Tween Sleep Patterns, Appetite Control, and Environment

Completed

• Conditions: Child Obesity; Eating Behavior; Sleep

• Registration Number: NCT05853393
• Lead Sponsor: Penn State University

Brief 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.

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 Timeline

• Study Start: 2023-04-20
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-10
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of eating in the absence of hunger (EAH) episodes	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 Outcome Measures

Name	Time	Method
Child restrained and disinhibited eating	At enrollment	Measured by child self report questionnaire (Dutch Eating Behavior Questionnaire)
Sleep duration	Daily over 2 weeks	Measured by actigraphy
Sleep maintenance efficiency	Daily over 2 weeks	Measured by actigraphy
Body mass index z-score	At enrollment	Calculated from measured height and weight
Visual analogue scale rating of hunger	Multiple measurements per day for 2 weeks	Collected via EMA
Visual analogue scale rating of fullness	Multiple measurements per day for 2 weeks	Collected via EMA
Visual analogue scale rating of desire to eat	Multiple measurements per day for 2 weeks	Collected via EMA
Child appetitive traits	At enrollment	Measured by parent report questionnaire (Child Eating Behavior Questionnaire)
Child mindful eating	At enrollment	Measured by child self report questionnaire (Mindful Eating Questionnaire)
Child eating motivations	At enrollment	Measured by child self report questionnaire (Palatable Eating Motives Questionnaire)

Trial Locations

Locations (1)

Pennyslvania State University; 🇺🇸 University Park, Pennsylvania, United States