Johns Hopkins University Great Lakes Hub
Duluth, Minnesota, 55812, United States
NCT Number: NCT04734015
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.
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Notify Me10 year and older
All sexes
Interventional
Not applicable
Duluth, Minnesota, 55812, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ADULT (target participants)
YOUTH
Exclusion criteria
ADULTS (target participants)
YOUTH
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: Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)
Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in Adult Participant Fasting HbA1c
Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
BMI change as indication of weight loss
Time frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
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.
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 27. Higher total score equates to worse outcome.
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 27. Higher total score equates to worse outcome.
Time frame: Day 0, Month 6, Month 12, and Month 24
Number of days of physical activity per week
Time frame: Day 0, Month 6, Month 12, and Month 24
Number of days of physical activity per week
Time frame: Day 0, Month 6, Month 12, and Month 24
Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome.
Time frame: Day 0, Month 6, Month 12, and Month 24
Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome.
Time frame: Day 0, Month 6, Month 12, and Month 24
Diabetes Empowerment Scale. Scoring ranges from 0 to 24. Higher score equates to better outcome.
Johns Hopkins Bloomberg School of Public Health
Other
Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
Acronym: TOD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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