Study Results
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Basic Information
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RECRUITING
NA
174 participants
INTERVENTIONAL
2024-07-16
2028-12-31
Brief Summary
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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
Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
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
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
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
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).
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-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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
25 Years
60 Years
ALL
No
Sponsors
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The University of Tennessee, Knoxville
OTHER
Responsible Party
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Hollie Raynor
Executive Associate Dean of Research & Operations, College of Education, Health, and Human Sciences
Locations
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Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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UTK IRB-23-07697-XP
Identifier Type: -
Identifier Source: org_study_id