University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Location status: Recruiting
Location contact
Annie Rice
CONTACT
NCT Number: NCT06252038
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
Location status: Recruiting
Annie Rice
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zoom delivery of the DPP. Participants have access to Prevent T2 Curriculum and connected technology to track weight and physical activity.
Self directed delivery of the DPP. Participants have access to online curriculum, lifestyle coach and connected technology to track weight and physical activity.
Time frame: Baseline to 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.
Time frame: Baseline to 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.
Time frame: Baseline to 12 months
CDC-NDPP weight loss goal will be categorized as the percentage of participants who achieve ≥ 5% weight loss across the 12 month intervention.
Time frame: Baseline to 12 months
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.
Contact information is provided by the study sponsor or research team.
University of Kansas Medical Center
Other
Acronym: RAD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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