Rural Alliance for Diabetes Prevention

PreDiabetes Clinical Trial

— RAD  

Official title:

Rural Alliance for Diabetes Prevention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06252038
• Other study ID #: STUDY00150103
• Secondary ID: R01DK132362
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: Annie Rice, M.S.
• Phone: 785-764-3770
• Email: arice7[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Kansas State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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