Enhanced DPP for Prediabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding better sleep habits and time-restricted eating to the standard Diabetes Prevention Program (DPP) can improve health measures for people with prediabetes. Participants will either follow the regular DPP or try the enhanced version, which emphasizes sleep and eating patterns. The trial targets adults diagnosed with prediabetes and a BMI over 25 (a measure of body fat based on height and weight). As an unphased trial, it provides a unique opportunity to explore innovative lifestyle changes that could significantly enhance health.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that the two additional components of the enhanced Diabetes Prevention Program (DPP++)—a sleep health app and time-restricted eating—are generally safe for people with prediabetes.
Research indicates that improving sleep can help control blood sugar. For example, one study found that increasing sleep over a few weeks improved blood sugar levels and insulin use. This suggests that sleep programs are usually easy for participants to follow.
Regarding time-restricted eating, research shows it can safely help improve blood sugar levels. One study found that eating within a 10-hour window led to better blood sugar management and was manageable for participants. Another study showed that this approach significantly reduced body weight and improved blood sugar control.
In summary, research supports that the additional components in DPP++ are safe and generally well-tolerated for most people with prediabetes.12345Why are researchers excited about this trial?
Researchers are excited about the Enhanced Diabetes Prevention Program (DPP++) for prediabetes because it goes beyond the standard lifestyle changes. Unlike the typical DPP, which focuses on healthy eating, exercise, and behavior changes, the enhanced version adds two innovative components: a digital app to improve sleep and a time-restricted eating plan. These additions aim to tackle prediabetes from new angles, potentially boosting the effectiveness of the program and helping participants achieve better health outcomes more efficiently.
What evidence suggests that this trial's treatments could be effective for prediabetes?
Studies have shown that the standard Diabetes Prevention Program (DPP) effectively helps people avoid developing type 2 diabetes. Participants in the program have reduced their diabetes risk by 58% through lifestyle changes like healthier eating and regular exercise. In this trial, some participants will receive the standard DPP, while others will receive an enhanced version, DPP++, which includes two new components: a sleep health digital application and time-restricted eating, meaning eating only during certain hours of the day. These additions aim to increase the program's effectiveness. While specific data on DPP++ is still being gathered, the improvements rely on strong evidence that better sleep and mindful eating can enhance overall health.678910
Are You a Good Fit for This Trial?
This trial is for adults in Delaware who are overweight or obese (BMI 25+; 23+ for Asian Americans) and have prediabetes, a history of gestational diabetes, or a high risk of developing type 2 diabetes. Participants must be at least 18 years old.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization
Participants are randomized to either the standard DPP or DPP++
Treatment
Participants receive either the standard DPP or the enhanced DPP++ with additional sleep health and time-restricted eating interventions
Follow-up
Participants are monitored for metabolic and cardiovascular health outcomes
What Are the Treatments Tested in This Trial?
Interventions
- National Diabetes Prevention Program (DPP)
- Sleep Health Digital Application
- Time-Restricted Eating (TRE)
Trial Overview
The study compares the standard Diabetes Prevention Program (DPP) to an enhanced version that adds a sleep health app and time-restricted eating. Participants are randomly assigned to one group to see which approach better improves heart and metabolic health.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive the standard 12-month DPP plus two additional evidence-based components delivered in months 5-6: (1) a sleep health digital application delivering self-guided behavioral strategies to improve sleep, and (2) a time-restricted eating intervention. Educational materials and a brief orientation session are provided at the time of randomization to support engagement with both added components.
Participants continue with the standard 12-month National Diabetes Prevention Program (DPP) as delivered by the University of Delaware Nutrition Clinic. The DPP is a 26-session, group-based lifestyle intervention focusing on healthy eating, increased physical activity, and behavior change strategies, with a primary goal of achieving 5-7% weight loss and 150 minutes of moderate-to-vigorous physical activity per week. Sessions are delivered weekly in months 1-4, bi-weekly in months 5-6, and monthly in months 7-12.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Delaware
Lead Sponsor
Citations
The Diabetes Prevention Program and Its Outcomes Study
After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated efficacy of both ...
2.
diabetesjournals.org
diabetesjournals.org/care/article/48/7/1150/160620/The-U-S-National-Diabetes-Prevention-Program-NDPPThe US National Diabetes Prevention Program (NDPP ...
The US National Diabetes Prevention Program (NDPP) shows promise as a cost-effective implementation strategy available.
Diabetes Prevention Programs: Effectiveness and Value
The Diabetes Prevention Program Trial (DPP Trial) demonstrated that the incidence of diabetes could be reduced using intensive diet and lifestyle counseling for ...
Evidence
It also found that successful completion of the National DPP lifestyle change program reduced progression to diabetes for these individuals by 35%. To access ...
What Is the National DPP?
Results from the study showed that this structured lifestyle change program—in which participants achieved weight loss of 5 to 7 percent of ...
The sleep for health study: A randomized clinical trial of the ...
This trial is testing whether a program to improve sleep will positively impact glycemia among those with prediabetes.
NCT06067139 | Sleep for Health Study on the Effects of ...
This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels ...
Insights from Ng et al. (2024) | SLEEP | Oxford Academic
2–7], the findings from Ng et al. reveal that moderate nightly sleep variations did not significantly affect next-day glucose profiles, nor did ...
Review Effects of sleep intervention on glucose control
Sleep extension from 7 to 14 days improved blood glucose control and insulin sensitivity in both healthy and diabetes participants. Diabetes sleep education and ...
Associations of impaired glucose tolerance and sleep ...
Conclusions Using the most updated US national data, we found a high risk of all-cause mortality among individuals with IGT having sleep ...
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