ObesityNCT03136016
Nudging, Healthy Diet and Physical Activity
A study testing educational activities, nudging and nudging + educational activities in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The present study is a randomized school-based trial of a sample of 5th and 6th grade students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- educational activities, nudging and nudging + educational activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 15 Dec 2017
- 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5th and 6th grades students consent form signed by parents/tutors
Who cannot join
- pregnant girls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design of a School Randomized Trial for Nudging Students Towards Healthy Diet and Physical Activity
The present study is a randomized school-based trial of a sample of 5th and 6th grade students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. The aim is to investigate whether adding nudging actions to the intervention group of PAAPPAS trial (PAAPAS Study, NCT02711488) increase fruits, vegetables and water consumption and daily energy expenditure, in a factorial design.
- Conditions
- Obesity
- Being tested
- educational activities, nudging, nudging + educational activities
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational activitiesBehavioural
Group 2 will receive classroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans
nudgingBehavioural
In group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices
nudging + educational activitiesBehavioural
Group 4 will receive both interventions
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | without any activity |
| educational activities | Experimental | The students will receive educational activities in the classroom. Receives: Behavioral: educational activities |
| nudging | Experimental | The students will receive changes in the school environment (nudge strategies); Receives: Behavioral: nudging |
| nudging + educational activities | Experimental | The students will receive educational activities and changes in the school environment. Receives: Behavioral: nudging + educational activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Sample size of PAAPPAS Nudge was calculated based on a minimum effect of 0.15 in BMI variation and considering intra and intergroup comparisons. Body mass index (BMI) will be determined as a ratio between body weight (kg) and squared height (m).
Measured: 6 months
Secondary outcomes (4)
Fruit consumption
Food intake will be assessed by a food frequency questionnaire validated for teenagers in Rio de Janeiro and one 24-hour recall (Rec24h). Netbooks containing a computer program developed for school use, based on a technique called "Multiple Pass Method" will be used.
Measured: 6 months
Vegetable consumption
Vegetable consumption will be assessed by one 24-hour recall (Rec24h). The food items in the Rec24h will be transformed into daily consumption and grouped according to similary in nutritional containing
Measured: 6 months
Water consumption
Water consumption will be assessed by a question regarding the number of glasses of water consumed during a day. Glasses of water consumed during a day will be assessed by a question at baseline and at the end of the study.
Measured: 6 months
Physical activity
Physical activity levels will be measured through a validated questionnaire including six questions about frequency and time of different physical activities domains.
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 posted2 May 2017
- Study start1 Mar 2017
- Primary completion15 Nov 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Responsible party
- Principal investigator, Rosely Sichieri, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136016
- Sponsor's protocol ID
- nudgingpaappas
- Status last verified
- Sep 2019
- First submitted
- 27 Apr 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antunes ABS, Hassan BK, Pinto RL, Sichieri R, Cunha DB. A choice architecture intervention targeting school meals and water frequency intake: A school-based randomized trial. Appetite. 2024 Feb 1;193:107118. doi: 10.1016/j.appet.2023.107118. Epub 2023 Nov 17.
PubMed 37977257
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a School Randomized Trial for Nudging Students Towards Healthy Diet and Physical Activity
- ClinicalTrials.gov ID
- NCT03136016
- Acronym / sponsor ID
- nudgingpaappas
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 2 May 2017 (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.
The present study is a randomized school-based trial of a sample of 5th and 6th grade students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. The aim is to investigate whether adding nudging actions to the intervention group of PAAPPAS trial (PAAPAS Study, NCT02711488) increase fruits, vegetables and water consumption and daily energy expenditure, in a factorial design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –without any activity |
| educational activities | Experimental | Behavioral: educational activitiesThe students will receive educational activities in the classroom. |
| nudging | Experimental | Behavioral: nudgingThe students will receive changes in the school environment (nudge strategies); |
| nudging + educational activities | Experimental | Behavioral: nudging + educational activitiesThe students will receive educational activities and changes in the school environment. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 5th and 6th grades students consent form signed by parents/tutors
Key exclusion criteria (1 listed)
- pregnant girls
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 |
|---|---|---|
| educational activitiesGroup 2 will receive classroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans | Behavioural | educational activities |
| nudgingIn group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices | Behavioural | nudging |
| nudging + educational activitiesGroup 4 will receive both interventions | Behavioural | nudging + educational activities |
Primary outcome
Body Mass Index
Time frame: 6 months
Sample size of PAAPPAS Nudge was calculated based on a minimum effect of 0.15 in BMI variation and considering intra and intergroup comparisons. Body mass index (BMI) will be determined as a ratio between body weight (kg) and squared height (m).
4 secondary outcomes
Fruit consumption
Time frame: 6 months
Vegetable consumption
Time frame: 6 months
Water consumption
Time frame: 6 months
Physical activity
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 17 Sep 2019.
- Derived from this study: PubMed 37977257Antunes ABS, Hassan BK, Pinto RL, Sichieri R, Cunha DB. A choice architecture intervention targeting school meals and water frequency intake: A school-based randomized trial. Appetite. 2024 Feb 1;193:107118. doi: 10.1016/j.appet.2023.107118. Epub 2023 Nov 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational activities, nudging and nudging + educational activities in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
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 1 inclusion and 1 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 17 Sep 2019. 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 Brazil. 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?
Body Mass Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136016, which also lists 1 linked publication.
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 17 Sep 2019.