STRIDE Program for Type 2 Diabetes

(STRIDE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Diabetes medications

Disqualifiers: Pregnancy, Cancer, Renal disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile phone program called STRIDE, designed to help people with type 2 diabetes manage their condition and receive more social support. Participants will either receive support from a family member or friend through text messages or be paired with a peer for mutual support. This trial suits individuals with type 2 diabetes who take daily diabetes medication and feel stressed about managing their condition. Participants should own a mobile phone and be open to involving a close friend or relative in the study. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for managing diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be prescribed at least one daily diabetes medication, it seems likely you can continue your current diabetes treatment.

What prior data suggests that the STRIDE program is safe for adults with type 2 diabetes?

Research has shown that the STRIDE program, which includes treatments like semaglutide, is generally well-tolerated by participants. In similar studies, only about 1% of participants experienced serious side effects from semaglutide. No deaths related to the treatment occurred, indicating its safety. This evidence suggests that the treatment is generally safe for people, with few serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The STRIDE treatment is unique because it focuses on social support as a method to manage Type 2 Diabetes, unlike standard treatments that typically focus on medications or lifestyle changes like diet and exercise. Researchers are excited about this approach because it introduces FAMS (Family and Friends Support) and PEER support systems, which integrate personal connections and community into the management process. These methods aim to empower patients by enhancing motivation and adherence to treatment goals through personalized support, which could lead to better long-term management of the condition.

What evidence suggests that the STRIDE program is effective for type 2 diabetes?

Research has shown that the STRIDE program, which participants in this trial will experience, might help people with type 2 diabetes manage their condition better. In an earlier study, participants in a similar program called SeCe-STRIVE improved their diabetes management skills. Another study on the FAMS program, part of STRIDE, found it reduced diabetes-related stress and improved overall well-being. However, better blood sugar levels (HbA1c) appeared only in those with support from non-cohabiting friends or family. These findings suggest that STRIDE could effectively help manage diabetes with the right social support. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are interested in a mobile phone-delivered intervention aimed at improving blood sugar management and social support. Specific eligibility criteria details were not provided.

Inclusion Criteria

PERSONS WITH DIABETES: Receiving outpatient care from a partnering clinic

PERSONS WITH DIABETES: Willing to invite a close friend or family member to co-participate

I have diabetes and feel overwhelmed or unsure about managing it.

Exclusion Criteria

I have diabetes and am currently receiving cancer treatment.

PERSONS WITH DIABETES: Does not take medication on his/her own/medication administered by someone else

PERSONS WITH DIABETES: Diagnosed with dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mobile phone-delivered intervention STRIDE, with randomization to FAMS or PEER support

6 months

Ongoing virtual support

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STRIDE

Trial Overview The STRIDE program, which uses mobile phones to deliver support to people with type 2 diabetes, is being tested for its feasibility and acceptability in helping manage the condition.

How Is the Trial Designed?

Group I: Experimental: Step 2: Optimal Second Line Treatment Experimental Treatment 2 Interventions

All PWD participants will be randomized at month 3 to FAMS or PEER. PWD participants assigned to Step 2 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD if not previously enrolled. PWD participants assigned to Step 2 treatment "PEER" will be paired with another participant to provide each other peer support. If they had previously enrolled a SP, the SP participant will stop receiving text messages.

Group II: Experimental: Step 1: Optimal First Line Treatment Experimental Treatment 2 Interventions

Persons with diabetes (PWD) participants will first be randomized to an optimal first line treatment in order to compare FAMS vs. PEER. PWD participants assigned to Step 1 treatment "FAMS" will have the option to co-enroll a friend/family member as a support person (SP) to receive text message support tailored to the goal set by the linked PWD. PWD participants assigned to Step 1 treatment "PEER" will be paired with another participant to provide each other peer support.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

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/PMC11960157/

A Community-Based Randomized Controlled Trial - PMC Patients with type 2 diabetes who received the SeCe-STRIVE program intervention showed significant improvements in self-management behaviors.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37742801/

Main, mediated, and subgroup effects from the FAMS 2.0 RCT FAMS improved PWDs' diabetes distress (d = -0.19) and global well-being (d = 0.21) during the intervention, with patterns of larger effects among minoritized ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/21501319251330384

A Community-Based Randomized Controlled Trial Patients with type 2 diabetes who received the SeCe-STRIVE program intervention showed significant improvements in self-management behaviors.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02928952?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(in%20stride))&rank=1

Mindful Stress Reduction in Diabetes Self-management ... There is, therefore, a critical need to determine the efficacy of this targeted mindfulness intervention for improving DRD, diabetes self-efficacy, DSM ...

5. medrxiv.org medrxiv.org/content/10.1101/2023.09.11.23295374v1.full-text

mediated, and subgroup effects from the FAMS 2.0 RCT Conclusions Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40169145/

Semaglutide and walking capacity in people with ... Semaglutide increased walking distance in patients with symptomatic peripheral artery disease and type 2 diabetes.

7. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00509-4/abstract

Semaglutide and walking capacity in people with ... STRIDE was a double-blind, randomised, placebo-controlled trial done at 112 outpatient clinical trial sites in 20 countries in North America, ...

8. sciencehub.novonordisk.com sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/esc2025/verma/documents/STRIDE_by_sex_ESC25_Oral_Presentation_Final_Presentation.pdf

STRIDE Outcomes by Sex In the STRIDE trial, once-weekly semaglutide 1.0 mg for 52 weeks improved walking distance, health-related quality of life. (QoL), ankle- ...

9. diabetes.org diabetes.org/newsroom/press-releases/semaglutide-increases-walking-capacity-patients-peripheral-artery-disease

Semaglutide Increases Walking Capacity in Patients with ... Semaglutide was well tolerated, with no treatment-related deaths and a low rate of serious adverse events (1%), consistent with its known safety ...

10. academic.oup.com academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.2287/7837549

Baseline patient reported outcomes in patients with peripheral ... The primary outcome of STRIDE is the change in maximum walking distance at week 52 on a constant load treadmill. Baseline PRO assessments ...