Trial Outcomes & Findings for Presessions for the National Diabetes Prevention Program (NCT NCT04022499)

Results Overview

Percent body weight change from baseline to 12 months

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

483 participants

Primary outcome timeframe

12 months

Results posted on

2025-09-05

Participant Flow

We will identify potential participants through referrals from Denver Health healthcare providers to the Denver Health NDPP, per routine practice since 2013. Providers refer through the electronic health record (EHR), following email prompts to provider listservs in the preceding months of a new NDPP starting. Recruitment efforts began summer 2019 and concluded winter 2023.

Participant milestones

Participant milestones
Measure	Pre-NDPP Presessions + usual care NDPP	Usual Care NDPP Usual care NDPP only
Overall Study STARTED	244	239
Overall Study COMPLETED	236	234
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-NDPP n=244 Participants Presessions + usual care NDPP	Usual Care NDPP n=239 Participants Usual care NDPP only	Total n=483 Participants Total of all reporting groups
Age, Continuous	46.6 years STANDARD_DEVIATION 13 • n=244 Participants	47.0 years STANDARD_DEVIATION 12.9 • n=239 Participants	46.8 years STANDARD_DEVIATION 12.9 • n=483 Participants
Sex: Female, Male Female	192 Participants n=244 Participants	190 Participants n=239 Participants	382 Participants n=483 Participants
Sex: Female, Male Male	52 Participants n=244 Participants	49 Participants n=239 Participants	101 Participants n=483 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 months

Population: Patients that were pregnant were excluded from the analysis

Percent body weight change from baseline to 12 months

Outcome measures

Outcome measures
Measure	Pre-NDPP n=236 Participants Presessions + usual care NDPP	Usual Care NDPP n=234 Participants Usual care NDPP only
Weight Loss	3.1 % of weight loss Standard Deviation 6.7	2.8 % of weight loss Standard Deviation 6.0

Adverse Events

Pre-NDPP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care NDPP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rocio Pereira, Medical Director, Community Integrated Health Care

Denver Health and Hospital Authority

Phone: 303-436-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place