The National Diabetes Prevention Program in Rural Communities

NCT05387434 | Completed Results

• 2 other identifiers: 001460555P20GM144269
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Weight Loss; Lifestyle Risk Reduction

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight From 0-6 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.

  Baseline - 6 months

Secondary Outcomes (2)

• Participant Retention

  6 months

• Average Program Attendance

  6 months

Study Arms (2)

DPP-R

EXPERIMENTAL

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.

Behavioral: Diabetes Prevention Program-Remote (DPP-R)

DPP-FB

EXPERIMENTAL

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.

Behavioral: Diabetes Prevention Program-Facebook (DPP-FB)

Interventions

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.

DPP-R

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.

DPP-FB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Kansas State University: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• 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.

  PMID: 40601375 DERIVED

MeSH Terms

Conditions

Prediabetic State; Weight Loss; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Anna Gorczyca
• Organization: University of Kansas Medical Center

agorczyca@kumc.edu

913-588-9077

Study Officials

• Anna M Gorczyca, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Two rural KSRE local units will be randomized in a 1:1 ratio to either DPP-FB or DPP-R.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 24, 2022
• Study Start: March 3, 2021
• Primary Completion: March 5, 2022
• Study Completion: March 29, 2022
• Last Updated: December 8, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)