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HealthySTARLITNCT04100967

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

An observational study of Healthy and Overweight, run by Oakland University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 22 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Overweight
How many people
116 participants
Where
1 siteUnited States
Study dates
14 Jun 2017to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 22 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: College freshmen

Who may be able to join

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

Who cannot join

  • Neurological problem
  • Head injury
  • Sleep disorder
  • Mood disorder
  • Anxiety disorder
  • Substance use disorder
Show all 10Show fewer
  • Psychosis
  • Suicidal ideation/plan
  • Lacking the ability to be ambulatory
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oakland University

    Rochester, Michigan, 48309

Other trials in United States

About this study

Official title: Examination of Habitual Sleep Trajectories Across the First Two Years of College: Relation to Weight Gain Risk Behaviors and Outcomes

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.

Conditions
Healthy, Overweight
Keywords
sleep, obesity, body fat composition, young adults, diet, activity, Dual X-ray Absorptiometry
Medical subject headings
Overweight, Obesity, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline total body fat percentage at 24 months

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2019
  2. Study start14 Jun 2017
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04100967
Sponsor's protocol ID
898494
Other IDs
1R15HL130955-01A1
Acronym
STARLIT
Status last verified
Apr 2022
First submitted
18 Sep 2019
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31870336

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Overweight, run by Oakland University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline total body fat percentage at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04100967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 5 Nov 2026.

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