ID

36694

Description

Impact of Sleep and Meal Timing on Food Intake Regulation; ODM derived from: https://clinicaltrials.gov/show/NCT02347020

Link

https://clinicaltrials.gov/show/NCT02347020

Keywords

Versions (1)
  1. 6/2/19 6/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Obesity NCT02347020

English

Eligibility Obesity NCT02347020

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02347020
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants free of any current and past sleep and psychiatric disorders, including eating disorders (ex.anorexia, bulimia, night eating syndrome)
Description

Sleep Disorders Free of | Mental disorders Free of | Eating Disorders Free of | Anorexia Free of | Bulimia Free of | Night Eating Syndrome Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C0013473
UMLS CUI [3,2]
C0332296
UMLS CUI [4,1]
C0003123
UMLS CUI [4,2]
C0332296
UMLS CUI [5,1]
C0006370
UMLS CUI [5,2]
C0332296
UMLS CUI [6,1]
C2203937
UMLS CUI [6,2]
C0332296
participants will not have diabetes and will normally consume a meal within 1 h after awakening at least 5 times/wk
Description

Diabetes Mellitus Absent | Meal Post Awakening

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1720052
participants with normal scores on the pittsburgh quality of sleep questionnaire [78] (global score <5) and epworth sleepiness scale [79] (score <10), no indication of sleep apnea (berlin questionnaire) [80], sleep disorders (sleep disorders inventory questionnaire) [81], depression (beck depression inventory ii) [82], significant delayed or advanced sleep phase (composite scale of morningness/eveningness) [83], and involuntary sleep movement, by self-report.
Description

Pittsburgh Sleep Quality Index score | Epworth Sleepiness Scale Questionnaire | Indication Absent Sleep Apnea Berlin questionnaire for sleep apnea | Sleep Disorders | Other Coding | Depressive disorder Beck depression inventory | Delayed sleep phase | Advanced sleep phase | Other Coding | Involuntary movements during sleep

Data type

boolean

Alias
UMLS CUI [1]
C4545801
UMLS CUI [2]
C3541276
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0037315
UMLS CUI [3,4]
C2919628
UMLS CUI [4]
C0851578
UMLS CUI [5]
C3846158
UMLS CUI [6,1]
C0011581
UMLS CUI [6,2]
C0451022
UMLS CUI [7]
C0854740
UMLS CUI [8]
C0854739
UMLS CUI [9]
C3846158
UMLS CUI [10]
C2078973
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
smokers (smoking any cigarettes or ex-smokers <3 y)
Description

Tobacco use | Former smoker

Data type

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0337671
non-day and rotating shift workers
Description

Night shift worker | Rotating shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2]
C0555009
persons who plan to travel across time zones within 4 wk of the study
Description

Travel across Time Zone

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C2828360
UMLS CUI [1,3]
C2825194
persons with a history of drug and alcohol abuse, drowsy driving, or excessive caffeine intake (>300 mg/d)
Description

Substance Use Disorders | Driving Drowsy | Excessive caffeine intake

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0004379
UMLS CUI [2,2]
C0013144
UMLS CUI [3]
C3714418
persons with recent weight change or who actively participated in a diet or weight loss program in the previous 3 mo.
Description

Body Weight Change | Participation Diet therapy | Participation Weight Reduction Program

Data type

boolean

Alias
UMLS CUI [1]
C0005911
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0012159
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C3179079
individuals with a neurologic condition that may disrupt the procedures will be excluded
Description

Condition Neurologic disrupting Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205494
UMLS CUI [1,3]
C0332454
UMLS CUI [1,4]
C0184661
persons with low hematocrit (<30%) due to the high blood sampling protocol *women who are pregnant or <1 y post-partum
Description

Hematocrit decreased

Data type

boolean

Alias
UMLS CUI [1]
C0744727
individuals with contraindications for fmri
Description

Medical contraindication fMRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0376335
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Similar models

Eligibility Obesity NCT02347020

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02347020
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Sleep Disorders Free of | Mental disorders Free of | Eating Disorders Free of | Anorexia Free of | Bulimia Free of | Night Eating Syndrome Free of
Item
participants free of any current and past sleep and psychiatric disorders, including eating disorders (ex.anorexia, bulimia, night eating syndrome)
boolean
C0851578 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0013473 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
C0003123 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
C0006370 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C2203937 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
Diabetes Mellitus Absent | Meal Post Awakening
Item
participants will not have diabetes and will normally consume a meal within 1 h after awakening at least 5 times/wk
boolean
C0011849 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1720052 (UMLS CUI [2,3])
Pittsburgh Sleep Quality Index score | Epworth Sleepiness Scale Questionnaire | Indication Absent Sleep Apnea Berlin questionnaire for sleep apnea | Sleep Disorders | Other Coding | Depressive disorder Beck depression inventory | Delayed sleep phase | Advanced sleep phase | Other Coding | Involuntary movements during sleep
Item
participants with normal scores on the pittsburgh quality of sleep questionnaire [78] (global score <5) and epworth sleepiness scale [79] (score <10), no indication of sleep apnea (berlin questionnaire) [80], sleep disorders (sleep disorders inventory questionnaire) [81], depression (beck depression inventory ii) [82], significant delayed or advanced sleep phase (composite scale of morningness/eveningness) [83], and involuntary sleep movement, by self-report.
boolean
C4545801 (UMLS CUI [1])
C3541276 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0037315 (UMLS CUI [3,3])
C2919628 (UMLS CUI [3,4])
C0851578 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0011581 (UMLS CUI [6,1])
C0451022 (UMLS CUI [6,2])
C0854740 (UMLS CUI [7])
C0854739 (UMLS CUI [8])
C3846158 (UMLS CUI [9])
C2078973 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Tobacco use | Former smoker
Item
smokers (smoking any cigarettes or ex-smokers <3 y)
boolean
C0543414 (UMLS CUI [1])
C0337671 (UMLS CUI [2])
Night shift worker | Rotating shift worker
Item
non-day and rotating shift workers
boolean
C0555008 (UMLS CUI [1])
C0555009 (UMLS CUI [2])
Travel across Time Zone
Item
persons who plan to travel across time zones within 4 wk of the study
boolean
C0040802 (UMLS CUI [1,1])
C2828360 (UMLS CUI [1,2])
C2825194 (UMLS CUI [1,3])
Substance Use Disorders | Driving Drowsy | Excessive caffeine intake
Item
persons with a history of drug and alcohol abuse, drowsy driving, or excessive caffeine intake (>300 mg/d)
boolean
C0038586 (UMLS CUI [1])
C0004379 (UMLS CUI [2,1])
C0013144 (UMLS CUI [2,2])
C3714418 (UMLS CUI [3])
Body Weight Change | Participation Diet therapy | Participation Weight Reduction Program
Item
persons with recent weight change or who actively participated in a diet or weight loss program in the previous 3 mo.
boolean
C0005911 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0012159 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3179079 (UMLS CUI [3,2])
Condition Neurologic disrupting Procedures
Item
individuals with a neurologic condition that may disrupt the procedures will be excluded
boolean
C0348080 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0332454 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
Hematocrit decreased
Item
persons with low hematocrit (<30%) due to the high blood sampling protocol *women who are pregnant or <1 y post-partum
boolean
C0744727 (UMLS CUI [1])
Medical contraindication fMRI
Item
individuals with contraindications for fmri
boolean
C1301624 (UMLS CUI [1,1])
C0376335 (UMLS CUI [1,2])
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