By InvitationNot Applicable

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

United States1,160 participantsStarted 2024-09-18

Plain-language 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.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

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)

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)

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)

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)

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)

Trial details

NCT IDNCT06020027

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-30

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