Water is K'é Intervention for Healthy Lifestyle

Overseen By Carmen George, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Relocation plans, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a cultural program for Navajo families, called Water is K'é, can encourage healthier drink choices, boost health, and strengthen family bonds. The program includes activities such as lesson plans, social media engagement, and a plan to improve water access. Families with children aged 2 to 5 enrolled in certain early childhood programs can participate. Participants will engage in a four-month program and be compared to families not yet enrolled to observe any health or lifestyle changes. As an unphased trial, this study offers families a unique opportunity to contribute to culturally relevant health research and potentially improve their well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on lifestyle changes rather than medication use.

What prior data suggests that the Water is K'é intervention is safe for families?

Research has shown that the Water is K'é program helps young children and their families develop healthier drinking habits by encouraging more water consumption and reducing sugary drinks. No reports of problems or safety issues have emerged with this program. It emphasizes teaching and community support, which are generally safe and manageable. As the program focuses on lifestyle and education rather than medicine or drugs, it is unlikely to pose any health risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The "Water is K'é" intervention is unique because it tackles health and wellness by focusing on family dynamics and community involvement, rather than just individual behavior change. Unlike traditional health approaches that might rely on medications or individual counseling, this method incorporates a lesson plan, social media engagement, and improved water access to foster healthier lifestyles at multiple levels. Researchers are excited because this holistic, culturally-tailored approach could lead to sustainable health improvements by empowering families and communities, potentially offering a new direction in preventive health strategies.

What evidence suggests that the Water is K'é intervention is effective for improving healthy beverage habits and family well-being?

Research has shown that the Water is K'é program aims to help Navajo families, especially young children, develop healthier drinking habits. In this trial, participants in the intervention arm will engage with the Water is K'é program, which uses lesson plans, social media, and a family water access plan to achieve its goals. Studies have found that this program can lead to increased water consumption and reduced intake of sugary drinks, which may help reduce diet-related health issues. Early results suggest that involving the whole family can improve health habits, health outcomes, and family unity. By focusing on cultural values and community involvement, Water is K'é appears promising in encouraging healthier lifestyles. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Navajo families with a child aged 2-5 enrolled in an early child education program. It's also open to primary caregivers and family members who interact daily with the child. Participants must plan to stay in their current household and participate in the ECE program for the full school year.

Inclusion Criteria

I plan to stay in the early childhood education program for the full school year.

I am involved with a child aged 2-5 in an early education program, either as their primary caregiver or a close family member.

You plan to remain in the same household for the ensuing year.

Exclusion Criteria

Plans to leave their residence in the next 12 months

I am not planning to stay in the early childhood education program for the full year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants take part in a four-month program at the early child education site, including lesson plans, a social media campaign, and a family water access plan.

16 weeks

Regular sessions at ECE sites

Follow-up

Participants are monitored for changes in beverage habits, health outcomes, and family cohesion.

8 months

Data collection at 4 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Water is K'é

Trial Overview 'Water is K'é' is a cultural intervention aiming to promote healthy beverage choices among Navajo families. Over four months, it involves lesson plans, social media campaigns, and water access planning at children's education sites, compared against families on a waitlist.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Water 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.

Group II: Control Arm Active Control 1 Intervention

Participants attending an ECE site randomly assigned to "waitlist" will receive usual programs and services at the site.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Harvard Medical School (HMS and HSDM)

Collaborator

Trials

208

Recruited

1,421,000+

University of California Nutrition Policy Institute

Collaborator

Trials

2

Recruited

1,400+

Published Research Related to This Trial

Water is essential for human health, and its intake is crucial for preventing nutrition-related diseases, especially as people increasingly consume caloric beverages instead of plain water.

There is a significant lack of comprehensive studies on total fluid intake and hydration status in populations, highlighting the need for more long-term research and controlled trials to better understand water requirements and their impact on health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water, hydration, and health. Popkin, BM., D'Anci, KE., Rosenberg, IH.[2022]

Participants in the Get Healthy Information and Coaching Service (GHS) maintained significant improvements in weight, waist circumference, and BMI six months after completing a 6-month coaching program, indicating the program's effectiveness in promoting long-term lifestyle changes.

While improvements in fruit and vegetable consumption were sustained, the increase in physical activity levels observed at the end of the program did not persist at the 12-month follow-up, suggesting a need for ongoing support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Australia's Get Healthy Information and Coaching Service: maintenance of self-reported anthropometric and behavioural changes after program completion. O'Hara, BJ., Phongsavan, P., Eakin, EG., et al.[2021]

Citations

1. healthyeatingresearch.org healthyeatingresearch.org/research/water-is-ke-a-community-based-intervention-to-increase-healthy-beverage-consumption-by-navajo-preschool-children/

Water is K'é: A Community-Based Intervention to Increase ... This research brief gives an overview of the Water is K'é intervention, conducted among Navajo Nation families.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39308387/

Water Is K'é: Learning from the Navajo Community to ... We worked with community partners to design a program to promote healthy beverage habits among young Navajo children.

3. healthyeatingresearch.org healthyeatingresearch.org/research/water-is-ke-learning-from-the-navajo-community-to-promote-early-child-health/

Water Is K'é: Learning from the Navajo Community to ... Drinking water instead of sugary drinks is key to reducing health disparities. Since beverage habits are shaped by complex personal, community, and ...

4. reporter.nih.gov reporter.nih.gov/search/HaCPQzHfG0OlA6_Uu-26GQ/project-details/11073110

Multi-level intervention to promote healthy beverage ... Using a mixed methods design, we will explore how intergenerational family dynamics influence the way in which Water is K'é shapes family health and wellbeing.

5. ucanr.edu ucanr.edu/sites/default/files/2023-02/379398.pdf

Water is K'é: A Community-Based Intervention to Increase ... to create a promising approach to improve drinking water consumption and to decrease consumption of sugary drinks. BACKGROUND. • Navajo Nation has ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10487536/

Teacher and Caregiver Perspectives on Water Is K'é The Water is K'é program was developed to increase water consumption and decrease consumption of sugar-sweetened beverages for young children ...

7. rwjf.org rwjf.org/en/insights/our-research/2024/01/water-is-ke-learning-from-the-navajo-community-to-promote-early-child-health.html

Water is K'e: Learning from the Navajo Community to ... This journal article describes a campaign to promote and increase access to safe drinking water on the Navajo Nation reservation, ...

8. ctv.veeva.com ctv.veeva.com/study/water-is-ke-multi-level-intervention-to-promote-healthy-beverage-choices-among-navajo-families

Water is K'é: Multi-level Intervention to Promote Healthy ... Water is K'é is a culturally-grounded, family-based intervention designed to promote healthy beverage consumption among Navajo families.

9. researchgate.net researchgate.net/publication/373626767_Teacher_and_Caregiver_Perspectives_on_Water_Is_K'e_An_Early_Child_Education_Program_to_Promote_Healthy_Beverages_among_Navajo_Children

(PDF) Teacher and Caregiver Perspectives on Water Is K'é The Water is K'é program was developed to increase water consumption and decrease consumption of sugar-sweetened beverages for young ...