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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:
Researchers will compare whether goals to eat most of a person's calories in the morning or evening work to treat obesity.
Participants will:
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 exploratory aims are to consider:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEPTH-Standard | Active Comparator | 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). |
|
| DEPTH-Morning | Experimental | 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). |
|
| DEPTH-Evening | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change | Percent change in weight (weight change in lbs at follow up / baseline weight in lbs) | 0, 3, 6, and 12 months |
| Body Mass Index (BMI) | Change in BMI calculated as weight in kg / height in m2 | 0, 3, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sleep |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hollie A Raynor, PhD | Contact | 865-974-9126 | 1 | hraynor@utk.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthy Eating and Activity Laboratory | Recruiting | Knoxville | Tennessee | 37996 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35856629 | Background | 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. | |
| 21845223 | Background | 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. |
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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.
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2024 | Jul 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Meetings will be 60 minutes and led by an interventionist with training at the M.S.- or Ph.D.-level in nutrition, exercise physiology, or behavioral psychology blinded to study hypotheses. Dependent measures will be assessed by a trained researcher blinded to treatment assignment at 0, 3, 6, and 12 months, unless otherwise indicated. The research assistant (blinded to treatment condition) will review all assessment data for accuracy and completion.
|
| 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). |
|
Hours of daily sleep objectively measured by accelerometry
| 0, 3, 6, and 12 months |
| 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 |
| Waist circumference | Change in waist circumference in inches | 0, 3, 6, and 12 months |
| Moderate- to vigorous-physical activity (MVPA) | Time in MVPA objectively measured by accelerometry | 0, 3, 6, and 12 months |
| 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 |
| Throughout the 12-month intervention |
| 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 |
| Process evaluation: Attendance | Number of sessions attended will be recorded | Throughout the 12-month intervention |
| 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 |
| 35834774 | Background | 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. |
| 23808897 | Background | 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. |
| 27044416 | Background | 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. |
| 30212231 | Background | 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. |
| 9040548 | Background | 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. |
| 23512957 | Background | 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. |
| 24311451 | Background | 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. |
| 24809437 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |