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Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren (PANPES)

Primary Purpose

Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interdisciplinary intervention
Routine
Sponsored by
Universidade Federal do vale do São Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiovascular Risk Factor focused on measuring Obesity, Cardiovascular risk factors, Interdisciplinary intervention

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Interdisciplinary Intervention

    Routine

    Arm Description

    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.

    Mothers and children followed their routine activities

    Outcomes

    Primary Outcome Measures

    Weight in kilograms
    The weight was determined on Wiso® digital platform, model W801, with a precision of up to 100 g.
    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.
    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.
    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.
    Left ventricular mass in grams
    Transthoracic echocardiography was performed using the Vivid S6 echocardiogram model of the General Eletric® brand, year of manufacture 2011.

    Secondary Outcome Measures

    Physical activity in minutes and bouts
    The level of physical activity was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.
    Sedentary behavior in minutes and bouts
    The sedentary behavior was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.

    Full Information

    First Posted
    January 24, 2017
    Last Updated
    February 2, 2017
    Sponsor
    Universidade Federal do vale do São Francisco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03041142
    Brief Title
    Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren
    Acronym
    PANPES
    Official Title
    Effects of an Interdisciplinary Intervention Program on Cardiovascular Risk Factors in Children With Overweight and Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    April 1, 2016 (Actual)
    Study Completion Date
    July 3, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do vale do São Francisco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    The intervention program was composed of physical activities, nutritional and psychological monitoring. The same lasted 10 weeks, where the meetings took place on Tuesdays and Thursdays with the children, in which they participated in 50 minutes of physical activity. On Saturdays, children were exposed to physical activity, guidance on healthy eating, and behavior change. On that day, mothers also participated in gym classes (duration of 50 minutes) and nutritional guidelines (duration of 50 minutes) and behavior change (duration of 120 minutes). It is noteworthy that the team was composed of ten psychology students and one teacher from the same area, three nutritionists, two teachers and five physical education students and four physicians. Physical activities consisted of games and popular games lasting 50-60 minutes. Thus, in order to keep the children physically active as long as possible, timing was 2 minutes interval for water between each activity, resulting in a total time of 6 minutes rest throughout the class. Thus, there were 30 physical activity sessions with the children. On Saturdays, mothers also participated in physical activities. Aerobic gymnastics and functional training were developed, lasting 50 minutes. During the classes, mothers were instructed to stay physically active during the week, performing, if possible, some physical activity at least five days a week. On Saturdays, children were also submitted to guidelines on healthy eating, where they were encouraged to eat the right way, also learned about the importance of food, the group to which each food is a part, especially the foods they make Part of the context of the child, learned a variety of fruits and vegetables, learned how to prepare their own healthy snack and were motivated to take the acquired knowledge home, stimulating the whole family to adhere to healthier eating habits. Nutrition counseling was also carried out with the mothers. At the meetings the nutritional needs for the age group of their children were exposed, the ideal foods to be consumed at each moment of the day, knowledge about the group to which each food belongs, adequate food According to the financial conditions, and a little book of recipes was created, where the food, fruits and typical dishes of the local region were emphasized, but in a healthier way. Behavior change was stimulated by therapy with psychology trainees. The children were divided into 2 groups, to facilitate the process of psychological monitoring. The meetings were held once a week, on Saturdays, where activities and dynamics were developed with the aim of encouraging adherence to healthy habits, both food and physical activity. The therapies happened during 1 hour and they occurred in a playful way to involve all the universe of the child. Mothers also had their moments of therapy, where they were motivated to be role models for their children, to stimulate this change in the children's lifestyle, they were also challenged to engage in some healthy activity during the week, at times alone, In others in the company of their children. Psychological encounters with mothers occurred on Saturdays, and they were divided into two groups to ensure greater control over the activities developed, as well as for them to feel more comfortable talking about themselves and their children. Parental relationships were extensively worked on in this practice. The meetings lasted two hours.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Risk Factor
    Keywords
    Obesity, Cardiovascular risk factors, Interdisciplinary intervention

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Interdisciplinary Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Routine
    Arm Type
    Active Comparator
    Arm Description
    Mothers and children followed their routine activities
    Intervention Type
    Behavioral
    Intervention Name(s)
    Interdisciplinary intervention
    Intervention Description
    Physical Activity, nutrition and Psychological
    Intervention Type
    Other
    Intervention Name(s)
    Routine
    Intervention Description
    The participants continued to maintain their routine
    Primary Outcome Measure Information:
    Title
    Weight in kilograms
    Description
    The weight was determined on Wiso® digital platform, model W801, with a precision of up to 100 g.
    Time Frame
    5 minutes
    Title
    Height in meters
    Description
    The stature was determined by means of a metal tape measure Sanny® attached to the wall, with precision of 0.1 cm.
    Time Frame
    5 minutes
    Title
    Blood Pressure in millimeters of mercury
    Description
    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.
    Time Frame
    20 minutes
    Title
    Lipid profile in milligrams per deciliter
    Description
    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.
    Time Frame
    20 minutes
    Title
    Left ventricular mass in grams
    Description
    Transthoracic echocardiography was performed using the Vivid S6 echocardiogram model of the General Eletric® brand, year of manufacture 2011.
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Physical activity in minutes and bouts
    Description
    The level of physical activity was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.
    Time Frame
    8 days.
    Title
    Sedentary behavior in minutes and bouts
    Description
    The sedentary behavior was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.
    Time Frame
    8 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ferdinando O Carvalho, Doctor
    Organizational Affiliation
    Federal university of san francisco valley
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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