Clinical trial NCT05387434: The National Diabetes Prevention Program in Rural Communities
Official title: The National Diabetes Prevention Program in Rural Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Weight Loss
Lifestyle Risk Reduction
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Kansas State University
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-05-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed 2-arm trial will compare the feasibility and effectiveness of Facebook or remote-delivery of the DPP in rural adults with prediabetes both delivered through the KSRE. The CES is a non-formal educational program, implemented in the U.S. through each state's designated land grant university, to help people use research-based knowledge to improve their lives. The KSRE maintains local units which are comprised of single counties or multi-county districts. Two KSRE local units serving rural counties will be identified by our partners at KSRE and randomized to the Facebook or remote delivery arms. Members of the KUMC research team will recruit and consent participants and will train KSRE personnel to deliver the 30 core-sessions of the DPP protocol over 12 mos. Outcomes will be assessed by the research team at the local CES offices at baseline, 3 mos. 6 mos. and 12 mos.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Age ≥18 yrs.
3. Willing to commit to participate on a weekly basis for the 6 month intervention
4. 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
5. Internet access and capability to use Zoom
6. Clearance from primary care physician

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Body Weight From 0-6 Months
timeFrame: Baseline - 6 months
Secondary outcomes:
measure: Participant Retention
timeFrame: 6 months
measure: Average Program Attendance
timeFrame: 6 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: