NCT07520786 Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women
| NCT ID | NCT07520786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Georgia |
| Condition | Sleep Quality |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2026-02-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Time-restricted Eating (TRE) is a dietary approach that limits food intake to 4 - 12-hour windows without intentionally altering diet quality. TRE has several benefits including modest reductions in body weight and fat mass, improved glucose control, and reduced inflammatory markers. While research supports the metabolic and weight related benefits of TRE, there is limited evidence of its effects on physical activity (PA), sedentary behavior (SB) and sleep - the core components of 24-hour Activity Cycle (24-HAC), which is a holistic framework that integrates the three health-related activities. TRE research has largely focused on clinical populations, leaving its feasibility and adherence in healthy younger adults understudied. Within this group, college students' misaligned circadian rhythms and unpredictable schedules may make adherence to TRE challenging, highlighting the need for research on its practicality in this group. These outcomes are also particularly important to investigate in women, considering that SB is more prevalent among college-aged women (69%) compared to men (46%). To address these issues, we will conduct a three-week intervention to study the effects of TRE on the 24-HAC outcomes. College aged women will be screened and enrolled, then assigned to either a control or TRE group. Participants in the TRE group will self-select the timing of their 8-hour eating window which they will maintain throughout the study (with compliance on at least six days per week needed to be considered adherent). The control group will receive a basic nutrition education at the start of the study and will have no restriction on eating times. 24 HAC behaviors will be measured continuously for one-week of baseline measurement and throughout the intervention by wrist-worn ActiGraph GT9X monitors. Participants will also record the timing of their first and last meal each day and receive periodic reminders to report their hunger and satiety ratings using visual analog scales.
Eligibility Criteria
Inclusion Criteria: * Female undergraduate and graduate students * Enrolled full-time at University of Georgia * Aged 18-26 years Exclusion Criteria: * having one of the following chronic diseases that maybe impacted by the diet changes: type 1 and 2 diabetes mellitus, cancer, cardiovascular diseases, hypertension, thyroid dysfunction, hepatic/renal impairment, inflammatory bowel disease and other gastrointestinal diseases, * report use of nicotine, thyroid medications, antidepressants, or anti-anxiety medications, melatonin * having clinically diagnosed sleep disorders * alcohol intake exceeds two drinks per day * clinically diagnosed or undiagnosed eating disorders * division-1 student athletes * pregnant or lactating or plan on getting pregnant within 6 months * report major ambulatory disorders, * recently (within the past two weeks) engaged in caloric restriction, timing-based dietary changes, weight loss regimens, or adhered to specialized diets such as ketogenic or paleo diets, * required to take medication with food, as these factors may interfere with sleep and physical activity outcomes or pose risks to participant health during restricted eating protocols. Students whose habitual eating time windows are \<10 hours will also not be eligible.
Contact & Investigator
Michael D Schmidt, Ph.D.
PRINCIPAL INVESTIGATOR
University of Georgia
Frequently Asked Questions
Who can join the NCT07520786 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 26 Years, studying Sleep Quality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07520786 currently recruiting?
Yes, NCT07520786 is actively recruiting participants. Contact the research team at tt34515@uga.edu for enrollment information.
Where is the NCT07520786 trial being conducted?
This trial is being conducted at Athens, United States.
Who is sponsoring the NCT07520786 clinical trial?
NCT07520786 is sponsored by University of Georgia. The principal investigator is Michael D Schmidt, Ph.D. at University of Georgia. The trial plans to enroll 36 participants.