Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT07216118

Conditions

Diabetes in Adolescence

Type 2 Diabetes

Social Needs

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

Tailored Resources

Universal Empowerment

Text Messages

Community Health Workers (CHW)

Study Details

Brief 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

Study ID

NCT07216118

Start date

Apr 21, 2026

Status verified date

Apr, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Adolescent-Caregiver Dyads will be recruited together.

Adolescent Inclusion Criteria:

  • Age 13 to 22 years old
  • known diagnosis of type 2 diabetes
  • followed clinically at UPMC Children's Hospital of Pittsburgh
  • able to provide assent/consent

Caregiver Inclusion Criteria:

  • Adult (18 years or older) identifying as a primary caretaker of an adolescent or young adult with type 2 diabetes
  • Has an adolescent/young adult who agrees to participate in the study
  • able to provide consent

Exclusion Criteria:

  • Inability to complete study questionnaires in English

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Tailored Resources and Text Messages

Tailored Resources AND Text Messages:

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).

Text Messages: Participants will receive text messages once per month for 3 months. Messages will state that community-based resources to address 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.

experimental: Tailored Resources and Community Health Worker

Tailored Resources AND Community Health Worker (CHW):

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.

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

experimental: Universal Empowerment and Text Messages

Assigned to Universal Empowerment AND Text Messages:

Universal Empowerment: Regardless of disclosed health-related social needs (HRSN), participants 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.

Text Messages: Participants randomized to text message will receive text messages once per month for 3 months. Messages will state that community-based resources to address 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 to participants.

experimental: Universal Empowerment and Community Health Worker

Universal Empowerment AND Community Health Worker (CHW):

Universal Empowerment: Regardless of disclosed health-related social needs (HRSN), participants 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.

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

Interventions

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).

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.

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.

Community Health Workers (CHW)

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

Primary outcome measure

  • Acceptability of Intervention: Health-Related Social Needs Screener [ Time Frame: at baseline clinic visit ]
  • Acceptability of Intervention: Tailored Approach to Address Health-Related Social Needs [ Time Frame: 1-week after baseline; 3 months ]
  • Acceptability of Intervention: Universal Empowerment Approach to Address Health-Related Social Needs [ Time Frame: at baseline visit; 1-week after baseline; 3 months ]
  • Acceptability of Intervention: Text Messages to Address Health-Related Social Needs [ Time Frame: 3 months ]
  • Acceptability of Intervention: Community Health Workers to Address Health-Related Social Needs [ Time Frame: 3 months ]
  • Fidelity of Intervention [ Time Frame: 1-week after baseline; 3 months; 6 months ]

Central Contacts and Locations

Central contacts

Mary Ellen Vajravelu, MD MSHP

412-692-6533maryellen.vajravelu@pitt.edu

Maya I Ragavan, MD MPH MS

maya.ragavan@chp.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Mary Ellen Vajravelu, MD MSHP

4126926533

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-27.