Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs

Summary

The goal of this clinical trial is to pilot test different strategies to address health related social needs (HRSN) experienced by adolescent and young adult patients with type 2 diabetes and their families. The main questions it aims to answer are:

* How feasible are the strategies?
* How acceptable are the strategies?
* How reliably and consistently can the strategies be implemented?

Participants will:

Attend regularly scheduled diabetes clinic visits. Complete surveys and interviews. Be connected to community resources and organizations to help address HRSN.

Conditions

• Diabetes in Adolescence
• Type 2 Diabetes
• Social Needs

Interventions

BEHAVIORAL

Tailored Resources

Participants will be offered resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinical team will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity).

BEHAVIORAL

Universal Empowerment

Regardless of disclosed health-related social needs (HRSN), participants will be offered resource lists and warm referral links for food, housing, and transportation needs. At clinic visit, all will be offered physical resources and the opportunity to meet with a social worker. In place of screening results, the clinical team will be sent a message requesting that, when seeing the patient in clinic, they use the provided, easily accessible empowering script about HRSN.

BEHAVIORAL

Text Messages

Participants will receive text messages once per month for 3 months. Messages will state that community-based resources to address health-related social needs (HRSN) are available if needed, with a link to opt-in to resource lists and warm referral links. Messages will include contact information for the study and clinical teams for optional HRSN discussion. Community Health Worker will not be assigned.

BEHAVIORAL

Community Health Workers (CHW)

Participants will be assigned a trained CHW to support connection with resources to address HRSN.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Mary Ellen Vajravelu, MD MSHP · University of Pittsburgh

• Maya I Ragavan, MD MPH MS · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-21

Primary Completion

2028-04-30

Completion

2028-07-31

Countries

• United States

Study Locations