Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,160
- 试验地点
- 2
- 主要终点
- Average daily intake of SSB (fluid ounces) among ECE children
研究概览
简要总结
The goal of this clinical trial is to understand if a cultural intervention for Navajo families will improve healthy beverage habits, health outcomes, and family cohesion. The main questions it aims to answer are:
- Does Water is K'é results in healthier beverage habits among children aged 2 to 5, compared with children in a control group?
- Does the intervention improve the health of other family members?
- How does the intervention affect family well-being?
Participants will take part in a four-month program at the early child education site (such as a Head Start or the Bureau of Indian Affair's Family and Child Education or FACE Program) where the child is enrolled. They will take part in lesson plans, a social media campaign, and a family water access plan. Researchers will compare the participating families with families at wait-list early child educations sites. We will collect information through surveys, health measurements, and qualitative interviews and compare results to learn if Water is K'e improves health behaviors, health outcomes, and family cohesion.
详细描述
Water is K'é is a culturally-grounded, family-based intervention designed to promote healthy beverage consumption among Navajo families. Delivered by early child education (ECE) staff, Water is K'é includes three strategies: promoting Diné (Navajo) culture through intergenerational sharing, increasing health literacy about water and sugar-sweetened beverages (SSBs), and increasing drinking water access in both home and ECE settings. Activities consist of a lesson plan for children and caregivers, a tailored access plan to promote confidence in water quality at home and ECE sites; and a social media campaign. Water is K'é is guided by the conceptual framework of the Navajo Wellness Model, addressing four aspects: spiritual; sustenance; family and kinship (K'é); and the environment. The intervention's goal is to promote healthy behaviors and intergenerational sharing of cultural teachings about water, resulting in better health among family members and greater family cohesion overall.
This prospective cluster-randomized trial evaluates the impact of Water is K'é on healthy beverage consumption, health outcomes, and family cohesion. A total of 25 ECE sites will be enrolled in the study, serving in the waitlist group for one year, and then the intervention group the following year based on random assignment. Stepwise roll-out will ensure adequate bandwidth to support intervention sites, while also gathering control data from waitlist sites. Primary caregivers will consent for themselves and the child who is enrolled in the ECE program; other family members will be invited to enroll in the study as well. Each site will enroll approximately 11 families per year, resulting in a total enrollment of 440 families (220 in the intervention group, 220 in the control group) and follow them for 12 months to evaluate the impact on behaviors (beverage consumption patterns) and health outcomes (body mass index, A1c among adults living with diabetes or pre-diabetes) of children and adults. In addition, convergent parallel mixed methods will be used to explore whether Water is K'é results in greater family cohesion through intergenerational cultural continuity. Specific aims are:
- Evaluate the impact of Water is K'é on children aged 2 to 5. Hypothesis: participating children will have healthier beverage habits and body mass indices compared with children in the control group.
- Evaluate intervention impact on the health of other family members. Hypothesis: participating individuals will have healthier beverage habits and body mass indices compared with the control group.
- Evaluate the intervention's impact on family well-being. Hypothesis: participating families will have stronger family cohesion through strengthening of intergenerational cultural continuity compared with families in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one of the following: child enrolled in participating early child education (ECE) program between 2 and 5 years of age; primary caregiver of that child (i.e. identifies as the person who assumes primary caregiver responsibilities of and resides in the same household as the child; or family member aged six or older identified by primary caregiver as an individual in the immediate family who either resides in the same household or visits frequently and day to day interactions with child);
- •Plans to reside in the same household for the next 12 months
- •If enrolled in ECE program, plans to participate in ECE program for the entire school year
排除标准
- •Plans to leave their residence in the next 12 months
- •If enrolled in ECE program, does not plan to participate in ECE program for the entire school year
结局指标
主要结局
Average daily intake of SSB (fluid ounces) among ECE children
时间窗: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences per BEVQ-PS measurements frequency and amount by beverage type, validated in children under 6
Average daily intake of SSB (fluid ounces) among family members
时间窗: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences per BEVQ-PS; measures frequency and amount by beverage type
Average daily energy intake from SSB (in calories) among family members
时间窗: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6
Average daily intake of water (fluid ounces) among ECE children
时间窗: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences based on Beverage Intake Questionnaire Preschool (BEVQ-PS) measurements in frequency and amount across beverage categories, validated in children under 6
Average daily energy intake from SSB (in calories) among ECE children
时间窗: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6
Average daily intake of water (fluid ounces) among family members
时间窗: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences per Beverage Intake Questionnaire (BEVQ-15); measures frequency and amount across beverage categories, validated for children 6 and older
Family cohesion score
时间窗: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences based on 10-question instrument adapted from Family Adaptability and Cohesion Scale, Short Form (FACES-SF) subscale to measure family cohesion; completed by all family members over 12. For each family, scores from all family members will be averaged to derive a single score per family.
次要结局
- Age-adjusted body mass index z-score among ECE children(Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline))
- Study arm differences in average World Health Organization-5 (WHO-5) score among family members(Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline))
- Perceived confidence in drinking water(Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline))
- Perceived access to drinking water(Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline))
- Knowledge of traditional teachings related to water(Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline))
- Influence of traditional teaching on beverage choices(Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline))
研究者
Sonya Sunhi Shin
Associate Physician
Brigham and Women's Hospital