Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren

NCT ID: NCT03041142

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2016-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Risk Factor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Interdisciplinary intervention

Intervention Type BEHAVIORAL

Physical Activity, nutrition and Psychological

Routine

Mothers and children followed their routine activities

Group Type ACTIVE_COMPARATOR

Routine

Intervention Type OTHER

The participants continued to maintain their routine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interdisciplinary intervention

Physical Activity, nutrition and Psychological

Intervention Type BEHAVIORAL

Routine

The participants continued to maintain their routine

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal do vale do São Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

THAYNA BEZERRA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ferdinando O Carvalho, Doctor

Role: STUDY_DIRECTOR

Federal university of san francisco valley

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

33

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Obesity Prevention for Pre-Adolescents
NCT00185978 COMPLETED PHASE2