ID

24867

Description

Worksite Nutrition Study; ODM derived from: https://clinicaltrials.gov/show/NCT00481897

Link

https://clinicaltrials.gov/show/NCT00481897

Keywords

Versions (1)
  1. 8/20/17 8/20/17 -
Uploaded on

August 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Overweight NCT00481897

English

Eligibility Overweight NCT00481897

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT00481897
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
employee at the intervention worksite or the control worksite;
Description

Employee Intervention Work site | Employee Control Work site

Data type

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0162579
UMLS CUI [2,1]
C0599987
UMLS CUI [2,2]
C1882979
UMLS CUI [2,3]
C0162579
bmi > 25 or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration > 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least six months;
Description

Body mass index | Diabetes Mellitus, Non-Insulin-Dependent | Plasma fasting glucose measurement Quantity | Hypoglycemic Agents

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0583513
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0020616
male or female;
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age at least 18 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability and willingness to participate in all components of the study; and
Description

Study Subject Participation Status Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
a willingness to be assigned to a low-fat, vegan diet or control group.
Description

Assignment Fat-Restricted Diet Group | Assignment Vegan diet Group | Assignment Control Group

Data type

boolean

Alias
UMLS CUI [1,1]
C1516050
UMLS CUI [1,2]
C0242970
UMLS CUI [1,3]
C0441833
UMLS CUI [2,1]
C1516050
UMLS CUI [2,2]
C0344353
UMLS CUI [2,3]
C0441833
UMLS CUI [3,1]
C1516050
UMLS CUI [3,2]
C0009932
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of alcohol abuse or dependency followed by any current use;
Description

Alcohol abuse | Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0001973
current or unresolved past drug abuse;
Description

Drug abuse | Drug abuse Unresolved

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0013146
UMLS CUI [2,2]
C1710575
pregnancy;
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
history of severe mental illness;
Description

Mental disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
unstable medical status;
Description

Unstable status Medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0205476
already following a low-fat, vegetarian diet;
Description

Fat-Restricted Diet | Vegetarian diet

Data type

boolean

Alias
UMLS CUI [1]
C0242970
UMLS CUI [2]
C0311164
an inordinate fear of blood draw; and
Description

Fear Blood draw

Data type

boolean

Alias
UMLS CUI [1,1]
C0015726
UMLS CUI [1,2]
C0005834
a1c <7 or >10.5% (for volunteers with diabetes).
Description

Glycosylated hemoglobin A | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0019018
UMLS CUI [2]
C0011849
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Similar models

Eligibility Overweight NCT00481897

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT00481897
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Employee Intervention Work site | Employee Control Work site
Item
employee at the intervention worksite or the control worksite;
boolean
C0599987 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0162579 (UMLS CUI [1,3])
C0599987 (UMLS CUI [2,1])
C1882979 (UMLS CUI [2,2])
C0162579 (UMLS CUI [2,3])
Body mass index | Diabetes Mellitus, Non-Insulin-Dependent | Plasma fasting glucose measurement Quantity | Hypoglycemic Agents
Item
bmi > 25 or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration > 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least six months;
boolean
C1305855 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0583513 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0020616 (UMLS CUI [4])
Gender
Item
male or female;
boolean
C0079399 (UMLS CUI [1])
Age
Item
age at least 18 years;
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status Willing
Item
ability and willingness to participate in all components of the study; and
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Assignment Fat-Restricted Diet Group | Assignment Vegan diet Group | Assignment Control Group
Item
a willingness to be assigned to a low-fat, vegan diet or control group.
boolean
C1516050 (UMLS CUI [1,1])
C0242970 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C1516050 (UMLS CUI [2,1])
C0344353 (UMLS CUI [2,2])
C0441833 (UMLS CUI [2,3])
C1516050 (UMLS CUI [3,1])
C0009932 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Alcohol abuse | Alcoholic Intoxication, Chronic
Item
a history of alcohol abuse or dependency followed by any current use;
boolean
C0085762 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
Drug abuse | Drug abuse Unresolved
Item
current or unresolved past drug abuse;
boolean
C0013146 (UMLS CUI [1])
C0013146 (UMLS CUI [2,1])
C1710575 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Mental disorder Severe
Item
history of severe mental illness;
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Unstable status Medical
Item
unstable medical status;
boolean
C0443343 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Fat-Restricted Diet | Vegetarian diet
Item
already following a low-fat, vegetarian diet;
boolean
C0242970 (UMLS CUI [1])
C0311164 (UMLS CUI [2])
Fear Blood draw
Item
an inordinate fear of blood draw; and
boolean
C0015726 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Glycosylated hemoglobin A | Diabetes Mellitus
Item
a1c <7 or >10.5% (for volunteers with diabetes).
boolean
C0019018 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
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