Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT06252038

Conditions

PreDiabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zoom Group Video (GV)

Self Directed (SD)

Study Details

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.

Conditions

PreDiabetes

Study ID

NCT06252038

Start date

Sep 24, 2024

Status verified date

Feb, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group Video Diabetes Prevention Program

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

active comparator: Self Directed Diabetes Prevention Program

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

Interventions

Zoom Group Video (GV)

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

Self Directed (SD)

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

Primary outcome measure

  • Weight change across 12 months [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Annie Rice, M.S.

785-764-3770arice7@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Diabetes Prevention Program
  • HbA1c
  • Physical Activity
  • Weight Loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-02-27.