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Sugar-sweetened Beverage Intake Substitution by Water to Prevent Overweight in Mexican Children

2 mars 2017 uppdaterad av: LILIA CASTILLO MARTINEz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Impact of a Randomized School-based Intervention on Sugar-sweetened Beverage Intake Substitution by Water to Prevent Excessive Weight in Mexican Scholars

The prevalence of overweight and obesity in children have increased in recent years and this has been associated with replacing plain water intake by sugar-sweetened beverages.

Because of this, the objective of the present study was to evaluate the impact of a school-based intervention that aimed to replace sugar-sweetened beverages by water.

A randomized community trial including 314 children aged 9-11 years from three public schools of the State of Hidalgo, Mexico was performed. Schools were randomized to intervention (two schools from municipality of Apan; six classes with 146 participants) or control group (one school from municipality of Emiliano Zapata; six classes with 168 participants) and followed during 6 months. Intervention included to place water filters at school and classroom lessons to increase water consumption and decreasing sugar-sweetened beverages.

Studieöversikt

Detaljerad beskrivning

This was a randomized community trial, that included children of both sexes belonging to public elementary schools, grades 4 and 5, in Hidalgo, Mexico, including the municipalities of Emiliano Zapata and Apan. It was excluded from school children with Type 1 Diabetes, heart failure, kidney or liver that limit fluid intake by medical prescription.

A sample size of 334 (167 in each group) children would allow to detect a difference of 9% in water consumption between the two groups15, considering a loss to follow-up of 20%, a power of 85% and a significance level of 0.05.

The selection of the schools of the two communes was based on the availability of a place to conduct physical assessments and intervention. Schools were randomly assigned to the intervention (IG) or control groups (CG). Each group included 3 classes of fourth grade and 3 classes of fifth grade.

Written informed consent was obtained from school principals, teachers, parents and students. The study was approved by the Ethics Committee of the Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran, in Mexico City.

Measurements Study variables were measured at baseline and at 6 months after intervention. Weight was measured with a portable scale (SECA professional scale model 750, Seca North America East, Hanover, MD) with a capacity of 150 kg and a precision of 1kg, height (SECA model 280 portable stadiometer, Seca North America East, Hanover, MD) with an amplitude of 220 cm and variation of 1 mm. Subjects were weighed and measured with minimal clothing and no shoes21. Body mass index (BMI) was calculated as weight (in kg) divided by stature2 (in m). Classification of nutritional status was based on z-scores of the BMI-for-age and sex from the distributions of the World Health Organization using the Anthro-Plus software22.

Body composition was evaluated by bioelectric impedance, using multiple frequency equipment (RJL Systems, Detroit, MI). Resistance and reactance were obtained to estimate body fat and fat-free mass were estimated using equations23.

Sugar-sweetened beverage and water plain consumption were measured at the beginning and end of the study through a 24-hour recall using ESHA Food software with an SQL processor (version 7.9, ESHA Research, Salem, OR, 2001)., with face-to-face interviews in each phase.

Intervention The intervention focused on encouraging students to change their drinking habits over 6 months (from January to June) in the school year of 2015.

In the intervention group, reusable plastic water bottles and jugs were delivered at school and water filters were placed. Classroom lessons lasting 30 minutes were conducted weekly by trained nutritionists. These sessions included general nutritional recommendations, encouragement of simple water plain consumption and discouragement of consumption of sugar-sweetened beverages, through a manual of drinks, developed by nutritionists. In the control group only general nutritional recommendations were given.

Studietyp

Interventionell

Inskrivning (Faktisk)

314

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

8 år till 12 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Children 8-12 years old
  • Both sexes
  • Belonging to public elementary schools, grades 4 and 5, in Hidalgo, Mexico

Exclusion Criteria:

  • Type 1 Diabetes
  • Heart kidney or liver failure
  • Limitation of fluid intake by medical prescription.

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: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Control
Only general nutritional recommendations were given.
Only general nutritional recommendations were given
Experimentell: Intervention
General nutritional recommendations, change their drinking habits.
General nutritional recommendations, change drinking habits
Andra namn:
  • General nutritional recommendations, change drinking habits

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change their drinking habits
Tidsram: Baseline and 6 months follow up
Decrease sugar-sweetened beverage and increase water plain consumption evaluating the change at the beginning and end of the study through a 24-hour recall using ESHA Food software with an SQL processor with face-to-face interviews in each phase.
Baseline and 6 months follow up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: LILIANA RUIZ-ARREGUI, PhD, INSTITUTO NACIONAL DE CIENCIAS MEDICAS Y NUTRICION SZ

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.

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 (Faktisk)

5 oktober 2015

Primärt slutförande (Faktisk)

15 juni 2016

Avslutad studie (Faktisk)

8 november 2016

Studieregistreringsdatum

Först inskickad

28 februari 2017

Först inskickad som uppfyllde QC-kriterierna

28 februari 2017

Första postat (Faktisk)

3 mars 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 mars 2017

Senast verifierad

1 mars 2017

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • NC001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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