I can. | day of surgery to 6 months prior to surgery | 
| Health related quality of life (HRQOL) | The health-related quality of life questionnaire will be asked via the transform10 website. This assesses how a patient's pain has impacted their day to day lives 12 months after their day of surgery. This is reported on a variety of scales depending on the questions asked. The scales include; 1 Excellent, 2 Very Good, 3 Good, 4 Fair, 5 Poor; 1 Much better now than one year ago, 2 Somewhat better now than one year ago, 3 About the same, 4 Somewhat worse now than one year ago, 5 Much worse now than one year ago; 1 Yes, limited a lot, 2 Yes, limited a little, 3 No, not limited at all; 1 Yes, 2 No; 1 Not at all, 2 Slightly, 3 Moderately, 4 Quite a bit, 5 Extremely; 1 None, 2 Very mild, 3 Mild, 4 Moderate, 5 Severe, 6 Very severe; 1 All of the time, 2 Most of the time, 3 A good bit of the time, 4 Some of the time, 5 A little of the time, 6 None of the time; 1 Definitely true, 2 Mostly true, 3 Don't know, 4 Mostly false, 5 Definitely false. | 12 months post-operation | 
| Possible postoperative complications | This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery. | PACU arrival time to 12 months post-operation | 
| Possible ICU Admission | This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery. | PACU arrival time to 12 months post-operation | 
| Possible patient readmission | This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery. | PACU arrival time to 12 months post-operation | 
| Postoperative length of stay | This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery. | PACU arrival time to 12 months post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prediabetes, hemoglobin a1c, hba1c, total hip arthroplasty