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
About this trial
This is an interventional prevention trial for Obesity, Childhood
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.
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
NCT ID
NCT03069274
First Posted
February 28, 2017
Last Updated
March 2, 2017
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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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