ID

38864

Description

A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians; ODM derived from: https://clinicaltrials.gov/show/NCT01084928

Link

https://clinicaltrials.gov/show/NCT01084928

Keywords

Versions (1)
  1. 11/10/19 11/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01084928

English

Eligibility Diabetes NCT01084928

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01084928
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
self-identified as being of south asian origin
Description

South Asian

Data type

boolean

Alias
UMLS CUI [1]
C1519427
live in or near atlanta, georgia
Description

Residence Georgia, USA

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0017452
bmi greater than 22 kg/m2 calculated from standardized weight and height measurements (a bmi of greater than 22 kg/m2 is indicative of overweight in the south asian population)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
a confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no prior diabetes diagnosis (physician diagnosis or on diabetes medication)
Description

Diabetes Mellitus Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0332197
a high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 120 (measured during screening)
Description

High risk of Diabetes Mellitus | Pre-diabetes | Capillary blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0011849
UMLS CUI [2]
C0362046
UMLS CUI [3]
C0457578
fasting glucose of 100-125 mg/dl (impaired fasting glucose tolerance) and/or 2-hour post-load glucose of 140-199 mg/dl (impaired glucose tolerance), measured at baseline visit
Description

Glucose measurement, fasting | Decreased glucose tolerance Fasting | Fasting glucose measurement Post Glucose load test

Data type

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2,1]
C0151671
UMLS CUI [2,2]
C0015663
UMLS CUI [3,1]
C0202045
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0730535
no history of heart disease, serious illness, or conditions that may impede or prohibit participation and are not currently pregnant
Description

Heart Disease Absent | Illness Serious Absent | Absence Condition Preventing Participation | Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0348080
UMLS CUI [3,3]
C1292733
UMLS CUI [3,4]
C0679823
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
capillary glucose less than 120
Description

Capillary blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0457578
fasting glucose less than 100 mg/dl or greater than 125 mg/dl or 2 hour post-load glucose less than 140 mg/dl or greater than 199 mg/dl
Description

Glucose measurement, fasting | Fasting glucose measurement Post Glucose load test

Data type

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2,1]
C0202045
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0730535
age less than 25 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bmi less than 22 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
history of heart disease or diabetes (other than gestational diabetes)
Description

Heart Disease | History of diabetes mellitus | Exception Gestational Diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0455488
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0085207
current functional difficulties
Description

With difficulty functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0332218
UMLS CUI [1,2]
C0205245
severe lung disease or cancer
Description

Lung disease Severe | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0006826
failure to pass cardiovascular stress test
Description

Cardiovascular stress test failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1384495
UMLS CUI [1,2]
C0231175
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Similar models

Eligibility Diabetes NCT01084928

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01084928
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
South Asian
Item
self-identified as being of south asian origin
boolean
C1519427 (UMLS CUI [1])
Residence Georgia, USA
Item
live in or near atlanta, georgia
boolean
C0237096 (UMLS CUI [1,1])
C0017452 (UMLS CUI [1,2])
Body mass index
Item
bmi greater than 22 kg/m2 calculated from standardized weight and height measurements (a bmi of greater than 22 kg/m2 is indicative of overweight in the south asian population)
boolean
C1305855 (UMLS CUI [1])
Age
Item
a confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.)
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus Absent
Item
no prior diabetes diagnosis (physician diagnosis or on diabetes medication)
boolean
C0011849 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
High risk of Diabetes Mellitus | Pre-diabetes | Capillary blood glucose measurement
Item
a high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 120 (measured during screening)
boolean
C0332167 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0362046 (UMLS CUI [2])
C0457578 (UMLS CUI [3])
Glucose measurement, fasting | Decreased glucose tolerance Fasting | Fasting glucose measurement Post Glucose load test
Item
fasting glucose of 100-125 mg/dl (impaired fasting glucose tolerance) and/or 2-hour post-load glucose of 140-199 mg/dl (impaired glucose tolerance), measured at baseline visit
boolean
C0202045 (UMLS CUI [1])
C0151671 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0202045 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0730535 (UMLS CUI [3,3])
Heart Disease Absent | Illness Serious Absent | Absence Condition Preventing Participation | Pregnancy Absent
Item
no history of heart disease, serious illness, or conditions that may impede or prohibit participation and are not currently pregnant
boolean
C0018799 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0348080 (UMLS CUI [3,2])
C1292733 (UMLS CUI [3,3])
C0679823 (UMLS CUI [3,4])
C0032961 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Capillary blood glucose measurement
Item
capillary glucose less than 120
boolean
C0457578 (UMLS CUI [1])
Glucose measurement, fasting | Fasting glucose measurement Post Glucose load test
Item
fasting glucose less than 100 mg/dl or greater than 125 mg/dl or 2 hour post-load glucose less than 140 mg/dl or greater than 199 mg/dl
boolean
C0202045 (UMLS CUI [1])
C0202045 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0730535 (UMLS CUI [2,3])
Age
Item
age less than 25 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi less than 22 kg/m2
boolean
C1305855 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Heart Disease | History of diabetes mellitus | Exception Gestational Diabetes
Item
history of heart disease or diabetes (other than gestational diabetes)
boolean
C0018799 (UMLS CUI [1])
C0455488 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0085207 (UMLS CUI [3,2])
With difficulty functional
Item
current functional difficulties
boolean
C0332218 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
Lung disease Severe | Malignant Neoplasms
Item
severe lung disease or cancer
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
Cardiovascular stress test failed
Item
failure to pass cardiovascular stress test
boolean
C1384495 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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