Effect of Three Non-drug Intervention in Treatment of Children With Overweight (AMO)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT01297374

First received: February 15, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 15, 2011
Last Updated Date	February 15, 2011
Start Date ^ICMJE	April 2010
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 15, 2011)	Changes in percentage body fat and basal metabolism after 1 year of randomization [ Time Frame: one year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Three Non-drug Intervention in Treatment of Children With Overweight
Official Title ^ICMJE	EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Obesity
Intervention ^ICMJE	Behavioral: physical activities, dietician counseling and behavioral changes 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
Study Arm (s)	Experimental: dietetic counseling Intervention: Behavioral: physical activities, dietician counseling and behavioral changes Experimental: physical activities Intervention: Behavioral: physical activities, dietician counseling and behavioral changes Experimental: Lifestyle counseling Intervention: Behavioral: physical activities, dietician counseling and behavioral changes
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	90
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	8 Years to 15 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01297374
Other Study ID Numbers ^ICMJE	HCPA100011, HCPA2010
Has Data Monitoring Committee	Not Provided
Responsible Party	Claudia Hallal Alves Gazal, Universidade Federal do Rio Grande do Sul
Study Sponsor ^ICMJE	Hospital de Clinicas de Porto Alegre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital de Clinicas de Porto Alegre
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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