The National Diabetes Prevention Program in Rural Communities

Weight Loss Clinical Trial

— Rural NDPP  

Official title:

The National Diabetes Prevention Program in Rural Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05387434
• Other study ID #: 00146055
• Secondary ID: 5P20GM144269
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: December 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 29, 2022
• Est. primary completion date: March 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lifestyle Risk Reduction
• PreDiabetes
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Kansas State University, National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant Retention	Retention will be defined as attendance at 6 mo. outcome testing.	6 months
Secondary	Average Program Attendance	Program attendance will be defined as average percentage of sessions attended by group.	6 months