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Water is K'é Intervention for Healthy Lifestyle

N/A

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

Awards & highlights

Study Summary

This trial will study how a cultural intervention helps Navajo families improve their healthy beverage habits, health, and family cohesion.

Who is the study for?

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.Check my eligibility

What is being tested?

'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.See study design

What are the potential side effects?

Since this study focuses on educational interventions rather than medical treatments, there are no direct side effects like those associated with medications or clinical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post intervention (at 4 months) and 8 months after intervention (at 12 months from baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average daily energy intake from SSB (in calories) among ECE children

Average daily energy intake from SSB (in calories) among family members

Average daily intake of SSB (fluid ounces) among ECE children

+4 more

Secondary outcome measures

Age-adjusted body mass index z-score among ECE children

Influence of traditional teaching on beverage choices

Knowledge of traditional teachings related to water

+3 more

Other outcome measures

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

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 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 ArmActive Control1 Intervention

Participants attending an ECE site randomly assigned to "waitlist" will receive usual programs and services at the site.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,491,339 Total Patients Enrolled

Harvard Medical School (HMS and HSDM)OTHER

195 Previous Clinical Trials

1,314,885 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,614 Previous Clinical Trials

11,469,675 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment currently recruiting participants?

"Per clinicaltrials.gov, this medical trial has concluded its recruitment process - the first post being on August 1st 2024 and the last update occurring on August 30th 2023. However, there are still 70 other trials that actively require patients at present."

Answered by AI

What is the primary purpose of this research trial?

"This trial will assess the average daily intake of sugary beverages in Early Childhood Education (ECE) children over a period of four and 12 months from baseline. Secondary measurements include differences in World Health Organization-5 scores among family members, as well as perceived access to drinking water and confidence therein on a Likert scale ranging from one to five."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Sonya Sunhi Shin 2024. "Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06020027.