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OpenTrials
Completed

NCT Number: NCT05853393

Tween 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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennyslvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual analogue scale rating of hunger

    Time frame: Multiple measurements per day for 2 weeks

    Collected via EMA

  2. Visual analogue scale rating of fullness

    Time frame: Multiple measurements per day for 2 weeks

    Collected via EMA

  3. Visual analogue scale rating of desire to eat

    Time frame: Multiple measurements per day for 2 weeks

    Collected via EMA

  4. Child appetitive traits

    Time frame: At enrollment

    Measured by parent report questionnaire (Child Eating Behavior Questionnaire)

  5. Child mindful eating

    Time frame: At enrollment

    Measured by child self report questionnaire (Mindful Eating Questionnaire)

  6. Child eating motivations

    Time frame: At enrollment

    Measured by child self report questionnaire (Palatable Eating Motives Questionnaire)

  7. Child restrained and disinhibited eating

    Time frame: At enrollment

    Measured by child self report questionnaire (Dutch Eating Behavior Questionnaire)

  8. Sleep duration

    Time frame: Daily over 2 weeks

    Measured by actigraphy

  9. Sleep maintenance efficiency

    Time frame: Daily over 2 weeks

    Measured by actigraphy

  10. Body mass index z-score

    Time frame: At enrollment

    Calculated from measured height and weight

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Sleep and Eating Behaviors in Rural Preadolescent Children (Tween SPACE [Sleep Patterns, Appetite Control, and Environment])

Acronym: TweenSPACE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 10, 2023
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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