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

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:

  1. Age 8 to 12 years
  2. Primary residence is in a rural ZIP code in the United States, as defined by Health Resources & Services Administration
  3. BMI for age ≥ 85th percentile OR BMI ≥ 15th percentile plus at least one biological parent with BMI ≥ 25 kg/m2
  4. Able to read and answer questions in English

Parent Inclusion criteria:

  1. Parent or caregiver of an eligible child
  2. Age 18 years or older
  3. Able to read and answer questions in English

Exclusion Criteria:

  1. 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)
  2. Unable to connect to a Zoom session via internet or cell-phone data from home
  3. 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.

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

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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