Presessions for the National Diabetes Prevention Program

NCT04022499 | Completed Results

• 1 other identifier: 18-2542
• Study Type: interventional
• Target: 483
• Locations: 1 country
• Sites: 1

Brief Summary

The National Diabetes Prevention Program (NDPP) is a widely available, evidence-based intervention that promotes weight loss to prevent type 2 diabetes; however, participant attendance is problematic and leads to suboptimal weight loss, especially among Hispanic, non-Hispanic black, and low-income non-Hispanic white participants. An innovative pre-session enhancement to the NDPP (Pre-NDPP) showed successful results upon initial application in a diverse and predominately low-income population, with doubled attendance and weight loss outcomes as compared to previous NDPP participants who did not receive a pre-session. If Pre-NDPP is shown to be successful upon more rigorous study, it can be widely adopted by NDPP providers across the country to help reduce diabetes prevalence and related health disparities.

Conditions

Prediabetic State; Obesity; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Percent body weight change from baseline to 12 months

  12 months

Study Arms (2)

Pre-NDPP

EXPERIMENTAL

Presessions + usual care NDPP

Behavioral: Presessions; Behavioral: National Diabetes Prevention Program

Usual care NDPP

ACTIVE COMPARATOR

Usual care NDPP only

Behavioral: National Diabetes Prevention Program

Interventions

Presessions BEHAVIORAL

The Pre-NDPP arm includes a "pre-session" with three components: 1) education about diabetes risks, 2) motivational interviewing (MI) to encourage participation in the NDPP and, 3) problem-solving of barriers to engagement.

Pre-NDPP

National Diabetes Prevention Program BEHAVIORAL

The Diabetes Prevention Program was a successful clinical trial demonstrating that intensive lifestyle support for weight loss reduced diabetes incidence by 58%. The intervention was translated into the National Diabetes Prevention Program (NDPP) and disseminated by the Centers for Disease Control and Prevention as a yearlong group-based program since 2012.

Pre-NDPP; Usual care NDPP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Denver Health patients
• BMI≥25 (≥23 if Asian)
• History of recent prediabetes or former gestational diabetes (GDM) diagnosis (patients without known prediabetes or past GDM may also be eligible based on a risk screening tool)

You may not qualify if:

• Pregnant at enrollment
• Known to have diabetes
• Non-English or non-Spanish-speaking.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• Ritchie ND, Holtrop JS, Gritz RM, Sauder KA, Durfee MJ, Dickinson LM, Kaufmann PG. Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 1;9(6):e15499. doi: 10.2196/15499.

  PMID: 32476659 DERIVED

MeSH Terms

Conditions

Prediabetic State; Obesity; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

A primary limitation of the randomized controlled trial (RCT) is that the planned sample size was calculated based on effect size data from an in-person NDPP pilot study, however, due to the Coronavirus Disease 2019 (COVID-19) pandemic, the RCT intervention was conducted as a virtual program. A smaller effect size for the virtual program may have resulted in the study being underpowered to detect a statistical difference between the two groups.

Results Point of Contact

• Title: Rocio Pereira, Medical Director, Community Integrated Health Care
• Organization: Denver Health and Hospital Authority

rocio.pereira@dhha.org

303-436-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: August 6, 2019
• Primary Completion: April 29, 2024
• Study Completion: August 1, 2024
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)