The National Diabetes Prevention Program in Rural Communities

NCT ID: NCT05387434

Last Updated: 2023-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2022-03-29

Brief Summary

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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

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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.

Conditions

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PreDiabetes Weight Loss Lifestyle Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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DPP-R

Weekly 60 min. group meetings, lead by trained KSRE staff, (12-15 participants) will be held by Zoom over 6 months followed by monthly 60 min. group meetings for the later 6 months. Approximately 5 min prior to the meeting time (typically early evening) participants will receive call in information to join the group meeting by video conferencing or phone.

Group Type EXPERIMENTAL

Diabetes Prevention Program-Remote (DPP-R)

Intervention Type BEHAVIORAL

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

DPP-FB

Participants will be asked to join a secret, research team moderated, Facebook® group, which is only accessible by group members. The health educator will post the module, de-identified participant self-monitoring data, and comment on individuals posts weekly. Brief discussion prompts are designed to reinforce the primary objectives of each module and to facilitate inter-participant discussion around these topics. Responses will be monitored and tracked. This is analogous to attendance in the Zoom® group.

Group Type EXPERIMENTAL

Diabetes Prevention Program-Facebook (DPP-FB)

Intervention Type BEHAVIORAL

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

Interventions

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Diabetes Prevention Program-Remote (DPP-R)

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

Intervention Type BEHAVIORAL

Diabetes Prevention Program-Facebook (DPP-FB)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kansas State University

OTHER

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna M Gorczyca, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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Wagner G, Koon LM, Smith P, Suire KB, Hastert M, Donnelly JE, Olfert MD, Estabrooks P, Gorczyca AM. Assessing the Fit of a Digitally Delivered National Diabetes Prevention Program Among Rural Living Adults: Qualitative Study. JMIR Form Res. 2025 Jul 2;9:e70406. doi: 10.2196/70406.

Reference Type DERIVED
PMID: 40601375 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5P20GM144269

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00146055

Identifier Type: -

Identifier Source: org_study_id