PreDiabetesRADNCT06252038
Rural Alliance for Diabetes Prevention
A study testing Zoom Group Video (GV) and Self Directed (SD) in people with PreDiabetes, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Zoom Group Video (GV) and Self Directed (SD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- BMI ≥25 kg/m2, ≥23 kg/m2 if Asian
- Blood test results in the pre diabetic range within the last year (HbA1C = 5.7%-6.4% or fasting plasma glucose= 100-125 mg/dl or 2-hr. plasma glucose following a 75-gm glucose load = 140-199 mg/dL) or have previous diagnosis of gestational diabetes or a positive screening for pre diabetes based on CDC pre diabetes risk test
- Willing to travel to KSRE site for orientation and outcome testing
- Available to attend pre-specified meeting time of GV for their respective KSRE location
- Medically stable as deemed by primary care provider consent
- English speaking
Who cannot join
- Previous diagnosis of Type I or II diabetes
- Taking FDA-approved weight loss medications
- Primary care provider stating that patient should not participate
- Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)
- Unable to engage in physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Annie Rice
About this study
The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas.
Read the detailed description
This 12 mo. Type II hybrid effectiveness-implementation trial will compare effectiveness (weight loss, physical activity, HbA1c) of Cooperative Extension delivering the Diabetes Prevention Program (DPP) by group video using Zoom® (GV) vs. a self-directed (SD) control. Active vs. passive participant recruitment strategies will be compared on recruitment outcomes including time to full enrollment, participant yield, and retention rates. Ten Cooperative Extension local units/districts serving rural Kansas counties will be allocated to either active or passive recruitment. Each of the sites will recruit adults with prediabetes living in the county served by Kansas State Research and Extension site and will be randomized to one of the 2 intervention arms. A centralized team of Cooperative Extension Agents who complete NDPP lifestyle coach training will serve as interventionists for both the GV and SD arms. Primary (weight) and secondary outcomes (HbA1c, the proportion of participants meeting weight loss (≥ 5%) and physical activity goals (≥150 min./wk.) will be assessed at baseline, 6 and 12 mos. Findings will inform best practices in the delivery of the DPP through Cooperative Extension in rural communities that could reach this high risk population.
- Conditions
- PreDiabetes
- Being tested
- Zoom Group Video (GV), Self Directed (SD)
- Keywords
- Diabetes Prevention Program, HbA1c, Physical Activity, Weight Loss
- Medical subject headings
- Prediabetic State, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoom Group Video (GV)Behavioural
Zoom delivery of the DPP. Participants have access to Prevent T2 Curriculum and connected technology to track weight and physical activity.
Self Directed (SD)Behavioural
Self directed delivery of the DPP. Participants have access to online curriculum, lifestyle coach and connected technology to track weight and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Group Video Diabetes Prevention Program | Experimental | Participants randomized to the group video DPP for 12-months. Receives: Behavioral: Zoom Group Video (GV) |
| Self Directed Diabetes Prevention Program | Active comparator | Participants randomized to the self directed DPP for 12-months. Receives: Behavioral: Self Directed (SD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change across 12 months
Weight (kg) will be assessed to the nearest 0.1 kg with a calibrated scale (Belfour Inc., Model #PS6600). All participants will be weighed between the hours of 6 and 10 am following an overnight fast of at least 8 hours in a standard hospital gown.
Measured: Baseline to 12 months
Secondary outcomes (3)
HbA1c change across 12 months
Hemoglobin A1c will be collected and assessed by Quest Diagnostic. Participants will be required to fast for at least 12 hours before blood draw. A total of 3-5 teaspoons of blood will be collected by inserting a needle in a vein in the arm for routine laboratory tests at each clinic visit. Participant blood samples will be used to measure HbA1c.
Measured: Baseline to 12 months
CDC-NDPP Weight Loss Goal
CDC-NDPP weight loss goal will be categorized as the percentage of participants who achieve ≥ 5% weight loss across the 12 month intervention.
Measured: Baseline to 12 months
CDC-NDPP Physical Activity Goal
CDC-NDPP physical activity goal will be categorized by the percentage of participants who achieve an average of ≥ 150 min./wk. of PA across the 12 month intervention.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start24 Sep 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Kansas State University
- Responsible party
- Sponsor
- Investigators
- Anna M Gorczyca, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252038
- Sponsor's protocol ID
- STUDY00150103
- Other IDs
- R01DK132362
- Acronym
- RAD
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Alliance for Diabetes Prevention
- ClinicalTrials.gov ID
- NCT06252038
- Acronym / sponsor ID
- RAD / STUDY00150103
- Conditions
- PreDiabetes
- Keywords
- Diabetes Prevention Program, HbA1c, Physical Activity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Kansas State University
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial is to compare the effectiveness of Cooperative Extension implementing two delivery methods (group video vs. self-directed) and participant recruitment strategies of the National Diabetes Prevention Program (NDPP) to adults in rural communities. Exploratory assessments of implementation facilitators and barriers will be completed to determine strategies that may impact intervention effectiveness and that may support or impede the implementation, dissemination, and effectiveness of Cooperative Extension to deliver the NDPP to prediabetic adults in rural areas.
Detailed description
This 12 mo. Type II hybrid effectiveness-implementation trial will compare effectiveness (weight loss, physical activity, HbA1c) of Cooperative Extension delivering the Diabetes Prevention Program (DPP) by group video using Zoom® (GV) vs. a self-directed (SD) control. Active vs. passive participant recruitment strategies will be compared on recruitment outcomes including time to full enrollment, participant yield, and retention rates. Ten Cooperative Extension local units/districts serving rural Kansas counties will be allocated to either active or passive recruitment. Each of the sites will recruit adults with prediabetes living in the county served by Kansas State Research and Extension site and will be randomized to one of the 2 intervention arms. A centralized team of Cooperative Extension Agents who complete NDPP lifestyle coach training will serve as interventionists for both the GV and SD arms. Primary (weight) and secondary outcomes (HbA1c, the proportion of participants meeting weight loss (≥ 5%) and physical activity goals (≥150 min./wk.) will be assessed at baseline, 6 and 12 mos. Findings will inform best practices in the delivery of the DPP through Cooperative Extension in rural communities that could reach this high risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Video Diabetes Prevention Program | Experimental | Behavioral: Zoom Group Video (GV)Participants randomized to the group video DPP for 12-months. |
| Self Directed Diabetes Prevention Program | Active comparator | Behavioral: Self Directed (SD)Participants randomized to the self directed DPP for 12-months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- BMI ≥25 kg/m2, ≥23 kg/m2 if Asian
- Blood test results in the pre diabetic range within the last year (HbA1C = 5.7%-6.4% or fasting plasma glucose= 100-125 mg/dl or 2-hr. plasma glucose following a 75-gm glucose load = 140-199 mg/dL) or have previous diagnosis of gestational diabetes or a positive screening for pre diabetes based on CDC pre diabetes risk test
- Willing to travel to KSRE site for orientation and outcome testing
- Available to attend pre-specified meeting time of GV for their respective KSRE location
Key exclusion criteria (5 listed)
- Previous diagnosis of Type I or II diabetes
- Taking FDA-approved weight loss medications
- Primary care provider stating that patient should not participate
- Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)
- Unable to engage 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 |
|---|---|---|
| Zoom Group Video (GV)Zoom delivery of the DPP. Participants have access to Prevent T2 Curriculum and connected technology to track weight and physical activity. | Behavioural | Group Video Diabetes Prevention Program |
| Self Directed (SD)Self directed delivery of the DPP. Participants have access to online curriculum, lifestyle coach and connected technology to track weight and physical activity. | Behavioural | Self Directed Diabetes Prevention Program |
Primary outcome
Weight change across 12 months
Time frame: Baseline to 12 months
Weight (kg) will be assessed to the nearest 0.1 kg with a calibrated scale (Belfour Inc., Model #PS6600). All participants will be weighed between the hours of 6 and 10 am following an overnight fast of at least 8 hours in a standard hospital gown.
3 secondary outcomes
HbA1c change across 12 months
Time frame: Baseline to 12 months
CDC-NDPP Weight Loss Goal
Time frame: Baseline to 12 months
CDC-NDPP Physical Activity Goal
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Zoom Group Video (GV) and Self Directed (SD) in people with PreDiabetes, run by University of Kansas Medical Center at 1 site in United States.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annie Rice, M.S. (785-764-3770, arice7@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change across 12 months (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.