Diet HabitDPASNCT04035421
Diet, Physical Activity, and Sleep Habits
An observational study of Diet Habit, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2019to 16 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Lab, University of Tennessee
Knoxville, Tennessee, 37996
About this study
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.
Read the detailed description
During young adulthood, patterns regarding physical activity,1,2 dietary intake,3 and weight status4 are established that track into later life and can impact health. Social and physical cues also impact patterns-particularly those cues that may influence biological and behavioral rhythms which can influence the Circadian Timing System (CTS).5 Chronotype, the timing of sleep patterns, is closely tied to the CTS as it reflects sleep in relation to the light and dark cycle, with morning-type (MT) having a pattern that should assist with better entrainment (sleep better entrained to the physical cues of light/dark).6 Research has found that chronotype is related to several areas important to health, including diet,6-11 physical activity,12-14 weight regulation.15-18. As a whole, research in this area suggests that MT individuals are more likely to consume a healthier eating pattern, be more physically active, and more successfully manage their weight. However, the research in this area for young adults is limited.
While there has been research regarding chronotype and diet, activity, and weight management, there is a paucity of research on the relationship between social cues and social rhythms, which also influence the CTS, and health related outcomes. Social rhythms, as measured by the Social Rhythm Metric (SRM), are related to chronotype, such that MT is related to a higher SRM.19-21 Due to the relationship between SRM and chronotype, and chronotype and diet, physical activity, and weight management, it would be anticipated that SRM is also related to these health outcomes. Specifically, it would be anticipated that more consistent social rhythms (higher SRM) would be related to a healthier eating pattern, greater physical activity, and weight management. However, this relationship has never been investigated.
Therefore, to better understand how social rhythms, which are triggered by social cues, are related to health, this investigation will be assessing both chronotype and SRM and collecting measures on diet quality, via food records, physical activity and sleep, via accelerometers, and anthropometrics, via BMI. The population of interest for this study is specifically young adults because young adulthood is a time period when health patterns are established for the rest of life. 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.
- Conditions
- Diet Habit
- Keywords
- Social Rhythm Metric, Chronotype, Young adult
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Quality 1
Healthy Eating Index Score calculated using a three-day food record
Measured: Through study completion, 1 week
Diet Quality 2
Total energy intake will be assessed using a three-day food record
Measured: Through study completion, 1 week
Physical Activity 1
Minutes of moderate to vigorous physical activity will be assessed using SenseWear Armbands
Measured: Through study completion, 1 week
Physical Activity 2
Energy expenditure from moderate to vigorous physical activity will be assessed using SenseWear Armbands
Measured: Through study completion, 1 week
Sleep 1
Length of sleep will be assessed using SenseWear Armbands
Measured: Through study completion, 1 week
Sleep 2
Sleep efficiency will be assessed using SenseWear Armbands
Measured: Through study completion, 1 week
Secondary outcomes (3)
Body Mass Index (BMI)
BMI will be calculated using height and weight measurements
Measured: Baseline appointment
Body Composition
Body fat percentage will be assessed using the Body Composition Analyzer TBF-300 (TANITA Corporation, Tokyo, Japan)
Measured: Baseline appointment
Chronotype
Chronotype will be assessed using the Composite Score for Morningness
Measured: Baseline appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start13 Jul 2019
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie Raynor, PhD, Principal investigator, University of Tennessee Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035421
- Sponsor's protocol ID
- UTK IRB-19-05178-XP
- Acronym
- DPAS
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2019
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10994912Nelson 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.
PubMed 18719665Dunn 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.
PubMed 10808981Serdula 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.
PubMed 8483856Monk 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.
PubMed 2299336Wright 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.
PubMed 23910656Fleig 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.
PubMed 19447353Gontijo 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.
PubMed 30212228Kogevinas 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.
PubMed 30016830Maukonen 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.
PubMed 30212231Rossbach 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.
PubMed 29231764Harrex 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.
PubMed 29160021Olds 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.
PubMed 21966061Shechter 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.
PubMed 25311835Arora 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.
PubMed 25135376
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Physical Activity, and Sleep Habits
- ClinicalTrials.gov ID
- NCT04035421
- Acronym / sponsor ID
- DPAS / UTK IRB-19-05178-XP
- Conditions
- Diet Habit
- Keywords
- Social Rhythm Metric, Chronotype, Young adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 13 Jul 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During young adulthood, patterns regarding physical activity,1,2 dietary intake,3 and weight status4 are established that track into later life and can impact health. Social and physical cues also impact patterns-particularly those cues that may influence biological and behavioral rhythms which can influence the Circadian Timing System (CTS).5 Chronotype, the timing of sleep patterns, is closely tied to the CTS as it reflects sleep in relation to the light and dark cycle, with morning-type (MT) having a pattern that should assist with better entrainment (sleep better entrained to the physical cues of light/dark).6 Research has found that chronotype is related to several areas important to health, including diet,6-11 physical activity,12-14 weight regulation.15-18. As a whole, research in this area suggests that MT individuals are more likely to consume a healthier eating pattern, be more physically active, and more successfully manage their weight. However, the research in this area for young adults is limited.
While there has been research regarding chronotype and diet, activity, and weight management, there is a paucity of research on the relationship between social cues and social rhythms, which also influence the CTS, and health related outcomes. Social rhythms, as measured by the Social Rhythm Metric (SRM), are related to chronotype, such that MT is related to a higher SRM.19-21 Due to the relationship between SRM and chronotype, and chronotype and diet, physical activity, and weight management, it would be anticipated that SRM is also related to these health outcomes. Specifically, it would be anticipated that more consistent social rhythms (higher SRM) would be related to a healthier eating pattern, greater physical activity, and weight management. However, this relationship has never been investigated.
Therefore, to better understand how social rhythms, which are triggered by social cues, are related to health, this investigation will be assessing both chronotype and SRM and collecting measures on diet quality, via food records, physical activity and sleep, via accelerometers, and anthropometrics, via BMI. The population of interest for this study is specifically young adults because young adulthood is a time period when health patterns are established for the rest of life. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diet Quality 1
Time frame: Through study completion, 1 week
Healthy Eating Index Score calculated using a three-day food record
Diet Quality 2
Time frame: Through study completion, 1 week
Total energy intake will be assessed using a three-day food record
Physical Activity 1
Time frame: Through study completion, 1 week
Minutes of moderate to vigorous physical activity will be assessed using SenseWear Armbands
Physical Activity 2
Time frame: Through study completion, 1 week
Energy expenditure from moderate to vigorous physical activity will be assessed using SenseWear Armbands
Sleep 1
Time frame: Through study completion, 1 week
Length of sleep will be assessed using SenseWear Armbands
Sleep 2
Time frame: Through study completion, 1 week
Sleep efficiency will be assessed using SenseWear Armbands
3 secondary outcomes
Body Mass Index (BMI)
Time frame: Baseline appointment
Body Composition
Time frame: Baseline appointment
Chronotype
Time frame: Baseline appointment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 10994912Caspersen 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.
- Background: PubMed 18719665Nelson 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.
- Background: PubMed 10808981Dunn 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.
- Background: PubMed 8483856Serdula 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.
- Background: PubMed 2299336Monk 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.
- Background: PubMed 23910656Wright 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.
- Background: PubMed 19447353Fleig 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.
- Background: PubMed 30212228Gontijo 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.
- Background: PubMed 30016830Kogevinas 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.
- Background: PubMed 30212231Maukonen 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.
- Background: PubMed 29231764Rossbach 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.
- Background: PubMed 29160021Harrex 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.
- Individual participant dataSharing planned: No
Related trials for Diet Habit
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Recruiting
Nutrition for Precision Health, Powered by the All of Us
Nutrition, Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie Raynor, PhD principal investigator
University of Tennessee Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Quality 1 (time frame: Through study completion, 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035421, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.