Together Overcoming Diabetes

NCT04734015 | Active Not Recruiting DMC

• 3 other identifiers: DK0912505R01DK091250-07IRB00010045
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention. Participants in this trial are American Indian adult caregivers diagnosed with type 2 diabetes and their youth, aged 10-16 years at enrollment. Adult/youth participant dyads will be enrolled across 5 Ojibwe tribal communities. Consenting participant dyads will be randomized into one of two groups: Group A: begin the intervention program immediately; Group B (waitlist): begin the intervention program in 2 years. Both groups will complete assessments with study staff at baseline, 3, 6, 12, 18, and 24 months to assess HbA1c, cholesterol, blood pressure (adults), biometric measures, and psychosocial and behavioral outcomes (adults and youth). The 14-lesson intervention program will be delivered in the participant's home by local Family Health Coaches over a 6-month period. Upon completion of the intervention, participants may also be invited to participate in a "Ripple Effects Mapping" (REM) session for discussions, and mapping of the intervention effects.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Family Intervention; Lifestyle Intervention; Indigenous; American Indian; Native American

Outcome Measures

Primary Outcomes (1)

• Change in Adult Participant Fasting HbA1c

  Change in hemoglobin A1c

  Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

Secondary Outcomes (2)

• Change in BMI/zBMI - Adult and Youth participants

  Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

• Change in Depression and Depressive symptoms - Adult and Youth participants

  Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

Other Outcomes (3)

• Change in Physical Activity - Adult and Youth participants

  Day 0, Month 6, Month 12, and Month 24

• Change in Communal Mastery - Adult and Youth participants

  Day 0, Month 6, Month 12, and Month 24

• Change in Diabetes Empowerment - Adult participants

  Day 0, Month 6, Month 12, and Month 24

Study Arms (2)

Together Overcoming Diabetes (TOD) curriculum

EXPERIMENTAL

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.

Behavioral: Together Overcoming Diabetes (TOD)

Waitlist Control

NO 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.

Interventions

Together Overcoming Diabetes (TOD) BEHAVIORAL

Curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. American Indian Family Health Coaches conduct motivational interviewing to help participant dyads (adult caregivers with Type 2 diabetes and their youth) set attainable goals and work through obstacles to reach those goals.

Also known as: Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)

Together Overcoming Diabetes (TOD) curriculum

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ADULT (target participants)
• Are greater than 18 years of age
• Self-identify as American Indian
• Have a completed verification form from a healthcare provider indicating a confirmed diagnosis of type 2 diabetes
• Live on or within 30 miles of participating reservations
• Are a caregiver to a 10-16 year-old who lives in their home
• Are willing to be randomly put into Group A (intervention) or Group B (waitlist control)
• Are willing to complete all lessons and assessments
• Speak and read English
• Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)
• YOUTH
• years of age
• Self-identify as American Indian
• Live with an adult who has joined the study
• Are willing to be randomly put into Group A or Group B

You may not qualify if:

• ADULTS (target participants)
• Are not American Indian
• No confirmed type 2 diabetes diagnosis
• Not a caregiver to a youth ages 10-16 in their home
• Is unable to complete the study procedures
• Has comorbidity(ies) that may have an impact on type 2 diabetes management
• YOUTH
• Are not American Indian
• Do not fall within the specified age range of 10-16 years at time of enrollment
• Do not have an enrolled Adult caregiver
• Unable to read and speak English
• Not willing to complete the study procedures

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins University Great Lakes Hub

Duluth, Minnesota, 55812, United States

Location

Related Publications (1)

• Walls ML, Sittner KJ, Gomez GJ, Cole RE, Perkins SR, Steinberg RI, Forsberg AK, Haroz EE, Barlow A. Trial and Participant Characteristics of a Home-Visiting Diabetes Intervention: The Together Overcoming Diabetes Study. J Diabetes Res. 2025 Apr 24;2025:6591307. doi: 10.1155/jdr/6591307. eCollection 2025.

  PMID: 40313359 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Melissa Walls, PhD

  Johns Hopkins University, Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An Independent Evaluation team will conduct assessments and be blinded to participant randomization status. The investigators will also be blinded to randomization status during data collection and initial analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Waitlist Control Design. Adult/youth participant dyads will be randomized to either the intervention group or the wait-list control group after eligibility screening, enrollment and completion of the baseline assessment. The intervention group will receive the 6-month intervention and 6-month maintenance phase immediately; the wait-list will receive standard care for 24 months and will then receive the intervention.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: June 18, 2021
• Primary Completion: April 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)