Childhood ObesityNCT04905966
Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren
A study testing Nutrition education and Physical activity intervention in people with Childhood Obesity, run by Patricia Celestina Ríos Mujica at 1 site in Paraguay.
Trial summary
Childhood obesity is a major global public health problem. Several strategies have been implemented to reduce the high prevalence, the most cost-effective of which were those that focused on the school environment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Nutrition education and Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,568 participants
- Where
- 1 siteParaguay
- Study dates
- 1 Jun 2018to 30 Mar 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being public or private schools of the 22 districts of Caaguazú Department
- Having a minimum of 100 students in each of the three grades of second level of basic school education during 2017 school year
- Having physical education teachers
Who cannot join
- Schools that had only one school shift
- Schools that expressed their refusal to participate
Trial locations and contacts
1 site in 1 country.
Paraguay1 site
Instituto Regional de Investigacion en Salud
Coronel Oviedo, Caaguazú Department, 00000
About this study
Official title: Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren From Caaguazu Department, Paraguay: A Clustered Randomized Controlled Trial
Childhood obesity is a major global public health problem. Several strategies have been implemented to reduce the high prevalence, the most cost-effective of which were those that focused on the school environment. Although there is vast research that focus on interventions that address obesity through interventions to improve schoolchildren diets and physical activity level in many countries of the Latin American region, there is lack of evidence of the effectiveness of multicomponent interventions that aim to reduce the prevalence of obesity among schoolchildren in the Paraguayan context.
Read the detailed description
Nutritional education and physical activity. Interventions that promote healthy eating and lifelong physical activity in schoolchildren through school programs aim to equip children with knowledge, attitudes and behavioral skills to help them establish and maintain a healthy lifestyle.
Poor diet quality has been identified as one of the main factors contributing to the obesity epidemic. Research has shown that a diet that includes the recommended servings of fruits and vegetables (VF) reduces morbidity and mortality from non-communicable diseases (NCDs) and has also been linked to a lower risk of adiposity. Therefore, the need to promote the consumption of VF from an early age through effective programs.
The interventions in Physical Activity have shown effective results in the decrease of BMI, the thickness of the skin folds and the percentage of fat mass in school-age children. Taking into account that currently the schoolchildren have decreased the amount of time dedicated to games, sports or other types of movement and the hours of sedentary life and in front of the screens (computers, tablets, television, mobile phones, others) have increased.
It is necessary to promote the performance of physical activity in the school environment through permanent programs that contribute to improving the physical condition of children, complying with daily recommendations.
- Conditions
- Childhood Obesity
- Being tested
- Nutrition education and Physical activity intervention
- Keywords
- Childhood Obesity, Nutrition Education, Physical Activity, Intervention, Schools
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition education and Physical activity interventionBehavioural
Schools randomized to the experimental group received nutrition education sessions and physical activity classes.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition education + Physical activity intervention | Experimental | Physical Activity and Nutrition Education: An additional 45 minute weekly physical education class and 5 weekly active break sessions of 10 minutes each will be added to the provisions of the children's curriculum. In addition, schools will receive high intensity nutrition education, that is, 3 weekly nutrition education classes of one hour in each session over a period of 6 months. Receives: Behavioral: Nutrition education and Physical activity intervention |
| Control | No intervention | Schools receiving a lower intensity nutrition education served as control. This group received 3 sessions of 1 hour with a total of 3 educational sessions over the 6 month period. The educational material was the same as the intervention group but the development of lessons was not as specific and deep as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skinfold thickness
Continuous variable, measured in millimeters (mm)
Measured: 6 months
Secondary outcomes (4)
Fruit and vegetables intake
Continuous variable, measured in servings per day
Measured: 6 months
Physical activity level
Categorical variable, measured using MET in minutes/week and classified as low, medium and high intensity
Measured: 6 months
Nutritional status
Categorical variable, measured using BMI/age an classified as undernourished, normal, overweight and obese according to WHO standards
Measured: 6 months
Waist circumference
Continuous variable, measured in centimeters (cm)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jun 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four groups of participants received four different interventions: (1) Nutrition education + Physical Activity; (2) Control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patricia Celestina Ríos Mujica
- Sponsor type
- University, hospital or other
- Collaborators
- PROCIENCIA, Consejo Nacional de Ciencia y Tecnología
- Responsible party
- Sponsor-investigator, Patricia Celestina Ríos Mujica, Instituto Regional de Investigación en Salud "Kaneo Shibata" UNCA
- Investigators
- Patricia Rios, Study director, IRIS UNCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905966
- Sponsor's protocol ID
- PINV15426
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Physical Activity and Nutrition Education Intervention on Obesity Prevalence in Schoolchildren From Caaguazu Department, Paraguay: A Clustered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04905966
- Acronym / sponsor ID
- PINV15426
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity, Nutrition Education, Physical Activity, Intervention, Schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,568 participants (actual)
- Lead sponsor
- Patricia Celestina Ríos MujicaUniversity, hospital or other
- Collaborators
- PROCIENCIA, Consejo Nacional de Ciencia y Tecnología
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 28 May 2021 (actual)
- 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.
Childhood obesity is a major global public health problem. Several strategies have been implemented to reduce the high prevalence, the most cost-effective of which were those that focused on the school environment. Although there is vast research that focus on interventions that address obesity through interventions to improve schoolchildren diets and physical activity level in many countries of the Latin American region, there is lack of evidence of the effectiveness of multicomponent interventions that aim to reduce the prevalence of obesity among schoolchildren in the Paraguayan context.
Detailed description
Nutritional education and physical activity. Interventions that promote healthy eating and lifelong physical activity in schoolchildren through school programs aim to equip children with knowledge, attitudes and behavioral skills to help them establish and maintain a healthy lifestyle.
Poor diet quality has been identified as one of the main factors contributing to the obesity epidemic. Research has shown that a diet that includes the recommended servings of fruits and vegetables (VF) reduces morbidity and mortality from non-communicable diseases (NCDs) and has also been linked to a lower risk of adiposity. Therefore, the need to promote the consumption of VF from an early age through effective programs.
The interventions in Physical Activity have shown effective results in the decrease of BMI, the thickness of the skin folds and the percentage of fat mass in school-age children. Taking into account that currently the schoolchildren have decreased the amount of time dedicated to games, sports or other types of movement and the hours of sedentary life and in front of the screens (computers, tablets, television, mobile phones, others) have increased.
It is necessary to promote the performance of physical activity in the school environment through permanent programs that contribute to improving the physical condition of children, complying with daily recommendations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Four groups of participants received four different interventions: (1) Nutrition education + Physical Activity; (2) Control
| Arm | Type | Receives |
|---|---|---|
| Nutrition education + Physical activity intervention | Experimental | Behavioral: Nutrition education and Physical activity interventionPhysical Activity and Nutrition Education: An additional 45 minute weekly physical education class and 5 weekly active break sessions of 10 minutes each will be added to the provisions of the children's curriculum. In addition, schools will receive high intensity nutrition education, that is, 3 weekly nutrition education classes of one hour in each session over a period of 6 months. |
| Control | No intervention | –Schools receiving a lower intensity nutrition education served as control. This group received 3 sessions of 1 hour with a total of 3 educational sessions over the 6 month period. The educational material was the same as the intervention group but the development of lessons was not as specific and deep as the intervention group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being public or private schools of the 22 districts of Caaguazú Department
- Having a minimum of 100 students in each of the three grades of second level of basic school education during 2017 school year
- Having physical education teachers
Key exclusion criteria (2 listed)
- Schools that had only one school shift
- Schools that expressed their refusal to participate
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 |
|---|---|---|
| Nutrition education and Physical activity interventionSchools randomized to the experimental group received nutrition education sessions and physical activity classes. | Behavioural | Nutrition education + Physical activity intervention |
Primary outcome
Skinfold thickness
Time frame: 6 months
Continuous variable, measured in millimeters (mm)
4 secondary outcomes
Fruit and vegetables intake
Time frame: 6 months
Physical activity level
Time frame: 6 months
Nutritional status
Time frame: 6 months
Waist circumference
Time frame: 6 months
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 28 May 2021.
- Individual participant dataSharing planned: Yes. Protocol
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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.
Patricia Rios study director
IRIS UNCA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education and Physical activity intervention in people with Childhood Obesity, run by Patricia Celestina Ríos Mujica at 1 site in Paraguay.
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 3 inclusion and 2 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Skinfold thickness (time frame: 6 months). 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 28 May 2021.