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Completed

NCT Number: NCT02653352

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.

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Key information

Conditions

Overweight Body Weight Children Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4th grade morning classes

Exclusion criteria

  • Pregnancy
  • Physical disabilities preventing anthropometric measurement

Treatment and study plan

Lifestyle Modification

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in overweight prevalence as assessed by percentage of overweight participants

    Time frame: baseline, 8 months

    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.

  2. Change in obesity prevalence as assessed by percentage of obese participants

    Time frame: baseline, 8 months

    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.

  3. Change in blood cholesterol

    Time frame: baseline, 8 months

  4. Change in blood glucose

    Time frame: baseline, 8 months

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Collaborators

  • National Research Council, Brazil
  • Universidade Federal do Rio de Janeiro

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jan 12, 2016
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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