NCT04100967

Brief Summary

This two-year prospective, observational study examines the relationship between habitual short sleep and weight gain, as well as the association between habitual short sleep and behaviors that put people at risk of weight gain. Habitual short sleep is defined as sleeping \<6 hours per night on average. Participants will be healthy freshmen college students who are normal weight or overweight. Exclusion criteria include pregnancy, an inability to be ambulatory, currently taking a medication that could influence or interfere with sleep, or reporting a past/current neurological problem, past/current head injury, past/current sleep disorder, current mood, anxiety, or substance use disorder, current psychosis, or current suicidal ideation/plans. Recruitment will be during new student orientations that occur prior to fall semester. Eligibility will be determined using a screening interview, the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult, and DSM-5 Self-Rated Level 2 measures. Eligible participants will be assessed at baseline (time 1), and 8, 16, and 24 months after Time 1. Sleep, physical activity, food/beverages, substance use, and technology use will be collected daily during each eight day recording period. Sleep will be measured with a sleep monitor, activity will be assessed using an accelerometer, food/beverages will be obtained using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Assessment Tool, and substance use and technology use will be measured via self-report. Participants will attend a session after each recording period to have weight and height measured, be scanned via Dual-energy x-ray absorptiometry (DXA), and complete a packet of questionnaires about demographics, health, sleep quality and beliefs, life events, food cravings, and physical development. It is hypothesized that participants will have different habitual sleep trajectories over time. It is also hypothesized that two particular sleep trajectories (stable habitual short sleep and increasingly shorter habitual sleep across time) will be significantly related to weight gain, increased body fat percent, and weight gain risk behaviors (i.e., increased caloric intake and decreased physical activity). Finally, it is hypothesized that the two sleep trajectories will be significantly associated with higher rates of media and technology use and higher rates of problematic sleep-related beliefs/behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

September 18, 2019

Last Update Submit

April 26, 2022

Conditions

Keywords

sleepobesitybody fat compositionyoung adultsdietactivityDual X-ray Absorptiometry

Outcome Measures

Primary Outcomes (1)

  • Change from baseline total body fat percentage at 24 months

    24 months

Eligibility Criteria

Age17 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

College freshmen

You may qualify if:

  • College freshmen
  • Traditional college age
  • BMI from 18.5-29.9.

You may not qualify if:

  • Neurological problem
  • Head injury
  • Sleep disorder
  • Mood disorder
  • Anxiety disorder
  • Substance use disorder
  • Psychosis
  • Suicidal ideation/plan
  • Lacking the ability to be ambulatory
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oakland University

Rochester, Michigan, 48309, United States

Location

Related Publications (1)

  • Kozak AT, Pickett SM, Jarrett NL, Markarian SA, Lahar KI, Goldstick JE. Project STARLIT: protocol of a longitudinal study of habitual sleep trajectories, weight gain, and obesity risk behaviors in college students. BMC Public Health. 2019 Dec 23;19(1):1720. doi: 10.1186/s12889-019-7697-x.

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Andrea T. Kozak, PhD

    Oakland University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 24, 2019

Study Start

June 14, 2017

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations