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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297374
First Posted: February 16, 2011
Last Update Posted: February 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose
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 Intervention
Obesity Behavioral: physical activities, dietician counseling and behavioral changes

Study Type: Interventional
Study Design: 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

Further study details as provided by Hospital de Clinicas de Porto Alegre:

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

Estimated Enrollment: 90
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: February 15, 2011
First Posted: February 16, 2011
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