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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 15, 2011
Last Updated: February 15, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014