Clinical trial NCT04195477: vDPP Facilitated With Community Care Coordination
Official title: Improving Health in Low Income Communities: Virtual Delivery of a Diabetes Prevention Program Facilitated With Community Care Coordination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2019-12-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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).

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.

Primary outcomes:
measure: Change in BMI
timeFrame: 16 weeks and 12 months
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: 16 weeks and 12 months
measure: Change in Total Cholesterol
timeFrame: 16 weeks and 12 months
measure: Change in Triglycerides
timeFrame: 16 weeks and 12 months
measure: Change in High-density Lipoprotein
timeFrame: 16 weeks and 12 months
measure: Change in Diet Quality
timeFrame: 16 weeks and 12 months
measure: Change in Physical Activity
timeFrame: 16 weeks and 12 months
Other outcomes:
Locations:
city: Derby
country: United States
facility: Griffin Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: 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
name: Rafael Perez-Escamilla, PhD
role: PRINCIPAL_INVESTIGATOR
References: