- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06549868
Using Yoga to Reduce Chaos and Improve Preschooler Sleep
The goal of this intervention study is to learn if a yoga-based bedtime routine is feasible for families to follow and to learn if the routine is effective at improving preschooler sleep. The main question it aims to answer is:
Will families be able to follow the routine regularly during the study period? Will following the yoga routine improve household chaos and preschooler sleep? Researchers will compare the yoga group to a control group to see if implementing the yoga routine works better than simple advice to read a bedtime story.
Participants will be asked to visit the lab 4 times. At the first visit, we will measure body size of parents and children, ask parents to complete some surveys, and fit each of them with an activity monitor. One week later, they will return for the second visit. At this visit, we will collect the activity monitor and assign the participants to either the intervention (yoga) or control (bedtime story) group. Families in the intervention group will learn about the intervention and be asked to follow it for the next four weeks. Families in the control group will receive a book and advice about reading stories at bedtime. After four weeks, families will return to the lab for a third visit and we will repeat the measurements from visit 1. Then, families in the intervention group will be asked to follow the yoga routine as much as they would like to for the next 4 weeks. Families in the control group will "cross over" to the intervention group and will follow the yoga intervention for 4 weeks. Then, families will return to the lab for a 4th visit, where we will repeat all of the measures from the first visit and the study will be complete.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Ohio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children between 2.0-5.9 years of age and their self-identified primary parent/guardian
Exclusion Criteria:
- Parent currently pregnant Child or parent unable to walk independently Child or parent has an upper body mobility limitation that precludes completion of yoga routine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga
Participants will be asked to follow a yoga-based bedtime routine for 4 weeks
|
Dyads in the yoga intervention group receive a picture book outlining a bedtime-themed yoga routine and are instructed to incorporate it into their bedtime routine at least four nights per week for four weeks. The routine guides children through a sequence of yoga poses, starting with the mountain pose and ending in child's pose, designed to calm them as the story progresses. Parents are given a bedtime diary to record the date, whether the child completed the yoga routine each evening, and any comments about their experience with the book. At week 6, families return to the lab, complete anthropometric assessments and questionnaires, and are fitted with accelerometers to wear for the next week. The accelerometers are returned and data is downloaded a week later. Families are then encouraged to continue using the yoga routine as often as they wish for an additional four weeks, although the frequency of use is not tracked during this maintenance period. |
|
Other: Story
Waitlist control arm.
Participants will complete a 4-week control period upon randomization.
After this control period is completed, they will crossover into the intervention group and follow the same 4 week intervention as the yoga group.
|
Dyads in the yoga intervention group receive a picture book outlining a bedtime-themed yoga routine and are instructed to incorporate it into their bedtime routine at least four nights per week for four weeks. The routine guides children through a sequence of yoga poses, starting with the mountain pose and ending in child's pose, designed to calm them as the story progresses. Parents are given a bedtime diary to record the date, whether the child completed the yoga routine each evening, and any comments about their experience with the book. At week 6, families return to the lab, complete anthropometric assessments and questionnaires, and are fitted with accelerometers to wear for the next week. The accelerometers are returned and data is downloaded a week later. Families are then encouraged to continue using the yoga routine as often as they wish for an additional four weeks, although the frequency of use is not tracked during this maintenance period. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention adherence
Time Frame: 4 weeks
|
Number of yoga sessions completed Percent of prescribed sessions completed
|
4 weeks
|
|
Household chaos
Time Frame: at week 1, week 5, and week 10
|
Measured using Chaos, Hubbub, and Order Scale (CHAOS) at enrollment, crossover point, and study completion.
A lower CHAOS score post-intervention would indicate an improvement in household chaos.
|
at week 1, week 5, and week 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child sleep duration
Time Frame: at week 1, week 5, and week 10
|
nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion
|
at week 1, week 5, and week 10
|
|
Parent sleep duration
Time Frame: 1 week at week 1, week 5, and week 10
|
nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion
|
1 week at week 1, week 5, and week 10
|
|
Parent sleep quality
Time Frame: 1 week at week 1, week 5, and week 10
|
nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion
|
1 week at week 1, week 5, and week 10
|
|
Child sleep quality
Time Frame: 1 week at week 1, week 5, and week 10
|
nightly sleep measured by waist-worn accelerometer
|
1 week at week 1, week 5, and week 10
|
|
Child sleep quality
Time Frame: 1 week at week 1, week 5, and week 10
|
measured by Children's Sleep Habits Questionnaire (CSHQ; scored using mean and standard deviation of survey items.
A higher CSHQ mean score indicates worse sleep quality)
|
1 week at week 1, week 5, and week 10
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-X-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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