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OpenTrials
Completed

NCT Number: NCT05387434

The National Diabetes Prevention Program in Rural Communities

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes Prevention Program-Remote (DPP-R)

Behavioral

The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Zoom.

Diabetes Prevention Program-Facebook (DPP-FB)

Behavioral

The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Facebook.

Primary outcomes

  1. 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

  1. Participant Retention

    Time frame: 6 months

    Retention will be defined as attendance at 6 mo. outcome testing.

  2. Average Program Attendance

    Time frame: 6 months

    Program attendance will be defined as average percentage of sessions attended by group.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Kansas State University
  • National Institute of General Medical Sciences (NIGMS)

Registry information

Acronym: Rural NDPP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 24, 2022
Registry last updated
Dec 8, 2023

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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