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

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention
General nutritional recommendations
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Only general nutritional recommendations were given.

    General nutritional recommendations, change their drinking habits.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 28, 2017
    Last Updated
    March 2, 2017
    Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03069274
    Brief Title
    Sugar-sweetened Beverage Intake Substitution by Water to Prevent Overweight in Mexican Children
    Official Title
    Impact of a Randomized School-based Intervention on Sugar-sweetened Beverage Intake Substitution by Water to Prevent Excessive Weight in Mexican Scholars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 5, 2015 (Actual)
    Primary Completion Date
    June 15, 2016 (Actual)
    Study Completion Date
    November 8, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    314 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Only general nutritional recommendations were given.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    General nutritional recommendations, change their drinking habits.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention
    Other Intervention Name(s)
    General nutritional recommendations, change drinking habits
    Intervention Description
    General nutritional recommendations, change drinking habits
    Intervention Type
    Behavioral
    Intervention Name(s)
    General nutritional recommendations
    Intervention Description
    Only general nutritional recommendations were given
    Primary Outcome Measure Information:
    Title
    Change their drinking habits
    Description
    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.
    Time Frame
    Baseline and 6 months follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    LILIANA RUIZ-ARREGUI, PhD
    Organizational Affiliation
    INSTITUTO NACIONAL DE CIENCIAS MEDICAS Y NUTRICION SZ
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20964842
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20693348
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19476678
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24054714
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26180950
    Citation
    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.
    Results Reference
    background

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

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