Clinical trial NCT05853393: Tween Sleep Patterns, Appetite Control, and Environment
Official title: Sleep and Eating Behaviors in Rural Preadolescent Children (Tween SPACE [Sleep Patterns, Appetite Control, and Environment])
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Obesity
Eating Behavior
Sleep
Keywords: sleep
eating in the absence of hunger
eating
preadolescent
rural
actigraphy
ecological momentary assessment
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 112
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of eating in the absence of hunger (EAH) episodes
timeFrame: Multiple measurements per day for 2 weeks starting at enrollment through 2 weeks
Secondary outcomes:
measure: Visual analogue scale rating of hunger
timeFrame: Multiple measurements per day for 2 weeks
measure: Visual analogue scale rating of fullness
timeFrame: Multiple measurements per day for 2 weeks
measure: Visual analogue scale rating of desire to eat
timeFrame: Multiple measurements per day for 2 weeks
measure: Child appetitive traits
timeFrame: At enrollment
measure: Child mindful eating
timeFrame: At enrollment
measure: Child eating motivations
timeFrame: At enrollment
measure: Child restrained and disinhibited eating
timeFrame: At enrollment
measure: Sleep duration
timeFrame: Daily over 2 weeks
measure: Sleep maintenance efficiency
timeFrame: Daily over 2 weeks
measure: Body mass index z-score
timeFrame: At enrollment
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennyslvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Emily E Hohman, PhD
role: PRINCIPAL_INVESTIGATOR
References: