- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734015
Together Overcoming Diabetes (TOD)
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angie Forsberg
- Phone Number: 218-724-1665
- Email: aforsbe2@jhu.edu
Study Locations
-
-
Minnesota
-
Duluth, Minnesota, United States, 55812
- Johns Hopkins University Great Lakes Hub
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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:
|
No Intervention: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Adult Participant Fasting HbA1c
Time Frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
|
Change in hemoglobin A1c
|
Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in BMI/zBMI - Adult and Youth participants
Time Frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
|
zBMI change as indication of weight loss
|
Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
|
Change in Depression and Depressive symptoms - Adult and 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 3. Higher total score equates to worse outcome.
|
Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Activity - Adult and Youth participants
Time Frame: Day 0, Month 6, Month 12, and Month 24
|
Survey questions will ask about physical activity duration, frequency, intensity.
Higher score equates to better outcome.
|
Day 0, Month 6, Month 12, and Month 24
|
Change in Communal Mastery - Adult and Youth participants
Time Frame: Day 0, Month 6, Month 12, and Month 24
|
Communal Mastery as a Coping Resource.
Scoring ranges from 0 to 3. Higher score equates to better outcome.
|
Day 0, Month 6, Month 12, and Month 24
|
Change in Diabetes Empowerment - Adult participants
Time Frame: Day 0, Month 6, Month 12, and Month 24
|
Diabetes Empowerment Scale (short form, Anderson, et al., 2003).
Scoring ranges from 0 to 3. Higher score equates to better outcome.
|
Day 0, Month 6, Month 12, and Month 24
|
Collaborators and Investigators
Investigators
- Principal Investigator: Melissa Walls, PhD, Johns Hopkins University, Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK091250
- 5R01DK091250-07 (U.S. NIH Grant/Contract)
- IRB00010045 (Other Identifier: JHSPH IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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