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Completed

NCT Number: NCT04734015

Together Overcoming Diabetes

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University Great Lakes Hub

Duluth, Minnesota, 55812, United States

About this study

Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention. The program activates family and cultural practices that encourage healthy diets and physical activities, promotes coping skills for dealing with stress, and reconnects families via a home-based intervention taught by American Indian (AI) paraprofessional Family Health Coaches.

Evaluation of TOD for this trial will happen via Community Based Participatory Research (CBPR). The study team will enroll "target" adult caregivers diagnosed with type 2 diabetes and their youth, ages 10-16 years at enrollment, with the goal of tapping motivational reciprocity between the two generations. The work involves collaboration with five Ojibwe tribal communities in the midwestern U.S. to implement a randomized controlled study with a wait-list design respectful of cultural norms of inclusion.

The study will evaluate effectiveness of the intervention on adult physiological (primary outcome = HbA1c), behavioral, and mental health and children's psychosocial, familial, behavioral and physiological risk and protective factors for diabetes. The research will also identify stress-coping mechanisms that mediate the impact of the intervention on health. A novel collaborative, qualitative evaluation technique will map potential "ripple effects" of the intervention within families and communities. If effective, the intervention will promote dissemination and scaling with tribal health coaches, community involvement, and stakeholder (health providers, health and human service agencies) input.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 10 -16 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
  • 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)

Exclusion criteria

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
  • Does not live within the distance inclusion criteria
  • 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

Treatment and study plan

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.

Other names: Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)

Primary outcomes

  1. Change in Adult Participant Fasting HbA1c

    Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

    Change in Adult Participant Fasting HbA1c

Secondary outcomes

  1. Change in BMI - Adult Participants

    Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

    BMI change as indication of weight loss

  2. Change in zBMI - Youth Participants

    Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

    z-score of BMI in children and adolescents that indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the population mean, based on age and sex. A lower z-score represents a better outcome (less obesity), with scores between -1.0 and +1.0 indicating normal weight. Numbers greater than -1.0 and +1.0 indicate overweight status.

  3. Change in Depression and Depressive Symptoms - Adult Participants

    Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

    Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome.

  4. Change in Depression and Depressive Symptoms - Youth Participants

    Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24

    Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome.

Other outcomes

  1. Change in Physical Activity - Adult Participants

    Time frame: Day 0, Month 6, Month 12, and Month 24

    Number of days of physical activity per week

  2. Change in Physical Activity - Youth Participants

    Time frame: Day 0, Month 6, Month 12, and Month 24

    Number of days of physical activity per week

  3. Change in Communal Mastery - Adult Participants

    Time frame: Day 0, Month 6, Month 12, and Month 24

    Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome.

  4. Change in Communal Mastery - Youth Participants

    Time frame: Day 0, Month 6, Month 12, and Month 24

    Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome.

  5. Change in Diabetes Empowerment - Adult Participants

    Time frame: Day 0, Month 6, Month 12, and Month 24

    Diabetes Empowerment Scale. Scoring ranges from 0 to 24. Higher score equates to better outcome.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

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

Registry information

Official study title

Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities

Acronym: TOD

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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