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

NCT06020027 | Enrolling By Invitation

• 1 other identifier: 2023P002075
• Study Type: interventional
• Target: 1,160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Water; Child Nutrition; Family Dynamics; Healthy Nutrition; Healthy Lifestyle; Health-Related Behavior; Obesity Prevention

Keywords

community; Navajo; indigenous; early child health; cultural intervention; family-based intervention; beverage consumption; sugar-sweetened beverages

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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.

  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

  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

  Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

• Perceived access to drinking water

  Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

• Perceived confidence in drinking water

  Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

• Knowledge of traditional teachings related to water

  Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

Other Outcomes (2)

• Exploratory: Study arm differences in change in glycosylated hemoglobin A1c among individuals living with diabetes or pre-diabetes

  Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

• Exploratory: Study arm differences in average age-adjusted body mass index z-score among family members

  Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Water is K'e

Intervention Arm

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator
• University of California Nutrition Policy Institute: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Navajo Nation Head Start

Window Rock, Arizona, 86515, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: September 18, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)