NCT03206476

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

January 25, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 28, 2017

Results QC Date

November 11, 2021

Last Update Submit

June 1, 2022

Conditions

Keywords

Food HabitsAdolescentsEducative InterventionNutrition AssessmentBehavior Modifications

Outcome Measures

Primary Outcomes (5)

  • Change in the Consumption of Fruits and Vegetables in the Short Term

    Change in the consumption of fruits and vegetables (portions / day) in the short term (at the end of the intervention)

    Change from baseline at 4 months

  • Change in the Consumption of Dairy in the Short Term

    Change in the consumption of dairy (portions / day) in the short term (at the end of the intervention)

    Change from baseline at 4 months

  • Change in the Consumption of Processed Foods in the Short Term

    Change in the consumption of processed foods (portions / day) in the short term (at the end of the intervention)

    Change from baseline at 4 months

  • Change in the Consumption of Sugary Drinks in the Short Term

    Change in the consumption of sugary drinks (portions / day) in the short term (at the end of the intervention)

    Change from baseline at 4 months

  • Change in the Consumption of Natural Water in the Short Term

    Change in the consumption of natural water (portions / day) in the short term (at the end of the intervention)

    Change from baseline at 4 months

Secondary Outcomes (5)

  • Change in the Consumption of Fruits and Vegetables in the Medium Term

    Change from baseline at 7 months

  • Change in the Consumption of Dairy in the Medium Term

    Change from baseline at 7 months

  • Change in the Consumption of Processed Foods in the Medium Term

    Change from baseline at 7 months

  • Change in the Consumption of Sugary Drinks in the Medium Term

    Change from baseline at 7 months

  • Change in the Consumption of Natural Water in the Medium Term

    Change from baseline at 7 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Nutritional intervention based on the SCT and the TM

Behavioral: Nutritional intervention based on the SCT and the TM

Control group

ACTIVE COMPARATOR

Nutritional information

Behavioral: Nutritional information

Interventions

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.

Intervention group

Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.

Control group

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escuela Secundaria Técnica #46 de Jalisco, Clave: 14DST0046G

Tonalá, Jalisco, 45405, Mexico

Location

Related Publications (14)

  • Aguilar Cordero MJ, Gonzalez Jimenez E, Garcia Garcia CJ, Garcia Lopez PA, Alvarez Ferre J, Padilla Lopez CA, Gonzalez Mendoza JL, Ocete Hita E. [Obesity in a school children population from Granada: assessment of the efficacy of an educational intervention]. Nutr Hosp. 2011 May-Jun;26(3):636-41. doi: 10.1590/S0212-16112011000300029. Spanish.

    PMID: 21892585BACKGROUND
  • 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

    BACKGROUND
  • Birnbaum AS, Lytle LA, Story M, Perry CL, Murray DM. Are differences in exposure to a multicomponent school-based intervention associated with varying dietary outcomes in adolescents? Health Educ Behav. 2002 Aug;29(4):427-43. doi: 10.1177/109019810202900404.

    PMID: 12137237BACKGROUND
  • Dewar DL, Lubans DR, Plotnikoff RC, Morgan PJ. Development and evaluation of social cognitive measures related to adolescent dietary behaviors. Int J Behav Nutr Phys Act. 2012 Apr 2;9:36. doi: 10.1186/1479-5868-9-36.

    PMID: 22472191BACKGROUND
  • Kapadia-Kundu N, Storey D, Safi B, Trivedi G, Tupe R, Narayana G. Seeds of prevention: the impact on health behaviors of young adolescent girls in Uttar Pradesh, India, a cluster randomized control trial. Soc Sci Med. 2014 Nov;120:169-79. doi: 10.1016/j.socscimed.2014.09.002. Epub 2014 Sep 6.

    PMID: 25254614BACKGROUND
  • 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.

    BACKGROUND
  • Lubans DR, Morgan PJ, Okely AD, Dewar D, Collins CE, Batterham M, Callister R, Plotnikoff RC. Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial. Arch Pediatr Adolesc Med. 2012 Sep 1;166(9):821-7. doi: 10.1001/archpediatrics.2012.41.

    PMID: 22566517BACKGROUND
  • Martinez MI, Hernandez MD, Ojeda M, Mena R, Alegre A, Alfonso JL. [Development of a program of nutritional education and valuation of the change of healthful nourishing habits in a population of students of Obligatory Secondary Education]. Nutr Hosp. 2009 Jul-Aug;24(4):504-10. Spanish.

    PMID: 19721933BACKGROUND
  • Perez Lopez IJ, Delgado Fernandez M. [A school breaks card game improves eating habits in adolescents]. Nutr Hosp. 2012 Nov-Dec;27(6):2055-65. doi: 10.3305/nh.2012.27.6.6071. Spanish.

    PMID: 23588457BACKGROUND
  • Rivera JA, Munoz-Hernandez O, Rosas-Peralta M, Aguilar-Salinas CA, Popkin BM, Willett WC. [Beverage consumption for a healthy life: recommendations for the Mexican population]. Rev Invest Clin. 2008 Mar-Apr;60(2):157-80. Spanish.

    PMID: 18637573BACKGROUND
  • Shamah Levy T, Morales Ruan C, Amaya Castellanos C, Salazar Coronel A, Jimenez Aguilar A, Mendez Gomez Humaran I. Effectiveness of a diet and physical activity promotion strategy on the prevention of obesity in Mexican school children. BMC Public Health. 2012 Mar 1;12:152. doi: 10.1186/1471-2458-12-152.

    PMID: 22381137BACKGROUND
  • Tsiros MD, Sinn N, Brennan L, Coates AM, Walkley JW, Petkov J, Howe PR, Buckley JD. Cognitive behavioral therapy improves diet and body composition in overweight and obese adolescents. Am J Clin Nutr. 2008 May;87(5):1134-40. doi: 10.1093/ajcn/87.5.1134.

    PMID: 18469231BACKGROUND
  • Turconi G, Guarcello M, Maccarini L, Cignoli F, Setti S, Bazzano R, Roggi C. Eating habits and behaviors, physical activity, nutritional and food safety knowledge and beliefs in an adolescent Italian population. J Am Coll Nutr. 2008 Feb;27(1):31-43. doi: 10.1080/07315724.2008.10719672.

    PMID: 18460479BACKGROUND
  • Velazquez Lopez L, Rico Ramos JM, Torres Tamayo M, Medina Bravo P, Toca Porraz LE, Escobedo de la Pena J. [The impact of nutritional education on metabolic disorders in obese children and adolescents]. Endocrinol Nutr. 2009 Dec;56(10):441-6. doi: 10.1016/S1575-0922(09)73311-X. Spanish.

    PMID: 20114013BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Limitations and Caveats

Parental participation was low

Results Point of Contact

Title
Dra. Gabriela Macedo Ojeda
Organization
Universidad de Guadalajara

Study Officials

  • Gabriela Macedo Ojeda, Doctor

    Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor researcher A

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

February 1, 2016

Primary Completion

June 30, 2016

Study Completion

September 30, 2016

Last Updated

June 27, 2022

Results First Posted

January 25, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations