Together Overcoming Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 10 years and 125 years
- Gender
- Both males and females
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 f...
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.
Tracking Information
- NCT #
- NCT04734015
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Principal Investigator: Melissa Walls, PhD Johns Hopkins University, Bloomberg School of Public Health
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