NCT06137963

Digital Diabetes Prevention Program Study

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-24
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2023-11-18
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States