Daily Eating Patterns for Total Health Study

Obesity Clinical Trial

— DEPTH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455995
• Other study ID #: UTK IRB-23-07697-XP
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: The University of Tennessee, Knoxville
• Contact: Hollie A Raynor, PhD
• Phone: 865-974-9126
• Email: hraynor[@]utk.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

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.
• 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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville

References & Publications (10)

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. Erratum In: Br J Nutr. 2017 Mar;117(5):766. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process evaluation: Self-monitoring of diet	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
Other	Process evaluation: Self-monitoring of physical activity	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
Other	Process evaluation: Attendance	Number of sessions attended will be recorded	Throughout the 12-month intervention
Other	Process evaluation: Fidelity	All sessions will be audiotaped and the PI will review 33% of these sessions for treatment fidelity	Throughout the 12-month intervention
Primary	Percent Weight Change	Percent change in weight (weight change in lbs at follow up / baseline weight in lbs)	0, 3, 6, and 12 months
Primary	Body Mass Index (BMI)	Change in BMI calculated as weight in kg / height in m2	0, 3, 6, and 12 months
Secondary	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	0, 3, 6, and 12 months
Secondary	Sleep	Hours of daily sleep objectively measured by accelerometry	0, 3, 6, and 12 months
Secondary	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	0, 3, 6, and 12 months
Secondary	Waist circumference	Change in waist circumference in inches	0, 3, 6, and 12 months
Secondary	Moderate- to vigorous-physical activity (MVPA)	Time in MVPA objectively measured by accelerometry	0, 3, 6, and 12 months
Secondary	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	0, 3, 6, and 12 months