Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families
Part of paid clinical trials in Window Rock, Arizona.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06020027
- Status
- Enrolling By Invitation
Conditions
- Child Nutrition
- Family Dynamics
- Health-Related Behavior
- Healthy Lifestyle
- Healthy Nutrition
- Obesity Prevention
- Water
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Water is K'é — BEHAVIORALFour-month multi-level, family-based intervention that is grounded in Navajo culture and promotes individual knowledge, motivation and skills; social norms; and environmental changes (access to drinking water). At minimum, the enrolled child and primary caregiver will attend monthly sessions, with an open invitation to other family members. Families will also receive social media posts and develop a family access plan by selecting strategies (if needed) to boost their confidence in their water sources at home. ECE sites will also develop a tailored access plan, selecting strategies to increase confidence in water offered at the ECE site, and implement their access plan with study team support.
Study Details
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.
Key Dates
- Start date
- Sep 18, 2024
- Status verified
- Mar 2025
- Primary completion
- Sep 30, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 1,160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Intervention ArmWater is K'é is a family-based intervention aimed at improving health and wellness of family members and of the family as a whole. The multi-level intervention targets change at environmental, community and family levels through three core activities: a lesson plan, social media campaign and water access plan. ECE staff will receive a brief training on the curriculum and its relation to the Navajo Wellness Model before delivering the lessons and posting messages. Four interactive lesson plans will be delivered by ECE staff. Caregiver and family sessions will be delivered at the Head Start / FACE facility or in the home, depending on staff preference.
- No Intervention: Control ArmParticipants attending an ECE site randomly assigned to "waitlist" will receive usual programs and services at the site.
Primary Outcome Measure
Average daily intake of water (fluid ounces) among ECE children [ Time Frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Navajo Nation Head Start | Window Rock | Arizona | 86515 | - |
Find similar trials in Window Rock, AZ
Related Studies
- Primary Prevention of Obesity in American Indian Youth in Rural Tribal SchoolsRecruiting · Northern Arizona University · Flagstaff, Arizona
- Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthNot Yet Recruiting · Yale University · New Haven, Connecticut
- Cognitive Remediation Intervention to Prepare for Transition of CarePHASE2 · Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
- Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older SubjectsPHASE2/PHASE3 · Recruiting · Cedars-Sinai Medical Center · Los Angeles, California