Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Delaware
About this trial
This nested pilot Randomized Clinical Trial will determine whether the Diabetes Prevention Program (DPP) enhanced with evidence-based sleep health and time restricted eating interventions ("DPP++") is more effective than the DPP alone for improving metabolic and cardiovascular metrics in 40 overweight/obese adults with prediabetes.
Eligibility criteria
Qualifiers
Adults aged 18 years or older
Prediabetes confirmed by blood test result within 12 months of enrollment, previous diagnosis of gestational diabetes mellitus (GDM), or positive screening for prediabetes based on the Prediabetes Risk Test
BMI of 25 kg/m² or greater (23 kg/m² or greater for Asian Americans)
Disqualifiers
Age younger than 18 years
BMI less than 25 kg/m² (less than 23 kg/m² for Asian Americans)
No current diagnosis of prediabetes or gestational diabetes mellitus
Prior diagnosis of type 1 or type 2 diabetes
Trial design
Treatments tested in this trial
- National Diabetes Prevention Program (DPP)
- Sleep Health Digital Application
- Time-Restricted Eating (TRE)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov