ID

38226

Description

The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2); ODM derived from: https://clinicaltrials.gov/show/NCT01511276

Link

https://clinicaltrials.gov/show/NCT01511276

Keywords

Versions (1)
  1. 9/29/19 9/29/19 -
Copyright Holder

See cinicaltrials.gov

Uploaded on

September 29, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Breast Cancer Risk NCT01511276

English

Eligibility Breast Cancer Risk NCT01511276

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
50-69 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
postmenopausal (>12 months after last menses)
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
bmi 25-35 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
sedentary (<2 hours per week of at least moderately intensive activities (>4 met))
Description

Sedentary lifestyle | Moderate exercise intensity hours per week

Data type

boolean

Alias
UMLS CUI [1]
C1532253
UMLS CUI [2,1]
C3841231
UMLS CUI [2,2]
C0556976
willing to be randomly assigned to one of the three study arms
Description

Random assignment Protocol Treatment Arm

Data type

boolean

Alias
UMLS CUI [1,1]
C0814868
UMLS CUI [1,2]
C1522541
informed consent to participate in all screening and study activities.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presently using sex-hormones
Description

Use of sex-hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0036884
maintenance use of corticosteroids
Description

Maintenance Use of Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0024501
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0001617
suffering cancer (in medical history) except for non-melanoma skin cancers
Description

Malignant Neoplasms | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
suffering type ii diabetes mellitus or other endocrine related diseases
Description

Diabetes Mellitus, Non-Insulin-Dependent | Endocrine System Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0014130
smoking
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
any disorder that might impede participation in the exercise programme
Description

Disease Interferes with Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0015259
following, or the intention to follow, a structured weight loss programme elsewhere
Description

Weight reduction regimen | Weight reduction regimen intended

Data type

boolean

Alias
UMLS CUI [1]
C0311130
UMLS CUI [2,1]
C0311130
UMLS CUI [2,2]
C1283828
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Similar models

Eligibility Breast Cancer Risk NCT01511276

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
50-69 years of age
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal (>12 months after last menses)
boolean
C0232970 (UMLS CUI [1])
Body mass index
Item
bmi 25-35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Sedentary lifestyle | Moderate exercise intensity hours per week
Item
sedentary (<2 hours per week of at least moderately intensive activities (>4 met))
boolean
C1532253 (UMLS CUI [1])
C3841231 (UMLS CUI [2,1])
C0556976 (UMLS CUI [2,2])
Random assignment Protocol Treatment Arm
Item
willing to be randomly assigned to one of the three study arms
boolean
C0814868 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Informed Consent
Item
informed consent to participate in all screening and study activities.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Use of sex-hormones
Item
presently using sex-hormones
boolean
C1524063 (UMLS CUI [1,1])
C0036884 (UMLS CUI [1,2])
Maintenance Use of Adrenal Cortex Hormones
Item
maintenance use of corticosteroids
boolean
C0024501 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
Malignant Neoplasms | Exception Skin carcinoma
Item
suffering cancer (in medical history) except for non-melanoma skin cancers
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent | Endocrine System Diseases
Item
suffering type ii diabetes mellitus or other endocrine related diseases
boolean
C0011860 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
Tobacco use
Item
smoking
boolean
C0543414 (UMLS CUI [1])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Disease Interferes with Exercise
Item
any disorder that might impede participation in the exercise programme
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
Weight reduction regimen | Weight reduction regimen intended
Item
following, or the intention to follow, a structured weight loss programme elsewhere
boolean
C0311130 (UMLS CUI [1])
C0311130 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
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