Actively Recruiting

Phase Not Applicable
Age: 13Years +
All Genders
Healthy Volunteers
ID07216118

Optimizing Navigation for Wellness And Resources Utilization in Youth With Type 2 Diabetes

Led by University of Pittsburgh · Updated on 2026-04-27

104

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating different strategies to address health-related social needs (HRSN) experienced by adolescents and young adults with type 2 diabetes and their families. The study aims to find out how feasible, acceptable, and consistently these strategies can be implemented to improve outcomes for youth with type 2 diabetes. Participants will be randomly assigned to one of several groups combining tailored resources, universal empowerment, text messages, and support from community health workers (CHW). Tailored resources include providing specific resource lists and physical items like food boxes based on individual needs. Universal empowerment offers general resources and opportunities to meet with social workers. Text messages are sent monthly for three months with information and opt-in links for resources. Community health workers provide personalized support connecting participants to resources. During the study, participants will attend regular diabetes clinic visits, complete surveys and interviews, and be connected to community resources. Researchers will assess how well the strategies are accepted and implemented, and track health-related social needs like food, housing, and transportation insecurity, as well as medical measures such as hemoglobin A1C and body mass index. The study will follow participants over several months to monitor these outcomes and support their ongoing care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescent aged 13 to 22 years with a known diagnosis of type 2 diabetes
  • Followed clinically at UPMC Children's Hospital of Pittsburgh
  • Able to provide assent or consent
  • Adult caregiver (18 years or older) who is primary caretaker of an adolescent or young adult with type 2 diabetes
  • Caregiver has an adolescent or young adult who agrees to participate
  • Caregiver able to provide consent
Not Eligible

You will not qualify if you...

  • Unable to complete study questionnaires in English

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive behavioral interventions to address health-related social needs (HRSN). Depending on group assignment, this includes tailored resource lists and warm referrals, universal empowerment with resource lists and social worker access, monthly text messages for 3 months, and/or support from a trained Community Health Worker (CHW).

Monthly visits or contacts for 3 months depending on intervention

Follow-up

Duration - 3 months after treatment ends

Participants are followed to assess acceptability and fidelity of interventions as well as health-related social needs and health outcomes such as Hemoglobin A1C and Body Mass Index.

Visits at 1 week after baseline, 3 months, and 6 months

Trial Site Locations

Total: 1 location

1

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

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Research Team

M

Mary Ellen Vajravelu, MD MSHP

M

Maya I Ragavan, MD MPH MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

4

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