vDPP Facilitated With Community Care Coordination

NCT04195477 | Completed

• 3 other identifiers: 2000026747U48DP006380-01-01U48DP006380-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Waist Circumference

  16 weeks and 12 months

• Change in Total Cholesterol

  16 weeks and 12 months

• Change in Triglycerides

  16 weeks and 12 months

• Change in High-density Lipoprotein

  16 weeks and 12 months

• Change in Diet Quality

  16 weeks and 12 months

Study Arms (1)

vDPP Full Study

EXPERIMENTAL

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

Behavioral: vDPP

Interventions

vDPP BEHAVIORAL

virtual Diabetes Prevention Program

vDPP Full Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: October 7, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)