- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520786
Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women (DAWG-TREAT)
DAWGS in Time-Restricted Eating and Activity Trends (DAWG-TREAT)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tejaswi Tamilmani Saraswathi, MS
- Phone Number: 19515362830
- Email: tt34515@uga.edu
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30605
- Recruiting
- Physical Activity Measurement Lab
-
Contact:
- Tejaswi Tamilmani Saraswathi, MS
- Phone Number: 9515362830
- Email: tt34515@uga.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Time Restricted Eating (TRE)
8-hour (self-selcted) TRE
|
Participants 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.
Other Names:
|
|
Other: Control
Normal eating
|
The control group in this study will receive a basic nutrition education.
This group will follow normal eating patterns for 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-Hour Activity Cycle
Time Frame: From enrollment to the end of study participation (4 weeks)
|
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.
|
From enrollment to the end of study participation (4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality: Objective
Time Frame: From enrollment to the end of study participation (4 weeks)
|
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).
|
From enrollment to the end of study participation (4 weeks)
|
|
Sleep quality: Subjective
Time Frame: At the beginnning of the study and at the end of study
|
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.
|
At the beginnning of the study and at the end of study
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger and Fullness
Time Frame: Three times on one randomly day for 4 weeks
|
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.
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Three times on one randomly day for 4 weeks
|
|
Mood states
Time Frame: Once a week for 4 weeks
|
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
|
Once a week for 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael D Schmidt, Ph.D., University of Georgia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Feeding Behavior
- Patient Acceptance of Health Care
- Fasting
- Sleep Initiation and Maintenance Disorders
- Motor Activity
- Sedentary Behavior
- Patient Compliance
- Intermittent Fasting
Other Study ID Numbers
- PROJECT00012891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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