Diabetes in AdolescenceONWARDNCT07216118
Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs
A study testing Tailored Resources, Universal Empowerment and Text Messages in people with Diabetes in Adolescence and Type 2 Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes in Adolescence, Type 2 Diabetes, Social Needs
- What is being tested?
- Tailored Resources, Universal Empowerment and Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Inability to complete study questionnaires in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maya I Ragavan, MD MPH MS contact
United States1 site, 1 recruiting
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Mary Ellen Vajravelu, MD MSHP, 4126926533
About this study
Official title: Optimizing Navigation for Wellness And Resources Utilization in Youth With Type 2 Diabetes
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.
- Conditions
- Diabetes in Adolescence, Type 2 Diabetes, Social Needs
- Being tested
- Tailored Resources, Universal Empowerment, Text Messages, Community Health Workers (CHW)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored ResourcesBehavioural
Also called Tailored
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).
Universal EmpowermentBehavioural
Also called Universal
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.
Text MessagesBehavioural
Also called Text Only
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.
Community Health Workers (CHW)Behavioural
Also called CHW
Participants will be assigned a trained CHW to support connection with resources to address HRSN.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Resources and Text Messages | Experimental | Tailored 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. Receives: Behavioral: Tailored Resources; Behavioral: Text Messages |
| Tailored Resources and Community Health Worker | Experimental | Tailored 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. Receives: Behavioral: Tailored Resources; Behavioral: Community Health Workers (CHW) |
| Universal Empowerment and Text Messages | Experimental | Assigned 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. Receives: Behavioral: Universal Empowerment; Behavioral: Text Messages |
| Universal Empowerment and Community Health Worker | Experimental | Universal 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. Receives: Behavioral: Universal Empowerment; Behavioral: Community Health Workers (CHW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-week after baseline; 3 months; 6 months
Secondary outcomes (5)
Health-related social needs: Food Insecurity
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.
Measured: Baseline, 3 months, 6 months
Health-related social needs: Housing Insecurity
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.
Measured: Baseline, 3 months, 6 months
Health-related social needs: Transportation Insecurity
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.
Measured: Baseline, 3 months, 6 months
Hemoglobin A1C
As measured during clinic visit; for adolescents only. Reported as %.
Measured: Baseline, 3 months, 6 months
Body Mass Index
As measured at clinic visits; for adolescents only. Reported as kg/m2.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start21 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Ellen Vajravelu, MD, University of Pittsburgh
- Investigators
- Mary Ellen Vajravelu, MD MSHP, Principal investigator, University of PittsburghMaya I Ragavan, MD MPH MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216118
- Sponsor's protocol ID
- STUDY25030030
- Other IDs
- 1R01DK142766-01
- Acronym
- ONWARD
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Navigation for Wellness And Resources Utilization in Youth With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07216118
- Acronym / sponsor ID
- ONWARD / STUDY25030030
- Conditions
- Diabetes in Adolescence, Type 2 Diabetes, Social Needs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tailored Resources and Text Messages | Experimental | Behavioral: Tailored Resources, Behavioral: Text MessagesTailored 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 | Experimental | Behavioral: Tailored Resources, Behavioral: Community Health Workers (CHW)Tailored 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 | Experimental | Behavioral: Universal Empowerment, Behavioral: Text MessagesAssigned 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 | Experimental | Behavioral: Universal Empowerment, Behavioral: Community Health Workers (CHW)Universal 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Inability to complete study questionnaires in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored ResourcesAlso: TailoredParticipants 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). | Behavioural | Tailored Resources and Community Health Worker, Tailored Resources and Text Messages |
| Universal EmpowermentAlso: UniversalRegardless 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. | Behavioural | Universal Empowerment and Community Health Worker, Universal Empowerment and Text Messages |
| Text MessagesAlso: Text OnlyParticipants 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. | Behavioural | Tailored Resources and Text Messages, Universal Empowerment and Text Messages |
| Community Health Workers (CHW)Also: CHWParticipants will be assigned a trained CHW to support connection with resources to address HRSN. | Behavioural | Tailored Resources and Community Health Worker, Universal Empowerment and Community Health Worker |
Primary outcome
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.
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.
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.
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.
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diabetes in Adolescence
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingPhase 3
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Type 1 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya I Ragavan, MD MPH MS contact
Mary Ellen Vajravelu, MD MSHP principal investigator
University of Pittsburgh
Maya I Ragavan, MD MPH MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Resources, Universal Empowerment and Text Messages in people with Diabetes in Adolescence and Type 2 Diabetes, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Ellen Vajravelu, MD MSHP (412-692-6533, maryellen.vajravelu@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention: Health-Related Social Needs Screener (time frame: at baseline clinic visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.