PreDiabetesRural NDPPNCT05387434

The National Diabetes Prevention Program in Rural Communities

A study testing Diabetes Prevention Program-Remote (DPP-R) and Diabetes Prevention Program-Facebook (DPP-FB) in people with PreDiabetes and Weight Loss, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: PreDiabetes, Weight Loss, Lifestyle Risk Reduction
What is being tested?: Diabetes Prevention Program-Remote (DPP-R) and Diabetes Prevention Program-Facebook (DPP-FB)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 3 Mar 2021to 29 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

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.

Read the 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.

Conditions: PreDiabetes, Weight Loss, Lifestyle Risk Reduction
Being tested: Diabetes Prevention Program-Remote (DPP-R), Diabetes Prevention Program-Facebook (DPP-FB)
Medical subject headings: Prediabetic State, Weight Loss, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diabetes Prevention Program-Remote (DPP-R)Behavioural
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)Behavioural
The DPP is an evidenced based lifestyle intervention that includes topics on nutrition and physical activity delivered over Facebook.

Study groups in NCT05387434
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Diabetes Prevention Program-Facebook (DPP-FB)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline - 6 months

Secondary outcomes (2)

Participant Retention
Retention will be defined as attendance at 6 mo. outcome testing.
Measured: 6 months
Average Program Attendance
Program attendance will be defined as average percentage of sessions attended by group.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202129 Mar 2022

First posted24 May 2022
Study start3 Mar 2021
Primary completion5 Mar 2022
Study completion29 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PreDiabetesStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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: Single blind
Who is masked: Participant
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05387434
Sponsor's protocol ID: 00146055
Other IDs: 5P20GM144269
Acronym: Rural NDPP
Status last verified: Dec 2023
First submitted: 12 May 2022
Last updated: 8 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40601375

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The National Diabetes Prevention Program in Rural Communities
ClinicalTrials.gov ID: NCT05387434
Acronym / sponsor ID: Rural NDPP / 00146055
Conditions: PreDiabetes, Weight Loss, Lifestyle Risk Reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: Kansas State University, National Institute of General Medical Sciences (NIGMS)
Study start: 3 Mar 2021 (actual)
Primary completion: 5 Mar 2022 (actual)
Study completion: 29 Mar 2022 (actual)
First posted: 24 May 2022 (actual)
Results: Posted 22 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
DPP-R	Experimental	Behavioral: Diabetes Prevention Program-Remote (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.
DPP-FB	Experimental	Behavioral: Diabetes Prevention Program-Facebook (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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	DPP-R
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.	Behavioural	DPP-FB

Primary outcome

Change in Body Weight From 0-6 Months
Time frame: Baseline - 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.

2 secondary outcomes

Participant Retention
Time frame: 6 months
Average Program Attendance
Time frame: 6 months

Results and safety

Results posted to the registry on 22 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DPP-R	16	14
DPP-FB	15	13

Primary outcome: Change in Body Weight From 0-6 Months

Time frame: Baseline - 6 months. Mean (Standard Deviation). Unit: kilograms

Measure	DPP-R n = 14	DPP-FB n = 13
Value	-6.0 (8.0)	-1.7 (3.3)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DPP-R	0 of 16 (0%)	0 of 16 (0%)	0 of 16
DPP-FB	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40601375Wagner 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.
Individual participant dataSharing planned: No

Related trials for PreDiabetes

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Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna M Gorczyca, PhD principal investigator

University of Kansas Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight From 0-6 Months (time frame: Baseline - 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05387434, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.