ID

42713

Description

E-coaching for Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02343107

Link

https://clinicaltrials.gov/show/NCT02343107

Keywords

Versions (2)
  1. 11/27/15 11/27/15 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Abdominal Obesity NCT02343107

English

Eligibility Abdominal Obesity NCT02343107

1 forms  
Inclusion criteria
Description

Inclusion criteria

Age and Consent
Description

subject, male or female, aged 18-75 years (inclusive) who agrees to participate in the study and who gave verbal consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1511481
Abdominal obesity defined by waist circumference
Description

abdominal obesity defined by waist circumference ≥ 102 cm for men and ≥ 88 cm for women

Data type

text

Alias
UMLS CUI [1]
C0311277
Diabetes mellitus and hba1c measurement the month prior to selection
Description

diabetic subject with hba1c between 5,6% and 8,5% in the month before selection (using venous or capillary blood samples)

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0202054
Must have already received a standard nutrition education
Description

subject have already received a standard nutrition education for the treatment of diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0204934
estimated average calorie intake between 1200 and 4000 calories
Description

Calorie intake

Data type

boolean

Alias
UMLS CUI [1]
C2095644
Under stable treatment for at least 3 months
Description

anti-diabetic treatments, antihypertensive or lipid-lowering therapy stable for at least 3 months (at the initial blood test)

Data type

boolean

Alias
UMLS CUI [1]
C0578998
UMLS CUI [2]
C0150544
UMLS CUI [3]
C0086440
Weight change of no more than 4kg 3 months prior to enlistment and without restrictive diet
Description

subject of a weight and a stable diet, not restrictive in the past 3 months (weight change ≤ 4 kg peak to peak)

Data type

boolean

Alias
UMLS CUI [1]
C0005911
UMLS CUI [2]
C0011878
Having Health Insurance or comparable health coverage
Description

affiliated to the social security system or having a similar regime

Data type

boolean

Alias
UMLS CUI [1]
C0021682
access to internet and usual use, possession of an email address
Description

Internet access

Data type

boolean

Alias
UMLS CUI [1]
C0282111
UMLS CUI [2]
C1705961
understanding and reading french
Description

understanding and reading french

Data type

boolean

Alias
UMLS CUI [1]
C0376246
UMLS CUI [2]
C1321605
Exclusion criteria
Description

Exclusion criteria

Alcohol abuse
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
symptomatic cardiovascular disease
Description

(myocardial infarction, angina pectoris, surgical or endovascular intervention, stroke older than 6 months, symptomatic lower limb arteritis)

Data type

boolean

Alias
UMLS CUI [1]
C0007222
subject receiving general or local treatment that may interfere with the assessment of the primary endpoint
Description

subject receiving general or local treatment that may interfere with the assessment of the primary endpoint

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
situation requiring rapid equilibration of diabetes
Description

situation requiring rapid equilibration of diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
subject with any severe or acute illness which may influence the results of the study or to life-threatening
Description

severe or acute illness which may influence the results of the study

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
subject in a situation which, in the opinion of the investigator, would interfere with the optimal participation in the study or be a particular risk to the patient
Description

interferance with the optimal participation in the study or particular risk to the patient

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
patient who underwent obesity surgery to the exclusion of a gastric band, loosened or removed for more than a year
Description

patient who underwent obesity surgery to the exclusion of a gastric band, loosened or removed for more than a year

Data type

boolean

Alias
UMLS CUI [1]
C2112820
UMLS CUI [2]
C1960832
for female subjects: pregnancy or lactation, or subject may become pregnant during the study
Description

Pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
for female subjects: subject may change hormone treatment under study (contraceptive or hormone replacement)
Description

Change of contraceptive treatment

Data type

boolean

Alias
UMLS CUI [1]
C1443485
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Similar models

Eligibility Abdominal Obesity NCT02343107

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Age and Consent
Item
Age and Consent
boolean
C0001779 (UMLS CUI [1])
C1511481 (UMLS CUI [2])
Item
Abdominal obesity defined by waist circumference
text
C0311277 (UMLS CUI [1])
Abdominal obesity defined by waist circumference
Code List
Abdominal obesity defined by waist circumference
CL Item
men≥ 102cm (1)
CL Item
women≥ 88cm (2)
Diabetes mellitus and hba1c measurement the month prior to selection
Item
Diabetes mellitus and hba1c measurement the month prior to selection
boolean
C0011849 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
nutrition education
Item
Must have already received a standard nutrition education
boolean
C0204934 (UMLS CUI [1])
Calorie intake
Item
estimated average calorie intake between 1200 and 4000 calories
boolean
C2095644 (UMLS CUI [1])
Under stable treatment for at least 3 months
Item
Under stable treatment for at least 3 months
boolean
C0578998 (UMLS CUI [1])
C0150544 (UMLS CUI [2])
C0086440 (UMLS CUI [3])
Weight change of no more than 4kg 3 month prior to enlistment and without restrictive diet
Item
Weight change of no more than 4kg 3 months prior to enlistment and without restrictive diet
boolean
C0005911 (UMLS CUI [1])
C0011878 (UMLS CUI [2])
Health Insurance
Item
Having Health Insurance or comparable health coverage
boolean
C0021682 (UMLS CUI [1])
Internet access
Item
access to internet and usual use, possession of an email address
boolean
C0282111 (UMLS CUI [1])
C1705961 (UMLS CUI [2])
understanding and reading french
Item
understanding and reading french
boolean
C0376246 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Item Group
Exclusion criteria
Alcohol abuse
Item
Alcohol abuse
boolean
C0038586 (UMLS CUI [1])
symptomatic cardiovascular disease
Item
symptomatic cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
subject receiving general or local treatment that may interfere with the assessment of the primary endpoint
Item
subject receiving general or local treatment that may interfere with the assessment of the primary endpoint
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
situation requiring rapid equilibration of diabetes
Item
situation requiring rapid equilibration of diabetes
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
severe or acute illness which may influence the results of the study
Item
subject with any severe or acute illness which may influence the results of the study or to life-threatening
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
interferance with the optimal participation in the study or particular risk to the patient
Item
subject in a situation which, in the opinion of the investigator, would interfere with the optimal participation in the study or be a particular risk to the patient
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Obesity surgery
Item
patient who underwent obesity surgery to the exclusion of a gastric band, loosened or removed for more than a year
boolean
C2112820 (UMLS CUI [1])
C1960832 (UMLS CUI [2])
Pregnancy or lactation
Item
for female subjects: pregnancy or lactation, or subject may become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Change of contraceptive treatment
Item
for female subjects: subject may change hormone treatment under study (contraceptive or hormone replacement)
boolean
C1443485 (UMLS CUI [1])
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