AzTrials
AzTrials

ObesityDEPTHNCT06455995

Daily Eating Patterns for Total Health Study

A study testing DEPTH, DEPTH-Morning and DEPTH-Evening in people with Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this randomized controlled trial is to learn how the time of day when calories are eaten affects weight loss in the long-term (12 months). The main aims are to learn: 1. The influence of time-based energy intake goals on longer-term weight loss. 2. Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Obesity
What is being tested?
DEPTH, DEPTH-Morning and DEPTH-Evening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteUnited States
Study dates
16 Jul 2024to Dec 2028
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 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Body mass index (BMI) between 27 and 45 kg/m2.

Who cannot join

  • Report not regularly (>/= 5 days/wk) consuming energy (>/= 100 kcal) prior to 12 pm, and not being able to consume energy every day (>/= 50 kcal) within one hour of awakening.
  • Report taking sleep medication or not regularly (>/= 5 nights/wk) getting at least 6 hrs of total sleep.
  • Report being a shift workers/alternative shift workers that work outside of 7 am and 7 pm.
  • Report being diagnosed with type 1, or type 2 diabetes and taking medication that requires eating to occur at certain time periods.
  • Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping.
Show all 12Show fewer
  • Report major psychiatric diseases or organic brain syndromes.
  • Report currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost >/= 5% of body weight during the past 6 months.
  • Report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 12 months.
  • Report being pregnant, lactating, < 6 months post-partum or plan to become pregnant (next 12 months).
  • Report planning to move outside of the metropolitan area within the time frame of the investigation.
  • Do not have daily access to PC with internet or smartphones (needed for self-monitoring).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hollie A Raynor, PhD contact

865-974-9126 ext. 1

hraynor@utk.edu

United States1 site, 1 recruiting

  • Healthy Eating and Activity Laboratory

    Knoxville, Tennessee, 37996

    Recruiting

Other trials in United States

About this study

Official title: Effect of Time-based Energy Intake Goals on Weight Loss During Obesity Treatment

The goal of this randomized controlled trial is to learn how the time of day when calories are eaten affects weight loss in the long-term (12 months). The main aims are to learn:

  1. The influence of time-based energy intake goals on longer-term weight loss.
  2. The influence of time-based energy intake goals on eating temporal patterns, sleep regularity, and appetite regulation.
Read more

Researchers will compare whether goals to eat most of a person's calories in the morning or evening work to treat obesity.

Participants will:

  1. Eat a reduced-calorie, low-fat diet (some participants will have goals to eat their calories at certain times of day based on their group)
  2. Be physically active at least 200 minutes
  3. Receive a cognitive behavioral intervention
Read the detailed description

This randomized controlled trial investigates the longer-term (12 months) effect of time-based energy intake goals on weight loss. It also explores whether enhanced appetite regulation is a mediator of the relationship and if chronotype moderates the effect. Adults with overweight or obesity are randomly assigned to one of three, 12-month lifestyle interventions: 1) Morning; 2) Evening; or 3) Standard. All conditions receive a reduced-energy, low-fat dietary prescription (1200-1500 kcal/d, < 30% energy from fat), physical activity goals (> 200 min/wk of moderate- to vigorous-intensity physical activity [MVPA]) and a cognitive behavioral intervention. To minimize the effect of other eating temporal variables on outcomes, guidance on the eating window length and the number of eating occasions in the day are consistent across all three conditions. Thus, the three conditions are instructed to have their first eating occasion < 60 minutes of awakening, and eat their three meals and one snack within a 12-hr eating window. Morning group has time-based energy intake goals of 70% of kcal within the first 6 hrs of the eating window and 30% of kcal within the last 6 hrs of the eating window (a morning-loaded energy distribution). Evening group has the opposite time-based energy intake goals (an afternoon/evening-loaded energy distribution). Standard group receives no guidance on energy intake distribution (standard lifestyle intervention). Assessments occur at 0, 3, 6, and 12 months on anthropometrics, diet (24-hr recalls with time-stamped digital images verifying timing of intake, combined with continuous blood glucose monitoring [CGM] to objectively assess for length of the eating window and number of eating occasions), sleep regularity (actigraphy supported by sleep logs collected via ecological momentary assessment [EMA] using smartphones), appetite regulation assessed via EMA using smartphones, chronotype (self-reported midpoint of sleep on work-free days), and MVPA (actigraphy).

The primary aims are to determine:

  1. The influence of time-based energy intake goals on longer-term weight loss.
  2. The influence of time-based energy intake goals on eating temporal patterns, sleep regularity, and appetite regulation.

The exploratory aims are to consider:

  1. If appetite regulation mediates the relationship between time-based energy intake goals and weight loss.
  2. The moderating effect of chronotype on weight loss and changes in eating temporal patterns, sleep regularity, and appetite regulation in the three conditions.
Conditions
Obesity
Being tested
DEPTH, DEPTH-Morning, DEPTH-Evening
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEPTHBehavioural

    All conditions will receive a reduced-energy, low-fat dietary prescription (1200-1500 kcal/d, < 30% energy from fat), physical activity goals (> 200 min/wk of moderate- to vigorous-intensity physical activity [MVPA]) and a cognitive behavioral intervention. To minimize the effect of other eating temporal variables on outcomes, guidance on the eating window length and the number of eating occasions in the day will be consistent across all three conditions. Thus, the three conditions will be instructed to have their first eating occasion < 60 minutes of awakening, and eat their three meals and one snack within a 12-hr eating window.

  • DEPTH-MorningBehavioural

    Morning will also have time-based energy intake goals of 70% of kcal within the first 6 hrs of the eating window and 30% of kcal within the last 6 hrs of the eating window (a morning-loaded energy distribution).

  • DEPTH-EveningBehavioural

    Evening will also have time-based energy intake goals of 30% of kcal within the first 6 hrs of the eating window and 70% of kcal within the last 6 hrs of the eating window (an evening-loaded energy distribution).

Study groups in NCT06455995
Study groupRoleWhat they receive
DEPTH-StandardActive comparatorParticipants in the Standard Group will receive a reduced-energy, low-fat dietary prescription (1200-1500 kcal/d, < 30% energy from fat), physical activity goals (> 200 min/wk of moderate- to vigorous-intensity physical activity [MVPA]) and a cognitive behavioral intervention. Standard group will receive no guidance on energy intake distribution (standard lifestyle intervention).
Receives: Behavioral: DEPTH
DEPTH-MorningExperimentalParticipants in the Morning Group will receive a reduced-energy, low-fat dietary prescription (1200-1500 kcal/d, < 30% energy from fat), physical activity goals (> 200 min/wk of moderate- to vigorous-intensity physical activity [MVPA]) and a cognitive behavioral intervention. They will also have time-based energy intake goals of 70% of kcal within the first 6 hrs of the eating window and 30% of kcal within the last 6 hrs of the eating window (a morning-loaded energy distribution).
Receives: Behavioral: DEPTH; Behavioral: DEPTH-Morning
DEPTH-EveningExperimentalParticipants in the Evening Group will receive a reduced-energy, low-fat dietary prescription (1200-1500 kcal/d, < 30% energy from fat), physical activity goals (> 200 min/wk of moderate- to vigorous-intensity physical activity [MVPA]) and a cognitive behavioral intervention. They will also have time-based energy intake goals of 30% of kcal within the first 6 hrs of the eating window and 70% of kcal within the last 6 hrs of the eating window (an evening-loaded energy distribution).
Receives: Behavioral: DEPTH; Behavioral: DEPTH-Evening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Weight Change

    Percent change in weight (weight change in lbs at follow up / baseline weight in lbs)

    Measured: 0, 3, 6, and 12 months

  2. Body Mass Index (BMI)

    Change in BMI calculated as weight in kg / height in m2

    Measured: 0, 3, 6, and 12 months

Secondary outcomes (6)

  1. Dietary intake

    Dietary intake will be assessed by 3 (2 weekdays and 1 weekend day), random, 24-hr dietary phone recalls, using the five-step, multiple-pass method

    Measured: 0, 3, 6, and 12 months

  2. Sleep

    Hours of daily sleep objectively measured by accelerometry

    Measured: 0, 3, 6, and 12 months

  3. Appetite regulation

    Time- and semi-random sampling will be initiated via a smartphone tone, prompting participants to complete ratings (i.e. hunger, fullness, temptation to eat, desire to eat, and control over eating), using 100 mm visual analogue scales

    Measured: 0, 3, 6, and 12 months

  4. Waist circumference

    Change in waist circumference in inches

    Measured: 0, 3, 6, and 12 months

  5. Moderate- to vigorous-physical activity (MVPA)

    Time in MVPA objectively measured by accelerometry

    Measured: 0, 3, 6, and 12 months

  6. Chronotype

    An individuals' circadian state (phase relationship between the circadian system of an individual and the zeitgeber cycle) measured via the shortened version of the Munich ChronoType Questionnaire

    Measured: 0, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start16 Jul 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455995
Sponsor's protocol ID
UTK IRB-23-07697-XP
Acronym
DEPTH
Status last verified
Jun 2026
First submitted
6 Jun 2024
Last updated
15 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Types and amount of scientific data expected to be generated in the project: Demographic, anthropometric, dietary intake, sleep and physical activity from actigraphy, appetite regulation collected via ecological momentary assessment, and chronotype data will be collected from 174 adults with overweight or obesity (described in detail in section c.3. of this application) at four time points (0, 3, 6, and 12 months). Raw data will be transformed by processing software (diet and actigraphy) and will generate 4 data sets (data organized by timepoint), which will be no more than 100 gigabytes. These four data sets will be used for statistical analyses and be placed in the repository. All data will be de-identified prior to receipt by the repository, and individual-level data will be made available for sharing.

Publications

  • Yong YN, Henry CJ, Haldar S. Is There a Utility of Chrono-Specific Diets in Improving Cardiometabolic Health? Mol Nutr Food Res. 2022 Sep;66(17):e2200043. doi: 10.1002/mnfr.202200043. Epub 2022 Jul 20.

    PubMed 35856629

  • Salgado-Delgado R, Tapia Osorio A, Saderi N, Escobar C. Disruption of circadian rhythms: a crucial factor in the etiology of depression. Depress Res Treat. 2011;2011:839743. doi: 10.1155/2011/839743. Epub 2011 Aug 8.

    PubMed 21845223

  • Petersen MC, Gallop MR, Flores Ramos S, Zarrinpar A, Broussard JL, Chondronikola M, Chaix A, Klein S. Complex physiology and clinical implications of time-restricted eating. Physiol Rev. 2022 Oct 1;102(4):1991-2034. doi: 10.1152/physrev.00006.2022. Epub 2022 Jul 14.

    PubMed 35834774

  • Wang JB, Patterson RE, Ang A, Emond JA, Shetty N, Arab L. Timing of energy intake during the day is associated with the risk of obesity in adults. J Hum Nutr Diet. 2014 Apr;27 Suppl 2:255-62. doi: 10.1111/jhn.12141. Epub 2013 Jun 27.

    PubMed 23808897

  • Hermenegildo Y, Lopez-Garcia E, Garcia-Esquinas E, Perez-Tasigchana RF, Rodriguez-Artalejo F, Guallar-Castillon P. Distribution of energy intake throughout the day and weight gain: a population-based cohort study in Spain. Br J Nutr. 2016 Jun;115(11):2003-10. doi: 10.1017/S0007114516000891. Epub 2016 Apr 5.

    PubMed 27044416

  • Maukonen M, Kanerva N, Partonen T, Mannisto S. Chronotype and energy intake timing in relation to changes in anthropometrics: a 7-year follow-up study in adults. Chronobiol Int. 2019 Jan;36(1):27-41. doi: 10.1080/07420528.2018.1515772. Epub 2018 Sep 13.

    PubMed 30212231

  • Keim NL, Van Loan MD, Horn WF, Barbieri TF, Mayclin PL. Weight loss is greater with consumption of large morning meals and fat-free mass is preserved with large evening meals in women on a controlled weight reduction regimen. J Nutr. 1997 Jan;127(1):75-82. doi: 10.1093/jn/127.1.75.

    PubMed 9040548

  • Jakubowicz D, Barnea M, Wainstein J, Froy O. High caloric intake at breakfast vs. dinner differentially influences weight loss of overweight and obese women. Obesity (Silver Spring). 2013 Dec;21(12):2504-12. doi: 10.1002/oby.20460. Epub 2013 Jul 2.

    PubMed 23512957

  • Rabinovitz HR, Boaz M, Ganz T, Jakubowicz D, Matas Z, Madar Z, Wainstein J. Big breakfast rich in protein and fat improves glycemic control in type 2 diabetics. Obesity (Silver Spring). 2014 May;22(5):E46-54. doi: 10.1002/oby.20654. Epub 2013 Dec 6.

    PubMed 24311451

  • Lombardo M, Bellia A, Padua E, Annino G, Guglielmi V, D'Adamo M, Iellamo F, Sbraccia P. Morning meal more efficient for fat loss in a 3-month lifestyle intervention. J Am Coll Nutr. 2014;33(3):198-205. doi: 10.1080/07315724.2013.863169. Epub 2014 May 8.

    PubMed 24809437

Questions about this trial

What is this clinical trial studying?

A study testing DEPTH, DEPTH-Morning and DEPTH-Evening in people with Obesity, run by The University of Tennessee, Knoxville 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 1 inclusion and 12 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 15 Jun 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 Hollie A Raynor, PhD (865-974-9126 ext. 1, hraynor@utk.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Weight Change (time frame: 0, 3, 6, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455995, which also lists 10 linked publications.

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 15 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in