TOD Program for Type 2 Diabetes

(TOD Trial)

Overseen By Angie Forsberg

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Non-American Indian, No type 2 diabetes, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help American Indian families manage and prevent type 2 diabetes through a culturally tailored program called Together Overcoming Diabetes (TOD). The program includes 14 lessons delivered in the participant's home by local Family Health Coaches over six months. Participants are American Indian adult caregivers with type 2 diabetes who live with a youth aged 10-16. The goal is to assess how this family-based approach affects health factors such as blood sugar, cholesterol, and blood pressure, along with psychosocial and behavioral outcomes. Some participants will start the program immediately, while others will begin after two years. As an unphased trial, this study allows participants to contribute to innovative research that could benefit their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Together Overcoming Diabetes (TOD) program is safe for participants?

Research has shown that the Together Overcoming Diabetes (TOD) program is a family-focused plan designed to help manage and prevent type 2 diabetes, specifically for American Indian communities. The program emphasizes lifestyle changes and education instead of medication or surgery, making it generally safer and easier to manage.

While specific safety data for the TOD program is limited, its approach suggests a low risk of side effects. Participants learn from Family Health Coaches about making lifestyle and behavior changes.

Since the program does not involve drugs, typical medication side effects are unlikely. Studies have not highlighted any safety concerns or negative effects, so the TOD program is considered safe for participants. It is important for anyone interested in joining to discuss their health with trial coordinators or healthcare providers first. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Together Overcoming Diabetes (TOD) program because it offers a fresh approach to managing Type 2 Diabetes by involving both youth and their caregivers in the treatment process. Unlike standard treatments that typically focus solely on medication or individual lifestyle changes, TOD emphasizes a family-centered approach. This strategy aims to improve both the psychosocial and behavioral outcomes of participants, potentially leading to more sustainable health improvements. By engaging families as a unit, TOD might enhance support systems and encourage lasting healthy habits, setting it apart from traditional diabetes management methods.

What evidence suggests that the Together Overcoming Diabetes (TOD) program might be an effective treatment for type 2 diabetes?

Research has shown that the Together Overcoming Diabetes (TOD) program, which participants in this trial may receive, can help manage type 2 diabetes in American Indian communities. Studies have found that this home-based program improves important health measures like HbA1c, which indicates blood sugar levels. The program targets both adults and youth, addressing the main causes of diabetes and its complications. Early results suggest that participants manage their diabetes better by adopting healthier lifestyle and behavior changes. The program is specially designed to fit the culture of the community, aiding families in managing diabetes more effectively. ^{2 6 7 8 9}

Who Is on the Research Team?

Melissa Walls, PhD

Principal Investigator

Johns Hopkins University, Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for American Indian adult caregivers with type 2 diabetes and their children aged 10-16. Adults must be over 18, speak English, live near participating reservations, and have a confirmed diabetes diagnosis. Children must also speak English and be willing to participate in the study.

Inclusion Criteria

I am willing to complete all lessons and assessments.

YOUTH: Speak and read English

ADULT: Self-identify as American Indian

Exclusion Criteria

I am a young participant without an adult caregiver enrolled in the study.

I have other health issues that could affect my diabetes management.

I am not between the ages of 10 and 16.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The 14-lesson intervention program delivered in the participant's home by local Family Health Coaches over a 6-month period

6 months

Home visits by Family Health Coaches

Assessment

Participants complete assessments at baseline, 3, 6, 12, 18, and 24 months to evaluate various health outcomes

24 months

Assessments at baseline, 3, 6, 12, 18, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Ripple Effects Mapping (optional)

Participants may be invited to participate in a session for discussions and mapping of the intervention effects

What Are the Treatments Tested in This Trial?

Interventions

• Together Overcoming Diabetes (TOD)

Trial Overview The 'Together Overcoming Diabetes' program is being tested. It's a family-based intervention delivered at home by health coaches over six months. Participants are randomly assigned to start immediately or after two years, with regular assessments of health outcomes.

How Is the Trial Designed?

Group I: Together Overcoming Diabetes (TOD) curriculum Experimental Treatment 1 Intervention

A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD). Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.

Group II: Waitlist Control Active Control 1 Intervention

A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months. Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study involving approximately 32,800 users of exenatide, there was a modestly higher incidence of claims for thyroid malignancies compared to users of metformin or glyburide, but this association was not significant when focusing on inpatient claims.

Exenatide use was not linked to an increased risk of benign thyroid neoplasms or pancreatic cancer, suggesting it may be a safe option regarding these specific cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. Dore, DD., Seeger, JD., Chan, KA.[2021]

Both generic and diabetes-specific self-management programs led to significant improvements in self-management knowledge and skills, as well as reductions in depression among 458 participants over a 12-week follow-up period.

Younger participants with higher self-efficacy and better health-related quality of life (HRQOL) showed the most improvement, highlighting the need to encourage participation from individuals with lower socio-economic status to avoid worsening health inequalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management programs conducted within a practice setting: who participates, who benefits and what can be learned? Packer, TL., Boldy, D., Ghahari, S., et al.[2022]

A systematic review of six controlled trials found that specific social support interventions, like group consultations and Internet-based peer support, can positively impact health outcomes for people with type 2 diabetes, improving measures like HbA1c and physical activity.

Traditional forms of social support, such as from family and friends, did not show significant improvements in diabetes control, suggesting that innovative support methods may be more effective in helping patients manage their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social support in diabetes: a systematic review of controlled intervention studies. van Dam, HA., van der Horst, FG., Knoops, L., et al.[2022]

A study involving 734 individuals with type 2 diabetes compared two self-management support programs: a standard program (CTH) and an enhanced version (EE-CTH) that included relationship-building strategies. Both programs led to significant improvements in self-management behaviors and psychological outcomes after 6 to 12 months.

The enhanced engagement program (EE-CTH) resulted in greater reductions in unhealthy food consumption, stress, and health-related distress, as well as improved depression symptoms compared to the standard program, highlighting the importance of addressing individual social challenges in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Hessler, D., Fisher, L., Dickinson, M., et al.[2022]

In a 32-week study involving 686 patients with Type 2 diabetes, insulin detemir (IDet) therapy was found to be safe, with no serious adverse drug reactions reported and a significant reduction in total hypoglycemic events from 435 to 204.

Patients experienced improved glycemic control, as indicated by a decrease in glycated hemoglobin A1c from 9.9% to 7.7% and fasting plasma glucose from 11.9 mmol/L to 7.4 mmol/L, alongside a slight reduction in body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. El Shiekh, AR., Farrag, HA., Ashour, T., et al.[2020]

A review of safety evidence for six major diabetes drug classes indicates that all options have reasonable safety margins when used appropriately, allowing for personalized treatment regimens for type 2 diabetes.

While established medications like metformin, sulfonylureas, and insulin are effective for most patients, there are still unmet clinical needs, highlighting the importance of early intervention and potential combination therapies tailored to individual patient circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond metformin: safety considerations in the decision-making process for selecting a second medication for type 2 diabetes management: reflections from a diabetes care editors' expert forum. Cefalu, WT., Buse, JB., Del Prato, S., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40313359/

The Together Overcoming Diabetes Study We describe baseline characteristics for AI participants enrolled in a culturally grounded, intergenerational, home-based T2D preventive ...

2. withpower.com withpower.com/trial/together-overcoming-diabetes-for-diabetes-1406d

Together Overcoming Diabetes for Diabetes The effectiveness of TOD in managing diabetes will be compared with those receiving usual care. How Is the Trial Designed? 2Treatment groups.

3. cih.jhu.edu cih.jhu.edu/programs/together-overcoming-diabetes/

Together Overcoming Diabetes (Niwii-shaagoojitoomin izhi ... A home-based, family-centered diabetes intervention program for Ojibwe communities. Our goal is to help adults living with type 2 diabetes manage their disease.

4. clinicaltrial.be clinicaltrial.be/en/details/48082?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Together Overcoming Diabetes The study will evaluate effectiveness of the intervention on adult physiological (primary outcome = HbA1c), behavioral, and mental health and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12045684/

Trial and Participant Characteristics of a Home-Visiting ... Briefly, the intervention component of the Together Overcoming Diabetes (TOD) study was designed to address the root causes of T2D and its complications with ...

6. withpower.com withpower.com/trial/phase-diabetes-mellitus-5-2021-9f94a

TOD Program for Type 2 Diabetes (TOD Trial) The treatment, known as dulaglutide, has been shown to be generally safe for adults with Type 2 diabetes, with a similar risk of low blood sugar (hypoglycemia) ...

7. clinicaltrial.be clinicaltrial.be/en/details/48082?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Together Overcoming Diabetes Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention.

8. jandonline.org jandonline.org/article/S2212-2672(20)31567-7/fulltext

Native Youth Participating in the Together on Diabetes 12 ... The aims of this study were to (1) examine the impact of the TOD program on diet quality using the AHEI-2010; (2) determine the association between diet quality ...

9. norc.org norc.org/content/dam/norc-org/pdfs/TOD%20Implementation%20Guide.pdf

Together on Diabetes Implementation Guide The Together on Diabetes Program is a diabetes prevention and management program designed and implemented by the Johns Hopkins Center for American Indian ...