Clinical trial NCT06020027: Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families
Official title: Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Water
Child Nutrition
Family Dynamics
Healthy Nutrition
Healthy Lifestyle
Health-Related Behavior
Obesity Prevention
Keywords: community
Navajo
indigenous
early child health
cultural intervention
family-based intervention
beverage consumption
sugar-sweetened beverages
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of California Nutrition Policy Institute
name: Harvard Medical School (HMS and HSDM)
First posted: 2023-08-31
Enrollment: 1160
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Water is K'é is an early child education (ECE) intervention designed to promote family-centered choice using a strength-based approach. Water is K'é promotes multilevel change through strengthened cultural connections, enhanced health literacy, and increased access to drinking water, with the goal of promoting family cohesion and improving health outcomes among family members.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Average daily intake of water (fluid ounces) among ECE children
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Average daily intake of SSB (fluid ounces) among ECE children
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Average daily energy intake from SSB (in calories) among ECE children
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Average daily intake of water (fluid ounces) among family members
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Average daily intake of SSB (fluid ounces) among family members
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Average daily energy intake from SSB (in calories) among family members
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Family cohesion score
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Secondary outcomes:
measure: Age-adjusted body mass index z-score among ECE children
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Study arm differences in average World Health Organization-5 (WHO-5) score among family members
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Perceived access to drinking water
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Perceived confidence in drinking water
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Knowledge of traditional teachings related to water
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Influence of traditional teaching on beverage choices
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Other outcomes:
measure: Exploratory: Study arm differences in change in glycosylated hemoglobin A1c among individuals living with diabetes or pre-diabetes
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
measure: Exploratory: Study arm differences in average age-adjusted body mass index z-score among family members
timeFrame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Locations:
city: Window Rock
country: United States
facility: Navajo Nation Head Start
state: Arizona
Study officials:
References: