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Rural Alliance for Diabetes Prevention

NCT ID: NCT06252038

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2028-05-31

Brief Summary

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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.

Detailed Description

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This 12 mo. Type II hybrid effectiveness-implementation trial will compare effectiveness (weight loss, physical activity, HbA1c) of Cooperative Extension delivering the Diabetes Prevention Program (DPP) by group video using Zoom® (GV) vs. a self-directed (SD) control. Active vs. passive participant recruitment strategies will be compared on recruitment outcomes including time to full enrollment, participant yield, and retention rates. Ten Cooperative Extension local units/districts serving rural Kansas counties will be allocated to either active or passive recruitment. Each of the sites will recruit adults with prediabetes living in the county served by Kansas State Research and Extension site and will be randomized to one of the 2 intervention arms. A centralized team of Cooperative Extension Agents who complete NDPP lifestyle coach training will serve as interventionists for both the GV and SD arms. Primary (weight) and secondary outcomes (HbA1c, the proportion of participants meeting weight loss (≥ 5%) and physical activity goals (≥150 min./wk.) will be assessed at baseline, 6 and 12 mos. Findings will inform best practices in the delivery of the DPP through Cooperative Extension in rural communities that could reach this high risk population.

Conditions

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PreDiabetes

Keywords

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Diabetes Prevention Program HbA1c Physical Activity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group Video Diabetes Prevention Program

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

Group Type EXPERIMENTAL

Zoom Group Video (GV)

Intervention Type BEHAVIORAL

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

Self Directed Diabetes Prevention Program

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

Group Type ACTIVE_COMPARATOR

Self Directed (SD)

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Kansas State University

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna M Gorczyca, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Annie Rice, M.S.

Role: CONTACT

Phone: 785-764-3770

Email: [email protected]

Facility Contacts

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Annie Rice

Role: primary

Other Identifiers

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R01DK132362

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00150103

Identifier Type: -

Identifier Source: org_study_id