ID

16644

Description

Make Better Choices Study; ODM derived from: https://clinicaltrials.gov/show/NCT00113672

Link

https://clinicaltrials.gov/show/NCT00113672

Keywords

Versions (1)
  1. 7/28/16 7/28/16 -
Uploaded on

July 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Diseases NCT00113672

English

Eligibility Cardiovascular Diseases NCT00113672

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
sedentary community dwelling adults with a suboptimal diet
Description

Community Dwelling Adult Sedentary lifestyle | Community Dwelling Adult Diet Suboptimal

Data type

boolean

Alias
UMLS CUI [1,1]
C4045975
UMLS CUI [1,2]
C0001675
UMLS CUI [1,3]
C1532253
UMLS CUI [2,1]
C4045975
UMLS CUI [2,2]
C0001675
UMLS CUI [2,3]
C0012155
UMLS CUI [2,4]
C2984009
motivated to make changes in diet and activity level
Description

Motivation Dietary Modification | Motivation Change activity level

Data type

boolean

Alias
UMLS CUI [1,1]
C0026605
UMLS CUI [1,2]
C0086153
UMLS CUI [2,1]
C0026605
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0683317
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
few exclusion criteria will be implemented in order to enhance generalizability
Description

Exclusion Criteria Generalized

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
for safety, participants with unstable medical conditions (uncontrolled hypertension, diabetes, recent myocardial infarction) will be excluded. those with stable medical conditions will require physician approval to participate but will not be excluded because the prescribed changes in diet and activity match healthy, attainable guidelines for all americans.
Description

medical condition Unstable Due to Safety | Uncontrolled hypertension | Diabetes Mellitus | Myocardial Infarction Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0036043
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0011849
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C0332185
cannot read the study questionnaires
Description

Able to read Clinical Trial Subject Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C3890411
committed to following an incompatible dietary regimen
Description

Diet Plan Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C1548788
pregnant, trying to get pregnant, or breastfeeding
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
people with anorexia, bulimia, or report active suicidal ideation will not be enrolled because they might practice overly severe dietary restrictions
Description

Anorexia | Bulimia | Feeling suicidal | dietary restrictions Severe

Data type

boolean

Alias
UMLS CUI [1]
C0003123
UMLS CUI [2]
C0006370
UMLS CUI [3]
C0424000
UMLS CUI [4,1]
C0425422
UMLS CUI [4,2]
C0205082
binge eating disorder
Description

Binge eating disorder

Data type

boolean

Alias
UMLS CUI [1]
C0596170
current substance abuse or dependence, other than nicotine dependence will be excluded because of concern about their ability to maintain accurate records of intake and activity. smokers will be accepted and during recreational laboratory sessions will be able to smoke cigarettes in an adjoining room that is used as a smoking laboratory.
Description

Substance Use Disorders | Substance Dependence | Nicotine Dependence | Compliance behavior Limited | Tobacco use allowed

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0028043
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0439801
UMLS CUI [5,1]
C0543414
UMLS CUI [5,2]
C0683607
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Similar models

Eligibility Cardiovascular Diseases NCT00113672

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Community Dwelling Adult Sedentary lifestyle | Community Dwelling Adult Diet Suboptimal
Item
sedentary community dwelling adults with a suboptimal diet
boolean
C4045975 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
C1532253 (UMLS CUI [1,3])
C4045975 (UMLS CUI [2,1])
C0001675 (UMLS CUI [2,2])
C0012155 (UMLS CUI [2,3])
C2984009 (UMLS CUI [2,4])
Motivation Dietary Modification | Motivation Change activity level
Item
motivated to make changes in diet and activity level
boolean
C0026605 (UMLS CUI [1,1])
C0086153 (UMLS CUI [1,2])
C0026605 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0683317 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Generalized
Item
few exclusion criteria will be implemented in order to enhance generalizability
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
medical condition Unstable Due to Safety | Uncontrolled hypertension | Diabetes Mellitus | Myocardial Infarction Recent
Item
for safety, participants with unstable medical conditions (uncontrolled hypertension, diabetes, recent myocardial infarction) will be excluded. those with stable medical conditions will require physician approval to participate but will not be excluded because the prescribed changes in diet and activity match healthy, attainable guidelines for all americans.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C1868885 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Able to read Clinical Trial Subject Questionnaire
Item
cannot read the study questionnaires
boolean
C0586740 (UMLS CUI [1,1])
C3890411 (UMLS CUI [1,2])
Diet Plan Inappropriate
Item
committed to following an incompatible dietary regimen
boolean
C0012155 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, trying to get pregnant, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Anorexia | Bulimia | Feeling suicidal | dietary restrictions Severe
Item
people with anorexia, bulimia, or report active suicidal ideation will not be enrolled because they might practice overly severe dietary restrictions
boolean
C0003123 (UMLS CUI [1])
C0006370 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
C0425422 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Binge eating disorder
Item
binge eating disorder
boolean
C0596170 (UMLS CUI [1])
Substance Use Disorders | Substance Dependence | Nicotine Dependence | Compliance behavior Limited | Tobacco use allowed
Item
current substance abuse or dependence, other than nicotine dependence will be excluded because of concern about their ability to maintain accurate records of intake and activity. smokers will be accepted and during recreational laboratory sessions will be able to smoke cigarettes in an adjoining room that is used as a smoking laboratory.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0028043 (UMLS CUI [3])
C1321605 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0543414 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
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