Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren

NCT03041142 | Completed DMC

• 1 other identifier: 33
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obesity has been considered as one of the primary factors for the development of pathologies and cardiovascular risk factors. In the child it has been mediator for the development of these comorbidities still in childhood, in the adolescence and more strongly in the adult age, at the time of most cardiovascular events with death records. Objective: To analyze the effects of an interdisciplinary intervention program on the cardiovascular risk factors of overweight and obese children. Methods: It was conducted a physical activity program, nutritional and psychological orientations, lasting ten weeks with overweighed children and their mothers. Thirty-three children with BMI considered overweight and obese participated in the study, they were divided into two groups, experimental (n=14) and control (n=19). Physical activities occurred 3 times a week with children and once a week with mothers. Nutritional and psychological counseling occurred once a week with both children and mothers. BMI, waist circumference, waist-height ratio, percentage of fat, cardiorespiratory fitness, systolic and diastolic blood pressure, lipid profile, glucose, left ventricular mass, daily energy intake and parental perception of children's weight were analyzed. For the statistical analysis it was first verified the normality of the data by the Shappiro Wilk test, with the variables that presented normality the possible differences were verified through the Anova test of mixed design with the post hoc of Bonferroni, for the normal variables, but that presented significant difference in the initial moment of the research, it was resorted to the Ancova, finally, for the non-normal variables the "U" tests of Mann Whitney and Wilcoxon.

Conditions

Cardiovascular Risk Factor

Keywords

Obesity; Cardiovascular risk factors; Interdisciplinary intervention

Outcome Measures

Primary Outcomes (5)

• Weight in kilograms

  The weight was determined on Wiso® digital platform, model W801, with a precision of up to 100 g.

  5 minutes

• Height in meters

  The stature was determined by means of a metal tape measure Sanny® attached to the wall, with precision of 0.1 cm.

  5 minutes

• Blood Pressure in millimeters of mercury

  In order to measure blood pressure values among children, the Omron device (HEM 742) was used, consisting of an electronic and digital arm device, with inflation and automatic air deflation.

  20 minutes

• Lipid profile in milligrams per deciliter

  For the dosages of the biochemical profile (triglycerides, total cholesterol, HDL-C and LDL-C) the blood was collected at the school itself by a nursing technique and the samples were taken to be analyzed in a specialized laboratory.

  20 minutes

• Left ventricular mass in grams

  Transthoracic echocardiography was performed using the Vivid S6 echocardiogram model of the General Eletric® brand, year of manufacture 2011.

  30 minutes

Secondary Outcomes (2)

• Physical activity in minutes and bouts

  8 days.

• Sedentary behavior in minutes and bouts

  8 days

Study Arms (2)

Interdisciplinary Intervention

EXPERIMENTAL

Children 3 sessions/week 50-60 minutes of physical activity; 1 session/week 60 minutes nutrition education week; 1 session/week 120 minutes behaviour therapy. Mothers 1 sessions/week 50-60 minutes of physical activity; 1 session/week 60 minutes nutrition education week; 1 session/week 120 minutes behaviour therapy.

Behavioral: Interdisciplinary intervention

Routine

ACTIVE COMPARATOR

Mothers and children followed their routine activities

Other: Routine

Interventions

Interdisciplinary intervention BEHAVIORAL

Physical Activity, nutrition and Psychological

Interdisciplinary Intervention

Routine OTHER

The participants continued to maintain their routine

Routine

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Are regularly enrolled in municipal schools in the city of Petrolina-Pernambuco;
• They are classified as overweight or obese according to the criteria used by the researchers;
• Do not present restrictions to the practice of physical activities;
• Do not use medications that may interfere with your search results.

You may not qualify if:

• That they refuse to participate at some point in the data collection;
• That they have some restriction to the practices developed in the research, acquired during the course of the study;
• That they present a number greater than 50% of absences in the proposed activities;
• That parents or guardians miss four meetings or more.

Sponsors & Collaborators

• Universidade Federal do vale do São Francisco: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ferdinando O Carvalho, Doctor

  Federal university of san francisco valley

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 2, 2017
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: July 3, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share