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vDPP Facilitated With Community Care Coordination

Improving Health in Low Income Communities: Virtual Delivery of a Diabetes Prevention Program Facilitated With Community Care Coordination

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04195477
Enrollment
96
Registered
2019-12-12
Start date
2020-10-07
Completion date
2024-07-31
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Prevention

Brief 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). 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: 1. 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. 2. 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. 3. 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. 4. 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.

Interventions

BEHAVIORALvDPP

virtual Diabetes Prevention Program

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in BMI16 weeks and 12 monthsBody 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.

Secondary

MeasureTime frameDescription
Change in Total Cholesterol16 weeks and 12 monthsTotal cholesterol (Tchol) will be collected at baseline and at 4 weeks.
Change in Triglycerides16 weeks and 12 monthsTriglycerides (TG) will be collected at baseline and at 4 weeks.
Change in Waist Circumference16 weeks and 12 monthsWaist circumference in centimeters will be collected at baseline and at 4 weeks.
Change in Diet Quality16 weeks and 12 monthsDietary 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).
Change in Physical Activity16 weeks and 12 monthsPhysical 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.
Change in High-density Lipoprotein16 weeks and 12 monthsHigh-density lipoprotein (HDL) will be collected at baseline and at 4 weeks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 15, 2026