Clinical trial NCT06252038: Rural Alliance for Diabetes Prevention
Official title: Rural Alliance for Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Keywords: Diabetes Prevention Program
HbA1c
Physical Activity
Weight Loss
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Kansas State University
First posted: 2024-02-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight change across 12 months
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: HbA1c change across 12 months
timeFrame: Baseline to 12 months
measure: CDC-NDPP Weight Loss Goal
timeFrame: Baseline to 12 months
measure: CDC-NDPP Physical Activity Goal
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Anna M Gorczyca, PhD
role: PRINCIPAL_INVESTIGATOR
References: