PreDiabetesNCT06137963
Digital Diabetes Prevention Program Study
A study testing Transform10 Diabetes Prevention Program in people with PreDiabetes, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Transform10 Diabetes Prevention Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- Able to provide informed consent
- Willing to accept a random assignment
- Readiness for change
- ASA 1 or 2
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: 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:
Read more
- Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty?
- Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty?
- 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.
Read the 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:
- Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty?
- Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty?
- 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
- PreDiabetes
- Being tested
- Transform10 Diabetes Prevention Program
- Keywords
- prediabetes, hemoglobin a1c, hba1c, total hip arthroplasty
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transform10 Diabetes Prevention ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Transform10 Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-surgical screening to 12 months post-operation
Secondary outcomes (8)
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.
Measured: Pre-surgical screening to 12 months post-operation
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.
Measured: 12 months post-operation
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".
Measured: day of surgery to 6 months prior to surgery
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.
Measured: 12 months post-operation
Possible postoperative complications
This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery.
Measured: PACU arrival time to 12 months post-operation
Possible ICU Admission
This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery.
Measured: PACU arrival time to 12 months post-operation
Possible patient readmission
This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery.
Measured: PACU arrival time to 12 months post-operation
Postoperative length of stay
This will be recorded from Epic from post-operative care unit (PACU) admission to 12 months post-surgery.
Measured: PACU arrival time to 12 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Jan 2024
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Why it stopped: This study is no longer feasible due to the increasing number of diabetic patients who are prescribed Ozempic and other GLP-1 agonists.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind randomized control trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jashvant Poeran, MD/PhD, Study director, Hospital for Special Surgery, Department of AnesthesiologyStephanie Cheng, MD, Principal investigator, Hospital for Special Surgery, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137963
- Sponsor's protocol ID
- 2023-2194
- Status last verified
- Apr 2024
- First submitted
- 14 Sep 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual patient data with other researchers.
Publications
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.
PubMed 29032962Santa 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.
PubMed 26300015Wexler 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.
PubMed 18697862Flocke 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.
PubMed 24856449Diabetes 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.
PubMed 12453955Ackermann 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.
PubMed 32080770Kirley 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.
PubMed 30510384Cha 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.
PubMed 24950683Wilson 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.
PubMed 28650899Michaelides 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.
PubMed 27651911
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Augmented Digital Diabetes Prevention Program for Adults With Prediabetes Having Elective Total Hip Arthroplasty: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06137963
- Acronym / sponsor ID
- 2023-2194
- Conditions
- PreDiabetes
- Keywords
- prediabetes, hemoglobin a1c, hba1c, total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is no longer feasible due to the increasing number of diabetic patients who are prescribed Ozempic and other GLP-1 agonists.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty?
- Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty?
- 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
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:
- Is an augmented digital diabetes prevention program an effective strategy for weight loss in adults with prediabetes undergoing elective total hip arthroplasty?
- Is an augmented digital diabetes prevention program an effective strategy to decrease HbA1c in adults with prediabetes undergoing elective total hip arthroplasty?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- double-blind randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Transform10 Waitlist | Other | Other: Transform10 Diabetes Prevention ProgramThe 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 | Experimental | Other: Transform10 Diabetes Prevention ProgramPatients 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transform10 Diabetes Prevention ProgramThe 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. | Other | Transform10, Transform10 Waitlist |
Primary outcome
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.
8 secondary outcomes
Change in percent Hgb A1C after a 6 month intervention period.
Time frame: Pre-surgical screening to 12 months post-operation
Patient satisfaction.
Time frame: 12 months post-operation
Patient readiness assessment
Time frame: day of surgery to 6 months prior to surgery
Health related quality of life (HRQOL)
Time frame: 12 months post-operation
Possible postoperative complications
Time frame: PACU arrival time to 12 months post-operation
Possible ICU Admission
Time frame: PACU arrival time to 12 months post-operation
Possible patient readmission
Time frame: PACU arrival time to 12 months post-operation
Postoperative length of stay
Time frame: PACU arrival time to 12 months post-operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 29032962Couwenberg 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.
- Background: PubMed 26300015Santa 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.
- Background: PubMed 18697862Wexler 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.
- Background: PubMed 24856449Flocke 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.
- Background: PubMed 12453955Diabetes 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.
- Background: PubMed 32080770Ackermann 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.
- Background: PubMed 30510384Kirley 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.
- Background: PubMed 24950683Cha 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.
- Background: PubMed 28650899Wilson 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.
- Background: PubMed 27651911Michaelides 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.
- Centers for Disease Control (CDC) National Diabetes Statistics ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual patient data with other researchers.
Related trials for PreDiabetes
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Active, not recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
RecruitingObservational study
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Overweight and Obesity, Diabetes Mellitus, Type 2
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Active, not recruitingEarly Phase 1
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jashvant Poeran, MD/PhD study director
Hospital for Special Surgery, Department of Anesthesiology
Stephanie Cheng, MD principal investigator
Hospital for Special Surgery, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transform10 Diabetes Prevention Program in people with PreDiabetes, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent of body weight before and after a 6 month intervention period. (time frame: Pre-surgical screening to 12 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06137963, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.