ID

31238

Description

Study of Macronutrients and Heart Disease Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00609271

Link

https://clinicaltrials.gov/show/NCT00609271

Keywords

Versions (1)
  1. 7/31/18 7/31/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 31, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Obesity NCT00609271

English

Eligibility Obesity NCT00609271

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00609271
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged 22 - 75 years, any race/ethnicity
Description

Age | Racial group Any | Ethnicity Any

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
bmi of 30 - 45 k/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
willing and able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of self-reported clinical cvd (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
Description

Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Coronary revascularisation | Heart failure | Cerebrovascular accident | Transient Ischemic Attack | Peripheral Arterial Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0877341
UMLS CUI [5]
C0018801
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0007787
UMLS CUI [8]
C1704436
medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
Description

Medical condition Low-carbohydrate diet Unfavorable | Diabetes Mellitus | Kidney Diseases | Malignant Neoplasms Treatment required for | Osteoporosis | Thyroid Disease untreated | Gout

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0259836
UMLS CUI [1,3]
C3640815
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0022658
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0332121
UMLS CUI [5]
C0029456
UMLS CUI [6,1]
C0040128
UMLS CUI [6,2]
C0332155
UMLS CUI [7]
C0018099
current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
Description

Antihypertensive Agents Quantity | Anticholesteremic Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0003277
UMLS CUI [2,2]
C1265611
for women, current pregnancy or breastfeeding or plans to become pregnant during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
consumption of more than 21 alcoholic beverages per week
Description

Consumption Alcoholic Beverages Quantity Weekly

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332174
currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss >15 pounds within 6 months of study entry
Description

Diet therapy | Weight-Loss Agents | Bariatric Surgery | Weight decreased Pounds Quantity Timespan

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0376606
UMLS CUI [3]
C1456587
UMLS CUI [4,1]
C1262477
UMLS CUI [4,2]
C0439219
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0872291
plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site
Description

Relocation of home Planned | Distance Study Site Difficulty

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0012751
UMLS CUI [2,2]
C2825164
UMLS CUI [2,3]
C0332218
participation of another household member in the study; employees or persons living with employees of the study
Description

Participation Household Member Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C4330269
UMLS CUI [1,3]
C0008976
participation in other lifestyle intervention trials currently
Description

Study Subject Participation Status | Life Style Intervention

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0023676
UMLS CUI [2,2]
C0184661
at the discretion of the study coordinator
Description

Study Coordinator Decision

Data type

boolean

Alias
UMLS CUI [1,1]
C1710220
UMLS CUI [1,2]
C0679006
Back to the top of the page

Similar models

Eligibility Obesity NCT00609271

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00609271
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Racial group Any | Ethnicity Any
Item
men or women aged 22 - 75 years, any race/ethnicity
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Body mass index
Item
bmi of 30 - 45 k/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Coronary revascularisation | Heart failure | Cerebrovascular accident | Transient Ischemic Attack | Peripheral Arterial Diseases
Item
history of self-reported clinical cvd (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
boolean
C0007222 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0877341 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C1704436 (UMLS CUI [8])
Medical condition Low-carbohydrate diet Unfavorable | Diabetes Mellitus | Kidney Diseases | Malignant Neoplasms Treatment required for | Osteoporosis | Thyroid Disease untreated | Gout
Item
medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
boolean
C3843040 (UMLS CUI [1,1])
C0259836 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0006826 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
C0029456 (UMLS CUI [5])
C0040128 (UMLS CUI [6,1])
C0332155 (UMLS CUI [6,2])
C0018099 (UMLS CUI [7])
Antihypertensive Agents Quantity | Anticholesteremic Agents Quantity
Item
current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003277 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
for women, current pregnancy or breastfeeding or plans to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Consumption Alcoholic Beverages Quantity Weekly
Item
consumption of more than 21 alcoholic beverages per week
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
Diet therapy | Weight-Loss Agents | Bariatric Surgery | Weight decreased Pounds Quantity Timespan
Item
currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss >15 pounds within 6 months of study entry
boolean
C0012159 (UMLS CUI [1])
C0376606 (UMLS CUI [2])
C1456587 (UMLS CUI [3])
C1262477 (UMLS CUI [4,1])
C0439219 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0872291 (UMLS CUI [4,4])
Relocation of home Planned | Distance Study Site Difficulty
Item
plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0012751 (UMLS CUI [2,1])
C2825164 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Participation Household Member Clinical Trial
Item
participation of another household member in the study; employees or persons living with employees of the study
boolean
C0679823 (UMLS CUI [1,1])
C4330269 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Study Subject Participation Status | Life Style Intervention
Item
participation in other lifestyle intervention trials currently
boolean
C2348568 (UMLS CUI [1])
C0023676 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
Study Coordinator Decision
Item
at the discretion of the study coordinator
boolean
C1710220 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial