Effect of Three Non-drug Intervention in Treatment of Children With Overweight (AMO)
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physical activities, dietician counseling and behavioral changes
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity
Eligibility Criteria
Inclusion Criteria:
- age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI > +2)
Exclusion Criteria:
- chronic diseases
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
dietetic counseling
physical activities
Lifestyle counseling
Arm Description
Outcomes
Primary Outcome Measures
Changes in percentage body fat and basal metabolism after 1 year of randomization
Secondary Outcome Measures
Full Information
NCT ID
NCT01297374
First Posted
February 15, 2011
Last Updated
February 15, 2011
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01297374
Brief Title
Effect of Three Non-drug Intervention in Treatment of Children With Overweight
Acronym
AMO
Official Title
EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of three different non-pharmacological interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the percentage of body fat and basal metabolism of children and Overweight and obesity in the metropolitan region of Porto Alegre (RS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dietetic counseling
Arm Type
Experimental
Arm Title
physical activities
Arm Type
Experimental
Arm Title
Lifestyle counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
physical activities, dietician counseling and behavioral changes
Intervention Description
One arm receive an schedule for physical activities. One arm receive a diet prescription. One arm receive general guidance on diet, physical activity and behavioral changes
Primary Outcome Measure Information:
Title
Changes in percentage body fat and basal metabolism after 1 year of randomization
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI > +2)
Exclusion Criteria:
chronic diseases
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Three Non-drug Intervention in Treatment of Children With Overweight
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