WaterNCT06020027
Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families
A study testing Water is K'é in people with Water and Child Nutrition, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Water, Child Nutrition, Family Dynamics
- What is being tested?
- Water is K'é
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Navajo Nation Head Start
Window Rock, Arizona, 86515
About this study
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.
Read the detailed description
Water is K'é is a culturally-grounded, family-based intervention designed to promote healthy beverage consumption among Navajo families. Delivered by early child education (ECE) staff, Water is K'é includes three strategies: promoting Diné (Navajo) culture through intergenerational sharing, increasing health literacy about water and sugar-sweetened beverages (SSBs), and increasing drinking water access in both home and ECE settings. Activities consist of a lesson plan for children and caregivers, a tailored access plan to promote confidence in water quality at home and ECE sites; and a social media campaign. Water is K'é is guided by the conceptual framework of the Navajo Wellness Model, addressing four aspects: spiritual; sustenance; family and kinship (K'é); and the environment. The intervention's goal is to promote healthy behaviors and intergenerational sharing of cultural teachings about water, resulting in better health among family members and greater family cohesion overall.
This prospective cluster-randomized trial evaluates the impact of Water is K'é on healthy beverage consumption, health outcomes, and family cohesion. A total of 25 ECE sites will be enrolled in the study, serving in the waitlist group for one year, and then the intervention group the following year based on random assignment. Stepwise roll-out will ensure adequate bandwidth to support intervention sites, while also gathering control data from waitlist sites. Primary caregivers will consent for themselves and the child who is enrolled in the ECE program; other family members will be invited to enroll in the study as well. Each site will enroll approximately 11 families per year, resulting in a total enrollment of 440 families (220 in the intervention group, 220 in the control group) and follow them for 12 months to evaluate the impact on behaviors (beverage consumption patterns) and health outcomes (body mass index, A1c among adults living with diabetes or pre-diabetes) of children and adults. In addition, convergent parallel mixed methods will be used to explore whether Water is K'é results in greater family cohesion through intergenerational cultural continuity. Specific aims are:
- Evaluate the impact of Water is K'é on children aged 2 to 5. Hypothesis: participating children will have healthier beverage habits and body mass indices compared with children in the control group.
- Evaluate intervention impact on the health of other family members. Hypothesis: participating individuals will have healthier beverage habits and body mass indices compared with the control group.
- Evaluate the intervention's impact on family well-being. Hypothesis: participating families will have stronger family cohesion through strengthening of intergenerational cultural continuity compared with families in the control group.
- Conditions
- Water, Child Nutrition, Family Dynamics, Healthy Nutrition, Healthy Lifestyle, Health-Related Behavior
- Being tested
- Water is K'é
- Keywords
- community, Navajo, indigenous, early child health, cultural intervention, family-based intervention, beverage consumption, sugar-sweetened beverages
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water is K'éBehavioural
Also called Water is K'e
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Water is K'é |
| Control Arm | No intervention | Participants attending an ECE site randomly assigned to "waitlist" will receive usual programs and services at the site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily intake of water (fluid ounces) among ECE children
Study arm differences based on Beverage Intake Questionnaire Preschool (BEVQ-PS) measurements in frequency and amount across beverage categories, validated in children under 6
Measured: 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
Study arm differences per BEVQ-PS measurements frequency and amount by beverage type, validated in children under 6
Measured: 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
Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6
Measured: 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
Study arm differences per Beverage Intake Questionnaire (BEVQ-15); measures frequency and amount across beverage categories, validated for children 6 and older
Measured: 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
Study arm differences per BEVQ-PS; measures frequency and amount by beverage type
Measured: 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
Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Family cohesion score
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.
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Secondary outcomes (6)
Age-adjusted body mass index z-score among ECE children
Height and weight collected using the National Health and Nutrition Examination Survey (NHANES) protocol
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences in average World Health Organization-5 (WHO-5) score among family members
WHO-5: 5-item questionnaire to measure well-being; range 0 to 2t with higher score reflecting greater wellbeing
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Perceived access to drinking water
Question (Likert score 1-5) on perceived access to reliable drinking water; range 0-5 with higher score reflecting greater access.
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Perceived confidence in drinking water
Question (Likert score 1-5) on confidence in drinking water' range 0-5 with higher score reflecting greater confidence.
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Knowledge of traditional teachings related to water
Question (Likert score 1-5) on knowledge of Navajo culture related to water; range 0-5 with higher score reflecting greater knowledge.
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Influence of traditional teaching on beverage choices
Question (Likert score 1-5) on influence of Navajo culture on what drinks offered to child; range 0-5 with higher score reflecting greater influence.
Measured: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start18 Sep 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WaterStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Water is K'é is an early child education (ECE) intervention designed to promote family-centered choice using a strength-based approach. Water is K'é promotes multilevel change through strengthened cultural connections, enhanced health literacy, and increased access to drinking water, with the goal of promoting family cohesion and improving health outcomes among family members.
- Masking
- None (open label)
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of California Nutrition Policy Institute, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Sonya Sunhi Shin, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020027
- Sponsor's protocol ID
- 2023P002075
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Per stipulations of the Navajo Research Code, all data belongs to Navajo Nation; researchers would need to direct any request for study data, including IPD, to the Navajo Nation Human Research Review Board
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families
- ClinicalTrials.gov ID
- NCT06020027
- Acronym / sponsor ID
- 2023P002075
- Conditions
- Water, Child Nutrition, Family Dynamics, Healthy Nutrition, Healthy Lifestyle, Health-Related Behavior
- Keywords
- community, Navajo, indigenous, early child health, cultural intervention, family-based intervention, beverage consumption, sugar-sweetened beverages
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of California Nutrition Policy Institute, Harvard Medical School (HMS and HSDM)
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Water is K'é is a culturally-grounded, family-based intervention designed to promote healthy beverage consumption among Navajo families. Delivered by early child education (ECE) staff, Water is K'é includes three strategies: promoting Diné (Navajo) culture through intergenerational sharing, increasing health literacy about water and sugar-sweetened beverages (SSBs), and increasing drinking water access in both home and ECE settings. Activities consist of a lesson plan for children and caregivers, a tailored access plan to promote confidence in water quality at home and ECE sites; and a social media campaign. Water is K'é is guided by the conceptual framework of the Navajo Wellness Model, addressing four aspects: spiritual; sustenance; family and kinship (K'é); and the environment. The intervention's goal is to promote healthy behaviors and intergenerational sharing of cultural teachings about water, resulting in better health among family members and greater family cohesion overall.
This prospective cluster-randomized trial evaluates the impact of Water is K'é on healthy beverage consumption, health outcomes, and family cohesion. A total of 25 ECE sites will be enrolled in the study, serving in the waitlist group for one year, and then the intervention group the following year based on random assignment. Stepwise roll-out will ensure adequate bandwidth to support intervention sites, while also gathering control data from waitlist sites. Primary caregivers will consent for themselves and the child who is enrolled in the ECE program; other family members will be invited to enroll in the study as well. Each site will enroll approximately 11 families per year, resulting in a total enrollment of 440 families (220 in the intervention group, 220 in the control group) and follow them for 12 months to evaluate the impact on behaviors (beverage consumption patterns) and health outcomes (body mass index, A1c among adults living with diabetes or pre-diabetes) of children and adults. In addition, convergent parallel mixed methods will be used to explore whether Water is K'é results in greater family cohesion through intergenerational cultural continuity. Specific aims are:
- Evaluate the impact of Water is K'é on children aged 2 to 5. Hypothesis: participating children will have healthier beverage habits and body mass indices compared with children in the control group.
- Evaluate intervention impact on the health of other family members. Hypothesis: participating individuals will have healthier beverage habits and body mass indices compared with the control group.
- Evaluate the intervention's impact on family well-being. Hypothesis: participating families will have stronger family cohesion through strengthening of intergenerational cultural continuity compared with families in the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Water is K'é is an early child education (ECE) intervention designed to promote family-centered choice using a strength-based approach. Water is K'é promotes multilevel change through strengthened cultural connections, enhanced health literacy, and increased access to drinking water, with the goal of promoting family cohesion and improving health outcomes among family members.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Water is K'éWater 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. |
| Control Arm | No intervention | –Participants attending an ECE site randomly assigned to "waitlist" will receive usual programs and services at the site. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water is K'éAlso: Water is K'eFour-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. | Behavioural | Intervention Arm |
Primary outcome
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)
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 children
Time frame: Post 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 children
Time frame: Post 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 members
Time frame: Post 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 members
Time frame: Post 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 members
Time frame: Post 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 score
Time frame: Post 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.
6 secondary outcomes
Age-adjusted body mass index z-score among ECE children
Time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Study arm differences in average World Health Organization-5 (WHO-5) score among family members
Time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Perceived access to drinking water
Time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Perceived confidence in drinking water
Time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Knowledge of traditional teachings related to water
Time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Influence of traditional teaching on beverage choices
Time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No. Per stipulations of the Navajo Research Code, all data belongs to Navajo Nation; researchers would need to direct any request for study data, including IPD, to the Navajo Nation Human Research Review Board
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water is K'é in people with Water and Child Nutrition, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.