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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01145833 |
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Date of registration:
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14/06/2010 |
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Primary sponsor: |
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Public title:
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Guided Self-help for Families With an Overweight Child
GSH |
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Scientific title:
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Guided Self-help Treatment for Families With an Overweight Child |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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49 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01145833 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kerri Boutelle, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCSD |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- child between the ages of 8 & 12
- an moderately overweight child with a BMI% between 85-97%
- child has a parent willing to participate
- child has a parent who can read English at a minimum of a 6th grade level
- family who is willing to commit to treatment attendance and attendance at all
assessments.
Exclusion Criteria:
- Child psychiatric disorder diagnoses (based on parent report)
- Child diagnoses of a serious current physical disease (such as diabetes)
- Child who is taking medications that may impact their weight
- Child with physical difficulties that limit the ability to exercise
- Child with an active eating disorder
- Child and parent will be moving out of the San Diego County before study completion
- Child and/or parent has a modified diet due to religious or socially conscious
reasons (such as Vegan, vegetarian)
Age minimum:
8 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Other: Delayed Treatment Group
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Other: Immediate Treatment Group
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Primary Outcome(s)
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The extent to which the guided self-help program affects body weight in the target child
[Time Frame: At post-treatment visit (after 5-month treatment) and 6-month follow-up]
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Secondary Outcome(s)
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The extent to which the guided self-help program affects dietary quality.
[Time Frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up]
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The extent to which the guided self-help program affects home food environment.
[Time Frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up]
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The extent to which the guided self-help program affects parent body weight.
[Time Frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up]
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The extent to which the guided self-help program affects physical activity.
[Time Frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up]
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The extent to which the guided self-help program affects sedentary activity.
[Time Frame: At post-treatment visit (after 5-month treatment) and at 6-month follow-up]
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Secondary ID(s)
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081129
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1R21DK080266-01A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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