ID

36691

Beskrivning

Framingham State Food Study; ODM derived from: https://clinicaltrials.gov/show/NCT02068885

Länk

https://clinicaltrials.gov/show/NCT02068885

Nyckelord

Versioner (1)
  1. 2019-06-01 2019-06-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Obesity NCT02068885

Engelsk

Eligibility Obesity NCT02068885

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02068885
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18 to 55 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
bmi ≥ 25 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
bmi < 40 kg/m2 and weight ≤ 300 lbs (136 kg)
Beskrivning

Body mass index | Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
medical clearance from a primary care provider
Beskrivning

Medical clearance note Primary care provider

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4483684
UMLS CUI [1,2]
C2735026
plans to matriculate as a student at framingham state university or work on campus throughout the academic year of enrollment in the study
Beskrivning

Matriculation University Planned | University student Work Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870860
UMLS CUI [1,2]
C0041740
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0597615
UMLS CUI [2,2]
C0043227
UMLS CUI [2,3]
C1301732
willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions
Beskrivning

Food Study Protocol Willing | Beverages Study Protocol Willing | Food Allergy Absent | Food aversion Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0016452
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0005329
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0016470
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0877173
UMLS CUI [4,2]
C0332197
willingness to eat in the dining hall
Beskrivning

Eating Dining room Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013470
UMLS CUI [1,2]
C0557648
UMLS CUI [1,3]
C0600109
willingness to abstain from consuming alcohol during participation
Beskrivning

Alcohol consumption Discontinue Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
change in body weight exceeding ±10% during prior year
Beskrivning

Change Body Weight Percentage Past Year

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0005910
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C4086728
recent adherence to a special diet
Beskrivning

Adherence Special Diet Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C1519433
recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)
Beskrivning

Adherence Vigorous physical activity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C4267713
chronic use of any medication or dietary supplement that could affect study outcomes
Beskrivning

Pharmaceutical Preparations chronic Affecting Research results | Dietary Supplements chronic Affecting Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0683954
current smoking (1 cigarette in the last week)
Beskrivning

Tobacco use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (≥
Beskrivning

Heavy alcohol consumption | Alcoholic drink Quantity Weekly | Binge Drinking

Datatyp

boolean

Alias
UMLS CUI [1]
C2030272
UMLS CUI [2,1]
C0001967
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332174
UMLS CUI [3]
C0556346
5 drinks in 1 day, anytime in past 6 months)
Beskrivning

Alcoholic drink Quantity Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001967
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332173
physician diagnosis of a major medical/psychiatric illness or eating disorder
Beskrivning

Illness Major | Mental disorders Major | Eating Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0013473
abnormal blood glucose, tsh, cbc, bun, creatinine
Beskrivning

Blood glucose abnormal | Serum TSH level abnormal | Full blood count abnormal | Blood urea abnormal | Serum creatinine abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0580546
UMLS CUI [2]
C0580434
UMLS CUI [3]
C0438216
UMLS CUI [4]
C0438242
UMLS CUI [5]
C0438243
alt greater than 150% of the normal upper limit
Beskrivning

Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
plans for a vacation during the study that would preclude adherence to prescribed diet
Beskrivning

Vacation Planned | Adherence Excluded Prescribed diet

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680199
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0517866
additional exclusions for female participants: irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment
Beskrivning

Exclusion Criteria Additional Gender | Irregular periods | Change Contraceptive Agents | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0079399
UMLS CUI [2]
C0156404
UMLS CUI [3,1]
C0392747
UMLS CUI [3,2]
C0009871
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0006147
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Similar models

Eligibility Obesity NCT02068885

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02068885
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18 to 55 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi ≥ 25 kg/m2
boolean
C1305855 (UMLS CUI [1])
Body mass index | Body Weight
Item
bmi < 40 kg/m2 and weight ≤ 300 lbs (136 kg)
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Medical clearance note Primary care provider
Item
medical clearance from a primary care provider
boolean
C4483684 (UMLS CUI [1,1])
C2735026 (UMLS CUI [1,2])
Matriculation University Planned | University student Work Planned
Item
plans to matriculate as a student at framingham state university or work on campus throughout the academic year of enrollment in the study
boolean
C0870860 (UMLS CUI [1,1])
C0041740 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0597615 (UMLS CUI [2,1])
C0043227 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Food Study Protocol Willing | Beverages Study Protocol Willing | Food Allergy Absent | Food aversion Absent
Item
willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions
boolean
C0016452 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0005329 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0016470 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0877173 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Eating Dining room Willing
Item
willingness to eat in the dining hall
boolean
C0013470 (UMLS CUI [1,1])
C0557648 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Alcohol consumption Discontinue Willing
Item
willingness to abstain from consuming alcohol during participation
boolean
C0001948 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Change Body Weight Percentage Past Year
Item
change in body weight exceeding ±10% during prior year
boolean
C0392747 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C4086728 (UMLS CUI [1,4])
Adherence Special Diet Therapy
Item
recent adherence to a special diet
boolean
C1510802 (UMLS CUI [1,1])
C1519433 (UMLS CUI [1,2])
Adherence Vigorous physical activity
Item
recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)
boolean
C1510802 (UMLS CUI [1,1])
C4267713 (UMLS CUI [1,2])
Pharmaceutical Preparations chronic Affecting Research results | Dietary Supplements chronic Affecting Research results
Item
chronic use of any medication or dietary supplement that could affect study outcomes
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0242295 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Tobacco use
Item
current smoking (1 cigarette in the last week)
boolean
C0543414 (UMLS CUI [1])
Heavy alcohol consumption | Alcoholic drink Quantity Weekly | Binge Drinking
Item
heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (≥
boolean
C2030272 (UMLS CUI [1])
C0001967 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
C0556346 (UMLS CUI [3])
Alcoholic drink Quantity Daily
Item
5 drinks in 1 day, anytime in past 6 months)
boolean
C0001967 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Illness Major | Mental disorders Major | Eating Disorders
Item
physician diagnosis of a major medical/psychiatric illness or eating disorder
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0013473 (UMLS CUI [3])
Blood glucose abnormal | Serum TSH level abnormal | Full blood count abnormal | Blood urea abnormal | Serum creatinine abnormal
Item
abnormal blood glucose, tsh, cbc, bun, creatinine
boolean
C0580546 (UMLS CUI [1])
C0580434 (UMLS CUI [2])
C0438216 (UMLS CUI [3])
C0438242 (UMLS CUI [4])
C0438243 (UMLS CUI [5])
Alanine aminotransferase increased
Item
alt greater than 150% of the normal upper limit
boolean
C0151905 (UMLS CUI [1])
Vacation Planned | Adherence Excluded Prescribed diet
Item
plans for a vacation during the study that would preclude adherence to prescribed diet
boolean
C0680199 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1510802 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0517866 (UMLS CUI [2,3])
Exclusion Criteria Additional Gender | Irregular periods | Change Contraceptive Agents | Pregnancy | Breast Feeding
Item
additional exclusions for female participants: irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
C0156404 (UMLS CUI [2])
C0392747 (UMLS CUI [3,1])
C0009871 (UMLS CUI [3,2])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
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