- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03041142
Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren (PANPES)
Effects of an Interdisciplinary Intervention Program on Cardiovascular Risk Factors in Children With Overweight and Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interdisciplinary Intervention
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. |
Physical Activity, nutrition and Psychological
|
|
Active Comparator: Routine
Mothers and children followed their routine activities
|
The participants continued to maintain their routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight in kilograms
Time Frame: 5 minutes
|
The weight was determined on Wiso® digital platform, model W801, with a precision of up to 100 g.
|
5 minutes
|
|
Height in meters
Time Frame: 5 minutes
|
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
Time Frame: 20 minutes
|
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
Time Frame: 20 minutes
|
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
Time Frame: 30 minutes
|
Transthoracic echocardiography was performed using the Vivid S6 echocardiogram model of the General Eletric® brand, year of manufacture 2011.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity in minutes and bouts
Time Frame: 8 days.
|
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.
|
8 days.
|
|
Sedentary behavior in minutes and bouts
Time Frame: 8 days
|
The sedentary behavior was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA).
The child wore the device at the waist for 8 days.
|
8 days
|
Collaborators and Investigators
Investigators
- Study Director: Ferdinando O Carvalho, Doctor, Federal university of san francisco valley
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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