vDPP Facilitated With Community Care Coordination

Diabetes Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04195477
• Other study ID #: 2000026747
• Secondary ID: U48DP006380-01-0
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Prevention

Intervention

Behavioral:
• vDPP
virtual Diabetes Prevention Program

Locations

Country	Name	City	State
United States	Griffin Hospital	Derby	Connecticut
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks and 12 months
Secondary	Change in Waist Circumference	Waist circumference in centimeters will be collected at baseline and at 4 weeks.	16 weeks and 12 months
Secondary	Change in Total Cholesterol	Total cholesterol (Tchol) will be collected at baseline and at 4 weeks.	16 weeks and 12 months
Secondary	Change in Triglycerides	Triglycerides (TG) will be collected at baseline and at 4 weeks.	16 weeks and 12 months
Secondary	Change in High-density Lipoprotein	High-density lipoprotein (HDL) will be collected at baseline and at 4 weeks.	16 weeks and 12 months
Secondary	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).	16 weeks and 12 months
Secondary	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.	16 weeks and 12 months