Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653352
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Sponsor:
Collaborators:
National Research Council, Brazil
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Rosely Sichieri, Rio de Janeiro State University

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.

Condition or disease Intervention/treatment Phase
Overweight Children Behavioral: Lifestyle modification Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School Randomised Trial on Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
Study Start Date : March 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
No Intervention: Control
The control group received two one-hour general sessions on health issues and printed general advices regarding healthy diets.
Experimental: Lifestyle modification
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
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 Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 4th grade morning classes

Exclusion Criteria:

  • Pregnancy
  • Physical disabilities preventing anthropometric measurement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653352


Sponsors and Collaborators
Rio de Janeiro State University
National Research Council, Brazil
Universidade Federal do Rio de Janeiro
Investigators
Layout table for investigator information
Principal Investigator: Rosely Sichieri, PhD State University of Rio de Janeiro
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Rosely Sichieri, Professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT02653352    
Other Study ID Numbers: 500404/2003-8
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: November 2015
Keywords provided by Rosely Sichieri, Rio de Janeiro State University:
randomized controlled trials
soft drinks
hypercholesterolemia
serum cholesterol
blood glucose
overweight
carbonated beverages
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Weight Gain
Body Weight
Body Weight Changes