Digital Diabetes Prevention Program Study

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06137963
• Other study ID #: 2023-2194
• Status: Withdrawn
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Centers for Disease Control (CDC) National Diabetes Statistics Report