Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
概览
- 阶段
- 不适用
- 干预措施
- Together Overcoming Diabetes (TOD)
- 疾病 / 适应症
- Type 2 Diabetes
- 发起方
- Johns Hopkins Bloomberg School of Public Health
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change in Adult Participant Fasting HbA1c
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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)
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Together Overcoming Diabetes (TOD)
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.
结局指标
主要结局
Change in Adult Participant Fasting HbA1c
时间窗: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Change in hemoglobin A1c
次要结局
- Change in Depression and Depressive symptoms - Adult and Youth participants(Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24)
- Change in BMI/zBMI - Adult and Youth participants(Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24)