TweenSPACE: Tween Sleep Patterns, Appetite Control, and Environment

Sponsor

Penn State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05853393

Collaborator

(none)

128

Enrollment

Location

13.4

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Obesity Eating Behavior Sleep

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

Study Type:

Observational

Anticipated Enrollment :

128 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 20, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

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

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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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