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NCT04100967: STARLIT

Examining the Longitudinal Relationship Between Sleep and Weight Gain in College Students

Completed Last updated 27 April 2022
What this trial tests

trial in Healthy in 116 participants. Completed in 30 June 2021.

Timeline
14 June 2017
Primary endpoint
30 June 2021
30 June 2021

Quick facts

Lead sponsorOakland University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment116
Start date14 June 2017
Primary completion30 June 2021
Estimated completion30 June 2021
Sites1 location across United States

Conditions studied

Sponsor

Oakland University

Who can join

Adults 17 to 22, any sex, with Healthy or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Project STARLIT: protocol of a longitudinal study of habitual sleep trajectories, weight gain, and obesity risk behaviors in college students.
    Kozak AT, Pickett SM, Jarrett NL, Markarian SA, et al · · 2019 · cited 1× · PMID 31870336 · DOI 10.1186/s12889-019-7697-x

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04100967.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing