Rural Alliance for Diabetes Prevention (RAD)

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.

Study Overview

• Status: Recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: Zoom Group Video (GV); Behavioral: Self Directed (SD)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annie Rice, M.S.; Phone Number: 785-764-3770; Email: arice7@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Annie Rice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Video Diabetes Prevention Program; Participants randomized to the group video DPP for 12-months.	Behavioral: 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.
Active Comparator: Self Directed Diabetes Prevention Program; Participants randomized to the self directed DPP for 12-months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c change across 12 months	Hemoglobin A1c will be collected and assessed by Quest Diagnostic. Participants will be required to fast for at least 12 hours before blood draw. A total of 3-5 teaspoons of blood will be collected by inserting a needle in a vein in the arm for routine laboratory tests at each clinic visit. Participant blood samples will be used to measure HbA1c.	Baseline to 12 months
CDC-NDPP Weight Loss Goal	CDC-NDPP weight loss goal will be categorized as the percentage of participants who achieve ≥ 5% weight loss across the 12 month intervention.	Baseline to 12 months
CDC-NDPP Physical Activity Goal	CDC-NDPP physical activity goal will be categorized by the percentage of participants who achieve an average of ≥ 150 min./wk. of PA across the 12 month intervention.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Kansas State University
• Investigators: Principal Investigator: Anna M Gorczyca, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; HbA1c; Weight Loss; Diabetes Prevention Program
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Weight Loss; Prediabetic State; Motor Activity
• Other Study ID Numbers: STUDY00150103; R01DK132362 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No