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

Healthy Clinical Trial

— STARLIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04100967
• Other study ID #: 898494
• Secondary ID: 1R15HL130955-01A
• Status: Completed
• Start date: June 14, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: Oakland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 22 Years

Eligibility

Inclusion Criteria:

• College freshmen

• Traditional college age

• BMI from 18.5-29.9.

Exclusion Criteria:

• Neurological problem

• Head injury

• Sleep disorder

• Mood disorder

• Anxiety disorder

• Substance use disorder

• Psychosis

• Suicidal ideation/plan

• Lacking the ability to be ambulatory

• Pregnancy

Related Conditions & MeSH terms

• Healthy
• Overweight
• Weight Gain

Locations

Country	Name	City	State
United States	Oakland University	Rochester	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Oakland University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline total body fat percentage at 24 months		24 months