ID

31506

Beskrivning

The Effect of Exercise on Preventing PostPartum Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00961402

Länk

https://clinicaltrials.gov/show/NCT00961402

Nyckelord

Versioner (1)
  1. 2018-08-29 2018-08-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility PostPartum Depression NCT00961402

Engelsk

Eligibility PostPartum Depression NCT00961402

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
we will recruit healthy, sedentary (defined as exercising 60 minutes or less per week) women who are at least 18 years of age and at least 28 weeks pregnant or less than one month postpartum (n=120). participants will be required to obtain written consent from their healthcare provider to participate. this written consent will be obtained following delivery of the newborn. participants will complete a telephone screening interview to assess eligibility. current depressive episode will be assessed using the phq-9 (cut-off will be 10 or higher). as we have done in previous trials, we will have a protocol in place that deals with participants expressing suicidal ideation ranging from referring them to their healthcare provider and/or calling emergency assistance, depending on intent. to be included, participants must be willing to be randomly assigned to either of the two study arms. additionally, participants will read and sign a consent form approved by the university of minnesota and have all of their questions will be answered prior to participating.
Beskrivning

Gender | Healthy Volunteers | Sedentary lifestyle | Exercise mins/week | Age | Pregnant weeks | Postpartum Period | Informed Consent Health care provider | Screening Telephone Interview Completion | Depressive episode PHQ-9 | Feeling suicidal | Randomization Protocol Treatment Arm | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1708335
UMLS CUI [3]
C1532253
UMLS CUI [4,1]
C0015259
UMLS CUI [4,2]
C0556975
UMLS CUI [5]
C0001779
UMLS CUI [6]
C0460089
UMLS CUI [7]
C0086839
UMLS CUI [8,1]
C0021430
UMLS CUI [8,2]
C0018724
UMLS CUI [9,1]
C0220908
UMLS CUI [9,2]
C0021823
UMLS CUI [9,3]
C0205197
UMLS CUI [10,1]
C0349217
UMLS CUI [10,2]
C4083201
UMLS CUI [11]
C0424000
UMLS CUI [12,1]
C0034656
UMLS CUI [12,2]
C1522541
UMLS CUI [13]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
no healthcare provider consent to participate
Beskrivning

Informed Consent Health care provider Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0018724
UMLS CUI [1,3]
C0332268
pre-existing hypertension or diabetes
Beskrivning

Hypertensive disease Pre-existing | Diabetes Mellitus Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C2347662
current participation in exercise (defined as exercising 60 or more minutes per week)
Beskrivning

Participation Exercise mins/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C0556975
currently enrolled in another exercise or weight management study
Beskrivning

Study Subject Participation Status | Exercise Study | Weight management Study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C2603343
UMLS CUI [3,1]
C0920298
UMLS CUI [3,2]
C2603343
less than 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
another member of household participating in the study
Beskrivning

Study Subject Participation Status | Household Member Other

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C4330269
UMLS CUI [2,2]
C0205394
unable to speak, comprehend, read, or write fluently in the english language
Beskrivning

Lacking Able to speak fluently English Language | Comprehension Very well English Language Unable | Lacking Able to read English Language Very well | Lacking Able to write English Language Very well

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564241
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C3641222
UMLS CUI [2,3]
C0376245
UMLS CUI [2,4]
C1299582
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0586740
UMLS CUI [3,3]
C0376245
UMLS CUI [3,4]
C3641222
UMLS CUI [4,1]
C0332268
UMLS CUI [4,2]
C0584993
UMLS CUI [4,3]
C0376245
UMLS CUI [4,4]
C3641222
unable to walk for 30 minutes continuously
Beskrivning

Lacking Able to walk Minutes Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [1,3]
C0439232
UMLS CUI [1,4]
C1265611
musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising
Beskrivning

Musculoskeletal problem Interferes with Exercise | Arthritis | Gout | Osteoporosis | Back Pain | Hip pain | Knee pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026859
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0015259
UMLS CUI [2]
C0003864
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0029456
UMLS CUI [5]
C0004604
UMLS CUI [6]
C0019559
UMLS CUI [7]
C0231749
exercise-induced asthma
Beskrivning

Asthma, Exercise-Induced

Datatyp

boolean

Alias
UMLS CUI [1]
C0004099
any condition that would make exercise unsafe or unwise
Beskrivning

Condition Exercise At risk | Condition Exercise Unfavorable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C3640815
taking medication that interferes with heart rate response to exercise such as beta blockers
Beskrivning

Pharmaceutical Preparation Interferes with Heart rate response Exercise | Adrenergic beta-Antagonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1997754
UMLS CUI [1,4]
C0015259
UMLS CUI [2]
C0001645
hospitalization for a psychiatric disorder in the past six months
Beskrivning

Hospitalization Due to Mental disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0004936
current depressive episode and/or currently receiving antidepressant medication or psychotherapy for depression (those who are depressed and who are not in treatment will be referred to their physician or psychiatrist for follow-up care)
Beskrivning

Depressive episode | Antidepressive Agents | Psychotherapy Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0349217
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0033968
UMLS CUI [3,2]
C0011581
in addition to the initial exclusion criteria listed above, we will withdraw the exercise intervention and instruct the participant to contact their healthcare provider if the participant develops a medical issue in which exercise would be unsafe.
Beskrivning

Medical Problem Exercise At risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C1444641
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Similar models

Eligibility PostPartum Depression NCT00961402

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Healthy Volunteers | Sedentary lifestyle | Exercise mins/week | Age | Pregnant weeks | Postpartum Period | Informed Consent Health care provider | Screening Telephone Interview Completion | Depressive episode PHQ-9 | Feeling suicidal | Randomization Protocol Treatment Arm | Informed Consent
Item
we will recruit healthy, sedentary (defined as exercising 60 minutes or less per week) women who are at least 18 years of age and at least 28 weeks pregnant or less than one month postpartum (n=120). participants will be required to obtain written consent from their healthcare provider to participate. this written consent will be obtained following delivery of the newborn. participants will complete a telephone screening interview to assess eligibility. current depressive episode will be assessed using the phq-9 (cut-off will be 10 or higher). as we have done in previous trials, we will have a protocol in place that deals with participants expressing suicidal ideation ranging from referring them to their healthcare provider and/or calling emergency assistance, depending on intent. to be included, participants must be willing to be randomly assigned to either of the two study arms. additionally, participants will read and sign a consent form approved by the university of minnesota and have all of their questions will be answered prior to participating.
boolean
C0079399 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C1532253 (UMLS CUI [3])
C0015259 (UMLS CUI [4,1])
C0556975 (UMLS CUI [4,2])
C0001779 (UMLS CUI [5])
C0460089 (UMLS CUI [6])
C0086839 (UMLS CUI [7])
C0021430 (UMLS CUI [8,1])
C0018724 (UMLS CUI [8,2])
C0220908 (UMLS CUI [9,1])
C0021823 (UMLS CUI [9,2])
C0205197 (UMLS CUI [9,3])
C0349217 (UMLS CUI [10,1])
C4083201 (UMLS CUI [10,2])
C0424000 (UMLS CUI [11])
C0034656 (UMLS CUI [12,1])
C1522541 (UMLS CUI [12,2])
C0021430 (UMLS CUI [13])
Item Group
C0680251 (UMLS CUI)
Informed Consent Health care provider Lacking
Item
no healthcare provider consent to participate
boolean
C0021430 (UMLS CUI [1,1])
C0018724 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Hypertensive disease Pre-existing | Diabetes Mellitus Pre-existing
Item
pre-existing hypertension or diabetes
boolean
C0020538 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
Participation Exercise mins/week
Item
current participation in exercise (defined as exercising 60 or more minutes per week)
boolean
C0679823 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0556975 (UMLS CUI [1,3])
Study Subject Participation Status | Exercise Study | Weight management Study
Item
currently enrolled in another exercise or weight management study
boolean
C2348568 (UMLS CUI [1])
C0015259 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0920298 (UMLS CUI [3,1])
C2603343 (UMLS CUI [3,2])
Age
Item
less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status | Household Member Other
Item
another member of household participating in the study
boolean
C2348568 (UMLS CUI [1])
C4330269 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Lacking Able to speak fluently English Language | Comprehension Very well English Language Unable | Lacking Able to read English Language Very well | Lacking Able to write English Language Very well
Item
unable to speak, comprehend, read, or write fluently in the english language
boolean
C0332268 (UMLS CUI [1,1])
C0564241 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C3641222 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C0586740 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
C3641222 (UMLS CUI [3,4])
C0332268 (UMLS CUI [4,1])
C0584993 (UMLS CUI [4,2])
C0376245 (UMLS CUI [4,3])
C3641222 (UMLS CUI [4,4])
Lacking Able to walk Minutes Quantity
Item
unable to walk for 30 minutes continuously
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Musculoskeletal problem Interferes with Exercise | Arthritis | Gout | Osteoporosis | Back Pain | Hip pain | Knee pain
Item
musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising
boolean
C0026859 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C0003864 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0029456 (UMLS CUI [4])
C0004604 (UMLS CUI [5])
C0019559 (UMLS CUI [6])
C0231749 (UMLS CUI [7])
Asthma, Exercise-Induced
Item
exercise-induced asthma
boolean
C0004099 (UMLS CUI [1])
Condition Exercise At risk | Condition Exercise Unfavorable
Item
any condition that would make exercise unsafe or unwise
boolean
C0348080 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
Pharmaceutical Preparation Interferes with Heart rate response Exercise | Adrenergic beta-Antagonists
Item
taking medication that interferes with heart rate response to exercise such as beta blockers
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1997754 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
C0001645 (UMLS CUI [2])
Hospitalization Due to Mental disorder
Item
hospitalization for a psychiatric disorder in the past six months
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Depressive episode | Antidepressive Agents | Psychotherapy Depressive disorder
Item
current depressive episode and/or currently receiving antidepressant medication or psychotherapy for depression (those who are depressed and who are not in treatment will be referred to their physician or psychiatrist for follow-up care)
boolean
C0349217 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0033968 (UMLS CUI [3,1])
C0011581 (UMLS CUI [3,2])
Medical Problem Exercise At risk
Item
in addition to the initial exclusion criteria listed above, we will withdraw the exercise intervention and instruct the participant to contact their healthcare provider if the participant develops a medical issue in which exercise would be unsafe.
boolean
C1254481 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
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