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
Recruitment status was Active, not recruiting
Sponsor:
Hospital de Clinicas de Porto Alegre
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
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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 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 June 18, 2013