Clinical trial NCT02653352: Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
Official title: School Randomised Trial on Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Children
Keywords: randomized controlled trials
soft drinks
hypercholesterolemia
serum cholesterol
blood glucose
overweight
carbonated beverages
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: National Research Council, Brazil
name: Universidade Federal do Rio de Janeiro
First posted: 2016-01-12
Enrollment: 1140
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 4th grade morning classes

Exclusion Criteria:

* Pregnancy
* Physical disabilities preventing anthropometric measurement

Primary outcomes:
measure: Change in body mass index (kg/m²)
timeFrame: baseline, 8 months
Secondary outcomes:
measure: Change in overweight prevalence as assessed by percentage of overweight participants
timeFrame: baseline, 8 months
measure: Change in obesity prevalence as assessed by percentage of obese participants
timeFrame: baseline, 8 months
measure: Change in blood cholesterol
timeFrame: baseline, 8 months
measure: Change in blood glucose
timeFrame: baseline, 8 months
Other outcomes:
Locations:
Study officials:
affiliation: State University of Rio de Janeiro
name: Rosely Sichieri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1001/jama.292.8.927.
citation: 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.
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.
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. doi: 10.1590/s0034-89102011000100007. English, Portuguese.