NCT01297374

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 16, 2011

Status Verified

February 1, 2011

Enrollment Period

1.7 years

First QC Date

February 15, 2011

Last Update Submit

February 15, 2011

Conditions

Keywords

Obesity

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

EXPERIMENTAL
Behavioral: physical activities, dietician counseling and behavioral changes

physical activities

EXPERIMENTAL
Behavioral: physical activities, dietician counseling and behavioral changes

Lifestyle counseling

EXPERIMENTAL
Behavioral: physical activities, dietician counseling and behavioral changes

Interventions

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

Lifestyle counselingdietetic counselingphysical activities

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations