Effect of Three Non-drug Intervention in Treatment of Children With Overweight
AMO
EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT
2 other identifiers
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 16, 2011
February 1, 2011
1.7 years
February 15, 2011
February 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in percentage body fat and basal metabolism after 1 year of randomization
one year
Study Arms (3)
dietetic counseling
EXPERIMENTALphysical activities
EXPERIMENTALLifestyle counseling
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI \> +2)
You may not qualify if:
- chronic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 16, 2011
Study Start
April 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 16, 2011
Record last verified: 2011-02