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

Primary Purpose

PreDiabetes, Weight Loss, Lifestyle Risk Reduction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program-Remote (DPP-R)
Diabetes Prevention Program-Facebook (DPP-FB)
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DPP-R

DPP-FB

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Participant retention
Retention will be defined as attendance at 6 mo. outcome testing.
Program attendance
Program attendance will be defined as being present as the beginning and end of the class/call and reporting weekly data.

Full Information

First Posted
May 12, 2022
Last Updated
January 6, 2023
Sponsor
University of Kansas Medical Center
Collaborators
Kansas State University
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1. Study Identification

Unique Protocol Identification Number
NCT05387434
Brief Title
The National Diabetes Prevention Program in Rural Communities
Acronym
Rural NDPP
Official Title
The National Diabetes Prevention Program in Rural Communities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
March 5, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Kansas State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Weight Loss, Lifestyle Risk Reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Two rural KSRE local units will be randomized in a 1:1 ratio to either DPP-FB or DPP-R.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DPP-R
Arm Type
Experimental
Arm Description
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.
Arm Title
DPP-FB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program-Remote (DPP-R)
Intervention Description
The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Zoom.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program-Facebook (DPP-FB)
Intervention Description
The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Facebook.
Primary Outcome Measure Information:
Title
Change in body weight from 0-6 months
Description
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.
Time Frame
Baseline - 6 months
Title
Change in moderate to vigorous physical activity (MVPA)
Description
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.
Time Frame
Baseline - 6 months
Secondary Outcome Measure Information:
Title
Participant retention
Description
Retention will be defined as attendance at 6 mo. outcome testing.
Time Frame
6 months
Title
Program attendance
Description
Program attendance will be defined as being present as the beginning and end of the class/call and reporting weekly data.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in moderate to vigorous physical activity (MVPA)
Description
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.
Time Frame
Baseline-12 months
Title
Program attendance
Description
Program attendance will be defined as being present as the beginning and end of the class/call and reporting weekly data.
Time Frame
12 months
Title
Participant retention
Description
Retention will be defined as attendance at 12 mo. outcome testing.
Time Frame
12 months
Title
Change in body weight from 0-12 months
Description
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.
Time Frame
Baseline - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna M Gorczyca, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The National Diabetes Prevention Program in Rural Communities

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