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Clinical trial

Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families

Invitation only · Not applicable · 1 countries · Registry ID NCT06020027

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age2 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionWater, Child Nutrition, Family Dynamics, Healthy Nutrition, Healthy Lifestyle, Health-Related Behavior, Obesity Prevention

Full registry 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

Treatments and study arms

Water is K'é

Behavioral

Four-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.

Primary outcomes

Average daily intake of water (fluid ounces) among ECE childrenPost 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 intake of SSB (fluid ounces) among ECE childrenPost 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 energy intake from SSB (in calories) among ECE childrenPost 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 membersPost 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

Average daily intake of SSB (fluid ounces) among family membersPost 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 membersPost 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

Family cohesion scorePost 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Navajo Nation Head Start🇺🇸 Window Rock, Arizona, United States
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