NCT02653352

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,140

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
Last Updated

January 12, 2016

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

November 23, 2015

Last Update Submit

January 8, 2016

Conditions

OverweightChildren

Keywords

randomized controlled trialssoft drinkshypercholesterolemiaserum cholesterolblood glucoseoverweightcarbonated beverages

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change in overweight prevalence as assessed by percentage of overweight participants

    baseline, 8 months

  • Change in obesity prevalence as assessed by percentage of obese participants

    baseline, 8 months

  • Change in blood cholesterol

    baseline, 8 months

  • Change in blood glucose

    baseline, 8 months

Study Arms (2)

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.

Behavioral: Lifestyle modification

Interventions

Lifestyle modificationBEHAVIORAL

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.

Lifestyle modification

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th grade morning classes

You may not qualify if:

  • Pregnancy
  • Physical disabilities preventing anthropometric measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 15328324BACKGROUND

  • 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.

    PMID: 23966427BACKGROUND

  • 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.

    PMID: 18559131RESULT

  • 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.

    PMID: 21181050RESULT

MeSH Terms

Conditions

OverweightHypercholesterolemia

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Study Officials

  • Rosely Sichieri, PhD

    State University of Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2015

First Posted

January 12, 2016

Study Start

March 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

January 12, 2016

Record last verified: 2015-11