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

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ClinicalTrials.gov Identifier: NCT01297374
Recruitment Status : Unknown
Verified February 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : February 16, 2011
Last Update Posted : February 16, 2011
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

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).

Condition or disease Intervention/treatment
Obesity Behavioral: physical activities, dietician counseling and behavioral changes

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT
Study Start Date : April 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: dietetic counseling 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
Experimental: physical activities 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
Experimental: Lifestyle counseling 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



Primary Outcome Measures :
  1. Changes in percentage body fat and basal metabolism after 1 year of randomization [ Time Frame: one year ]


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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297374


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre

Responsible Party: Claudia Hallal Alves Gazal, Universidade Federal do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01297374     History of Changes
Other Study ID Numbers: HCPA100011
HCPA2010 ( Other Identifier: HCPA )
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: February 16, 2011
Last Verified: February 2011

Keywords provided by Hospital de Clinicas de Porto Alegre:
Obesity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms