Sugar IntakePhase 3PAPASNCT01046474
Reducing Beverages and Sugar and Increasing Physical Activity in Public School Adolescents From Brazil
A Phase 3 study testing lifestyle in people with Sugar Intake and Beverage Intake, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Sugar Intake, Beverage Intake, Fruit Intake
- What is being tested?
- lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child
Who may be able to join
- 5th grades
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro
The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.
Read the detailed description
Specific objectives are:
- To compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from 7th and 8th grades from schools under intervention and from the ones not subjected to the intervention program.
- To compare sweetened beverages consumption and sugar intake before and after the intervention in both groups of schools.
- To evaluate the impact of the intervention on the selling of sweetened beverages in the cafeterias.
- To compare change in family expenditures with sweetened beverages and sugar.
- Conditions
- Sugar Intake, Beverage Intake, Fruit Intake, Beans Intake, Physical Activity
- Being tested
- lifestyle
- Keywords
- school children, body mass index, sugar intake, beverage intake
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyleBehavioural
Based on beliefs and behaviors of children sections of education will be delivered via classroom activities.
Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
Children will also be stimulated to increase everyday activities such as walking and playing games at home and school. Also, activities with parents and family members such as walking around the neighborhood on weekends will be promoted.
| Study group | Role | What they receive |
|---|---|---|
| reducing beverages and sugar and increase physical activity | Experimental | reduction of beverages and sugar and increasing physical activity Receives: Behavioral: lifestyle |
| control -no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: one year
Secondary outcomes (1)
Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sugar IntakeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046474
- Sponsor's protocol ID
- IMS-PAPAS-project
- Acronym
- PAPAS
- Status last verified
- Jul 2011
- First submitted
- 11 Jan 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Munoz-Espinosa LE, Torre A, Cisneros L, Montalvo I, Male R, Mejia S, Aguilar JR, Lizardi J, Zuniga-Noriega J, Eugenia Icaza M, Gasca-Diaz F, Hernandez-Hernandez L, Cordero-Perez P, Chi L, Torres L, Rodriguez-Alvarez F, Tapia G, Poo JL. Noninvasive Evaluation of Prolonged-Release Pirfenidone in Compensated Liver Cirrhosis. ODISEA Study, a Randomised Trial. Liver Int. 2025 Jun;45(6):e70131. doi: 10.1111/liv.70131.
PubMed 40402087Cunha DB, de Souza Bda S, Pereira RA, Sichieri R. Effectiveness of a randomized school-based intervention involving families and teachers to prevent excessive weight gain among adolescents in Brazil. PLoS One. 2013;8(2):e57498. doi: 10.1371/journal.pone.0057498. Epub 2013 Feb 25.
PubMed 23451237
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro
- ClinicalTrials.gov ID
- NCT01046474
- Acronym / sponsor ID
- PAPAS / IMS-PAPAS-project
- Conditions
- Sugar Intake, Beverage Intake, Fruit Intake, Beans Intake, Physical Activity
- Keywords
- school children, body mass index, sugar intake, beverage intake
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Jan 2010 (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.
The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.
Detailed description
Specific objectives are:
- To compare total, lean, and fatty body mass variation in adolescents aged 11 to 14, from 7th and 8th grades from schools under intervention and from the ones not subjected to the intervention program.
- To compare sweetened beverages consumption and sugar intake before and after the intervention in both groups of schools.
- To evaluate the impact of the intervention on the selling of sweetened beverages in the cafeterias.
- To compare change in family expenditures with sweetened beverages and sugar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reducing beverages and sugar and increase physical activity | Experimental | Behavioral: lifestylereduction of beverages and sugar and increasing physical activity |
| control -no intervention | No intervention | – |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 5th grades
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| lifestyleBased on beliefs and behaviors of children sections of education will be delivered via classroom activities. Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class. Children will also be stimulated to increase everyday activities such as walking and playing games at home and school. Also, activities with parents and family members such as walking around the neighborhood on weekends will be promoted. | Behavioural | reducing beverages and sugar and increase physical activity |
Primary outcome
Body mass index
Time frame: one year
1 secondary outcome
Mean lean and fatty body mass proportions: measured by portable electrical bioimpedance bean
Time frame: one year
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 20 Jul 2011.
- Derived from this study: PubMed 40402087Munoz-Espinosa LE, Torre A, Cisneros L, Montalvo I, Male R, Mejia S, Aguilar JR, Lizardi J, Zuniga-Noriega J, Eugenia Icaza M, Gasca-Diaz F, Hernandez-Hernandez L, Cordero-Perez P, Chi L, Torres L, Rodriguez-Alvarez F, Tapia G, Poo JL. Noninvasive Evaluation of Prolonged-Release Pirfenidone in Compensated Liver Cirrhosis. ODISEA Study, a Randomised Trial. Liver Int. 2025 Jun;45(6):e70131. doi: 10.1111/liv.70131.
- Derived from this study: PubMed 23451237Cunha DB, de Souza Bda S, Pereira RA, Sichieri R. Effectiveness of a randomized school-based intervention involving families and teachers to prevent excessive weight gain among adolescents in Brazil. PLoS One. 2013;8(2):e57498. doi: 10.1371/journal.pone.0057498. Epub 2013 Feb 25.
Related trials for Sugar Intake
RecruitingPhase 1
Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake
Diet Therapy, Healthy Volunteers
Recruiting
Effect of Different Carbohydrate Intake Patterns on Glycemic Control in Patients With Type 1 Diabetes
Type 1 Diabetes, Diet Intervention
Recruiting
Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor
Obstetric Labor
Not yet recruiting
Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise
Type 1 Diabetes Mellitus, Exercise Physiology
Active, not recruiting
Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
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 Phase 3 study testing lifestyle in people with Sugar Intake and Beverage Intake, 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 20 Jul 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: one year). 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 NCT01046474, which also lists 2 linked publications.
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 20 Jul 2011.