- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195477
vDPP Facilitated With Community Care Coordination
Improving Health in Low Income Communities: Virtual Delivery of a Diabetes Prevention Program Facilitated With Community Care Coordination
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rafael Perez-Escamilla, PhD
- Phone Number: (203) 737-5882
- Email: rafael.perez-escamilla@yale.edu
Study Locations
-
-
Connecticut
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Derby, Connecticut, United States, 06418
- Griffin Hospital
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New Haven, Connecticut, United States, 06510
- Yale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vDPP Full Study
Participants will take part in a 52 week study receiving the vDPP intervention.
|
virtual Diabetes Prevention Program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
16 weeks and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Waist Circumference
Time Frame: 16 weeks and 12 months
|
Waist circumference in centimeters will be collected at baseline and at 4 weeks.
|
16 weeks and 12 months
|
Change in Total Cholesterol
Time Frame: 16 weeks and 12 months
|
Total cholesterol (Tchol) will be collected at baseline and at 4 weeks.
|
16 weeks and 12 months
|
Change in Triglycerides
Time Frame: 16 weeks and 12 months
|
Triglycerides (TG) will be collected at baseline and at 4 weeks.
|
16 weeks and 12 months
|
Change in High-density Lipoprotein
Time Frame: 16 weeks and 12 months
|
High-density lipoprotein (HDL) will be collected at baseline and at 4 weeks.
|
16 weeks and 12 months
|
Change in Diet Quality
Time Frame: 16 weeks and 12 months
|
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).
|
16 weeks and 12 months
|
Change in Physical Activity
Time Frame: 16 weeks and 12 months
|
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.
|
16 weeks and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rafael Perez-Escamilla, PhD, 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2000026747
- U48DP006380-01-01 (Other Identifier: Centers for Disease Control and Prevention)
- U48DP006380-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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