NCT06549868

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

July 24, 2024

Last Update Submit

August 8, 2024

Conditions

Keywords

sleepchildrenpreschoolyogaparentshousehold chaos

Outcome Measures

Primary Outcomes (2)

  • Intervention adherence

    Number of yoga sessions completed Percent of prescribed sessions completed

    4 weeks

  • Household chaos

    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 Outcomes (5)

  • Child sleep duration

    at week 1, week 5, and week 10

  • Parent sleep duration

    1 week at week 1, week 5, and week 10

  • Parent sleep quality

    1 week at week 1, week 5, and week 10

  • Child sleep quality

    1 week at week 1, week 5, and week 10

  • Child sleep quality

    1 week at week 1, week 5, and week 10

Study Arms (2)

Yoga

EXPERIMENTAL

Participants will be asked to follow a yoga-based bedtime routine for 4 weeks

Behavioral: Yoga-based bedtime routine

Story

OTHER

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.

Behavioral: Yoga-based bedtime routine

Interventions

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.

StoryYoga

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children between 2.0-5.9 years of age and their self-identified primary parent/guardian

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 12, 2024

Study Start

July 15, 2019

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations