ID

22208

Beschreibung

Strength and Nutrition Outcomes for Latino Adolescents; ODM derived from: https://clinicaltrials.gov/show/NCT00697580

Link

https://clinicaltrials.gov/show/NCT00697580

Stichworte

Versionen (1)
  1. 23.05.17 23.05.17 -
Hochgeladen am

23. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Obesity NCT00697580

Englisch

Eligibility Obesity NCT00697580

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00697580
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
overweight (age- & sex-specific body mass index ≥ 85th percentile based on cdc bmi growth charts [us department of health and human services, 2000], calculated by epi info software, version 3.3)
Beschreibung

Overweight Body mass index | Body mass index Age Specific | Body mass index Gender Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497406
UMLS CUI [1,2]
C1305855
UMLS CUI [2,1]
C1305855
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C1305855
UMLS CUI [3,2]
C0079399
UMLS CUI [3,3]
C0205369
latino (both sets of grandparents must be of latino heritage as defined by self-report; limited to latinos to maintain a homogeneous sample and because latinos are at increased risk of insulin resistance and type 2 diabetes.) if the participant or the parent is unsure of the country of origin of all 4 grandparents they will be excluded from the study. the participants and their families are not asked whether or not their grandparents are undocumented immigrants.
Beschreibung

Latinos | Homogeneous Sample Selection | Insulin Resistance Risk Increased | Non-Insulin-Dependent Diabetes Mellitus Risk Increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086528
UMLS CUI [2]
C2348990
UMLS CUI [3,1]
C0021655
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0205217
UMLS CUI [4,1]
C0011860
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C0205217
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
presently taking medication(s) or diagnosed with any syndrome or disease that could influence dietary intake, exercise ability, body composition and fat distribution, or insulin action and secretion.
Beschreibung

Pharmaceutical Preparations Affecting Dietary intake | Pharmaceutical Preparations Affecting Exercise Ability | Pharmaceutical Preparations Affecting Body Composition | Pharmaceutical Preparations Affecting Body Fat Distribution | Pharmaceutical Preparations Affecting Insulin Effect | Pharmaceutical Preparations Affecting insulin secretion | Disease Affecting Dietary intake | Disease Affecting Exercise Ability | Disease Affecting Body Composition | Disease Affecting Body Fat Distribution | Disease Affecting Insulin Effect | Disease Affecting insulin secretion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1286104
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0015259
UMLS CUI [2,4]
C0085732
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0005885
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0424621
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0021641
UMLS CUI [5,4]
C1280500
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C1256369
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0392760
UMLS CUI [7,3]
C1286104
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0392760
UMLS CUI [8,3]
C0015259
UMLS CUI [8,4]
C0085732
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0392760
UMLS CUI [9,3]
C0005885
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0392760
UMLS CUI [10,3]
C0424621
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0392760
UMLS CUI [11,3]
C0021641
UMLS CUI [11,4]
C1280500
UMLS CUI [12,1]
C0012634
UMLS CUI [12,2]
C0392760
UMLS CUI [12,3]
C1256369
previously diagnosed with any major illness since birth (e.g. severe intrauterine growth retardation, chronic birth asphyxia, cancer).
Beschreibung

Illness Major | Severe intrauterine growth retardation | Asphyxia Neonatorum chronic | Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C1855843
UMLS CUI [3,1]
C0004045
UMLS CUI [3,2]
C0205191
UMLS CUI [4]
C0006826
children will not be eligible for participation if they have any diagnostic criteria for diabetes including polyuria, polydipsia with or without unexplained weight loss, fasting plasma glucose > 126 mg/dl, or a 2-hour plasma glucose >200 mg/dl during an oral glucose tolerance test. children will also be excluded if they test positive for diabetes-related auto-antibodies, including ica512 and gad. children testing positive for type 2 diabetes will be referred for treatment. children with impaired glucose tolerance (fasting glucose >110 mg/dl or 2-hour glucose >140 mg/dl during an ogtt) and/or conditions associated with insulin resistance (e.g. acanthosis nigricans, hypertension, dyslipidemia, pcos) will be eligible, as long as they are not receiving treatment and meet other eligibility criteria.
Beschreibung

Diabetes Mellitus | Polyuria | Polydipsia | Unexplained weight loss | Plasma fasting glucose measurement | Plasma Glucose Measurement 2 Hours | Oral Glucose Tolerance Test | Autoantibodies Diabetes Mellitus Related | ICA512 autoantibody | Glutamic Acid Decarboxylase Antibody | Diabetes Mellitus, Non-Insulin-Dependent | Impaired glucose tolerance | Condition Associated with Insulin Resistance | Acanthosis Nigricans | Hypertensive disease | Dyslipidemias | Polycystic Ovary Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0032617
UMLS CUI [3]
C0085602
UMLS CUI [4]
C1828173
UMLS CUI [5]
C0583513
UMLS CUI [6,1]
C0202042
UMLS CUI [6,2]
C1292425
UMLS CUI [7]
C0029161
UMLS CUI [8,1]
C0004358
UMLS CUI [8,2]
C0011849
UMLS CUI [8,3]
C0439849
UMLS CUI [9]
C0382981
UMLS CUI [10]
C0443891
UMLS CUI [11]
C0011860
UMLS CUI [12]
C0271650
UMLS CUI [13,1]
C0348080
UMLS CUI [13,2]
C0332281
UMLS CUI [13,3]
C0021655
UMLS CUI [14]
C0000889
UMLS CUI [15]
C0020538
UMLS CUI [16]
C0242339
UMLS CUI [17]
C0032460
participants who are involved in any weight training, exercise, nutrition, or weight loss program or have been in the past 6 months.
Beschreibung

Weight Lifting | Exercise | Feeding and dietary regimes | Weight Reduction Programs

Datentyp

boolean

Alias
UMLS CUI [1]
C0043095
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0600072
UMLS CUI [4]
C3179079
participants that do not follow the rules and guidelines of appropriate conduct during participation, i.e., disruptive behavior, derogatory or racist comments, or any acts of physical violence towards study staff or other participants, and use of illegal substances. the principal investigator dr. michael goran will decide if this conduct warrants exclusion or removal from the study.
Beschreibung

Protocol Compliance Unwilling | Disruptive Behavior | Physical violence | Illicit drug use

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2]
C0474416
UMLS CUI [3]
C0476480
UMLS CUI [4]
C0281875
pregnancy test comes out positive.
Beschreibung

Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0240802
children who live further than 20 miles away from the general clinic research center (gcrc).
Beschreibung

Residence Distance Clinic / Center - Research

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0012751
UMLS CUI [1,3]
C1552456
we can terminate participation if the child fails to follow the rules and guidelines of appropriate behavior and conduct during participation.
Beschreibung

Study Subject Participation Status Compliance behavior Dependent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1701901
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Ähnliche Modelle

Eligibility Obesity NCT00697580

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00697580
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Overweight Body mass index | Body mass index Age Specific | Body mass index Gender Specific
Item
overweight (age- & sex-specific body mass index ≥ 85th percentile based on cdc bmi growth charts [us department of health and human services, 2000], calculated by epi info software, version 3.3)
boolean
C0497406 (UMLS CUI [1,1])
C1305855 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C1305855 (UMLS CUI [3,1])
C0079399 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Latinos | Homogeneous Sample Selection | Insulin Resistance Risk Increased | Non-Insulin-Dependent Diabetes Mellitus Risk Increased
Item
latino (both sets of grandparents must be of latino heritage as defined by self-report; limited to latinos to maintain a homogeneous sample and because latinos are at increased risk of insulin resistance and type 2 diabetes.) if the participant or the parent is unsure of the country of origin of all 4 grandparents they will be excluded from the study. the participants and their families are not asked whether or not their grandparents are undocumented immigrants.
boolean
C0086528 (UMLS CUI [1])
C2348990 (UMLS CUI [2])
C0021655 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0205217 (UMLS CUI [3,3])
C0011860 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0205217 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting Dietary intake | Pharmaceutical Preparations Affecting Exercise Ability | Pharmaceutical Preparations Affecting Body Composition | Pharmaceutical Preparations Affecting Body Fat Distribution | Pharmaceutical Preparations Affecting Insulin Effect | Pharmaceutical Preparations Affecting insulin secretion | Disease Affecting Dietary intake | Disease Affecting Exercise Ability | Disease Affecting Body Composition | Disease Affecting Body Fat Distribution | Disease Affecting Insulin Effect | Disease Affecting insulin secretion
Item
presently taking medication(s) or diagnosed with any syndrome or disease that could influence dietary intake, exercise ability, body composition and fat distribution, or insulin action and secretion.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1286104 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
C0085732 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005885 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0424621 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0021641 (UMLS CUI [5,3])
C1280500 (UMLS CUI [5,4])
C0013227 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C1256369 (UMLS CUI [6,3])
C0012634 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C1286104 (UMLS CUI [7,3])
C0012634 (UMLS CUI [8,1])
C0392760 (UMLS CUI [8,2])
C0015259 (UMLS CUI [8,3])
C0085732 (UMLS CUI [8,4])
C0012634 (UMLS CUI [9,1])
C0392760 (UMLS CUI [9,2])
C0005885 (UMLS CUI [9,3])
C0012634 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0424621 (UMLS CUI [10,3])
C0012634 (UMLS CUI [11,1])
C0392760 (UMLS CUI [11,2])
C0021641 (UMLS CUI [11,3])
C1280500 (UMLS CUI [11,4])
C0012634 (UMLS CUI [12,1])
C0392760 (UMLS CUI [12,2])
C1256369 (UMLS CUI [12,3])
Illness Major | Severe intrauterine growth retardation | Asphyxia Neonatorum chronic | Malignant Neoplasms
Item
previously diagnosed with any major illness since birth (e.g. severe intrauterine growth retardation, chronic birth asphyxia, cancer).
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1855843 (UMLS CUI [2])
C0004045 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4])
Diabetes Mellitus | Polyuria | Polydipsia | Unexplained weight loss | Plasma fasting glucose measurement | Plasma Glucose Measurement 2 Hours | Oral Glucose Tolerance Test | Autoantibodies Diabetes Mellitus Related | ICA512 autoantibody | Glutamic Acid Decarboxylase Antibody | Diabetes Mellitus, Non-Insulin-Dependent | Impaired glucose tolerance | Condition Associated with Insulin Resistance | Acanthosis Nigricans | Hypertensive disease | Dyslipidemias | Polycystic Ovary Syndrome
Item
children will not be eligible for participation if they have any diagnostic criteria for diabetes including polyuria, polydipsia with or without unexplained weight loss, fasting plasma glucose > 126 mg/dl, or a 2-hour plasma glucose >200 mg/dl during an oral glucose tolerance test. children will also be excluded if they test positive for diabetes-related auto-antibodies, including ica512 and gad. children testing positive for type 2 diabetes will be referred for treatment. children with impaired glucose tolerance (fasting glucose >110 mg/dl or 2-hour glucose >140 mg/dl during an ogtt) and/or conditions associated with insulin resistance (e.g. acanthosis nigricans, hypertension, dyslipidemia, pcos) will be eligible, as long as they are not receiving treatment and meet other eligibility criteria.
boolean
C0011849 (UMLS CUI [1])
C0032617 (UMLS CUI [2])
C0085602 (UMLS CUI [3])
C1828173 (UMLS CUI [4])
C0583513 (UMLS CUI [5])
C0202042 (UMLS CUI [6,1])
C1292425 (UMLS CUI [6,2])
C0029161 (UMLS CUI [7])
C0004358 (UMLS CUI [8,1])
C0011849 (UMLS CUI [8,2])
C0439849 (UMLS CUI [8,3])
C0382981 (UMLS CUI [9])
C0443891 (UMLS CUI [10])
C0011860 (UMLS CUI [11])
C0271650 (UMLS CUI [12])
C0348080 (UMLS CUI [13,1])
C0332281 (UMLS CUI [13,2])
C0021655 (UMLS CUI [13,3])
C0000889 (UMLS CUI [14])
C0020538 (UMLS CUI [15])
C0242339 (UMLS CUI [16])
C0032460 (UMLS CUI [17])
Weight Lifting | Exercise | Feeding and dietary regimes | Weight Reduction Programs
Item
participants who are involved in any weight training, exercise, nutrition, or weight loss program or have been in the past 6 months.
boolean
C0043095 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0600072 (UMLS CUI [3])
C3179079 (UMLS CUI [4])
Protocol Compliance Unwilling | Disruptive Behavior | Physical violence | Illicit drug use
Item
participants that do not follow the rules and guidelines of appropriate conduct during participation, i.e., disruptive behavior, derogatory or racist comments, or any acts of physical violence towards study staff or other participants, and use of illegal substances. the principal investigator dr. michael goran will decide if this conduct warrants exclusion or removal from the study.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0474416 (UMLS CUI [2])
C0476480 (UMLS CUI [3])
C0281875 (UMLS CUI [4])
Pregnancy test positive
Item
pregnancy test comes out positive.
boolean
C0240802 (UMLS CUI [1])
Residence Distance Clinic / Center - Research
Item
children who live further than 20 miles away from the general clinic research center (gcrc).
boolean
C0237096 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C1552456 (UMLS CUI [1,3])
Study Subject Participation Status Compliance behavior Dependent
Item
we can terminate participation if the child fails to follow the rules and guidelines of appropriate behavior and conduct during participation.
boolean
C2348568 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1701901 (UMLS CUI [1,3])
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