ID

32875

Beskrivning

Changing Lifestyles for Better Health; ODM derived from: https://clinicaltrials.gov/show/NCT00848757

Länk

https://clinicaltrials.gov/show/NCT00848757

Nyckelord

Versioner (1)
  1. 2018-11-18 2018-11-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 november 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00848757

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00848757

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
in order to be eligible for this study, the following criteria must be met:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ili (the john martinez school).
Beskrivning

Protocol Compliance | Clinic Visits | Lifestyle Therapy Program

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0008952
UMLS CUI [3,1]
C1517876
UMLS CUI [3,2]
C3484370
subjects must have had a 2 hour 75 gram oral glucose tolerance test (ogtt) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
Beskrivning

Oral Glucose Tolerance Test | Glucose measurement, fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0029161
UMLS CUI [2]
C0202045
willingness to undergo fasting blood testing: homa-ir, fasting lipid profile (including total cholesterol, hdl, ldl cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the ogtt) and repeated at 12 months.
Beskrivning

Hematologic Test Fasting | Homeostasis model assessment | Fasting lipid profile | Serum total cholesterol measurement | High density lipoprotein measurement | Serum LDL cholesterol measurement | Triglycerides measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0015663
UMLS CUI [2]
C1829779
UMLS CUI [3]
C0430044
UMLS CUI [4]
C1445957
UMLS CUI [5]
C0392885
UMLS CUI [6]
C0428474
UMLS CUI [7]
C0202236
subjects must have no medical contraindications to exercise or dieting.
Beskrivning

Medical contraindication Absent Exercise | Medical contraindication Absent Diet therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0015259
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0012159
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ili program.
Beskrivning

Diabetes Mellitus | Medical condition Serious Lifestyle Therapy Excluded | Mental condition Serious Lifestyle Therapy Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1517876
UMLS CUI [2,4]
C0332196
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C1517876
UMLS CUI [3,4]
C0332196
subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
Beskrivning

Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Causing Weight loss | Prescribed medication | Drugs, Non-Prescription | Herbal Supplements

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0043094
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C1262477
UMLS CUI [3]
C2239117
UMLS CUI [4]
C0013231
UMLS CUI [5]
C1504473
women who are pregnant or planning to become pregnant will not be enrolled in this study.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
Beskrivning

Abnormal behavior Interferes with Completion Program | Psychosocial problem Interferes with Completion Program | Eating Disorder Study Subject Participation Status Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233514
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C3484370
UMLS CUI [2,1]
C0740697
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C3484370
UMLS CUI [3,1]
C0013473
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
subjects cannot participate if they have concurrent membership in a comprehensive weight management program.
Beskrivning

Membership Weight maintenance regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680038
UMLS CUI [1,2]
C0920298
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00848757

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
in order to be eligible for this study, the following criteria must be met:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Protocol Compliance | Clinic Visits | Lifestyle Therapy Program
Item
subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ili (the john martinez school).
boolean
C0525058 (UMLS CUI [1])
C0008952 (UMLS CUI [2])
C1517876 (UMLS CUI [3,1])
C3484370 (UMLS CUI [3,2])
Oral Glucose Tolerance Test | Glucose measurement, fasting
Item
subjects must have had a 2 hour 75 gram oral glucose tolerance test (ogtt) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
boolean
C0029161 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
Hematologic Test Fasting | Homeostasis model assessment | Fasting lipid profile | Serum total cholesterol measurement | High density lipoprotein measurement | Serum LDL cholesterol measurement | Triglycerides measurement
Item
willingness to undergo fasting blood testing: homa-ir, fasting lipid profile (including total cholesterol, hdl, ldl cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the ogtt) and repeated at 12 months.
boolean
C0018941 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C1829779 (UMLS CUI [2])
C0430044 (UMLS CUI [3])
C1445957 (UMLS CUI [4])
C0392885 (UMLS CUI [5])
C0428474 (UMLS CUI [6])
C0202236 (UMLS CUI [7])
Medical contraindication Absent Exercise | Medical contraindication Absent Diet therapy
Item
subjects must have no medical contraindications to exercise or dieting.
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0012159 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus | Medical condition Serious Lifestyle Therapy Excluded | Mental condition Serious Lifestyle Therapy Excluded
Item
subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ili program.
boolean
C0011849 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1517876 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
C3840291 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C1517876 (UMLS CUI [3,3])
C0332196 (UMLS CUI [3,4])
Pharmaceutical Preparations Causing Weight Gain | Pharmaceutical Preparations Causing Weight loss | Prescribed medication | Drugs, Non-Prescription | Herbal Supplements
Item
subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0043094 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1262477 (UMLS CUI [2,3])
C2239117 (UMLS CUI [3])
C0013231 (UMLS CUI [4])
C1504473 (UMLS CUI [5])
Pregnancy | Pregnancy, Planned
Item
women who are pregnant or planning to become pregnant will not be enrolled in this study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Abnormal behavior Interferes with Completion Program | Psychosocial problem Interferes with Completion Program | Eating Disorder Study Subject Participation Status Excluded
Item
any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
boolean
C0233514 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C3484370 (UMLS CUI [1,4])
C0740697 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C3484370 (UMLS CUI [2,4])
C0013473 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Membership Weight maintenance regimen
Item
subjects cannot participate if they have concurrent membership in a comprehensive weight management program.
boolean
C0680038 (UMLS CUI [1,1])
C0920298 (UMLS CUI [1,2])
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