Tween Sleep Patterns, Appetite Control, and Environment

Sleep Clinical Trial

— TweenSPACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853393
• Other study ID #: STUDY00020663
• Status: Recruiting
• Start date: April 20, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Penn State University
• Contact: Emily E Hohman, PhD
• Phone: 8148655245
• Email: eeh12[@]psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Obesity
• Eating Behavior
• Pediatric Obesity
• Sleep

Locations

Country	Name	City	State
United States	Pennyslvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

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