- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02653352
Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
8 januari 2016 uppdaterad av: Rosely Sichieri, Rio de Janeiro State University
School Randomised Trial on 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
1140
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
9 år till 12 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 4th grade morning classes
Exclusion Criteria:
- Pregnancy
- Physical disabilities preventing anthropometric measurement
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Control
The control group received two one-hour general sessions on health issues and printed general advices regarding healthy diets.
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in body mass index (kg/m²)
Tidsram: 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.
|
baseline, 8 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in overweight prevalence as assessed by percentage of overweight participants
Tidsram: 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.
|
baseline, 8 months
|
Change in obesity prevalence as assessed by percentage of obese participants
Tidsram: 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.
|
baseline, 8 months
|
Change in blood cholesterol
Tidsram: baseline, 8 months
|
baseline, 8 months
|
|
Change in blood glucose
Tidsram: baseline, 8 months
|
baseline, 8 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Rosely Sichieri, PhD, State University of Rio de Janeiro
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2005
Primärt slutförande (Faktisk)
1 december 2005
Avslutad studie (Faktisk)
1 december 2005
Studieregistreringsdatum
Först inskickad
23 november 2015
Först inskickad som uppfyllde QC-kriterierna
8 januari 2016
Första postat (Uppskatta)
12 januari 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 januari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 januari 2016
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 500404/2003-8
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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