ObesityPAAPAS-DCNCT02711488
Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
A study testing Intervention group in people with Obesity, run by Rio de Janeiro State University.
Trial summary
The objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Obesity
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Dec 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 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both prevention programs
- 5th and 6th grades students
- consent form signed by parents/tutors
- Secondary prevention program
- Overweight and obese children
Who cannot join
- pregnant girls
About this study
The objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.
Read the detailed description
The study will combine primary prevention activities at the school level with secondary prevention at the household level, both focusing on behavior strategies such as mindfulness, reduction of eating rate; eating with others at a dinning table; healthy eating, increasing physical activity and reducing sedentary lifestyle habits.
- Conditions
- Obesity
- Being tested
- Intervention group
- Keywords
- school-based intervention, sedentary behavior, physical activity, sugar sweetened beverages
- Medical subject headings
- Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
The proposed intervention will focus on encouraging students to change their eating habits and food consumption over 9 months (from March to November). Monthly 1-h sessions in the classroom will be given by the class teacher, and includes playing games, staging theater sketches, watching movies and puppet shows, and writing and drawing contests. The activities were designed to discourage students from consuming sugar-sweetened beverages as well as getting them to replace snacks, particularly processed foods (especially cookies) with fresh fruit or healthy homemade food. To reinforce the messages of the in-class nutritional sessions, a set of messages will be sent to the families in the form of illustrated booklets and recipes.
The secondary prevention strategy at households will be developed for those with excessive weight. The family will receive additional motivation to change these behaviors, using the community health agents as the encourager.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Combine primary prevention activities at the school level with secondary prevention at the household level Receives: Behavioral: Intervention group |
| Control group | No intervention | No intervention |
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)
Body composition
body composition will be estimated by bioelectrical impedance, using the leg=to=leg method with Tanita scales
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 posted17 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion15 Nov 2016
- Study completion1 Dec 2016
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro
- Responsible party
- Principal investigator, Rosely Sichieri, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711488
- Sponsor's protocol ID
- IMS-PAAPAS-project
- Acronym
- PAAPAS-DC
- Status last verified
- Sep 2019
- First submitted
- 15 Feb 2016
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sgambato MR, Cunha DB, Henriques VT, Estima CC, Souza BS, Pereira RA, Yokoo EM, Paravidino VB, Sichieri R. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention. BMC Public Health. 2016 Aug 17;16(1):809. doi: 10.1186/s12889-016-3473-3.
PubMed 27534742
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
- Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
- ClinicalTrials.gov ID
- NCT02711488
- Acronym / sponsor ID
- PAAPAS-DC / IMS-PAAPAS-project
- Conditions
- Obesity
- Keywords
- school-based intervention, sedentary behavior, physical activity, sugar sweetened beverages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio de Janeiro
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 17 Mar 2016 (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 objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.
Detailed description
The study will combine primary prevention activities at the school level with secondary prevention at the household level, both focusing on behavior strategies such as mindfulness, reduction of eating rate; eating with others at a dinning table; healthy eating, increasing physical activity and reducing sedentary lifestyle habits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupCombine primary prevention activities at the school level with secondary prevention at the household level |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both prevention programs
- 5th and 6th grades students
- consent form signed by parents/tutors
- Secondary prevention program
- Overweight and obese children
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 |
|---|---|---|
| Intervention groupThe proposed intervention will focus on encouraging students to change their eating habits and food consumption over 9 months (from March to November). Monthly 1-h sessions in the classroom will be given by the class teacher, and includes playing games, staging theater sketches, watching movies and puppet shows, and writing and drawing contests. The activities were designed to discourage students from consuming sugar-sweetened beverages as well as getting them to replace snacks, particularly processed foods (especially cookies) with fresh fruit or healthy homemade food. To reinforce the messages of the in-class nutritional sessions, a set of messages will be sent to the families in the form of illustrated booklets and recipes. The secondary prevention strategy at households will be developed for those with excessive weight. The family will receive additional motivation to change these behaviors, using the community health agents as the encourager. | Behavioural | Intervention group |
Primary outcome
Body Mass Index
Time frame: one year
1 secondary outcome
Body composition
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 17 Sep 2019.
- Derived from this study: PubMed 27534742Sgambato MR, Cunha DB, Henriques VT, Estima CC, Souza BS, Pereira RA, Yokoo EM, Paravidino VB, Sichieri R. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention. BMC Public Health. 2016 Aug 17;16(1):809. doi: 10.1186/s12889-016-3473-3.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Obesity, run by Rio de Janeiro State University.
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 5 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.
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: 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 NCT02711488, 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.