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

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the TOD program, which helps American Indian families manage type 2 diabetes through home-based coaching on healthy living. It targets adults with diabetes and their children, aiming to improve their health by promoting good habits and reducing stress. The Together on Diabetes (TOD) program was developed through community-based participatory research and has been tested in multiple studies involving American Indian youth and their families.

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.

Is the TOD Program for Type 2 Diabetes safe for humans?

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) compared to other treatments. ^{1 2 3 4 5}

How is the TOD treatment for type 2 diabetes different from other treatments?

The TOD Program for Type 2 Diabetes is unique because it focuses on a collaborative approach to managing diabetes, potentially involving structured education and lifestyle interventions, which may differ from traditional medication-based treatments. This approach emphasizes community support and lifestyle changes, which can be more sustainable and empowering for patients. ^{6 7 8 9 10}

What data supports the effectiveness of the TOD treatment for Type 2 Diabetes?

Research shows that self-management support programs, which are part of the TOD treatment, can improve diabetes outcomes by addressing personal challenges and enhancing patient engagement. Additionally, social support interventions, similar to those in TOD, have been found to improve self-care and diabetes management. ^{11 12 13 14 15}

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

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]

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]

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]

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]

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. England 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. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Self-management programs conducted within a practice setting: who participates, who benefits and what can be learned? [2022]

3. England pubmed.ncbi.nlm.nih.gov

Impact of a social network-based intervention promoting diabetes self-management in socioeconomically deprived patients: a qualitative evaluation of the intervention strategies. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Contextually Appropriate Tools and Solutions to Facilitate Healthy Eating Identified by People with Type 2 Diabetes. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Social support in diabetes: a systematic review of controlled intervention studies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. [2022]

7. India 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. [2020]

8. England 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Combination of Saxagliptin and Metformin Is Effective as Initial Therapy in New-Onset Type 2 Diabetes Mellitus With Severe Hyperglycemia. [2022]

10. United States 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a structured outpatient group education program for intensive insulin therapy. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Development of an Interactive Lifestyle Programme for Adolescents at Risk of Developing Type 2 Diabetes: PRE-STARt. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods. [2021]

14. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacoeconomics of diabetes surveillance and detection programmes. [2018]

15. England pubmed.ncbi.nlm.nih.gov

A large-scale diabetes prevention program in real-life settings in Qingdao of China (2006-2012). [2022]