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NCT Number: NCT06455995

Daily Eating Patterns for Total Health Study

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

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996, United States

Location status: Recruiting

About this study

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:

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

The exploratory aims are to consider:

  • If appetite regulation mediates the relationship between time-based energy intake goals and weight loss.
  • The moderating effect of chronotype on weight loss and changes in eating temporal patterns, sleep regularity, and appetite regulation in the three conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DEPTH

Behavioral

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-Morning

Behavioral

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-Evening

Behavioral

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).

Primary outcomes

  1. 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)

  2. Body Mass Index (BMI)

    Time frame: 0, 3, 6, and 12 months

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

Secondary outcomes

  1. 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

  2. Sleep

    Time frame: 0, 3, 6, and 12 months

    Hours of daily sleep objectively measured by accelerometry

  3. 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

  4. Waist circumference

    Time frame: 0, 3, 6, and 12 months

    Change in waist circumference in inches

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

    Time frame: 0, 3, 6, and 12 months

    Time in MVPA objectively measured by accelerometry

  6. 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

Other outcomes

  1. 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)

  2. 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.

  3. Process evaluation: Attendance

    Time frame: Throughout the 12-month intervention

    Number of sessions attended will be recorded

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hollie A Raynor, PhD

CONTACT

[email protected]

865-974-9126 ext. 1

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Registry information

Official study title

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

Acronym: DEPTH

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 13, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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