- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05853393
Tween Sleep Patterns, Appetite Control, and Environment (TweenSPACE)
November 4, 2024 updated by: Emily Hohman, Penn State University
Sleep and Eating Behaviors in Rural Preadolescent Children (Tween SPACE [Sleep Patterns, Appetite Control, and Environment])
The goal of this study is to learn about how children's sleep is related to their eating behaviors the next day, and to learn about factors that relate to eating behaviors and sleep health that are specific to preadolescent children living in rural communities.
Study Overview
Status
Completed
Conditions
Detailed Description
The aims of this study are to a) describe the prevalence and characteristics of eating in the absence of hunger (EAH) in rural preadolescent children using a novel methodology, ecological momentary assessment (EMA); b) to examine the within-person temporal relationship between daily changes in sleep health (i.e., duration and quality) and EAH; and c) examine associations between family, child, and environmental characteristics, sleep, and eating behaviors in rural preadolescent children.
Parent-child dyads will participate in the study via remote data collection methods including Zoom interviews, online surveys, EMA survey completed by smartphone, and actigraphy.
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Pennyslvania State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Children 8-12 years old and a parent/guardian (n=64 parent-child dyads for a total of 128 individuals)
Description
Child Inclusion Criteria:
- Age 8 to 12 years
- Primary residence is in a rural ZIP code in the United States, as defined by Health Resources & Services Administration
- BMI for age ≥ 85th percentile OR BMI ≥ 15th percentile plus at least one biological parent with BMI ≥ 25 kg/m2
- Able to read and answer questions in English
Parent Inclusion criteria:
- Parent or caregiver of an eligible child
- Age 18 years or older
- Able to read and answer questions in English
Exclusion Criteria:
- Any medical condition that significantly impacts eating, sleep, growth, or ability to operate the mEMA smartphone platform (e.g., eating disorder, Type I diabetes, blindness) (Child participants only)
- Unable to connect to a Zoom session via internet or cell-phone data from home
- Unable to receive and sign for package with study supplies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of eating in the absence of hunger (EAH) episodes
Time Frame: Multiple measurements per day for 2 weeks starting at enrollment through 2 weeks
|
Eating events where pre-meal hunger is less than 35 on a 100 point visual analogue scale, as reported on smartphone surveys that are completed multiple times a day over a 2 week period.
|
Multiple measurements per day for 2 weeks starting at enrollment through 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale rating of hunger
Time Frame: Multiple measurements per day for 2 weeks
|
Collected via EMA
|
Multiple measurements per day for 2 weeks
|
|
Visual analogue scale rating of fullness
Time Frame: Multiple measurements per day for 2 weeks
|
Collected via EMA
|
Multiple measurements per day for 2 weeks
|
|
Visual analogue scale rating of desire to eat
Time Frame: Multiple measurements per day for 2 weeks
|
Collected via EMA
|
Multiple measurements per day for 2 weeks
|
|
Child appetitive traits
Time Frame: At enrollment
|
Measured by parent report questionnaire (Child Eating Behavior Questionnaire)
|
At enrollment
|
|
Child mindful eating
Time Frame: At enrollment
|
Measured by child self report questionnaire (Mindful Eating Questionnaire)
|
At enrollment
|
|
Child eating motivations
Time Frame: At enrollment
|
Measured by child self report questionnaire (Palatable Eating Motives Questionnaire)
|
At enrollment
|
|
Child restrained and disinhibited eating
Time Frame: At enrollment
|
Measured by child self report questionnaire (Dutch Eating Behavior Questionnaire)
|
At enrollment
|
|
Sleep duration
Time Frame: Daily over 2 weeks
|
Measured by actigraphy
|
Daily over 2 weeks
|
|
Sleep maintenance efficiency
Time Frame: Daily over 2 weeks
|
Measured by actigraphy
|
Daily over 2 weeks
|
|
Body mass index z-score
Time Frame: At enrollment
|
Calculated from measured height and weight
|
At enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emily E Hohman, PhD, Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2023
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
July 30, 2024
Study Registration Dates
First Submitted
April 21, 2023
First Submitted That Met QC Criteria
May 9, 2023
First Posted (Actual)
May 10, 2023
Study Record Updates
Last Update Posted (Actual)
November 6, 2024
Last Update Submitted That Met QC Criteria
November 4, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00020663
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
De-identified participant data may be made available at the conclusion of the study by request to the PI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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