Type 2 DiabetesTODNCT04734015
Together Overcoming Diabetes
A study testing Together Overcoming Diabetes (TOD) in people with Type 2 Diabetes, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Together Overcoming Diabetes (TOD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 11 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Great Lakes Hub
Duluth, Minnesota, 55812
About this study
Official title: Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Together Overcoming Diabetes (TOD)
- Keywords
- Diabetes, Family Intervention, Lifestyle Intervention, Indigenous, American Indian, Native American
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Together Overcoming Diabetes (TOD)Behavioural
Also called Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adult Participant Fasting HbA1c
Change in Adult Participant Fasting HbA1c
Measured: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary outcomes (4)
Change in BMI - Adult Participants
BMI change as indication of weight loss
Measured: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in zBMI - Youth Participants
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.
Measured: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in Depression and Depressive Symptoms - Adult Participants
Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome.
Measured: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in Depression and Depressive Symptoms - Youth Participants
Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome.
Measured: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start18 Jun 2021
- Primary completion30 Apr 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Walls, PhD, Principal investigator, Johns Hopkins University, Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734015
- Sponsor's protocol ID
- DK091250
- Other IDs
- 5R01DK091250-07, IRB00010045
- Acronym
- TOD
- Status last verified
- Jun 2026
- First submitted
- 25 Jan 2021
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40313359
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
- ClinicalTrials.gov ID
- NCT04734015
- Acronym / sponsor ID
- TOD / DK091250
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Family Intervention, Lifestyle Intervention, Indigenous, American Indian, Native American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Posted 16 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Together Overcoming Diabetes (TOD) curriculum | Experimental | Behavioral: Together Overcoming Diabetes (TOD)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. |
| 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Together Overcoming Diabetes (TOD)Also: Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)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. | Behavioural | Together Overcoming Diabetes (TOD) curriculum |
Primary outcome
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
4 secondary outcomes
Change in BMI - Adult Participants
Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in zBMI - Youth Participants
Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in Depression and Depressive Symptoms - Adult Participants
Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in Depression and Depressive Symptoms - Youth Participants
Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40313359Walls 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Walls, PhD principal investigator
Johns Hopkins University, Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Together Overcoming Diabetes (TOD) in people with Type 2 Diabetes, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adult Participant Fasting HbA1c (time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.