Strategies for Type 2 Diabetes in Youth

(ONWARD Trial)

Overseen By Maya I Ragavan, MD MPH MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to assist young people with type 2 diabetes and their families by connecting them to community resources that address health-related social needs. Researchers aim to evaluate the ease and effectiveness of these strategies, including text messaging and support from community health workers. Participants will attend regular diabetes clinic visits, complete surveys, and access resources for essentials like food and housing. This trial suits young people aged 13 to 22 with type 2 diabetes who receive treatment at UPMC Children's Hospital of Pittsburgh, along with their caregivers. As an unphased trial, it offers participants a unique opportunity to contribute to innovative approaches in diabetes care and support.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on strategies to address social needs rather than medication changes.

Is there any evidence suggesting that this trial's strategies are likely to be safe?

Research shows that personalized text message programs for people with type 2 diabetes are generally well-received. Studies have found that these messages can help reduce diabetes-related stress, increase social support, improve knowledge, boost self-care and confidence, and enhance overall quality of life for participants. Receiving personalized messages without a community health worker (CHW) is considered safe.

Adding a community health worker also appears safe. Research has shown that digital health programs, when combined with CHW support, are effective. This combination helps people monitor and manage their health without major negative effects.

For text messages aimed at everyone, safety remains consistent. Programs designed for young people have been found to work well and are accepted without significant safety issues. When paired with a community health worker, studies show positive results without added risk.

Overall, these programs are well-received and do not present major safety concerns according to available data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these strategies for managing Type 2 Diabetes in youth because they focus on personalized and community-based support, rather than just medication. Unlike traditional treatments that mainly involve drugs like metformin or insulin, these approaches incorporate digital tools and community health workers (CHWs) to address social factors affecting health. Tailored text messages and resource lists empower young patients by connecting them directly to local resources for food, housing, and transportation. The involvement of CHWs offers a personalized touch, helping families navigate their unique health-related social needs, which could lead to more holistic management of diabetes. This trial aims to find out if these supportive interventions can improve health outcomes by addressing the broader social determinants of health that often go unaddressed in standard care.

What evidence suggests that this trial's strategies could be effective for addressing health-related social needs in youth with type 2 diabetes?

Research has shown that personalized text messages can help prevent type 2 diabetes from worsening. For instance, one study found that people who received these messages were less likely to develop diabetes compared to those who didn't. In this trial, some participants will receive text messages without additional support, while others will receive text messages combined with support from community health workers (CHWs). When combined with CHW support, these messages can enhance social support and encourage self-care. Studies indicate that CHWs provide practical health advice, helping people manage their diabetes more effectively. Another approach in this trial involves sending motivational messages, known as universal empowerment, which can inspire healthier habits. Additionally, improved text support has increased clinic visits and better overall diabetes management. ^{1 3 4 5 6}

Who Is on the Research Team?

Mary Ellen Vajravelu, MD MSHP

Principal Investigator

University of Pittsburgh

Maya I Ragavan, MD MPH MS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for young people with Type 2 diabetes who feel lonely or have health-related social needs. They should be willing to attend regular clinic visits, complete surveys, and engage with community resources. Specific eligibility details are not provided.

Inclusion Criteria

I will participate in the study with my caregiver.

I am 13-22 years old with type 2 diabetes and receive care at UPMC Children's Hospital of Pittsburgh.

I am the main caregiver for a young person with type 2 diabetes who agrees to join the study.

Exclusion Criteria

I cannot complete questionnaires in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive tailored resources and text messages to address health-related social needs, with or without community health worker support.

3 months

Monthly text messages and regular clinic visits

Follow-up

Participants are monitored for the acceptability and feasibility of the intervention, including surveys and interviews.

3 months

Regular clinic visits and surveys

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Resources
• Text Messages and Community Health Workers (CHW)
• Text Messages without Community Health Workers (CHW)
• Universal Empowerment

Trial Overview The study tests how well different strategies work to help youth with Type 2 diabetes by sending text messages, connecting them with Community Health Workers, providing tailored resources, and using empowerment techniques.

How Is the Trial Designed?

Group I: Universal Empowerment and Text Messages without CHW Experimental Treatment 2 Interventions

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.

Group II: Universal Empowerment and Text Messages with Community Health Worker Experimental Treatment 2 Interventions

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.

Group III: Tailored Resources and Text Messages without Community Health Worker Experimental Treatment 2 Interventions

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.

Group IV: Tailored Resources and Text Messages with Community Health Worker Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481002/

Tailored mobile text messaging interventions targeting type ... This study aimed to identify, assess and summarize available scientific evidence on tailored text messaging interventions focused on type 2 diabetes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618152/

Advancing Type 2 Diabetes Prevention through Text ... The text-messages' group had a lower diabetes conversion rate (22.2%) compared to the control group (28%) but a higher conversion than the in- ...

3. diabetes.jmir.org diabetes.jmir.org/2024/1/e55473/

Impact of a Text Messaging Intervention as an In-Between ... Our study showed improved diabetes distress, social support, knowledge, self-care, self-efficacy, and quality of life among patients highly engaged in the SMS ...

4. diabetesjournals.org diabetesjournals.org/care/article/47/Supplement_1/S77/153949/5-Facilitating-Positive-Health-Behaviors-and-Well

5. Facilitating Positive Health Behaviors and Well-being to ... Building positive health behaviors and maintaining psychological well-being are foundational for achieving diabetes management goals and maximizing quality of ...

5. link.springer.com link.springer.com/article/10.1007/s11606-022-07639-6

Digital Health and Community Health Worker Support for ... The aim of this study was to evaluate the effectiveness of a digital health intervention plus community health worker (CHW) support on self-monitoring of blood ...

6. meddatax.com meddatax.com/clinical-trials/NCT07216118

Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 ... 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 ...