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Modifications in the Eating Habits of Adolescents of Secondary Education as a Result of a Nutritional Intervention

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ClinicalTrials.gov Identifier: NCT03206476
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Gabriela Macedo Ojeda, Centro Universitario de Ciencias de la Salud, Mexico

Brief Summary:

The objective of the study was to demonstrate the efficacy of a nutritional intervention based on the Social Cognitive Theory and the Transtheoric Model in the favorable modification of eating habits in adolescents of secondary education.

The hypothesis was that secondary school adolescents receiving a nutritional intervention based on Social Cognitive Theory and the Transtheoric Model presented more favorable modifications in their eating habits than adolescents who only received nutritional information.

A community trial was conducted with pilot testing for the validation of the study instruments. Adolescents from the second grade of the afternoon shift of the Jalisco Technical High School Nº46 participated in the 2015-2016 cycle.

Self-completed questionnaires evaluated socioeconomic variables, physical activity habits, stage of change (Transtheoric Model), constructs of the Social Cognitive Theory and five eating habits: consumption of fruits and vegetables, natural water, dairy products, sugary drinks and processed foods ; As well as anthropometric variables.

The intervention group had twelve workshops on healthy eating habits and two sessions for parents. The control group received three sessions of nutritional information.

All variables were measured again at the end of the intervention to evaluate results in the short term and three months later to know results in the medium term.


Condition or disease Intervention/treatment Phase
Food Habits Behavioral: Nutritional intervention based on the SCT and the TM Behavioral: Nutritional information Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modifications in the Eating Habits of Secondary Education Adolescents, as a Result of a Nutritional Intervention Based on the Social Cognitive Theory and the Transtheoric Model.
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : September 30, 2016

Arm Intervention/treatment
Experimental: Intervention group
Nutritional intervention based on the SCT and the TM
Behavioral: Nutritional intervention based on the SCT and the TM
Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
Active Comparator: Control group
Nutritional information
Behavioral: Nutritional information
Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.



Primary Outcome Measures :
  1. Change in the consumption of fruits and vegetables (average portions / day) in the short term (at the end of the intervention) [ Time Frame: Change from baseline at 4 months ]
    Quantitative variable

  2. Change in the consumption of dairy (average portions / day) in the short term (at the end of the intervention) [ Time Frame: Change from baseline at 4 months ]
    Quantitative variable

  3. Change in the consumption of processed foods (average portions / day) in the short term (at the end of the intervention) [ Time Frame: Change from baseline at 4 months ]
    Quantitative variable

  4. Change in the consumption of sugary drinks (average portions / day) in the short term (at the end of the intervention) [ Time Frame: Change from baseline at 4 months ]
    Quantitative variable

  5. Change in the consumption of natural water (average portions / day) in the short term (at the end of the intervention) [ Time Frame: Change from baseline at 4 months ]
    Quantitative variable


Secondary Outcome Measures :
  1. Change in the consumption of fruits and vegetables (average portions / day) in the medium term (3 months after the end of the intervention) [ Time Frame: Change from baseline at 7 months ]
    Quantitative variable

  2. Change in the consumption of dairy (average portions / day) in the medium term (3 months after the end of the intervention) [ Time Frame: Change from baseline at 7 months ]
    Quantitative variable

  3. Change in the consumption of processed foods (average portions / day) in the medium term (3 months after the end of the intervention) [ Time Frame: Change from baseline at 7 months ]
    Quantitative variable

  4. Change in the consumption of sugary drinks (average portions / day) in the medium term (3 months after the end of the intervention) [ Time Frame: Change from baseline at 7 months ]
    Quantitative variable

  5. Change in the consumption of natural water (average portions / day) in the medium term (3 months after the end of the intervention) [ Time Frame: Change from baseline at 7 months ]
    Quantitative variable



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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent signed by parent or guardian.
  • Informed consent signed by the adolescent.

Non-inclusion criteria

  • Presence of diagnosed disease, through which dietary habits (diabetes mellitus, kidney disease, etc.) have been modified.
  • Pregnancy or lactation period.
  • Voluntary practice of vegetarian diets (abstention of food of animal origin).

Exclusion Criteria:

  • Two missing assessments.
  • Voluntary decision to leave the study.
  • Attendance at sessions <50%.
  • Initiation of medical or nutritional treatment that influences their eating habits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206476


Locations
Mexico
Escuela Secundaria Técnica #46 de Jalisco, Clave: 14DST0046G
Tonalá, Jalisco, Mexico, 45405
Sponsors and Collaborators
Gabriela Macedo Ojeda
Investigators
Study Director: Gabriela Macedo Ojeda, Doctor Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Publications:
Aguirre ML, Castillo CD, Le Roy C. Emergent Challenges in Adolescent Nutrition. Rev Chil Pediatr. 2010; 81(6): 488-97. doi: 10.4067/S0370-41062010000600002
López E. Stages of behavioral changes in relation to intake of fruits and vegetables, weight control and physical exercise of students in the University of Desarrollo, Concepción, Chile. Rev Chil Nutr. 2008; 35 (3): 215-24. doi: 10.4067/S0717-75182008000300007.

Responsible Party: Gabriela Macedo Ojeda, Professor researcher A, Centro Universitario de Ciencias de la Salud, Mexico
ClinicalTrials.gov Identifier: NCT03206476     History of Changes
Other Study ID Numbers: CI-01017
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriela Macedo Ojeda, Centro Universitario de Ciencias de la Salud, Mexico:
Food Habits
Adolescents
Educative Intervention
Nutrition Assessment
Behavior Modifications