NCT04035421

Brief Summary

This study aims to observe if consistency in a young adult's schedule is related to health factors and outcomes, such as diet quality, amount of physical activity and sleep, and weight.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 13, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2.1 years

First QC Date

July 13, 2019

Last Update Submit

August 16, 2021

Conditions

Diet Habit

Keywords

Social Rhythm MetricChronotypeYoung adult

Outcome Measures

Primary Outcomes (6)

  • Diet Quality 1

    Healthy Eating Index Score calculated using a three-day food record

    Through study completion, 1 week

  • Diet Quality 2

    Total energy intake will be assessed using a three-day food record

    Through study completion, 1 week

  • Physical Activity 1

    Minutes of moderate to vigorous physical activity will be assessed using SenseWear Armbands

    Through study completion, 1 week

  • Physical Activity 2

    Energy expenditure from moderate to vigorous physical activity will be assessed using SenseWear Armbands

    Through study completion, 1 week

  • Sleep 1

    Length of sleep will be assessed using SenseWear Armbands

    Through study completion, 1 week

  • Sleep 2

    Sleep efficiency will be assessed using SenseWear Armbands

    Through study completion, 1 week

Secondary Outcomes (3)

  • Body Mass Index (BMI)

    Baseline appointment

  • Body Composition

    Baseline appointment

  • Chronotype

    Baseline appointment

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adult between the ages of 18 and 35 years, taking classes and/or working, able to engage in physical activity, and having no dietary restrictions.

You may qualify if:

  • Between the ages of 18-35 years
  • Able to pass the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) indicating that they have no health conditions that limit their ability to engage in physical activity
  • Access to an email address and internet each day during their participation
  • An town when all measures are collected
  • Taking classes and/or working a job when all measures are collected

You may not qualify if:

  • Pregnant
  • Allergy to stainless steel, making the participant unable to wear Body Media Armband
  • Dietary restrictions of any kind
  • Shift work, here defined as having to work a shift for any period of time between the hours of 12 am and 6 am

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Lab, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (21)

  • Caspersen CJ, Pereira MA, Curran KM. Changes in physical activity patterns in the United States, by sex and cross-sectional age. Med Sci Sports Exerc. 2000 Sep;32(9):1601-9. doi: 10.1097/00005768-200009000-00013.

    PMID: 10994912BACKGROUND

  • Nelson MC, Story M, Larson NI, Neumark-Sztainer D, Lytle LA. Emerging adulthood and college-aged youth: an overlooked age for weight-related behavior change. Obesity (Silver Spring). 2008 Oct;16(10):2205-11. doi: 10.1038/oby.2008.365. No abstract available.

    PMID: 18719665BACKGROUND

  • Dunn JE, Liu K, Greenland P, Hilner JE, Jacobs DR Jr. Seven-year tracking of dietary factors in young adults: the CARDIA study. Am J Prev Med. 2000 Jan;18(1):38-45. doi: 10.1016/s0749-3797(99)00114-2.

    PMID: 10808981BACKGROUND

  • Serdula MK, Ivery D, Coates RJ, Freedman DS, Williamson DF, Byers T. Do obese children become obese adults? A review of the literature. Prev Med. 1993 Mar;22(2):167-77. doi: 10.1006/pmed.1993.1014.

    PMID: 8483856BACKGROUND

  • Monk TH, Flaherty JF, Frank E, Hoskinson K, Kupfer DJ. The Social Rhythm Metric. An instrument to quantify the daily rhythms of life. J Nerv Ment Dis. 1990 Feb;178(2):120-6. doi: 10.1097/00005053-199002000-00007.

    PMID: 2299336BACKGROUND

  • Wright KP Jr, McHill AW, Birks BR, Griffin BR, Rusterholz T, Chinoy ED. Entrainment of the human circadian clock to the natural light-dark cycle. Curr Biol. 2013 Aug 19;23(16):1554-8. doi: 10.1016/j.cub.2013.06.039. Epub 2013 Aug 1.

    PMID: 23910656BACKGROUND

  • Fleig D, Randler C. Association between chronotype and diet in adolescents based on food logs. Eat Behav. 2009 Apr;10(2):115-8. doi: 10.1016/j.eatbeh.2009.03.002. Epub 2009 Mar 29.

    PMID: 19447353BACKGROUND

  • Gontijo CA, Cabral BBM, Balieiro LCT, Teixeira GP, Fahmy WM, Maia YCP, Crispim CA. Time-related eating patterns and chronotype are associated with diet quality in pregnant women. Chronobiol Int. 2019 Jan;36(1):75-84. doi: 10.1080/07420528.2018.1518328. Epub 2018 Sep 13.

    PMID: 30212228BACKGROUND

  • Kogevinas M, Espinosa A, Castello A, Gomez-Acebo I, Guevara M, Martin V, Amiano P, Alguacil J, Peiro R, Moreno V, Costas L, Fernandez-Tardon G, Jimenez JJ, Marcos-Gragera R, Perez-Gomez B, Llorca J, Moreno-Iribas C, Fernandez-Villa T, Oribe M, Aragones N, Papantoniou K, Pollan M, Castano-Vinyals G, Romaguera D. Effect of mistimed eating patterns on breast and prostate cancer risk (MCC-Spain Study). Int J Cancer. 2018 Nov 15;143(10):2380-2389. doi: 10.1002/ijc.31649. Epub 2018 Jul 17.

    PMID: 30016830BACKGROUND

  • 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: 30212231BACKGROUND

  • Rossbach S, Diederichs T, Nothlings U, Buyken AE, Alexy U. Relevance of chronotype for eating patterns in adolescents. Chronobiol Int. 2018 Mar;35(3):336-347. doi: 10.1080/07420528.2017.1406493. Epub 2017 Dec 12.

    PMID: 29231764BACKGROUND

  • Harrex HAL, Skeaff SA, Black KE, Davison BK, Haszard JJ, Meredith-Jones K, Quigg R, Saeedi P, Stoner L, Wong JE, Skidmore PML. Sleep timing is associated with diet and physical activity levels in 9-11-year-old children from Dunedin, New Zealand: the PEDALS study. J Sleep Res. 2018 Aug;27(4):e12634. doi: 10.1111/jsr.12634. Epub 2017 Nov 20.

    PMID: 29160021BACKGROUND

  • Olds TS, Maher CA, Matricciani L. Sleep duration or bedtime? Exploring the relationship between sleep habits and weight status and activity patterns. Sleep. 2011 Oct 1;34(10):1299-307. doi: 10.5665/SLEEP.1266.

    PMID: 21966061BACKGROUND

  • Shechter A, St-Onge MP. Delayed sleep timing is associated with low levels of free-living physical activity in normal sleeping adults. Sleep Med. 2014 Dec;15(12):1586-9. doi: 10.1016/j.sleep.2014.07.010. Epub 2014 Sep 2.

    PMID: 25311835BACKGROUND

  • Arora T, Taheri S. Associations among late chronotype, body mass index and dietary behaviors in young adolescents. Int J Obes (Lond). 2015 Jan;39(1):39-44. doi: 10.1038/ijo.2014.157. Epub 2014 Aug 19.

    PMID: 25135376BACKGROUND

  • Culnan E, Kloss JD, Grandner M. A prospective study of weight gain associated with chronotype among college freshmen. Chronobiol Int. 2013 Jun;30(5):682-90. doi: 10.3109/07420528.2013.782311. Epub 2013 May 20.

    PMID: 23688114BACKGROUND

  • Ross KM, Graham Thomas J, Wing RR. Successful weight loss maintenance associated with morning chronotype and better sleep quality. J Behav Med. 2016 Jun;39(3):465-71. doi: 10.1007/s10865-015-9704-8. Epub 2015 Dec 10.

    PMID: 26660638BACKGROUND

  • Ruiz-Lozano T, Vidal J, de Hollanda A, Scheer FAJL, Garaulet M, Izquierdo-Pulido M. Timing of food intake is associated with weight loss evolution in severe obese patients after bariatric surgery. Clin Nutr. 2016 Dec;35(6):1308-1314. doi: 10.1016/j.clnu.2016.02.007. Epub 2016 Feb 16.

    PMID: 26948400BACKGROUND

  • Martin JS, Hebert M, Ledoux E, Gaudreault M, Laberge L. Relationship of chronotype to sleep, light exposure, and work-related fatigue in student workers. Chronobiol Int. 2012 Apr;29(3):295-304. doi: 10.3109/07420528.2011.653656.

    PMID: 22390242BACKGROUND

  • Mongrain V, Carrier J, Dumont M. Chronotype and sex effects on sleep architecture and quantitative sleep EEG in healthy young adults. Sleep. 2005 Jul;28(7):819-27. doi: 10.1093/sleep/28.7.819.

    PMID: 16124660BACKGROUND

  • Monk TH, Buysse DJ, Potts JM, DeGrazia JM, Kupfer DJ. Morningness-eveningness and lifestyle regularity. Chronobiol Int. 2004 May;21(3):435-43. doi: 10.1081/cbi-120038614.

    PMID: 15332448BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Hollie Raynor, PhD

    University of Tennessee Knoxville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2019

First Posted

July 29, 2019

Study Start

July 13, 2019

Primary Completion

August 16, 2021

Study Completion

August 16, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)