vDPP Facilitated With Community Care Coordination

NCT ID: NCT04195477

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2024-07-31

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.

Conditions

Diabetes Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

vDPP Full Study

Participants will take part in a 52 week study receiving the vDPP intervention.

Group Type: EXPERIMENTAL

vDPP

Intervention Type: BEHAVIORAL

virtual Diabetes Prevention Program

Interventions

vDPP

virtual Diabetes Prevention Program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Perez-Escamilla, PhD

Role: 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

Locations

Griffin Hospital

Derby, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

U48DP006380-01-01

Identifier Type: OTHER

Identifier Source: secondary_id

U48DP006380-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000026747

Identifier Type: -

Identifier Source: org_study_id