Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas

Overweight Clinical Trial

Official title:

School Randomised Trial on Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653352
• Other study ID #: 500404/2003-8
• Status: Completed
• Phase: N/A
• First received: November 23, 2015
• Last updated: January 8, 2016
• Start date: March 2005
• Est. completion date: December 2005

Study information

• Verified date: November 2015
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1140
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• 4th grade morning classes

Exclusion Criteria:

• Pregnancy

• Physical disabilities preventing anthropometric measurement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Children
• Overweight
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rio de Janeiro State University	National Research Council, Brazil, Universidade Federal do Rio de Janeiro

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. English, Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 8 months	No
Secondary	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.	baseline, 8 months	No
Secondary	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.	baseline, 8 months	No
Secondary	Change in blood cholesterol		baseline, 8 months	No
Secondary	Change in blood glucose		baseline, 8 months	No