Together Overcoming Diabetes for Diabetes

Overseen By Courtney Claussen, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Pregnant, Nursing, Dialysis, Cushing's, others

Compensation: Varies

Number of Visits: 2

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a diabetes program called TOD Great Plains, designed specifically for American Indian and Alaska Native communities. The focus is on understanding how social and environmental factors affect diabetes management and finding ways to improve health outcomes. American Indian or Alaska Native adults with Type 2 diabetes living near Rapid City, who also care for a young person at home, might be a good fit. Participants will either try the new program or continue with standard care while waiting to try the program later. As an unphased trial, this study offers a unique opportunity to contribute to culturally tailored diabetes care improvements in the 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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the TOD Great Plains intervention is safe for AI/AN populations?

Research has shown that the Together Overcoming Diabetes (TOD) program is generally safe. Previous studies have examined how well participants handle this diabetes program. Reports indicate that the program helps reduce diabetes risk factors, such as lowering body mass index (BMI) and alleviating symptoms of depression. No clear evidence links the TOD program to serious side effects or negative events. Since this trial does not involve medication, it is less likely to cause the side effects associated with drugs. This suggests that participants generally tolerate the program well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Together Overcoming Diabetes (TOD) intervention because it offers a culturally tailored approach specifically designed for the Lakota community. Unlike standard diabetes care, which typically involves general dietary and lifestyle guidance, TOD integrates culturally relevant education and support for caregivers and their families. This personalized approach aims to enhance engagement and effectiveness by respecting and incorporating cultural values, which could lead to better diabetes management outcomes.

What evidence suggests that the Together Overcoming Diabetes intervention is effective for diabetes?

Studies have shown that the Together Overcoming Diabetes (TOD) program can help manage type 2 diabetes, particularly in American Indian/Alaska Native communities. Research indicates that TOD focuses on lowering blood sugar levels, measured by HbA1c—a key indicator of diabetes control. Initial findings suggest that TOD improves not only physical health but also behavioral and mental well-being for participants. In this trial, participants will either receive the TOD intervention, adapted for Lakota caregivers and their families, or be waitlisted to receive the intervention while receiving standard care. This program uniquely addresses diabetes holistically, considering the spiritual, mental, physical, and emotional health of the families involved. Overall, the program shows promise in providing culturally tailored support to effectively manage diabetes. ^{2 3 4 6 7}

Who Is on the Research Team?

Donald Warne, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for American Indian/Alaska Native individuals who have diabetes. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and be willing to follow the study procedures.

Inclusion Criteria

Adult Index Participants: Self-identifies as American Indian or Alaska Native

Adult Index Participants: Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center

Youth Support Participants: Self-identifies as American Indian or Alaska Native

Exclusion Criteria

I am able to fully participate without any planned interruptions.

Adult Index Participants: Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

I am a youth currently in foster care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Together Overcoming Diabetes (TOD) intervention tailored for Lakota caregivers

6 months

Visits at baseline, 2 months, 4 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TOD Great Plains

Trial Overview The study tests a tailored diabetes intervention called Together Overcoming Diabetes (TOD) against a waitlist standard of care in AI/AN populations. The effectiveness of TOD in managing diabetes will be compared with those receiving usual care.

How Is the Trial Designed?

Group I: Together Overcoming Diabetes Intervention Experimental Treatment 1 Intervention

Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families

Group II: Waitlist Standard of Care Placebo Group 1 Intervention

Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

The NIH Community Engagement Alliance

Collaborator

Trials

1

Recruited

80+

Oyate Health Center

Collaborator

Trials

1

Recruited

80+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The Gestational Diabetes Group Program (GDGP) effectively improved diabetes self-management education for pregnant women, leading to significant increases in knowledge and empowerment regarding their condition.

Participants in the GDGP reported high satisfaction levels and experienced optimal pregnancy outcomes, demonstrating the program's efficacy in supporting underserved populations through an interdisciplinary care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gestational Diabetes Group Program. Nasso, J., McCloskey, C., Nordquist, S., et al.[2020]

A systematic review of 68 observational studies on non-serious adverse drug events (ADEs) in type 2 diabetes revealed that many studies used inadequate methods for detecting ADEs, with only a third exceeding regulatory requirements for sample size and follow-up duration.

The most effective method for identifying a diverse range of ADEs was solicited surveillance by healthcare professionals, while patient surveys primarily focused on specific issues like hypoglycemia, indicating a need for better methodologies and a combination of approaches to fully capture ADEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. Hakobyan, L., Haaijer-Ruskamp, FM., de Zeeuw, D., et al.[2022]

A study analyzing FDA Adverse Event Reporting System data from January 2013 to March 2022 found that different DPP-4 inhibitors have varying risks for serious side effects, such as acute kidney injury and pemphigoid, which can guide treatment choices for diabetes patients.

Specifically, alogliptin showed a significantly lower risk of acute kidney injury compared to sitagliptin, but a higher risk of pemphigoid, highlighting the importance of selecting the appropriate DPP-4 inhibitor based on a patient's specific health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. Ogura, T., Shiraishi, C.[2023]

Citations

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

Together Overcoming Diabetes for Diabetes The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to ...

2. trial.medpath.com trial.medpath.com/clinical-trial/79dd51aea898b008/nct04734015-family-based-diabetes-intervention

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8966038/

Centering the Strengths of American Indian Culture, Families ... The TOD curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. Preliminary evidence suggests TOD is ...

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

The Together Overcoming Diabetes Study This study provides comprehensive information about physiological, psychological, behavioral, and sociodemographic characteristics for a sample of AI families ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04734015

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

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35368509/

Centering the Strengths of American Indian Culture ... Preliminary evidence suggests TOD is effective in reducing diabetes risk factors including lowering BMI and depressive symptoms, and the program ...