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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK091250-07 | U.S. NIH Grant/Contract | View source | |
| IRB00010045 | Other Identifier | JHSPH IRB |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adult Participant Fasting HbA1c | Change in Adult Participant Fasting HbA1c | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI - Adult Participants | BMI change as indication of weight loss | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity - Adult Participants | Number of days of physical activity per week | Day 0, Month 6, Month 12, and Month 24 |
| Change in Physical Activity - Youth Participants | Number of days of physical activity per week |
Inclusion Criteria:
ADULT (target participants)
YOUTH
Exclusion Criteria:
ADULTS (target participants)
YOUTH
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Walls, PhD | Johns Hopkins University, Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University Great Lakes Hub | Duluth | Minnesota | 55812 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40313359 | Derived | 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. |
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A total of 162 participants (81 adults and 81 youth) were enrolled and randomized after completing the Baseline assessment.
82 participants (41 adults and 41 youth) were assigned to the Intervention group to immediately receive the TOD curriculum while 80 participants (40 adults and 40 youth) were assigned to the Waitlist group and received the intervention after completion of assessment visits (baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
128 adult/youth dyads submitted Interest Forms. 47 adult/youth dyads were excluded: 23 dyads did not meet inclusion criteria, 13 dyads the adult declined to enroll, 11 dyads were unresponsive/unable to contact.
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| ID | Title | Description |
|---|---|---|
| FG000 | Together Overcoming Diabetes (TOD) Curriculum | 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. |
| FG001 | Waitlist Control | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adult Caregivers and Youth
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| ID | Title | Description |
|---|---|---|
| BG000 | Together Overcoming Diabetes (TOD) Curriculum | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | There was missing data for age for one youth participant at baseline; age was not measured after baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Adult Participant Fasting HbA1c | Change in Adult Participant Fasting HbA1c | Adult participants with data collected | Posted | Mean | Standard Deviation | Percentage Glycated Hemoglobin | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
From enrollment (baseline assessment) up to 24 month assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Together Overcoming Diabetes (TOD) Curriculum - ADULTS | A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth). 41 adults were 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant became ineligible due to progression of memory loss | General disorders | Non-systematic Assessment | Participant moved out of independent home into memory care living facility |
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Limitations of this study include potential sample biases. It may be that families already motivated to address health were drawn to the current study; as such, characteristics of participants reported here could be conservative estimates of health conditions relative to communities overall. Another factor that may yield conservative results in this study is that some of our outcomes rely on self-reports of behaviors or health conditions (especially for youth).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Walls, PhD | Johns Hopkins Bloomberg School of Public Health, Center for Indigenous Health | 218-724-1665 | mwalls3@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2024 | Apr 14, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2026 | Apr 14, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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.
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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.
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| 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. | 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. | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Day 0, Month 6, Month 12, and Month 24 |
| Change in Communal Mastery - Adult Participants | Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome. | Day 0, Month 6, Month 12, and Month 24 |
| Change in Communal Mastery - Youth Participants | Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome. | Day 0, Month 6, Month 12, and Month 24 |
| Change in Diabetes Empowerment - Adult Participants | Diabetes Empowerment Scale. Scoring ranges from 0 to 24. Higher score equates to better outcome. | Day 0, Month 6, Month 12, and Month 24 |
| BG001 | Waitlist Control | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Youth Sex/Gender: There was missing data for gender for one youth participant at baseline. | Count of Participants | Participants |
|
| Sex: Female, Male | Adult caregivers | Adult caregivers | Count of Participants | Participants |
|
| Race (NIH/OMB) | The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth. | Count of Participants | Participants |
|
| Adult participant Fasting HbA1c | Adult participants with data collected. HbA1c was not measured for youth. | Mean | Standard Deviation | Percentage Glycated Hemoglobin |
|
| Waitlist Control |
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. |
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| Secondary | Change in BMI - Adult Participants | BMI change as indication of weight loss | Adult participants with data collected | Posted | Mean | Standard Deviation | kg/m^2 | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
|
| Secondary | 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. | Youth participants with data collected | Posted | Mean | Standard Deviation | Z-score | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
|
| Secondary | 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. | Adult participants with data collected | Posted | Mean | Standard Deviation | Score on a scale | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
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|
|
| Secondary | 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. | Youth participants with data collected | Posted | Mean | Standard Deviation | Score on a scale | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 |
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| Other Pre-specified | Change in Physical Activity - Adult Participants | Number of days of physical activity per week | Adult participants with data collected | Posted | Mean | Standard Deviation | Days per week | Day 0, Month 6, Month 12, and Month 24 |
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| Other Pre-specified | Change in Physical Activity - Youth Participants | Number of days of physical activity per week | Youth participants with data collected | Posted | Mean | Standard Deviation | Days per week | Day 0, Month 6, Month 12, and Month 24 |
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| Other Pre-specified | Change in Communal Mastery - Adult Participants | Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome. | Adult participants with data collected | Posted | Mean | Standard Deviation | Score on a scale | Day 0, Month 6, Month 12, and Month 24 |
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| Other Pre-specified | Change in Communal Mastery - Youth Participants | Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome. | Youth participants with data collected | Posted | Mean | Standard Deviation | Score on a scale | Day 0, Month 6, Month 12, and Month 24 |
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| Other Pre-specified | Change in Diabetes Empowerment - Adult Participants | Diabetes Empowerment Scale. Scoring ranges from 0 to 24. Higher score equates to better outcome. | Adult participants with data collected | Posted | Mean | Standard Deviation | Score on a scale | Day 0, Month 6, Month 12, and Month 24 |
|
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|
|
| 1 |
| 41 |
| 1 |
| 41 |
| 0 |
| 41 |
| EG001 | Together Overcoming Diabetes (TOD) Curriculum - YOUTH | A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth). 41 youth were 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. | 0 | 41 | 0 | 41 | 0 | 41 |
| EG002 | Waitlist Control - ADULTS | A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth). 40 adults were 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. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG003 | Waitlist Control - YOUTH | A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth). 40 youth were 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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| Different identity |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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