Diabetes PreventionNCT04195477
vDPP Facilitated With Community Care Coordination
A study testing vDPP in people with Diabetes Prevention, run by Yale University at 2 sites in United States.
Trial summary
The goal of the proposed Implementation Research project is to assess the feasibility of and pathways for implementation of a virtually-delivered DPP (v-DPP) supported by community-based care coordination facilitated by community health workers (CHWs) and hospital-based community nurses (HCNs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Prevention
- What is being tested?
- vDPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2020to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- BMI ≥ 25 kg/m2, based on self-reported weight and height;
- Eligible for Medicaid, as determined by self-reported income, household size, and Connecticut state guidelines for Medicaid eligibility;
- At risk for prediabetes, as evidenced by a score of 5 points or higher on the CDC prediabetes risk screening test. [https://www.cdc.gov/prediabetes/takethetest/]
- Participants in New Haven must also be residents of an ECC community (Housing Authority).
- Participants in Derby and Ansonia must demonstrate proof of residency of either town (i.e., bill or other mail addressed to them).
Who cannot join
- Failure to meet inclusion criteria;
- Anticipated inability to complete study protocol for any reason;
- Self-reported current eating disorder;
- Inability to exercise;
- Non-English speaking;
- Pregnant or planned pregnancy in next 12 months;
- Self-reported diagnosis of type 1 or type 2 diabetes;
- Failure to pass vDPP provider's required qualification step assessing readiness to change, when available.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Griffin Hospital
Derby, Connecticut, 06418
Yale University
New Haven, Connecticut, 06510
About this study
Official title: Improving Health in Low Income Communities: Virtual Delivery of a Diabetes Prevention Program Facilitated With Community Care Coordination
The goal of the proposed Implementation Research project is to assess the feasibility of and pathways for implementation of a virtually-delivered DPP (v-DPP) supported by community-based care coordination facilitated by community health workers (CHWs) and hospital-based community nurses (HCNs). The goal of the intervention is to improve body weight, blood pressure, diet quality, and physical activity levels among low-income individuals at risk for type 2 diabetes.
Read the detailed description
Specific aims and hypotheses:
- Conduct formative research with community partners (via focus groups and interviews with key stakeholders and a small pilot) to assess community, systemic, technology, and structural level barriers to implementation of a virtually-delivered Diabetes Prevention Program. Hypothesis: These efforts will identify individual and community needs, barriers, and resources affecting the feasibility of v-DPP implementation. In addition, strategies for facilitating the delivery of the v-DPP to low-income communities will be developed.
- In collaboration with community partners, utilize strategies identified in Aim A1 to maximize impact of the v-DDP in target communities, as evidenced by measures of reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) and assess factors influencing RE-AIM outcomes (e.g. social determinants of health, demographic variables, self-efficacy). Hypothesis: The v-DPP facilitated by community-based care coordination will produce favorable RE-AIM outcomes. Factors influencing these outcomes will be explored as well.
- Demonstrate improvements in body weight, blood pressure, diet quality, and physical activity in low-income individuals at risk for type 2 diabetes who participate in a v-DPP facilitated by community-based care coordination. Hypothesis: The v-DPP, facilitated by community-based care coordination provided by CHWs and HCNs, will improve body weight, blood pressure, diet quality, and physical activity levels in the study communities.
- Collaborate with community partners to develop and implement a strategic approach to sustain the v-DPP facilitated by community-based care coordination in the study communities and translate it to other community settings.
Hypothesis: The implementation approach will be packaged, including strategies for implementation in different settings and related costs, providing a process for implementation in other low-income communities in our region and nationally.
- Conditions
- Diabetes Prevention
- Being tested
- vDPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vDPPBehavioural
virtual Diabetes Prevention Program
| Study group | Role | What they receive |
|---|---|---|
| vDPP Full Study | Experimental | Participants will take part in a 52 week study receiving the vDPP intervention. Receives: Behavioral: vDPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Body mass index (BMI) will be measured as a participant's weight in kilograms divided by his/her height in meters squared. Height will be collected by a RA/CHW/HCN using a stadiometer at baseline and at 4 weeks.
Measured: 16 weeks and 12 months
Secondary outcomes (6)
Change in Waist Circumference
Waist circumference in centimeters will be collected at baseline and at 4 weeks.
Measured: 16 weeks and 12 months
Change in Total Cholesterol
Total cholesterol (Tchol) will be collected at baseline and at 4 weeks.
Measured: 16 weeks and 12 months
Change in Triglycerides
Triglycerides (TG) will be collected at baseline and at 4 weeks.
Measured: 16 weeks and 12 months
Change in High-density Lipoprotein
High-density lipoprotein (HDL) will be collected at baseline and at 4 weeks.
Measured: 16 weeks and 12 months
Change in Diet Quality
Dietary quality will be assessed at baseline and 4 weeks for the study. Participants will complete a 24-hour dietary recall using a web-based Automated Self-Administered 24-Hour Recall (ASA24) (available from the National Cancer Institute at ttp://riskfactor.cancer.gov/tools/instruments/asa24/), which will guide them through the process of completing the recall. Diet quality based on the information provided will be assessed using the Healthy Eating Index 2010 (HEI-2010).
Measured: 16 weeks and 12 months
Change in Physical Activity
Physical activity level (PA) will be assessed at baseline and 4 weeks for the study. The International Physical Activity Questionnaire (IPAQ). It is a comprehensive tool containing information on weekly household and yard-work activities, occupational activity, transport, leisure time physical activity, and sedentary behavior.
Measured: 16 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start7 Oct 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes PreventionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Rafael Perez-Escamilla, PhD, Principal investigator, Professor of Public Health, Director of the Office of Public Health Practice, and Director of the Global Health Concentration at the Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195477
- Sponsor's protocol ID
- 2000026747
- Other IDs
- U48DP006380-01-01, U48DP006380-01
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2019
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LaMonaca K, Campbell-Britton M, Duffany KO, Comerford BP, Morales SI, Ayettey RG, Astudillo K, Swansiger M, Kidd C, Rue B, Santilli A, Njike VY, McGuire T, Deyling M, Perez-Escamilla R. Community-engaged design of a virtual diabetes prevention program intervention with care coordination. BMC Health Serv Res. 2026 Jun 13. doi: 10.1186/s12913-026-14860-0. Online ahead of print.
PubMed 42288862
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health in Low Income Communities: Virtual Delivery of a Diabetes Prevention Program Facilitated With Community Care Coordination
- ClinicalTrials.gov ID
- NCT04195477
- Acronym / sponsor ID
- 2000026747
- Conditions
- Diabetes Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 12 Dec 2019 (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 goal of the proposed Implementation Research project is to assess the feasibility of and pathways for implementation of a virtually-delivered DPP (v-DPP) supported by community-based care coordination facilitated by community health workers (CHWs) and hospital-based community nurses (HCNs). The goal of the intervention is to improve body weight, blood pressure, diet quality, and physical activity levels among low-income individuals at risk for type 2 diabetes.
Detailed description
Specific aims and hypotheses:
- Conduct formative research with community partners (via focus groups and interviews with key stakeholders and a small pilot) to assess community, systemic, technology, and structural level barriers to implementation of a virtually-delivered Diabetes Prevention Program. Hypothesis: These efforts will identify individual and community needs, barriers, and resources affecting the feasibility of v-DPP implementation. In addition, strategies for facilitating the delivery of the v-DPP to low-income communities will be developed.
- In collaboration with community partners, utilize strategies identified in Aim A1 to maximize impact of the v-DDP in target communities, as evidenced by measures of reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) and assess factors influencing RE-AIM outcomes (e.g. social determinants of health, demographic variables, self-efficacy). Hypothesis: The v-DPP facilitated by community-based care coordination will produce favorable RE-AIM outcomes. Factors influencing these outcomes will be explored as well.
- Demonstrate improvements in body weight, blood pressure, diet quality, and physical activity in low-income individuals at risk for type 2 diabetes who participate in a v-DPP facilitated by community-based care coordination. Hypothesis: The v-DPP, facilitated by community-based care coordination provided by CHWs and HCNs, will improve body weight, blood pressure, diet quality, and physical activity levels in the study communities.
- Collaborate with community partners to develop and implement a strategic approach to sustain the v-DPP facilitated by community-based care coordination in the study communities and translate it to other community settings.
Hypothesis: The implementation approach will be packaged, including strategies for implementation in different settings and related costs, providing a process for implementation in other low-income communities in our region and nationally.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vDPP Full Study | Experimental | Behavioral: vDPPParticipants will take part in a 52 week study receiving the vDPP intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI ≥ 25 kg/m2, based on self-reported weight and height;
- Eligible for Medicaid, as determined by self-reported income, household size, and Connecticut state guidelines for Medicaid eligibility;
- At risk for prediabetes, as evidenced by a score of 5 points or higher on the CDC prediabetes risk screening test. [https://www.cdc.gov/prediabetes/takethetest/]
- Participants in New Haven must also be residents of an ECC community (Housing Authority).
- Participants in Derby and Ansonia must demonstrate proof of residency of either town (i.e., bill or other mail addressed to them).
Key exclusion criteria (8 listed)
- Failure to meet inclusion criteria;
- Anticipated inability to complete study protocol for any reason;
- Self-reported current eating disorder;
- Inability to exercise;
- Non-English speaking;
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 |
|---|---|---|
| vDPPvirtual Diabetes Prevention Program | Behavioural | vDPP Full Study |
Primary outcome
Change in BMI
Time frame: 16 weeks and 12 months
Body mass index (BMI) will be measured as a participant's weight in kilograms divided by his/her height in meters squared. Height will be collected by a RA/CHW/HCN using a stadiometer at baseline and at 4 weeks.
6 secondary outcomes
Change in Waist Circumference
Time frame: 16 weeks and 12 months
Change in Total Cholesterol
Time frame: 16 weeks and 12 months
Change in Triglycerides
Time frame: 16 weeks and 12 months
Change in High-density Lipoprotein
Time frame: 16 weeks and 12 months
Change in Diet Quality
Time frame: 16 weeks and 12 months
Change in Physical Activity
Time frame: 16 weeks and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 42288862LaMonaca K, Campbell-Britton M, Duffany KO, Comerford BP, Morales SI, Ayettey RG, Astudillo K, Swansiger M, Kidd C, Rue B, Santilli A, Njike VY, McGuire T, Deyling M, Perez-Escamilla R. Community-engaged design of a virtual diabetes prevention program intervention with care coordination. BMC Health Serv Res. 2026 Jun 13. doi: 10.1186/s12913-026-14860-0. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Diabetes Prevention
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
New T-UP: Engaging Vulnerable Students in Diabetes Prevention
Prediabetes, Type 2 Diabetes
Not yet recruitingPhase 2/3
Diabetes Prevention Through Genetics, Familial History and Behavior Change
Prediabetes, Weight Loss
Not yet recruitingPhase 2
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Type 1 Diabetes Mellitus With Diabetic Nephropathy
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.
Rafael Perez-Escamilla, PhD principal investigator
Professor of Public Health, Director of the Office of Public Health Practice, and Director of the Global Health Concentration at the Yale School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vDPP in people with Diabetes Prevention, run by Yale University at 2 sites 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 5 inclusion and 8 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 BMI (time frame: 16 weeks and 12 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 NCT04195477, 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 18 Nov 2024.