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Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas

Primary Purpose

Overweight, Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring randomized controlled trials, soft drinks, hypercholesterolemia, serum cholesterol, blood glucose, overweight, carbonated beverages

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 4th grade morning classes

Exclusion Criteria:

  • Pregnancy
  • Physical disabilities preventing anthropometric measurement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Lifestyle modification

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Change in blood cholesterol
    Change in blood glucose

    Full Information

    First Posted
    November 23, 2015
    Last Updated
    January 8, 2016
    Sponsor
    Rio de Janeiro State University
    Collaborators
    National Research Council, Brazil, Universidade Federal do Rio de Janeiro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02653352
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rio de Janeiro State University
    Collaborators
    National Research Council, Brazil, Universidade Federal do Rio de Janeiro

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Children
    Keywords
    randomized controlled trials, soft drinks, hypercholesterolemia, serum cholesterol, blood glucose, overweight, carbonated beverages

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group received two one-hour general sessions on health issues and printed general advices regarding healthy diets.
    Arm Title
    Lifestyle modification
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle modification
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in body mass index (kg/m²)
    Description
    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.
    Time Frame
    baseline, 8 months
    Secondary Outcome Measure Information:
    Title
    Change in overweight prevalence as assessed by percentage of overweight participants
    Description
    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.
    Time Frame
    baseline, 8 months
    Title
    Change in obesity prevalence as assessed by percentage of obese participants
    Description
    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.
    Time Frame
    baseline, 8 months
    Title
    Change in blood cholesterol
    Time Frame
    baseline, 8 months
    Title
    Change in blood glucose
    Time Frame
    baseline, 8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 4th grade morning classes Exclusion Criteria: Pregnancy Physical disabilities preventing anthropometric measurement
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rosely Sichieri, PhD
    Organizational Affiliation
    State University of Rio de Janeiro
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15328324
    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.
    Results Reference
    background
    PubMed Identifier
    23966427
    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.
    Results Reference
    background
    PubMed Identifier
    18559131
    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.
    Results Reference
    result
    PubMed Identifier
    21181050
    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.
    Results Reference
    result

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    Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas

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