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Completed

NCT Number: NCT04195477

vDPP Facilitated With Community Care Coordination

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Griffin Hospital, Derby, Connecticut, United States

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About this study

Specific aims and hypotheses:

  • 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.

  • 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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vDPP

Behavioral

virtual Diabetes Prevention Program

Primary outcomes

  1. Change in BMI

    Time frame: 16 weeks and 12 months

    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.

Secondary outcomes

  1. Change in Waist Circumference

    Time frame: 16 weeks and 12 months

    Waist circumference in centimeters will be collected at baseline and at 4 weeks.

  2. Change in Total Cholesterol

    Time frame: 16 weeks and 12 months

    Total cholesterol (Tchol) will be collected at baseline and at 4 weeks.

  3. Change in Triglycerides

    Time frame: 16 weeks and 12 months

    Triglycerides (TG) will be collected at baseline and at 4 weeks.

  4. Change in High-density Lipoprotein

    Time frame: 16 weeks and 12 months

    High-density lipoprotein (HDL) will be collected at baseline and at 4 weeks.

  5. Change in Diet Quality

    Time frame: 16 weeks and 12 months

    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).

  6. Change in Physical Activity

    Time frame: 16 weeks and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2019
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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