Together Overcoming Diabetes (TOD)
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|ClinicalTrials.gov Identifier: NCT04734015|
Recruitment Status : Not yet recruiting
First Posted : February 2, 2021
Last Update Posted : February 5, 2021
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. A total of 280 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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Together Overcoming Diabetes (TOD)||Not Applicable|
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 (N = 280 family dyads) 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Randomized Waitlist Control Design. N = 280 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:||Single (Outcomes Assessor)|
|Masking Description:||An Independent Evaluation team will conduct assessments and be blinded to participant randomization status.|
|Primary Purpose:||Health Services Research|
|Official Title:||Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities|
|Estimated Study Start Date :||May 1, 2021|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: Together Overcoming Diabetes (TOD) curriculum
A randomized waitlist control trial (RCT) design will be employed with 140 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)
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 Name: Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)
No Intervention: Waitlist Control
A randomized waitlist control trial (RCT) design will be employed with 140 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734015
|Contact: Angie Forsbergfirstname.lastname@example.org|
|Principal Investigator:||Melissa Walls, PhD||Johns Hopkins University, Bloomberg School of Public Health|