Cardiovascular Risk FactorPANPESNCT03041142
Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren
A study testing Interdisciplinary intervention and Routine in people with Cardiovascular Risk Factor, run by Universidade Federal do vale do São Francisco.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Interdisciplinary intervention and Routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 3 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effects of an Interdisciplinary Intervention Program on Cardiovascular Risk Factors in Children With Overweight and Obesity
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Interdisciplinary intervention, Routine
- Keywords
- Obesity, Cardiovascular risk factors, Interdisciplinary intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary interventionBehavioural
Physical Activity, nutrition and Psychological
RoutineOther
The participants continued to maintain their routine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Interdisciplinary intervention |
| Routine | Active comparator | Mothers and children followed their routine activities Receives: Other: Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in kilograms
The weight was determined on Wiso® digital platform, model W801, with a precision of up to 100 g.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Oct 2015
- Primary completion1 Apr 2016
- Study completion3 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do vale do São Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, THAYNA BEZERRA, Universidade Federal do vale do São Francisco
- Investigators
- Ferdinando O Carvalho, Doctor, Study director, Federal university of san francisco valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041142
- Sponsor's protocol ID
- 33
- Acronym
- PANPES
- Status last verified
- Feb 2017
- First submitted
- 24 Jan 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Interdisciplinary Intervention Program on Cardiovascular Risk Factors in Children With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT03041142
- Acronym / sponsor ID
- PANPES / 33
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Obesity, Cardiovascular risk factors, Interdisciplinary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universidade Federal do vale do São FranciscoUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 3 Jul 2016 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary Intervention | Experimental | Behavioral: Interdisciplinary interventionChildren 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. |
| Routine | Active comparator | Other: RoutineMothers and children followed their routine activities |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdisciplinary interventionPhysical Activity, nutrition and Psychological | Behavioural | Interdisciplinary Intervention |
| RoutineThe participants continued to maintain their routine | Other | Routine |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Physical activity in minutes and bouts
Time frame: 8 days.
Sedentary behavior in minutes and bouts
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferdinando O Carvalho, Doctor study director
Federal university of san francisco valley
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary intervention and Routine in people with Cardiovascular Risk Factor, run by Universidade Federal do vale do São Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight in kilograms (time frame: 5 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.