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ID

42713

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02343107

Trefwoorden

Versies (2)
  1. 27-11-15 27-11-15 -
  2. 17-09-21 17-09-21 -
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17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Abdominal Obesity NCT02343107

    Engels

    Eligibility Abdominal Obesity NCT02343107

    1 Formulieren  
    Inclusion criteria
    Beschrijving

    Inclusion criteria

    Age and Consent
    Beschrijving

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

    Datatype

    boolean

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

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

    Datatype

    text

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

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

    Datatype

    boolean

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

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

    Datatype

    boolean

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

    Calorie intake

    Datatype

    boolean

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

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

    Datatype

    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
    Beschrijving

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

    Datatype

    boolean

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

    affiliated to the social security system or having a similar regime

    Datatype

    boolean

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

    Internet access

    Datatype

    boolean

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

    understanding and reading french

    Datatype

    boolean

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

    Exclusion criteria

    Alcohol abuse
    Beschrijving

    Alcohol abuse

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    symptomatic cardiovascular disease
    Beschrijving

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

    Datatype

    boolean

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

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

    Datatype

    boolean

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

    situation requiring rapid equilibration of diabetes

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

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

    Datatype

    boolean

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

    Pregnancy or lactation

    Datatype

    boolean

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

    Change of contraceptive treatment

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1443485
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    Similar models

    Eligibility Abdominal Obesity NCT02343107

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

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