Effectiveness of an Augmented Digital Diabetes Prevention Program for Adults With Prediabetes Having Elective Total Hip Arthroplasty: A Randomized Control Trial
Phase: NA
Conditions: PreDiabetes
Sponsor: Hospital for Special Surgery, New York

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Effectivemess of an Augmented Digital Diabetes 
Prevention Program for Adults With Prediabetes 
Having Elective Total Hip Arthroplasty: A 
Randomized Control Trial 
 
FUNDER: 
Anesthesiology Research Department 
PROTOCOL NO.: 
2023-2194 
VERSION & DATE: 
Version 1; November 7, 2023 
 
 
 
 
 
 
 
 
 
 
 
 

 
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This document contains the confidential information of the Hospital for Special Surgery.  It is provided to you and your company’s personnel for 
review.  Your acceptance of this document constitutes an agreement that you will not disclose the information contained herein to others without 
the prior written consent of the Hospital for Special Surgery.  No other use or reproduction is authorized by Hospital for Special Surgery, nor does 
the Hospital for Special Surgery assume any responsibility for unauthorized use of this protocol. 
 
 
TABLE OF CONTENTS 
TABLE OF CONTENTS................................................................................................................... 2 
PROTOCOL SYNOPSIS.................................................................................................................. 3 
1.0     INTRODUCTION .................................................................................................................... 4 
    2.0 
PRODUCT DESCRIPTION………………………..……………………………………………….4 
3.0      OBJECTIVE OF CLINICAL STUDY ...................................................................................... 4 
4.0      STUDY HYPOTHESIS ........................................................................................................... 4 
5.0      STUDY DESIGN .................................................................................................................... 4 
5.1 
Study Duration ................................................................................................................ 4 
5.2 
Endpoints ....................................................................................................................... 4 
5.2.1 
Primary Endpoint ...................................................................................................... 4 
5.2.2 
Secondary Endpoints ................................................................................................ 4 
5.2.3 
Safety Evaluations. ................................................................................................... 4 
5.3 
Study Site ....................................................................................................................... 4 
6.0        STUDY POPULATION ......................................................................................................... 4 
6.1 
Number of Subjects ........................................................................................................ 4 
6.2 
Inclusion Criteria............................................................................................................. 5 
6.3 
Exclusion Criteria: .......................................................................................................... 5 
    6.4        Randomization………………………………………………………………………………..5 
7.0         PROCEDURES .................................................................................................................... 5 
7.1 
Surgical Procedure ......................................................................................................... 5 
 
7.1.1. Investigational Product Administration………………………………………………. .…..5 
7.2 
Imaging Procedure ......................................................................................................... 5 
7.3 
Medical Record Requirements ....................................................................................... 5 
7.4 
Data Collection ............................................................................................................... 5 
    7.5        Schedule of Assessments……………………………………………………..…………….. 6 
7.6 
Radiological Evaluations ................................................................................................ 7 
7.7 
Clinical Evaluations ........................................................................................................ 7 
 
7.7.1. Revision Surgery………………………………………………………………………. .……7 
8.0         STATISTICAL ANALYSIS .................................................................................................. 7 
9.0         ADVERSE EVENT ASSESSMENT ..................................................................................... 7 
9.1 
Adverse Event (AE) ........................................................................................................ 7 
9.2 
Serious Adverse Events (SAE) ...................................................................................... 7 
9.3 
Subsequent Surgical Interventions Definitions .............................................................. 7 
9.4 
Adverse Event Relationship ........................................................................................... 7 
9.5 
Adverse Event Recording .............................................................................................. 7 
9.6 
Adverse Event Reporting ............................................................................................... 7 
10.0         INVESTIGATOR RESPONSIBILITIES, RECORD AND REPORTS ................................ 7 
10.1 
Subject Consent and Information ................................................................................... 7 
10.2 
Subject Data Protection ................................................................................................. 7 
10.3 
Staff Information ............................................................................................................. 8 

 
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10.4 
Protocol Reviews............................................................................................................ 8 
10.5 
Investigator Records ...................................................................................................... 8 
10.6 
Investigator Reports ....................................................................................................... 8 
 11.0  
REFERENCES……………………………………………………………….………………….8 
APPENDIX A: Case Report Forms .............................................................................................. 9 
 
PROTOCOL SYNOPSIS 
Protocol Title: 
Effectiveness of an Augmented Digital Diabetes Prevention 
Program for Adults With Prediabetes Having Elective Total Hip 
Arthroplasty: A Randomized Control Trial 
Protocol Number: 
2023-2194 
Protocol Date: 
11/7/2023 
Sponsor: 
Anesthesiology Department 
Principal 
Investigator: 
Stephanie Cheng 
Products: 
N/A 
Objective: 
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. 
Study Design: 
Randomized Clinical Trial 
Enrollment: 
114 
Subject Criteria: 
Inclusion: 
• 
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: 
• Not meeting all inclusion criteria 
• Diagnosed with Type I or II diabetes 
• Diagnosed with congestive heart failure, coronary 

 
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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 
Study Duration: 
2 years 
Data Collection: 
Sources: Epic, Medical Records, Transofrm10 website, and 
Patient Reported 
 
Variables: Name, MRN, DOB, Race, Gender, Ethnicity, Height, 
Weight, Initial BMI, HbA1c, Active Minutes, Co-morbities, 
Medications to manage pre-existing conditions, Postoperative 
complications, ICU admission, Patient readmission, 
Postoperative length of stay, Postoperative health-related quality 
of life, Payer source 
Statistical Analysis: 
Proposed analysis: 
     Two-sided paired t-test 
Interim analysis planned? No 
Alpha level 0.05 

 
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Beta or power level: 0.80 
Number of groups being compared: 2 
Resulting number per group: 57 
Total sample size: 114 
 
 
 

 
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1.0 INTRODUCTION 
 
Poor glycemic control is an increasingly prevalent risk factor, with one in three adults in the 
United States living with prediabetes. Each percentage increase in HbA1c has been shown 
to be associated with increased major perioperative complications, ICU admission, and 
hospital length of stay. Further, the preoperative period is considered a ‘teachable moment’ 
in healthcare. The prevalence of obesity in patients undergoing total hip arthroplasty is 
disproportionately higher than in the general population. Given most patients have improved 
gradual ability to walk, and an operative procedure represents a teachable moment in 
healthcare, the perioperative period represents a novel distribution strategy. 
2.0 PRODUCT DESCRIPTION 
The 6 month long diabetes prevention program is offered via an interactive website called 
Transform10. This is a self-paced curriculum which 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. 
3.0 OBJECTIVE OF CLINICAL STUDY 
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 programs. 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 primary outcome of interest is change in percent of body weight 
before and after a 6-month intervention period. The secondary outcomes consist of change 
in percent HbA1c, postoperative outcomes, patient satisfaction, and patient readiness for 
change. 
 
4.0 STUDY HYPOTHESES 
1. An augmented digital diabetes prevention program is an effective strategy for weight 
loss in adults with prediabetes undergoing elective total hip arthroplasty. 

 
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2. An augmented digital diabetes prevention program is an effective strategy to 
decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty. 
3. An augmented digital diabetes prevention program is an effective strategy to improve 
postoperative outcomes and patient satisfaction in adults with prediabetes 
undergoing elective total hip arthroplasty. 
5.0 STUDY DESIGN 
 
5.1 
Study Duration 
2 years  
5.2 
Endpoints 
 
5.2.1 
Primary Endpoint 
• 
Body mass index will be measured at pre-surgical screening and again after 
a 6 month and 12-month period. The percentage change in body weight will 
be recorded at program completion and 6 months prior to program 
completion. 
5.2.2 
Secondary Endpoints 
• 
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. 
• 
Postoperative complications, ICU admission, patient readmission, and 
postoperative length of stay will be recorded from Epic from post-operative 
care unit (PACU) admission to 12 months post-surgery. 
• 
Patient satisfaction will be a questionnaire that is asked by the Transform10 
website 1 year after surgery. This questionnaire assess how satisfied patients 
have been with their post operative pain management. 
• 
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". 
• 
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. 
 
5.3 
Study Sites 
Hospital for Special Surgery- Main Campus 

 
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6.0 STUDY POPULATION 
6.1 
Number of Subjects 
A total of 114 subjects will be enrolled. 
 
 
6.2 
Inclusion Criteria 
Subjects of either gender will be included if they: 
• 
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 
 
6.3 
Exclusion Criteria 
Subjects will be excluded from the study if they: 
• 
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 

 
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• 
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 
 
6.4 
Randomization 
 A computer-generated, 1:1 ratio randomization schedule with blocks of sizes 4 and 6 will be 
created by a statistician not otherwise involved in the study. 
Participants will be randomized to 1 of 2 groups: 
• 
Group 1 Diabetes Prevention Program Intervention Group 
• 
Group 2 Diabetes Prevention Program Delayed Intervention Group 
7.0 PROCEDURES 
7.1 
Surgical Procedure 
Total Hip Arthroplasty 
7.2 
 Medical Record Requirements 
EPIC 
7.3 
Data Collection 
 
The following data will be collected: 
 
Pre-operative/Baseline 
• 
basic demographic data 
• 
patient weight & height, BMI, HbA1c 
 
Surgical procedure 
• 
date of surgery 
• 
type of surgery 
 
Follow-up visits (6 weeks, 1 year) 
• 
HbA1c 
• 
Postoperative health-related quality of life questionnaire 
• 
Patient satisfaction questionnaire 

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7.4 
Schedule of Assessments 
Procedures 
Day(s) 
prior to 
surgery 
Pre-
surgical 
screening 
Pre-op 
(holding 
Area) 
POD 1 (24 
hours 
after 
surgery) 
6 months 
after day 
of surgery 
12 
months 
after day 
of 
surgery 
Identify eligible patients before 
surgery 
X 
 
 
 
 
 
Obtain consent (e-consent or in 
person) 
X 
 
 
 
 
 
Transform 10 website 
 
 
X 
(Intervention 
Group) 
 
X (Control 
Group) 
 
HbA1c Test 
 
X (Both 
Groups) 
 
 
X (Both 
Groups) 
X (Both 
Groups) 
Patient Satisfaction and Health-
related quality of life survey 
(HRQOL) 
 
 
 
 
 
X (Both 
Groups) 

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8.0 STATISTICAL ANALYSIS 
Proposed analysis: 
Two-sided paired t-test 
Interim analysis planned? No 
Alpha level: 0.05 
Beta or power level: 0.80 
Number of groups being compared: 2 
Resulting number per group: 57 
Total sample size: 114 
 
 
9.0 ADVERSE EVENT ASSESSMENT 
All Adverse Events (AEs) will be reported in the final study report. Definitions for Adverse 
Event (AE) used in this study are listed below and are based on FDA and international 
guidelines: 
 
9.1 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical product which does not necessarily have to have a 
causal relationship with this treatment. An adverse event (AE) can therefore be any 
unfavorable and unintended sign (including an abnormal laboratory finding, for 
example), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not considered related to the medicinal 
(investigational) product. 
 
9.2 
Serious Adverse Events (SAE) 
The event is serious and should be reported to FDA when the patient outcome is: 
Death, Life-threatening, Hospitalization (initial or prolonged), Disability or Permanent 
Damage, Congenital Anomaly/Birth Defect, Required Intervention to Prevent 
Permanent Impairment or Damage (Devices), Other Serious (Important Medical 
Events). 
 
9.3 
Adverse Event Relationship 
Relationship to study: definitely, probably, possibly, not related. 
 
 

 
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10.0 INVESTIGATOR RESPONSIBILITIES, RECORD AND REPORTS 
 
10.1 Subject Consent and Information 
Research assistants will screen the co-investigating surgeons' patients  
undergoing ambulatory total hip arthroplasty surgery. Screening will involve  
reviewing the patient's EPIC chart to ensure that they meet the inclusion criteria  
and are not excluded due to any of the exclusion criteria listed. Patients who  
meet the inclusion criteria will be identified as potential study participants. After  
the investigating anesthesiologists have confirmed the eligibility of all potential  
participants, one of the research assistants will call the patient, explain the rationale for the  
study, and ask if the patient is interested in participating. 
10.2 Subject Data Protection 
Subject privacy and confidentiality will be maintained through the storage of study data in a 
password-protected computer database maintained by the Research Director and 
accessible only to the principal investigator, in addition to other IRB-approved study 
personnel. Each subject will be assigned a unique study number for identification in the 
study database. This unique study number will not be derived from or related to information 
about the individual. The key linking this unique study number to patient identifiers (i.e., 
name, medical record number, date of birth, registry number) will be maintained in a 
different password-protected database maintained by Research Director, to which only the 
primary investigator will have access. 
10.3 Staff Information 
Primary Investigator: Stephanie Cheng, MD 
Research Assistant: Miriam Sheetz 646-714-6685 
 
 
          Angela Puglisi 646-714-6849 
 
10.4 Protocol Reviews 
Study protocol reviewed and approved by: 
• Anesthesiology CRP 
• Hospital for Special Surgery Institutional Review Board 
 
11.0 REFERENCES 
1. https://www.cdc.gov/diabetes/data/statistics-report/index.html 
2. 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; PMCID: 
PMC2582564. 
3. Flocke SA, Clark E, Antognoli E, Mason MJ, Lawson PJ, Smith S, Cohen DJ. 
Teachable moments for health behavior change and intermediate patient outcomes. 

 
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Patient Educ Couns. 2014 Jul;96(1):43-9. doi: 10.1016/j.pec.2014.03.014. Epub 
2014 May 1. PMID: 24856449; PMCID: PMC4427843. 
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. PMID: 30510384; PMCID: PMC6243222. 
5. 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; PMCID: PMC4169327. 
 

 
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