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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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
February 15, 2011
Last Updated
February 15, 2011
Sponsor
Hospital de Clinicas de Porto Alegre
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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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