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

1160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the Water is K'é intervention generally safe for humans?

The Water is K'é program, aimed at promoting water consumption, was well-received and considered acceptable by participants in a pilot program, suggesting it is safe. However, excessive water intake can lead to hyponatremia (low sodium levels in the blood), which is dangerous, so it's important to consume water in moderation. ^{1 2 3 4 5}

How does the Water is K'é treatment differ from other treatments for promoting a healthy lifestyle?

The Water is K'é treatment is unique because it focuses on increasing water consumption and reducing sugar-sweetened beverage intake through a culturally centered curriculum, specifically designed for young children and caregivers in the Navajo Nation. This approach is distinct from other treatments as it integrates cultural elements to promote healthy behavior changes, which can have a broader impact on the community. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Water is K'é for a healthy lifestyle?

The research highlights the effectiveness of lifestyle interventions, such as exercise and behavioral plans, in improving health outcomes like body weight and psychological well-being. Programs that focus on lifestyle changes, similar to Water is K'é, have shown success in promoting healthy habits and maintaining improvements over time. ^{9 10 11 12 13}

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

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Obesity in the kaiser permanente patient population and positive outcomes of online weight-management programs. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An interactive diary for diet management (DAI): a new telemedicine system able to promote body weight reduction, nutritional education, and consumption of fresh local produce. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Use of the Health Improvement Card by Chinese physical therapy students: A pilot study. [2020]

4. England 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. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effective diet and exercise treatments for overweight and recommendations for intervention. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Teacher and Caregiver Perspectives on Water Is K'é: An Early Child Education Program to Promote Healthy Beverages among Navajo Children. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Long-term process evaluation of a school-based programme for overweight prevention. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Hydration, morbidity, and mortality in vulnerable populations. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Death from hyponatremia as a result of acute water intoxication in an Army basic trainee. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Water, hydration, and health. [2022]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Factors associated with low water intake among South Korean adolescents - Korea National Health and Nutrition Examination Survey, 2007-2010. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Changes in water and sugar-containing beverage consumption and body weight outcomes in children. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Association between water consumption and body weight outcomes: a systematic review. [2023]