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

Healthy Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06020027
• Other study ID #: 2023P002075
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: Sonya Shin, MD
• Phone: 617-872-0310
• Email: sshin[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1160
• Est. completion date: December 31, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition
• Family Dynamics
• Healthy Lifestyle
• Obesity Prevention
• Water

Intervention

Behavioral:
• Water is K'é
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.

Locations

Country	Name	City	State
United States	Navajo Nation Head Start	Window Rock	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Harvard Medical School (HMS and HSDM), National Institutes of Health (NIH), University of California Nutrition Policy Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Study arm differences in change in glycosylated hemoglobin A1c among individuals living with diabetes or pre-diabetes	Average value of two A1c measures taken at each time point	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Other	Exploratory: Study arm differences in average age-adjusted body mass index z-score among family members	Height and weight collected using NHANES protocol	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Age-adjusted body mass index z-score among ECE children	Height and weight collected using the National Health and Nutrition Examination Survey (NHANES) protocol	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Secondary	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	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Secondary	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.	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Secondary	Perceived confidence in drinking water	Question (Likert score 1-5) on confidence in drinking water' range 0-5 with higher score reflecting greater confidence.	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Secondary	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.	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
Secondary	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.	Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)