OverweightNCT02653352
Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
A study testing Lifestyle modification in people with Overweight and Children, run by Rio de Janeiro State University.
Trial summary
The purpose of this study was to encourage students to reduce soft drinks intake, substituting it by water, in order to prevent and control overweight prevalence. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Children
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,140 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Dec 2005
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4th grade morning classes
Who cannot join
- Pregnancy
- Physical disabilities preventing anthropometric measurement
About this study
Official title: School Randomised Trial on Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
The purpose of this study was to encourage students to reduce soft drinks intake, substituting it by water, in order to prevent and control overweight prevalence.
Read the detailed description
During seven months of one school year, a healthy lifestyle education programme was implemented using simple messages encouraging water consumption instead of sugar sweetened carbonated beverages. The messages were previously tested for understanding in two small groups of children of the same age and socio-economic background as the study participants. Also, beliefs and behaviors of children in these focus groups were recorded in order to orient activities and the production of printed materials to be given to participants. Education was delivered via classroom activities; banners were hung promoting water consumption, and water bottles with the logo of the campaign were given to children and schoolteachers.
- Conditions
- Overweight, Children
- Being tested
- Lifestyle modification
- Keywords
- randomized controlled trials, soft drinks, hypercholesterolemia, serum cholesterol, blood glucose, overweight, carbonated beverages
- Medical subject headings
- Overweight, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
The centre of the campaign was to encourage the exchange of sugar-sweetened beverages for water. Ten one-hour sessions of activities facilitated by four trained research assistants were assigned for each class. The activities required 20-30 min and teachers were encouraged to reiterate the message during their lesson. Classroom quizzes and games using water v. sugar-sweetened carbonated beverages as the theme, as well as song and drawing competitions, were promoted. In addition, a musician using a tambourine helped each class to collectively develop songs related to drinking water and reducing the consumption of sugar-sweetened carbonated beverages. This musical activity was conducted during three one-hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group received two one-hour general sessions on health issues and printed general advices regarding healthy diets. |
| Lifestyle modification | Experimental | Intervention was focused on the reduction in consumption of sugar-sweetened carbonated beverages by students. During seven months of one school year, a healthy lifestyle education programme was implemented using simple messages encouraging water consumption instead of sugar-sweetened carbonated beverages. Education was delivered via classroom activities; banners were hung promoting water consumption, and water bottles with the logo of the campaign were given to children and schoolteachers. Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (kg/m²)
We have calculated changes in body mass index (BMI in follow-up minus BMI on baseline) and compared mean changes between control and intervention groups, in order to address differences in BMI gain among groups.
Measured: baseline, 8 months
Secondary outcomes (4)
Change in overweight prevalence as assessed by percentage of overweight participants
Prevalence of overweight was assessed in both groups (intervention and control) in baseline and at the end of follow-up, according to standard definition proposed by Cole et al., 2000. Then, we evaluated changes in prevalences among groups.
Measured: baseline, 8 months
Change in obesity prevalence as assessed by percentage of obese participants
Prevalence of obesity was assessed in both groups (intervention and control) in baseline and at the end of follow-up, according to standard definition proposed by Cole et al., 2000. Then, we evaluated changes in prevalences among groups.
Measured: baseline, 8 months
Change in blood cholesterol
Measured: baseline, 8 months
Change in blood glucose
Measured: baseline, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- None (open label)
- Enrolment
- 1,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Brazil, Universidade Federal do Rio de Janeiro
- Responsible party
- Principal investigator, Rosely Sichieri, Rio de Janeiro State University
- Investigators
- Rosely Sichieri, PhD, Principal investigator, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653352
- Sponsor's protocol ID
- 500404/2003-8
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schulze MB, Manson JE, Ludwig DS, Colditz GA, Stampfer MJ, Willett WC, Hu FB. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA. 2004 Aug 25;292(8):927-34. doi: 10.1001/jama.292.8.927.
PubMed 15328324Malik VS, Pan A, Willett WC, Hu FB. Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Oct;98(4):1084-102. doi: 10.3945/ajcn.113.058362. Epub 2013 Aug 21.
PubMed 23966427Sichieri R, Paula Trotte A, de Souza RA, Veiga GV. School randomised trial on prevention of excessive weight gain by discouraging students from drinking sodas. Public Health Nutr. 2009 Feb;12(2):197-202. doi: 10.1017/S1368980008002644. Epub 2008 Jun 18.
PubMed 18559131Vargas IC, Sichieri R, Sandre-Pereira G, da Veiga GV. Evaluation of an obesity prevention program in adolescents of public schools. Rev Saude Publica. 2011 Feb;45(1):59-68. doi: 10.1590/s0034-89102011000100007. English, Portuguese.
PubMed 21181050
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Randomised Trial on Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
- ClinicalTrials.gov ID
- NCT02653352
- Acronym / sponsor ID
- 500404/2003-8
- Conditions
- Overweight, Children
- Keywords
- randomized controlled trials, soft drinks, hypercholesterolemia, serum cholesterol, blood glucose, overweight, carbonated beverages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,140 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- National Research Council, Brazil, Universidade Federal do Rio de Janeiro
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Jan 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 purpose of this study was to encourage students to reduce soft drinks intake, substituting it by water, in order to prevent and control overweight prevalence.
Detailed description
During seven months of one school year, a healthy lifestyle education programme was implemented using simple messages encouraging water consumption instead of sugar sweetened carbonated beverages. The messages were previously tested for understanding in two small groups of children of the same age and socio-economic background as the study participants. Also, beliefs and behaviors of children in these focus groups were recorded in order to orient activities and the production of printed materials to be given to participants. Education was delivered via classroom activities; banners were hung promoting water consumption, and water bottles with the logo of the campaign were given to children and schoolteachers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group received two one-hour general sessions on health issues and printed general advices regarding healthy diets. |
| Lifestyle modification | Experimental | Behavioral: Lifestyle modificationIntervention was focused on the reduction in consumption of sugar-sweetened carbonated beverages by students. During seven months of one school year, a healthy lifestyle education programme was implemented using simple messages encouraging water consumption instead of sugar-sweetened carbonated beverages. Education was delivered via classroom activities; banners were hung promoting water consumption, and water bottles with the logo of the campaign were given to children and schoolteachers. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4th grade morning classes
Key exclusion criteria (2 listed)
- Pregnancy
- Physical disabilities preventing anthropometric measurement
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 |
|---|---|---|
| Lifestyle modificationThe centre of the campaign was to encourage the exchange of sugar-sweetened beverages for water. Ten one-hour sessions of activities facilitated by four trained research assistants were assigned for each class. The activities required 20-30 min and teachers were encouraged to reiterate the message during their lesson. Classroom quizzes and games using water v. sugar-sweetened carbonated beverages as the theme, as well as song and drawing competitions, were promoted. In addition, a musician using a tambourine helped each class to collectively develop songs related to drinking water and reducing the consumption of sugar-sweetened carbonated beverages. This musical activity was conducted during three one-hour sessions. | Behavioural | Lifestyle modification |
Primary outcome
Change in body mass index (kg/m²)
Time frame: baseline, 8 months
We have calculated changes in body mass index (BMI in follow-up minus BMI on baseline) and compared mean changes between control and intervention groups, in order to address differences in BMI gain among groups.
4 secondary outcomes
Change in overweight prevalence as assessed by percentage of overweight participants
Time frame: baseline, 8 months
Change in obesity prevalence as assessed by percentage of obese participants
Time frame: baseline, 8 months
Change in blood cholesterol
Time frame: baseline, 8 months
Change in blood glucose
Time frame: baseline, 8 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 12 Jan 2016.
- Background: PubMed 15328324Schulze MB, Manson JE, Ludwig DS, Colditz GA, Stampfer MJ, Willett WC, Hu FB. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA. 2004 Aug 25;292(8):927-34. doi: 10.1001/jama.292.8.927.
- Background: PubMed 23966427Malik VS, Pan A, Willett WC, Hu FB. Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Oct;98(4):1084-102. doi: 10.3945/ajcn.113.058362. Epub 2013 Aug 21.
- Results publication: PubMed 18559131Sichieri R, Paula Trotte A, de Souza RA, Veiga GV. School randomised trial on prevention of excessive weight gain by discouraging students from drinking sodas. Public Health Nutr. 2009 Feb;12(2):197-202. doi: 10.1017/S1368980008002644. Epub 2008 Jun 18.
- Results publication: PubMed 21181050Vargas IC, Sichieri R, Sandre-Pereira G, da Veiga GV. Evaluation of an obesity prevention program in adolescents of public schools. Rev Saude Publica. 2011 Feb;45(1):59-68. doi: 10.1590/s0034-89102011000100007. English, Portuguese.
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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.
Rosely Sichieri, PhD principal investigator
State University of Rio de Janeiro
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with Overweight and Children, 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 1 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 12 Jan 2016. 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?
Change in body mass index (kg/m²) (time frame: baseline, 8 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 NCT02653352, which also lists 4 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 12 Jan 2016.