The National Diabetes Prevention Program in Rural Communities (Rural NDPP)

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; PreDiabetes; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: Diabetes Prevention Program-Remote (DPP-R); Behavioral: Diabetes Prevention Program-Facebook (DPP-FB)

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Retention	Retention will be defined as attendance at 6 mo. outcome testing.	6 months
Average Program Attendance	Program attendance will be defined as average percentage of sessions attended by group.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in moderate to vigorous physical activity (MVPA)	Physical activity will be assessed using an ActiGraph (wGT3x-BT) portable tri-axial accelerometer (ArchiMed Co, Lyon, Auvergne-Rhone-Alpes, France). Participants will wear the ActiGraph on a belt over the non-dominant hip at the anterior axillary line during waking hours for 7 consecutive days, except for bathing, swimming, and contact sports. A 7-day monitoring period provides a reliable estimate of moderate-to-vigorous PA. ActiGraphs will be given to participants during outcomes testing with a prepaid envelope to mail back to the investigators after wearing for 7 days.	Baseline-12 months
Program attendance	Program attendance will be defined as being present as the beginning and end of the class/call and reporting weekly data.	12 months
Participant retention	Retention will be defined as attendance at 12 mo. outcome testing.	12 months
Change in body weight from 0-12 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 - 12 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Kansas State University; National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Anna M Gorczyca, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): March 5, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 00146055; 5P20GM144269 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No