xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06020027</url>
    </required_header>
    <id_info>
      <org_study_id>2023P002075</org_study_id>
      <nct_id>NCT06020027</nct_id>
    </id_info>
    <brief_title>Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families</brief_title>
    <official_title>Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California Nutrition Policy Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Harvard Medical School (HMS and HSDM)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Brigham and Women's Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to understand if a cultural intervention for Navajo&#xD;
        families will improve healthy beverage habits, health outcomes, and family cohesion. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          -  Does Water is K'é results in healthier beverage habits among children aged 2 to 5,&#xD;
             compared with children in a control group?&#xD;
  &#xD;
          -  Does the intervention improve the health of other family members?&#xD;
  &#xD;
          -  How does the intervention affect family well-being?&#xD;
  &#xD;
        Participants will take part in a four-month program at the early child education site (such&#xD;
        as a Head Start or the Bureau of Indian Affair's Family and Child Education or FACE Program)&#xD;
        where the child is enrolled. They will take part in lesson plans, a social media campaign,&#xD;
        and a family water access plan. Researchers will compare the participating families with&#xD;
        families at wait-list early child educations sites. We will collect information through&#xD;
        surveys, health measurements, and qualitative interviews and compare results to learn if&#xD;
        Water is K'e improves health behaviors, health outcomes, and family cohesion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Water is K'é is a culturally-grounded, family-based intervention designed to promote healthy&#xD;
        beverage consumption among Navajo families. Delivered by early child education (ECE) staff,&#xD;
        Water is K'é includes three strategies: promoting Diné (Navajo) culture through&#xD;
        intergenerational sharing, increasing health literacy about water and sugar-sweetened&#xD;
        beverages (SSBs), and increasing drinking water access in both home and ECE settings.&#xD;
        Activities consist of a lesson plan for children and caregivers, a tailored access plan to&#xD;
        promote confidence in water quality at home and ECE sites; and a social media campaign. Water&#xD;
        is K'é is guided by the conceptual framework of the Navajo Wellness Model, addressing four&#xD;
        aspects: spiritual; sustenance; family and kinship (K'é); and the environment. The&#xD;
        intervention's goal is to promote healthy behaviors and intergenerational sharing of cultural&#xD;
        teachings about water, resulting in better health among family members and greater family&#xD;
        cohesion overall.&#xD;
  &#xD;
        This prospective cluster-randomized trial evaluates the impact of Water is K'é on healthy&#xD;
        beverage consumption, health outcomes, and family cohesion. A total of 25 ECE sites will be&#xD;
        enrolled in the study, serving in the waitlist group for one year, and then the intervention&#xD;
        group the following year based on random assignment. Stepwise roll-out will ensure adequate&#xD;
        bandwidth to support intervention sites, while also gathering control data from waitlist&#xD;
        sites. Primary caregivers will consent for themselves and the child who is enrolled in the&#xD;
        ECE program; other family members will be invited to enroll in the study as well. Each site&#xD;
        will enroll approximately 11 families per year, resulting in a total enrollment of 440&#xD;
        families (220 in the intervention group, 220 in the control group) and follow them for 12&#xD;
        months to evaluate the impact on behaviors (beverage consumption patterns) and health&#xD;
        outcomes (body mass index, A1c among adults living with diabetes or pre-diabetes) of children&#xD;
        and adults. In addition, convergent parallel mixed methods will be used to explore whether&#xD;
        Water is K'é results in greater family cohesion through intergenerational cultural&#xD;
        continuity. Specific aims are:&#xD;
  &#xD;
          1. Evaluate the impact of Water is K'é on children aged 2 to 5. Hypothesis: participating&#xD;
             children will have healthier beverage habits and body mass indices compared with&#xD;
             children in the control group.&#xD;
  &#xD;
          2. Evaluate intervention impact on the health of other family members. Hypothesis:&#xD;
             participating individuals will have healthier beverage habits and body mass indices&#xD;
             compared with the control group.&#xD;
  &#xD;
          3. Evaluate the intervention's impact on family well-being. Hypothesis: participating&#xD;
             families will have stronger family cohesion through strengthening of intergenerational&#xD;
             cultural continuity compared with families in the control group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Average daily intake of water (fluid ounces) among ECE children</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Study arm differences based on Beverage Intake Questionnaire Preschool (BEVQ-PS) measurements in frequency and amount across beverage categories, validated in children under 6</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average daily intake of SSB (fluid ounces) among ECE children</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Study arm differences per BEVQ-PS measurements frequency and amount by beverage type, validated in children under 6</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average daily energy intake from SSB (in calories) among ECE children</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average daily intake of water (fluid ounces) among family members</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Study arm differences per Beverage Intake Questionnaire (BEVQ-15); measures frequency and amount across beverage categories, validated for children 6 and older</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average daily intake of SSB (fluid ounces) among family members</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Study arm differences per BEVQ-PS; measures frequency and amount by beverage type</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Average daily energy intake from SSB (in calories) among family members</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Family cohesion score</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age-adjusted body mass index z-score among ECE children</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Height and weight collected using the National Health and Nutrition Examination Survey (NHANES) protocol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study arm differences in average World Health Organization-5 (WHO-5) score among family members</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>WHO-5: 5-item questionnaire to measure well-being; range 0 to 2t with higher score reflecting greater wellbeing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived access to drinking water</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Question (Likert score 1-5) on perceived access to reliable drinking water; range 0-5 with higher score reflecting greater access.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived confidence in drinking water</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Question (Likert score 1-5) on confidence in drinking water' range 0-5 with higher score reflecting greater confidence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge of traditional teachings related to water</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Question (Likert score 1-5) on knowledge of Navajo culture related to water; range 0-5 with higher score reflecting greater knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Influence of traditional teaching on beverage choices</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Exploratory: Study arm differences in change in glycosylated hemoglobin A1c among individuals living with diabetes or pre-diabetes</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Average value of two A1c measures taken at each time point</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory: Study arm differences in average age-adjusted body mass index z-score among family members</measure>
      <time_frame>Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)</time_frame>
      <description>Height and weight collected using NHANES protocol</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1160</enrollment>
    <condition>Water</condition>
    <condition>Child Nutrition</condition>
    <condition>Family Dynamics</condition>
    <condition>Healthy Nutrition</condition>
    <condition>Healthy Lifestyle</condition>
    <condition>Health-Related Behavior</condition>
    <condition>Obesity Prevention</condition>
    <arm_group>
      <arm_group_label>Intervention Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants attending an ECE site randomly assigned to &quot;waitlist&quot; will receive usual programs and services at the site.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Water is K'é</intervention_name>
      <description>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.</description>
      <arm_group_label>Intervention Arm</arm_group_label>
      <other_name>Water is K'e</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least one of the following: child enrolled in participating early child education&#xD;
               (ECE) program between 2 and 5 years of age; primary caregiver of that child (i.e.&#xD;
               identifies as the person who assumes primary caregiver responsibilities of and resides&#xD;
               in the same household as the child; or family member aged six or older identified by&#xD;
               primary caregiver as an individual in the immediate family who either resides in the&#xD;
               same household or visits frequently and day to day interactions with child);&#xD;
  &#xD;
            -  Plans to reside in the same household for the next 12 months&#xD;
  &#xD;
            -  If enrolled in ECE program, plans to participate in ECE program for the entire school&#xD;
               year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Plans to leave their residence in the next 12 months&#xD;
  &#xD;
            -  If enrolled in ECE program, does not plan to participate in ECE program for the entire&#xD;
               school year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sonya Shin, MD</last_name>
      <phone>617-872-0310</phone>
      <email>sshin@mgb.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carmen George, MS</last_name>
      <phone>505-860-7861</phone>
      <email>cvgeorge@mgb.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Navajo Nation Head Start</name>
        <address>
          <city>Window Rock</city>
          <state>Arizona</state>
          <zip>86515</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rolanda Billy</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
      <investigator_full_name>Sonya Sunhi Shin</investigator_full_name>
      <investigator_title>Associate Physician</investigator_title>
    </responsible_party>
    <keyword>community</keyword>
    <keyword>Navajo</keyword>
    <keyword>indigenous</keyword>
    <keyword>early child health</keyword>
    <keyword>cultural intervention</keyword>
    <keyword>family-based intervention</keyword>
    <keyword>beverage consumption</keyword>
    <keyword>sugar-sweetened beverages</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>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</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06020027
  org study id: 2023P002075
  nct id: NCT06020027
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Prevention
  masking: None (Open Label)
  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)
  description: Study arm differences based on Beverage Intake Questionnaire Preschool (BEVQ-PS) measurements in frequency and amount across beverage categories, validated in children under 6
  measure: 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)
  description: Study arm differences per BEVQ-PS measurements frequency and amount by beverage type, validated in children under 6
  measure: 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)
  description: Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6
  measure: 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)
  description: Study arm differences per Beverage Intake Questionnaire (BEVQ-15); measures frequency and amount across beverage categories, validated for children 6 and older
  measure: 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)
  description: Study arm differences per BEVQ-PS; measures frequency and amount by beverage type
  measure: 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)
  description: Study arm differences per BEVQ-PS; measures frequency and amount by beverage type, validated in children under 6
  measure: Family cohesion score
  time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
  description: 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.
  measure: 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)
  description: Height and weight collected using the National Health and Nutrition Examination Survey (NHANES) protocol
  measure: 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)
  description: WHO-5: 5-item questionnaire to measure well-being; range 0 to 2t with higher score reflecting greater wellbeing
  measure: Perceived access to drinking water
  time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
  description: Question (Likert score 1-5) on perceived access to reliable drinking water; range 0-5 with higher score reflecting greater access.
  measure: Perceived confidence in drinking water
  time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
  description: Question (Likert score 1-5) on confidence in drinking water' range 0-5 with higher score reflecting greater confidence.
  measure: Knowledge of traditional teachings related to water
  time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
  description: Question (Likert score 1-5) on knowledge of Navajo culture related to water; range 0-5 with higher score reflecting greater knowledge.
  measure: Influence of traditional teaching on beverage choices
  time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
  description: 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.
  measure: Exploratory: Study arm differences in change in glycosylated hemoglobin A1c among individuals living with diabetes or pre-diabetes
  time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
  description: Average value of two A1c measures taken at each time point
  measure: Exploratory: Study arm differences in average age-adjusted body mass index z-score among family members
  time frame: Post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)
  description: Height and weight collected using NHANES protocol
  arm group label: Intervention Arm
  arm group type: Experimental
  description: 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.
  arm group label: Control Arm
  arm group type: No Intervention
  description: Participants attending an ECE site randomly assigned to "waitlist" will receive usual programs and services at the site.
  intervention type: Behavioral
  intervention name: Water is K'é
  description: 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.
  arm group label: Intervention Arm
  other name: Water is K'e
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sonya Shin, MD
  phone: 617-872-0310
  email: sshin@mgb.org
  last name: Carmen George, MS
  phone: 505-860-7861
  email: cvgeorge@mgb.org
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Sonya Sunhi Shin
  investigator title: Associate Physician
  sharing ipd: No
  ipd description: 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