Child ObesityTweenSPACENCT05853393
Tween Sleep Patterns, Appetite Control, and Environment
An observational study of Child Obesity and Eating Behavior, run by Penn State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Obesity, Eating Behavior, Sleep
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children 8-12 years old and a parent/guardian (n=64 parent-child dyads for a total of 128 individuals)
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennyslvania State University
University Park, Pennsylvania, 16802
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Obesity, Eating Behavior, Sleep
- Keywords
- sleep, eating in the absence of hunger, eating, preadolescent, rural, actigraphy, ecological momentary assessment
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of eating in the absence of hunger (EAH) episodes
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.
Measured: Multiple measurements per day for 2 weeks starting at enrollment through 2 weeks
Secondary outcomes (10)
Visual analogue scale rating of hunger
Collected via EMA
Measured: Multiple measurements per day for 2 weeks
Visual analogue scale rating of fullness
Collected via EMA
Measured: Multiple measurements per day for 2 weeks
Visual analogue scale rating of desire to eat
Collected via EMA
Measured: Multiple measurements per day for 2 weeks
Child appetitive traits
Measured by parent report questionnaire (Child Eating Behavior Questionnaire)
Measured: At enrollment
Child mindful eating
Measured by child self report questionnaire (Mindful Eating Questionnaire)
Measured: At enrollment
Child eating motivations
Measured by child self report questionnaire (Palatable Eating Motives Questionnaire)
Measured: At enrollment
Child restrained and disinhibited eating
Measured by child self report questionnaire (Dutch Eating Behavior Questionnaire)
Measured: At enrollment
Sleep duration
Measured by actigraphy
Measured: Daily over 2 weeks
Sleep maintenance efficiency
Measured by actigraphy
Measured: Daily over 2 weeks
Body mass index z-score
Calculated from measured height and weight
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start20 Apr 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Hohman, Penn State University
- Investigators
- Emily E Hohman, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853393
- Sponsor's protocol ID
- STUDY00020663
- Acronym
- TweenSPACE
- Status last verified
- Nov 2024
- First submitted
- 21 Apr 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified participant data may be made available at the conclusion of the study by request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Eating Behaviors in Rural Preadolescent Children (Tween SPACE [Sleep Patterns, Appetite Control, and Environment])
- ClinicalTrials.gov ID
- NCT05853393
- Acronym / sponsor ID
- TweenSPACE / STUDY00020663
- Conditions
- Child Obesity, Eating Behavior, Sleep
- Keywords
- sleep, eating in the absence of hunger, eating, preadolescent, rural, actigraphy, ecological momentary assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children 8-12 years old and a parent/guardian (n=64 parent-child dyads for a total of 128 individuals)
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Visual analogue scale rating of hunger
Time frame: Multiple measurements per day for 2 weeks
Visual analogue scale rating of fullness
Time frame: Multiple measurements per day for 2 weeks
Visual analogue scale rating of desire to eat
Time frame: Multiple measurements per day for 2 weeks
Child appetitive traits
Time frame: At enrollment
Child mindful eating
Time frame: At enrollment
Child eating motivations
Time frame: At enrollment
Child restrained and disinhibited eating
Time frame: At enrollment
Sleep duration
Time frame: Daily over 2 weeks
Sleep maintenance efficiency
Time frame: Daily over 2 weeks
Body mass index z-score
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: Undecided. De-identified participant data may be made available at the conclusion of the study by request to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily E Hohman, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Obesity and Eating Behavior, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.