Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas

NCT ID: NCT02653352

Last Updated: 2016-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

The control group received two one-hour general sessions on health issues and printed general advices regarding healthy diets.

Group Type NO_INTERVENTION

No interventions assigned to this group

Lifestyle modification

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.

Group Type EXPERIMENTAL

Lifestyle modification

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifestyle modification

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 4th grade morning classes

Exclusion Criteria

* Pregnancy
* Physical disabilities preventing anthropometric measurement
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Council, Brazil

OTHER

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role collaborator

Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rosely Sichieri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rosely Sichieri, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15328324 (View on PubMed)

Malik 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.

Reference Type BACKGROUND
PMID: 23966427 (View on PubMed)

Sichieri 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.

Reference Type RESULT
PMID: 18559131 (View on PubMed)

Vargas 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.

Reference Type RESULT
PMID: 21181050 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

500404/2003-8

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.