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
About this trial
This is an interventional other trial for Cardiovascular Risk Factor focused on measuring Obesity, Cardiovascular risk factors, Interdisciplinary intervention
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.
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
NCT ID
NCT03041142
First Posted
January 24, 2017
Last Updated
February 2, 2017
Sponsor
Universidade Federal do vale do São Francisco
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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Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren
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