Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs
NCT ID: NCT07216118
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
104 participants
INTERVENTIONAL
2026-04-30
2028-07-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Tailored Resources and Text Messages without Community Health Worker
Tailored Resources AND Text Messages without Community Health Workers (CHW):
Tailored Resources: Participants will be texted resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinician will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. If the family requested to meet with the social worker on the screener, a message will also be sent to the clinic social worker. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity).
Text Messages without CHW: 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. CHW will not be assigned.
Tailored Resources
Participants will be texted resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinician will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. If the family requested to meet with the social worker on the screener, a message will also be sent to the clinic social worker. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity).
Text Messages without Community Health Workers (CHW)
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. CHW will not be assigned.
Tailored Resources and Text Messages with Community Health Worker
Tailored Resources AND Text Messages with Community Health Worker (CHW):
Tailored Resources: Participants will be texted resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinician will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. If the family requested to meet with the social worker on the screener, a message will also be sent to the clinic social worker. Participants will be offered physical resources related to disclosed HRSN.
Text Messages and CHW: Participants will receive text messages about HRSN resources as described in arms without CHW but will also be assigned trained CHW from local community organizations to support connection with resources to address HRSN.
Tailored Resources
Participants will be texted resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinician will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. If the family requested to meet with the social worker on the screener, a message will also be sent to the clinic social worker. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity).
Text Messages and Community Health Workers (CHW)
Participants will receive text messages about health-related social needs (HRSN) resources as described in arms without CHW but will also be assigned trained CHW from local community organizations to support connection with resources to address HRSN.
Universal Empowerment and Text Messages without CHW
Assigned to Universal Empowerment AND Text Messages without Community Health Worker (CHW):
Universal Empowerment: Regardless of disclosed health-related social needs (HRSN), participants will be texted 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, clinicians 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. CHW will not be assigned to participants.
Universal Empowerment
Regardless of disclosed health-related social needs (HRSN), participants will be texted 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, clinicians 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 without Community Health Workers (CHW)
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. CHW will not be assigned.
Universal Empowerment and Text Messages with Community Health Worker
Universal Empowerment AND Text Messages with Community Health Worker (CHW):
Universal Empowerment: Regardless of disclosed health-related social needs (HRSN), participants will be texted 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, clinicians 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 and CHW: Participants will receive text messages about HRSN resources as described in arms without CHW but will also be assigned trained CHW from local community organizations to support connection with resources to address HRSN.
Universal Empowerment
Regardless of disclosed health-related social needs (HRSN), participants will be texted 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, clinicians 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 and Community Health Workers (CHW)
Participants will receive text messages about health-related social needs (HRSN) resources as described in arms without CHW but will also be assigned trained CHW from local community organizations to support connection with resources to address HRSN.
Interventions
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Tailored Resources
Participants will be texted resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinician will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. If the family requested to meet with the social worker on the screener, a message will also be sent to the clinic social worker. 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 texted 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, clinicians 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 without Community Health Workers (CHW)
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. CHW will not be assigned.
Text Messages and Community Health Workers (CHW)
Participants will receive text messages about health-related social needs (HRSN) resources as described in arms without CHW but will also be assigned trained CHW from local community organizations to support connection with resources to address HRSN.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
13 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Mary Ellen Vajravelu, MD
Assistant Professor
Principal Investigators
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Mary Ellen Vajravelu, MD MSHP
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Maya I Ragavan, MD MPH MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Mary Ellen Vajravelu, MD MSHP
Role: primary
Other Identifiers
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STUDY25030030
Identifier Type: -
Identifier Source: org_study_id