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NCT Number: NCT07216118

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

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.

Recruiting

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location status: Recruiting

Location contact

Mary Ellen Vajravelu, MD MSHP

CONTACT

4126926533

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Resources

Behavioral

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).

Other names: Tailored

Universal Empowerment

Behavioral

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.

Other names: Universal

Text Messages

Behavioral

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.

Other names: Text Only

Community Health Workers (CHW)

Behavioral

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

Other names: CHW

Primary outcomes

  1. Acceptability of Intervention: Health-Related Social Needs Screener

    Time frame: at baseline clinic visit

    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.

  2. Acceptability of Intervention: Tailored Approach to Address Health-Related Social Needs

    Time frame: 1-week after baseline; 3 months

    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.

  3. Acceptability of Intervention: Universal Empowerment Approach to Address Health-Related Social Needs

    Time frame: at baseline visit; 1-week after baseline; 3 months

    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.

  4. Acceptability of Intervention: Text Messages to Address Health-Related Social Needs

    Time frame: 3 months

    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.

  5. Acceptability of Intervention: Community Health Workers to Address Health-Related Social Needs

    Time frame: 3 months

    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.

  6. Fidelity of Intervention

    Time frame: 1-week after baseline; 3 months; 6 months

    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.

Secondary outcomes

  1. Health-related social needs: Food Insecurity

    Time frame: Baseline, 3 months, 6 months

    Six-Item Standard Measure from USDA Economic Research Service; completed by adolescents and caregivers. Food insecurity assessment includes 5 questions assessing presence and frequency of experiences consistent with food insecurity; responses include "often," "sometimes," or "never" as well as "yes" and "no." "Often," "sometimes," or "never" are scored as 1, 2, and 3 respectively, with yes=1 and no=2. The sum of affirmative responses ("often," "sometimes," "yes") is the raw score, with 0-1 indicating high or marginal food security, 2-4 low food security, 5-6 very low food security. Percentage of positive responses (food insecurity: marginal, low, or very low food security) will be reported.

  2. Health-related social needs: Housing Insecurity

    Time frame: Baseline, 3 months, 6 months

    3 items from the PhenX repository; completed by adolescents and caregivers. Housing is assessed using 3 questions about living situation, stress related to rent/mortgage, and problems with housing; responses describing worry about losing a place to live or not having a steady place to live, as well as problems with housing, or always, usually, or sometimes worrying about not having enough money to pay rent or mortgage indicate positive housing insecurity. Percentage of positive responses (housing insecurity) will be reported.

  3. Health-related social needs: Transportation Insecurity

    Time frame: Baseline, 3 months, 6 months

    1 item from the PhenX repository; completed by adolescents and caregivers to assess lack of reliable transportation for medical appointments (yes/no). Percentage of affirmative responses (transportation insecurity) will be reported.

  4. Hemoglobin A1C

    Time frame: Baseline, 3 months, 6 months

    As measured during clinic visit; for adolescents only. Reported as %.

  5. Body Mass Index

    Time frame: Baseline, 3 months, 6 months

    As measured at clinic visits; for adolescents only. Reported as kg/m2.

Other outcomes

  1. Physical activity

    Time frame: Baseline, 3 months, 6 months

    PACE questionnaire is a 2-item survey to evaluate frequency of engagement in at least 60 minutes of daily physical activity over the past 7 days and a typical week. Higher numbers of days indicates greater adherence to physical activity guidelines for adolescents. Administered to adolescent participants only.

  2. Health Literacy

    Time frame: Baseline, 3 months, 6 months

    BRIEF Health Literacy Survey is a 4-item questionnaire with 5 response options each ranging from "not at all" to "extremely." Responses are totaled for a possible score of 4-20, with higher scores corresponding to higher health literacy.

  3. Mood

    Time frame: Baseline, 3 months, 6 months

    The Mood and Feelings Questionnaire: Short Version will be used to evaluate mood in adolescent and caregiver participants. This 13-item survey includes responses of "not true", "sometimes", and "true", scored as 0, 1, and 2. Total scores range from 0-26, with higher scores indicating higher severity.

  4. Social Support

    Time frame: Baseline, 3 months, 6 months

    Multidimensional Scale of Perceived Support Scale (Zimet, Dahlem, Zimet, Farley, 1988); completed by adolescents and caregivers. The 12-item survey includes a 7-item scale of response from "very strongly disagree" (1) to "very strongly agree" (7). There are 3 subscales to indicate significant other, family, and friends support. Responses will be averaged by subscale, with higher numbers indicating greater support. A total score (average of 12 response) will be reported.

  5. Connection with community health workers (CHW)

    Time frame: Baseline, 3 months, 6 months

    Investigator-developed survey around hours of connection with CHW, activities conducted with CHW, and resource connections made through CHW; completed by adolescents and caregivers assigned to CHW

  6. Diet quality

    Time frame: Baseline, 3 months, 6 months

    Rapid Prime Diet Quality Screener, a 13-item survey to quantify frequency of intake of each food category. Scores range from 0-26, with higher scores indicating higher-quality diet.

  7. Diabetes distress

    Time frame: Baseline, 3 months, 6 months

    Problem Areas in Diabetes Scale; completed by adolescents only. The 5-item scale includes a range of 5 responses, from "not a problem" (=0) to "serious problem" (=4). A total score of >=8 indicates possible diabetes related emotional distress.

  8. Medication adherence

    Time frame: Baseline, 3 months, 6 months

    Investigator-developed survey of doses of diabetes medication missed; completed by adolescents only. Questions include the number of days that daily diabetes medications were taken in the past 7 days, as well as number of times in the past 4 weeks that weekly diabetes medications were taken. Respondents will be categorized into fully adherent if they report taking daily medications 6-7 days out of the past 7 days and weekly medications at least 3 out of 4 past weeks; for those taking both daily and weekly, both daily and weekly medication adherence criteria must be met for fully adherent classification. Those not "fully adherent" will be categorized as non-adherent.

  9. Trustworthiness of Physicians and Social workers.

    Time frame: Baseline, 3 months, 6 months

    Adapted version of Trust in Physician Scale (adapted from Merenstein Z, Shuemaker JC, Phillips RL 2023) to add one question about trust in social workers. This 12-item scale includes response options ranging from "strongly disagree" to "strongly agree", with items indicating mistrust reverse scored. Total and average scores will be reported, with higher scores indicating greater trust.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Ellen Vajravelu, MD MSHP

CONTACT

[email protected]

412-692-6533

Maya I Ragavan, MD MPH MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ONWARD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 14, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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