Digital Diabetes Prevention Program Study

February 22, 2024 updated by: Hospital for Special Surgery, New York

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Miriam Sheetz, BS
  • Phone Number: 646-714-6685
  • Email: sheetzm@hss.edu

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percent of body weight before and after a 6 month intervention period.
Time Frame: Pre-surgical screening to 12 months post-operation
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.
Time Frame: Pre-surgical screening to 12 months post-operation
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 readiness assessment
Time Frame: day of surgery to 6 months prior to surgery
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
Possible postoperative complications
Time Frame: PACU arrival time to 12 months post-operation
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
Time Frame: PACU arrival time to 12 months post-operation
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
Time Frame: PACU arrival time to 12 months post-operation
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
Time Frame: PACU arrival time to 12 months post-operation
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
Patient satisfaction.
Time Frame: 12 months post-operation
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
Health related quality of life (HRQOL)
Time Frame: 12 months post-operation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Study Director: Justas Lauzadis, PhD, Hospital for Special Surgery, Department of Anesthesiology
  • Principal Investigator: Stephanie Cheng, MD, Hospital for Special Surgery, Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Actual)

January 24, 2024

Study Completion (Actual)

January 24, 2024

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual patient data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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