Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-01-24
2024-04-04
Brief Summary
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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
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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 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Transform10 Waitlist
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.
Transform10 Diabetes Prevention Program
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.
Transform10
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.
Transform10 Diabetes Prevention Program
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.
Interventions
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Transform10 Diabetes Prevention Program
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Jashvant Poeran, MD/PhD
Role: STUDY_DIRECTOR
Hospital for Special Surgery, Department of Anesthesiology
Stephanie Cheng, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, Department of Anesthesiology
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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References
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Couwenberg AM, de Beer FSA, Intven MPW, Burbach JPM, Smits AB, Consten ECJ, Schiphorst AHW, Wijffels NAT, de Roos MAJ, Hamaker ME, van Grevenstein WMU, Verkooijen HM. The impact of postoperative complications on health-related quality of life in older patients with rectal cancer; a prospective cohort study. J Geriatr Oncol. 2018 Mar;9(2):102-109. doi: 10.1016/j.jgo.2017.09.005. Epub 2017 Oct 10.
Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966-9. doi: 10.1139/apnm-2015-0084. Epub 2015 May 13.
Wexler DJ, Nathan DM, Grant RW, Regan S, Van Leuvan AL, Cagliero E. Prevalence of elevated hemoglobin A1c among patients admitted to the hospital without a diagnosis of diabetes. J Clin Endocrinol Metab. 2008 Nov;93(11):4238-44. doi: 10.1210/jc.2008-1090. Epub 2008 Aug 12.
Flocke SA, Clark E, Antognoli E, Mason MJ, Lawson PJ, Smith S, Cohen DJ. Teachable moments for health behavior change and intermediate patient outcomes. Patient Educ Couns. 2014 Jul;96(1):43-9. doi: 10.1016/j.pec.2014.03.014. Epub 2014 May 1.
Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
Ackermann RT, O'Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Curr Diab Rep. 2020 Feb 20;20(3):9. doi: 10.1007/s11892-020-1293-4.
Kirley K, Sachdev N. Digital Health-Supported Lifestyle Change Programs to Prevent Type 2 Diabetes. Diabetes Spectr. 2018 Nov;31(4):303-309. doi: 10.2337/ds18-0019.
Cha E, Kim KH, Umpierrez G, Dawkins CR, Bello MK, Lerner HM, Narayan KM, Dunbar SB. A feasibility study to develop a diabetes prevention program for young adults with prediabetes by using digital platforms and a handheld device. Diabetes Educ. 2014 Sep-Oct;40(5):626-37. doi: 10.1177/0145721714539736. Epub 2014 Jun 20.
Wilson MG, Castro Sweet CM, Edge MD, Madero EN, McGuire M, Pilsmaker M, Carpenter D, Kirschner S. Evaluation of a Digital Behavioral Counseling Program for Reducing Risk Factors for Chronic Disease in a Workforce. J Occup Environ Med. 2017 Aug;59(8):e150-e155. doi: 10.1097/JOM.0000000000001091.
Michaelides A, Raby C, Wood M, Farr K, Toro-Ramos T. Weight loss efficacy of a novel mobile Diabetes Prevention Program delivery platform with human coaching. BMJ Open Diabetes Res Care. 2016 Sep 5;4(1):e000264. doi: 10.1136/bmjdrc-2016-000264. eCollection 2016.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2023-2194
Identifier Type: -
Identifier Source: org_study_id