Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs
ONWARD
Optimizing Navigation for Wellness And Resources Utilization in Youth With Type 2 Diabetes
2 other identifiers
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2025
CompletedFirst Posted
Study publicly available on registry
October 14, 2025
CompletedStudy Start
First participant enrolled
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 27, 2026
April 1, 2026
1.9 years
October 9, 2025
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Acceptability of Intervention: Health-Related Social Needs Screener
4-item Acceptability of Intervention Measure; completed by all adolescents and caregivers. Questions are specific to acceptability of the screening questionnaire used to assess health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
at baseline clinic visit
Acceptability of Intervention: Tailored Approach to Address Health-Related Social Needs
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using a tailored approach (not universal empowerment). Questions are specific to acceptability of the tailored approach used to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
1-week after baseline; 3 months
Acceptability of Intervention: Universal Empowerment Approach to Address Health-Related Social Needs
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using a universal empowerment approach (not tailored approach). Questions are specific to acceptability of the universal empowerment approach used to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
at baseline visit; 1-week after baseline; 3 months
Acceptability of Intervention: Text Messages to Address Health-Related Social Needs
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using text messages without community health workers to support resource connection. Questions are specific to acceptability of the text messages without community health worker approach used to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
3 months
Acceptability of Intervention: Community Health Workers to Address Health-Related Social Needs
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using text messages with community health workers to support resource connection. Questions are specific to acceptability of community health workers in addition to text messages to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
3 months
Fidelity of Intervention
Investigator developed survey around receipt of intervention components including resources requested and used, community health worker interactions, and text message receipt; completed by adolescents and caregivers in all arms. Frequency and types of resources used, as well as community organizations with which respondents interacted will be reported. Frequency and duration of contact with community health workers will be reported for those assigned to arms using community health workers.
1-week after baseline; 3 months; 6 months
Secondary Outcomes (5)
Health-related social needs: Food Insecurity
Baseline, 3 months, 6 months
Health-related social needs: Housing Insecurity
Baseline, 3 months, 6 months
Health-related social needs: Transportation Insecurity
Baseline, 3 months, 6 months
Hemoglobin A1C
Baseline, 3 months, 6 months
Body Mass Index
Baseline, 3 months, 6 months
Other Outcomes (9)
Physical activity
Baseline, 3 months, 6 months
Health Literacy
Baseline, 3 months, 6 months
Mood
Baseline, 3 months, 6 months
- +6 more other outcomes
Study Arms (4)
Tailored Resources and Text Messages
EXPERIMENTALTailored 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.
Tailored Resources and Community Health Worker
EXPERIMENTALTailored 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.
Universal Empowerment and Text Messages
EXPERIMENTALAssigned 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.
Universal Empowerment and Community Health Worker
EXPERIMENTALUniversal 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
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).
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.
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.
Participants will be assigned a trained CHW to support connection with resources to address HRSN.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Inability to complete study questionnaires in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Ellen Vajravelu, MD MSHP
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Maya I Ragavan, MD MPH MS
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 9, 2025
First Posted
October 14, 2025
Study Start
April 21, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years after the publication of results.
- Access Criteria
- Investigators must submit a proposal in writing that describes planned analyses, and a data sharing agreement with the University of Pittsburgh must be signed.
We will share de-identified individual-participant level (IPD) data including demographic and health-related social needs data from participant self-report, clinical laboratory and body mass index data upon reasonable request from investigators.