Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-26
SponsorUniversity of Georgia
About this trial
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
This trial accepts healthy volunteersQualifiers
Female undergraduate and graduate students
Enrolled full-time at University of Georgia
Aged 18-26 years
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Time Restricted Eating
BehavioralParticipants randomized to the TRE group will self-select a consistent 8-hour daily eating window that aligns with their usual schedule. Participants will be instructed to consume all caloric intake within this 8-hour window and abstain from caloric intake outside of the window for 3 weeks. Participants will be instructed not to intentionally modify diet quality or caloric intake during the intervention period, aside from restricting meal timing. Consumption of water and non-caloric beverages (e.g., black coffee, unsweetened tea) will be permitted outside the eating window to maintain hydration.
Control
BehavioralThe control group in this study will receive a basic nutrition education. This group will follow normal eating patterns for 3 weeks.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Time Restricted Eating (TRE)Experimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
24-Hour Activity Cycle
Physical activity (PA), sedentary behavior (SB) and sleep duration, the three main components of 24-Hour Activity Cycle will be measured using an ActiGraph GT9X (wrist watch style activity monitor) worn continuously on the non-dominant wrist during baseline and intervention weeks. ActiGraph accelerometers are widely used for measuring PA intensity and SB time, energy expenditure and sleep. Non-sedentary time will be used as a metric to measure time spent in PA. The Choi 90-minute algorithm will be used to identify ActiGraph non-wear times. Participants will report their sleep time and wake time in the Daily Survey. Total sleep time will be calculated as the difference in their self-reported sleep and wake times.
Time frame
From enrollment to the end of study participation (4 weeks)Secondary outcomes
1
Sleep quality: Objective
ActiGraph sleep measures will be used to objectively estimate sleep quality. ActiGraphy has been previously used in TRE studies to track sleep quality. Sleep quality parameters from the ActiGraph include sleep latency, sleep efficiency and wake after sleep onset (WASO).
Time frame
From enrollment to the end of study participation (4 weeks)2
Sleep quality: Subjective
For a subjective measure of sleep quality, Pittsburgh Sleep Quality Index (PSQI) will be used. PSQI is a self-report questionnaire that assesses multiple dimensions of sleep, including both subjective and objective parameters. PSQI has a total global score ranging from 0 to 21. A score of 0 indicates the best sleep quality, while 21 indicates the worst. A total score greater than 5 is generally considered to indicate poor sleep quality. It is a well validated and reliable measure of sleep quality over a one-month interval.
Time frame
At the beginnning of the study and at the end of studyOther outcomes
1
Hunger and Fullness
A Hunger and Fullness visual analogue scale will be used to assess hunger and appetite. Participants will self-administer this scale three times (wake time, midday, and bedtime) on a randomly chosen day each week.
Time frame
Three times on one randomly day for 4 weeks2
Mood states
Mood states will be assessed using Positive and Negative Affect Schedule-Short Form (PANAS-SF), which will be administered three times (wake-time, midday, and sleep time) on a randomly selected day once a week. Scores for both Positive Affect (PA) and Negative Affect (NA) range from 10 to 50, with higher scores indicating higher levels of that emotional state
Time frame
Once a week for 4 weeksSponsors and contacts
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Source ClinicalTrials.gov