Digital Diabetes Prevention Program Study

NCT06137963 | Withdrawn

• 1 other identifier: 2023-2194
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

PreDiabetes

Keywords

prediabetes; hemoglobin a1c; hba1c; total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in percent Hgb A1C after a 6 month intervention period.

  Pre-surgical screening to 12 months post-operation

• Patient satisfaction.

  12 months post-operation

• Patient readiness assessment

  day of surgery to 6 months prior to surgery

• Health related quality of life (HRQOL)

  12 months post-operation

• Possible postoperative complications

  PACU arrival time to 12 months post-operation

Study Arms (2)

Transform10 Waitlist

OTHER

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

Transform10

EXPERIMENTAL

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

Interventions

Transform10 Diabetes Prevention Program OTHER

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; Transform10 Waitlist

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (10)

• 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.

  PMID: 29032962 BACKGROUND

• 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.

  PMID: 26300015 BACKGROUND

• 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.

  PMID: 18697862 BACKGROUND

• 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.

  PMID: 24856449 BACKGROUND

• 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.

  PMID: 12453955 BACKGROUND

• 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.

  PMID: 32080770 BACKGROUND

• 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.

  PMID: 30510384 BACKGROUND

• 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.

  PMID: 24950683 BACKGROUND

• 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.

  PMID: 28650899 BACKGROUND

• 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.

  PMID: 27651911 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jashvant Poeran, MD/PhD

  Hospital for Special Surgery, Department of Anesthesiology

  STUDY DIRECTOR

• Stephanie Cheng, MD

  Hospital for Special Surgery, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patient will be blinded because they will be told that they are getting the DPP within 0-6 months. RA's will not know what group patients are in because Transform10 will be asking all of the questionnaires via their platform.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind randomized control trial

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: November 18, 2023
• Study Start: January 24, 2024
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)