Prevention of Eating Habits Associated With Obesity

NCT05865444 | Completed

• 1 other identifier: ETK-43/21-22
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of a Wise Intervention based on a values alignment approach to improve obesity-related eating habits in Spanish adolescents. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.

Conditions

Obesity, Adolescent; Eating, Healthy

Keywords

Adolescence; Prevention; Healthy food intake; Unhealthy food intake; Wise intervention

Outcome Measures

Primary Outcomes (2)

• Change from baseline scores of healthy and unhealthy food intake using the questionnaire developed by Stok et al. (2015).

  It consists of four items that ask frequency of consumption of healthy and unhealthy food. It provides an index of unhealthy eating. Five response categories are provided: "none", "1", "2", "3", "4", or "more than 4 per day".

  Baseline, 1 week, 3 months

• Change from baseline scores of body mass index.

  Self-reported height (cm) and weight (kg) for BMI calculation.

  Baseline, 3 months

Secondary Outcomes (2)

• Change from baseline scores of the alignment of healthy eating habits with the values of adolescents using a questionnaire developed from Bryan et al. (2019).

  Baseline, 1 week, 3 months

• Change from baseline scores of the social attractiveness of healthy eating using a questionnaire developed by Bryan et al. (2019).

  Baseline, 1 week, 3 months

Study Arms (2)

Values alignment wise intervention

EXPERIMENTAL

1 hour wise intervention (based on a values alignment approach) consisting on several tasks (online and paper-based tasks) to be completed individually.

Behavioral: Values alignment wise intervention

Traditional educational intervention

ACTIVE COMPARATOR

1 hour traditional educational intervention on nutrition and physical exercise. This will also include reading and writing exercises.

Behavioral: Educational traditional intervention

Interventions

Values alignment wise intervention BEHAVIORAL

The intervention includes: (1) reading materials, such as recent journalistic works that expose the deceptive and manipulative marketing practices of food companies and the harmful effects of these practices on society, with particular emphasis on harm to young children and the economically disadvantaged. Stories from other young people will also be included in order to contribute to the perception of widespread outrage and to suggest how that outrage can be channeled into taking a stand against the injustice perpetrated by food companies by eating less unhealthy or healthier food; (2) writing exercises, such as a story with a brief statement of what the participants would tell a younger child about the ads; and (3) an interactive activity, called "Make It Real" in which they are shown pictures of food ads and allowed to write and draw about them, making whatever changes (e.g., crossing out and substituting words) they feel necessary to make the ad "real" (i.e., no longer misleading).

Values alignment wise intervention

Educational traditional intervention BEHAVIORAL

The educational intervention includes information on nutrition and physical exercise. It includes reading and writing exercises.

Traditional educational intervention

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent by the adolescents and their parents.
• To be fluent in Spanish and/or Euskera.

You may not qualify if:

• Lack of permission by parents and the adolescent.
• Lack of understanding of the instructions.

Sponsors & Collaborators

• University of Deusto: lead

Study Sites (1)

University of Deusto

Bilbao, Vizcaya, 48003, Spain

Location

Related Publications (6)

• Ashton LM, Sharkey T, Whatnall MC, Williams RL, Bezzina A, Aguiar EJ, Collins CE, Hutchesson MJ. Effectiveness of Interventions and Behaviour Change Techniques for Improving Dietary Intake in Young Adults: A Systematic Review and Meta-Analysis of RCTs. Nutrients. 2019 Apr 11;11(4):825. doi: 10.3390/nu11040825.

  PMID: 30979065 BACKGROUND

• Bryan CJ, Yeager DS, Hinojosa CP. A values-alignment intervention protects adolescents from the effects of food marketing. Nat Hum Behav. 2019 Jun;3(6):596-603. doi: 10.1038/s41562-019-0586-6. Epub 2019 Apr 15.

  PMID: 30988478 BACKGROUND

• Bryan CJ, Yeager DS, Hinojosa CP, Chabot A, Bergen H, Kawamura M, Steubing F. Harnessing adolescent values to motivate healthier eating. Proc Natl Acad Sci U S A. 2016 Sep 27;113(39):10830-5. doi: 10.1073/pnas.1604586113. Epub 2016 Sep 12.

  PMID: 27621440 BACKGROUND

• Kobes A, Kretschmer T, Timmerman G, Schreuder P. Interventions aimed at preventing and reducing overweight/obesity among children and adolescents: a meta-synthesis. Obes Rev. 2018 Aug;19(8):1065-1079. doi: 10.1111/obr.12688. Epub 2018 Apr 19.

  PMID: 29671938 BACKGROUND

• Stok FM, de Vet E, de Wit JB, Luszczynska A, Safron M, de Ridder DT. The proof is in the eating: subjective peer norms are associated with adolescents' eating behaviour. Public Health Nutr. 2015 Apr;18(6):1044-51. doi: 10.1017/S1368980014001268. Epub 2014 Jun 18.

  PMID: 24940622 BACKGROUND

• Walton GM, Wilson TD. Wise interventions: Psychological remedies for social and personal problems. Psychol Rev. 2018 Oct;125(5):617-655. doi: 10.1037/rev0000115.

  PMID: 30299141 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esther Calvete, PhD

  University of Deusto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Allocation will be concealed to the participants and teachers. Assessment will be done online through self-reports.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Deusto Stress Research Team

Model Details: A randomized controlled trial with two groups will be used. Randomization will be done by clusters, using the classroom as the unit. First, the schools will be selected according to their characteristics. Then, for each school and grade, half of the classrooms will be randomly assigned to the experimental condition (values alignment condition) and the other half to the active control condition (traditional educational intervention) in parallel for the duration of the study.

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: May 18, 2023
• Study Start: February 23, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol and informed consent protocol will be published at clinicaltrials.org Data will be available at OSF when the results are published.
• Access Criteria: Public

Locations

ES (1)