Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
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|ClinicalTrials.gov Identifier: NCT02653352|
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : January 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overweight Children||Behavioral: Lifestyle modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- Change in blood cholesterol [ Time Frame: baseline, 8 months ]
- Change in blood glucose [ Time Frame: baseline, 8 months ]
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
|Principal Investigator:||Rosely Sichieri, PhD||State University of Rio de Janeiro|