ID

42713

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02343107

Stichworte

Versionen (2)
  1. 27.11.15 27.11.15 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Abdominal Obesity NCT02343107

Englisch

Eligibility Abdominal Obesity NCT02343107

1 Formulare  
Inclusion criteria
Beschreibung

Inclusion criteria

Age and Consent
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

text

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

Calorie intake

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

affiliated to the social security system or having a similar regime

Datentyp

boolean

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

Internet access

Datentyp

boolean

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

understanding and reading french

Datentyp

boolean

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

Exclusion criteria

Alcohol abuse
Beschreibung

Alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
symptomatic cardiovascular disease
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

boolean

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

situation requiring rapid equilibration of diabetes

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

Pregnancy or lactation

Datentyp

boolean

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

Change of contraceptive treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C1443485
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Ähnliche Modelle

Eligibility Abdominal Obesity NCT02343107

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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