Daily Eating Patterns for Total Health Study

NCT06455995 | Recruiting

• 1 other identifier: UTK IRB-23-07697-XP
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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. 1.The influence of time-based energy intake goals on longer-term weight loss.
2. 2.The influence of time-based energy intake goals on eating temporal patterns, sleep regularity, and appetite regulation.
3. 3.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)
4. 4.Be physically active at least 200 minutes
5. 5.Receive a cognitive behavioral intervention

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Dietary intake

  0, 3, 6, and 12 months

• Sleep

  0, 3, 6, and 12 months

• Appetite regulation

  0, 3, 6, and 12 months

• Waist circumference

  0, 3, 6, and 12 months

• Moderate- to vigorous-physical activity (MVPA)

  0, 3, 6, and 12 months

Other Outcomes (4)

• Process evaluation: Self-monitoring of diet

  Throughout the 12-month intervention

• Process evaluation: Self-monitoring of physical activity

  Throughout the 12-month intervention

• Process evaluation: Attendance

  Throughout the 12-month intervention

Study Arms (3)

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).

Behavioral: DEPTH

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).

Behavioral: DEPTH; Behavioral: DEPTH-Morning

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).

Behavioral: DEPTH; Behavioral: DEPTH-Evening

Interventions

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-Evening; DEPTH-Morning; DEPTH-Standard

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-Morning

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).

DEPTH-Evening

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 35856629 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.

  PMID: 21845223 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.

  PMID: 35834774 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.

  PMID: 23808897 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.

  PMID: 27044416 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.

  PMID: 30212231 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.

  PMID: 9040548 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.

  PMID: 23512957 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.

  PMID: 24311451 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.

  PMID: 24809437 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hollie A Raynor, PhD

CONTACT

865-974-9126; hraynor@utk.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Associate Dean of Research & Operations, College of Education, Health, and Human Sciences

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)