NCT03069274

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

February 28, 2017

Last Update Submit

March 2, 2017

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

  • Change their drinking habits

    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

Study Arms (2)

Control

OTHER

Only general nutritional recommendations were given.

Behavioral: General nutritional recommendations

Intervention

EXPERIMENTAL

General nutritional recommendations, change their drinking habits.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

General nutritional recommendations, change drinking habits

Also known as: General nutritional recommendations, change drinking habits
Intervention
General nutritional recommendationsBEHAVIORAL

Only general nutritional recommendations were given

Control

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Barquera S, Campirano F, Bonvecchio A, Hernandez-Barrera L, Rivera JA, Popkin BM. Caloric beverage consumption patterns in Mexican children. Nutr J. 2010 Oct 21;9:47. doi: 10.1186/1475-2891-9-47.

    PMID: 20964842BACKGROUND

  • Malik VS, Popkin BM, Bray GA, Despres JP, Willett WC, Hu FB. Sugar-sweetened beverages and risk of metabolic syndrome and type 2 diabetes: a meta-analysis. Diabetes Care. 2010 Nov;33(11):2477-83. doi: 10.2337/dc10-1079. Epub 2010 Aug 6.

    PMID: 20693348BACKGROUND

  • Nissinen K, Mikkila V, Mannisto S, Lahti-Koski M, Rasanen L, Viikari J, Raitakari OT. Sweets and sugar-sweetened soft drink intake in childhood in relation to adult BMI and overweight. The Cardiovascular Risk in Young Finns Study. Public Health Nutr. 2009 Nov;12(11):2018-26. doi: 10.1017/S1368980009005849. Epub 2009 May 28.

    PMID: 19476678BACKGROUND

  • Hoelscher DM, Kirk S, Ritchie L, Cunningham-Sabo L; Academy Positions Committee. Position of the Academy of Nutrition and Dietetics: interventions for the prevention and treatment of pediatric overweight and obesity. J Acad Nutr Diet. 2013 Oct;113(10):1375-94. doi: 10.1016/j.jand.2013.08.004.

    PMID: 24054714BACKGROUND

  • Kenney EL, Gortmaker SL, Carter JE, Howe MC, Reiner JF, Cradock AL. Grab a Cup, Fill It Up! An Intervention to Promote the Convenience of Drinking Water and Increase Student Water Consumption During School Lunch. Am J Public Health. 2015 Sep;105(9):1777-83. doi: 10.2105/AJPH.2015.302645. Epub 2015 Jul 16.

    PMID: 26180950BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • LILIANA RUIZ-ARREGUI, PhD

    INSTITUTO NACIONAL DE CIENCIAS MEDICAS Y NUTRICION SZ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Rearch Investigator

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

October 5, 2015

Primary Completion

June 15, 2016

Study Completion

November 8, 2016

Last Updated

March 6, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share