Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tailored Resources, Universal Empowerment, Text Messages, Community Health Workers (CHW).
- Who it may be relevant to
- Registry conditions: Diabetes in Adolescence, Type 2 Diabetes, Social Needs. Basic parameters: from 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Navigation for Wellness And Resources Utilization in Youth With Type 2 Diabetes
Overview
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.
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.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Health-related social needs: Food Insecurity [Time frame: Baseline, 3 months, 6 months]
- Health-related social needs: Housing Insecurity [Time frame: Baseline, 3 months, 6 months]
- Health-related social needs: Transportation Insecurity [Time frame: Baseline, 3 months, 6 months]
- Hemoglobin A1C [Time frame: Baseline, 3 months, 6 months]
- Body Mass Index [Time frame: Baseline, 3 months, 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07216118 · STUDY25030030 · 1R01DK142766-01