Daily Eating Patterns for Total Health Study (DEPTH)

November 25, 2024 updated by: Hollie Raynor, The University of Tennessee, Knoxville

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hollie A Raynor, PhD
  • Phone Number: 1 865-974-9126
  • Email: hraynor@utk.edu

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Recruiting
        • Healthy Eating and Activity Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DEPTH-Standard
Participants 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).
Behavioral: DEPTH
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.
Experimental: DEPTH-Morning
Participants 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).
Behavioral: DEPTH
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.
Behavioral: DEPTH-Morning
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).
Experimental: DEPTH-Evening
Participants 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).
Behavioral: DEPTH
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.
Behavioral: DEPTH-Evening
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: 0, 3, 6, and 12 months
Change in BMI calculated as weight in kg / height in m2
0, 3, 6, and 12 months
Percent Weight Change
Time Frame: 0, 3, 6, and 12 months
Percent change in weight (weight change in lbs at follow up / baseline weight in lbs)
0, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake
Time Frame: 0, 3, 6, and 12 months
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
0, 3, 6, and 12 months
Sleep
Time Frame: 0, 3, 6, and 12 months
Hours of daily sleep objectively measured by accelerometry
0, 3, 6, and 12 months
Appetite regulation
Time Frame: 0, 3, 6, and 12 months
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
0, 3, 6, and 12 months
Waist circumference
Time Frame: 0, 3, 6, and 12 months
Change in waist circumference in inches
0, 3, 6, and 12 months
Moderate- to vigorous-physical activity (MVPA)
Time Frame: 0, 3, 6, and 12 months
Time in MVPA objectively measured by accelerometry
0, 3, 6, and 12 months
Chronotype
Time Frame: 0, 3, 6, and 12 months
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
0, 3, 6, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process evaluation: Self-monitoring of diet
Time Frame: Throughout the 12-month intervention
Achievement of condition specific diet goals (adherence) will be documented (days/wk for overall energy and fat goal [staying with + 5% of each goal]; first eating occasion < 60 minutes of awakening; daily eating window length < 12 hours; four eating occasions per day; and time-based energy intake goals [staying within + 5% of each goal] for Morning and Evening only)
Throughout the 12-month intervention
Process evaluation: Self-monitoring of physical activity
Time Frame: Throughout the 12-month intervention
From physical activity self-monitoring records, number of weeks minutes that MVPA is within + 5% of the goal will be documented.
Throughout the 12-month intervention
Process evaluation: Attendance
Time Frame: Throughout the 12-month intervention
Number of sessions attended will be recorded
Throughout the 12-month intervention
Process evaluation: Fidelity
Time Frame: Throughout the 12-month intervention
All sessions will be audiotaped and the PI will review 33% of these sessions for treatment fidelity
Throughout the 12-month intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Tennessee, Knoxville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTK IRB-23-07697-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available as soon as possible or at the time of associated publication, whichever comes first. Data on Dryad are retained indefinitely.

IPD Sharing Access Criteria

Dataset(s) resulting from this research will be shared via the generalist repository Dryad, which provides metadata, persistent identifiers (i.e., DOIs), and long-term access. Dryad is the institutional data repository supported by the University of California and all data is shared under a CC0 waiver, which makes the dataset(s) publicly available. Data will be made available as soon as possible or at the time of associated publication. Dryad datasets are backed up to Merritt, the UC's CoreTrustSeal-certified digital repository, for long-term storage and accessibility. Procedures in place to ensure dataset preservation include storage of data files in multiple geographic locations, regular audits for fixity and authenticity, and succession plans in the event of repository closure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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