NCT06252038

Brief Summary

The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Sep 2024May 2028

First Submitted

Initial submission to the registry

January 12, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

September 24, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

January 12, 2024

Last Update Submit

February 25, 2026

Conditions

PreDiabetes

Keywords

Diabetes Prevention ProgramHbA1cPhysical ActivityWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight change across 12 months

    Weight (kg) will be assessed to the nearest 0.1 kg with a calibrated scale (Belfour Inc., Model #PS6600). All participants will be weighed between the hours of 6 and 10 am following an overnight fast of at least 8 hours in a standard hospital gown.

    Baseline to 12 months

Secondary Outcomes (3)

  • HbA1c change across 12 months

    Baseline to 12 months

  • CDC-NDPP Weight Loss Goal

    Baseline to 12 months

  • CDC-NDPP Physical Activity Goal

    Baseline to 12 months

Study Arms (2)

Group Video Diabetes Prevention Program

EXPERIMENTAL

Participants randomized to the group video DPP for 12-months.

Behavioral: Zoom Group Video (GV)

Self Directed Diabetes Prevention Program

ACTIVE COMPARATOR

Participants randomized to the self directed DPP for 12-months.

Behavioral: Self Directed (SD)

Interventions

Zoom Group Video (GV)BEHAVIORAL

Zoom delivery of the DPP. Participants have access to Prevent T2 Curriculum and connected technology to track weight and physical activity.

Group Video Diabetes Prevention Program
Self Directed (SD)BEHAVIORAL

Self directed delivery of the DPP. Participants have access to online curriculum, lifestyle coach and connected technology to track weight and physical activity.

Self Directed Diabetes Prevention Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • BMI ≥25 kg/m2, ≥23 kg/m2 if Asian
  • Blood test results in the pre diabetic range within the last year (HbA1C = 5.7%-6.4% or fasting plasma glucose= 100-125 mg/dl or 2-hr. plasma glucose following a 75-gm glucose load = 140-199 mg/dL) or have previous diagnosis of gestational diabetes or a positive screening for pre diabetes based on CDC pre diabetes risk test
  • Willing to travel to KSRE site for orientation and outcome testing
  • Available to attend pre-specified meeting time of GV for their respective KSRE location
  • Medically stable as deemed by primary care provider consent
  • English speaking

You may not qualify if:

  • Previous diagnosis of Type I or II diabetes
  • Taking FDA-approved weight loss medications
  • Primary care provider stating that patient should not participate
  • Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)
  • Unable to engage in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic StateMotor ActivityWeight Loss

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna M Gorczyca, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie Rice, M.S.

CONTACT

785-764-3770arice7@kumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 9, 2024

Study Start

September 24, 2024

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)