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Clinical Trials/NCT05387434
NCT05387434CompletedNot Applicable

The National Diabetes Prevention Program in Rural Communities

University of Kansas Medical Center2 sites in 1 country31 target enrollmentStarted: March 3, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Locations
2
Primary Endpoint
Change in Body Weight From 0-6 Months

Study Overview

Brief Summary

The purpose of this pilot trial is to compare feasibility and effectiveness of remote delivery (social media or video conferencing) of the National Diabetes Prevention Program (N-DPP) to adults in rural communities. The research team will train a Kansas State Research and Extension staff to deliver the video conferencing arm while a research team member will lead the social media arm.

Detailed Description

This pilot trial will compare the feasibility and effectiveness of DPP delivered through Facebook (DPP-FB) or group format delivered remotely by Zoom (DPP-R) in adults in rural communities. Both interventions will recruit through the Corporative Extension Service (CES), which serves as the community outreach arm of all land grant universities through over 2,900 offices across the U.S. The Kansas State Research and Extension (KSRE) (Kansas version of CES), is well positioned, but underutilized for the delivery of DPP in rural areas. Delivery of DPP by a well-recognized entity, such as the KSRE, may improve the probability of dissemination and long-term program sustainability. Two CES offices serving rural counties in Kansas will be randomized (1:1) to the DPP-FB or DPP-R arms. Our research team will train one professional staff from KSRE (with backgrounds in nutrition programming and family consumer science) to deliver the DPP-R intervention. A research team member will deliver the DPP-FB intervention. This project will address the following aims:

Primary aim: Compare weight and MVPA between DPP-FB and DPP-R across 6 mos. The investigators expect greater weight loss and MVPA in the DPP-R arm compared with the DPP-FB arm.

Secondary aim: Compare the feasibility of DPP-FB and DPP-R across 6 mos. based on participant retention and program attendance. The investigators expect greater participant retention and program attendance in the DPP-R arm compared with the DPP-FB arm.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

Two rural KSRE local units will be randomized in a 1:1 ratio to either DPP-FB or DPP-R.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Prediabetes as defined as A1C = 5.7-6.4%, fasting glucose = 100-125 mg/dl, (confirmed from physician/medical record in the previous year), history of gestation diabetes mellitus OR a positive result based on the CDC- DPP screener
  • Age ≥18 yrs.
  • Willing to commit to participate on a weekly basis for the 6 month intervention
  • Living in the county of a rural KSRE local unit. Rural counties will be defined using the American Community Survey definition which categorizes a county as rural if the population is < 65,000
  • Internet access and capability to use Zoom
  • Clearance from primary care physician

Exclusion Criteria

  • Diagnosis of Type 2 diabetes
  • Unable to participate in physical activity.

Outcomes

Primary Outcomes

Change in Body Weight From 0-6 Months

Time Frame: Baseline - 6 months

Anthropometric measurements: Body weight will be assessed to the nearest 0.1 kg with a calibrated scale (Belfour Inc., Model #PS6600, Saukville, WI). All participants will be weighed between the hours of 6 and 11 am following a 12 hr. fast in a standard hospital gown.

Secondary Outcomes

  • Participant Retention(6 months)
  • Average Program Attendance(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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