Sleep QualityDAWG-TREATNCT07520786
Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women
A study testing Time Restricted Eating in people with Sleep Quality and Compliance, run by University of Georgia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Compliance, Physical Activity
- What is being tested?
- Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female undergraduate and graduate students
- Enrolled full-time at University of Georgia
- Aged 18-26 years
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Physical Activity Measurement Lab
Athens, Georgia, 30605
Tejaswi Tamilmani Saraswathi, MS, 9515362830, tt34515@uga.edu
About this study
Official title: DAWGS in Time-Restricted Eating and Activity Trends (DAWG-TREAT)
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.
- Being tested
- Time Restricted Eating, Control
- Keywords
- Time restricted eating, Sleep quality, 24-Hour activity cycle
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Patient Compliance, Motor Activity, Sedentary Behavior, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
Also called 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.
ControlBehavioural
The control group in this study will receive a basic nutrition education. This group will follow normal eating patterns for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating (TRE) | Experimental | 8-hour (self-selcted) TRE Receives: Behavioral: Time Restricted Eating |
| Control | Other | Normal eating Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of study participation (4 weeks)
Secondary outcomes (2)
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).
Measured: From enrollment to the end of study participation (4 weeks)
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.
Measured: At the beginnning of the study and at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will complete 1 week of baseline period. Participants will then be randomized in a 2:1 ratio to either the TRE or control group. Participants assigned to the TRE group will self-select and restrict all food intake to an 8-hour eating window that best fits their daily schedule for 3 weeks. Those in the control group will receive basic nutrition education and follow normal eating patterns for 3 weeks.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Schmidt, University of Georgia
- Investigators
- Michael D Schmidt, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520786
- Sponsor's protocol ID
- PROJECT00012891
- Acronym
- DAWG-TREAT
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAWGS in Time-Restricted Eating and Activity Trends (DAWG-TREAT)
- ClinicalTrials.gov ID
- NCT07520786
- Acronym / sponsor ID
- DAWG-TREAT / PROJECT00012891
- Keywords
- Time restricted eating, Sleep quality, 24-Hour activity cycle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will complete 1 week of baseline period. Participants will then be randomized in a 2:1 ratio to either the TRE or control group. Participants assigned to the TRE group will self-select and restrict all food intake to an 8-hour eating window that best fits their daily schedule for 3 weeks. Those in the control group will receive basic nutrition education and follow normal eating patterns for 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating (TRE) | Experimental | Behavioral: Time Restricted Eating8-hour (self-selcted) TRE |
| Control | Other | Behavioral: ControlNormal eating |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female undergraduate and graduate students
- Enrolled full-time at University of Georgia
- Aged 18-26 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted EatingAlso: TREParticipants 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. | Behavioural | Time Restricted Eating (TRE) |
| ControlThe control group in this study will receive a basic nutrition education. This group will follow normal eating patterns for 3 weeks. | Behavioural | Control |
Primary outcome
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.
2 secondary outcomes
Sleep quality: Objective
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael D Schmidt, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating in people with Sleep Quality and Compliance, run by University of Georgia 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tejaswi Tamilmani Saraswathi, MS (19515362830, tt34515@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-Hour Activity Cycle (time frame: From enrollment to the end of study participation (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.