Prevention of Eating Habits Associated With Obesity

NCT ID: NCT05865444

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

591 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obesity in adolescence is associated with physical and mental health problems and predicts obesity in adulthood. Adolescence may be an ideal time to target interventions, as this is when numerous health-related habits are consolidated. Several universal preventive interventions have been carried out in educational centers for the promotion of healthy eating habits. However, the results of reviews and meta-analyses have concluded that most are not cost-effective for producing long-term changes in the dietary preferences of young people. The so-called wise interventions paradigm is an innovative approach to interventions that involve a set of rigorous techniques grounded in research to help people improve in a variety of life settings. Recently, it has been developed a wise intervention aimed at improving adolescents' daily dietary choices. This intervention, called the values alignment intervention, focused on the role of marketing on the behavior of children and adolescents who are exposed to a relentless barrage of marketing from the food industry. The values alignment intervention seeks to neutralize the positive emotional associations with junk food that marketing generates and presents the rejection of unhealthy foods in favor of healthy alternatives as a way to live up to two values that are important to adolescents: (1) the desire to be autonomous from adult control, and (2) the desire for social justice. In two randomized controlled trials, it has been demonstrated that the intervention reduced implicit positive associations with junk food and substantially improved dietary choices, especially in boys. In addition, there were significant differences in attitudinal variables related to healthy eating. These promising results suggest that reframing unhealthy eating as incompatible with important youth values could be a low-cost solution to produce changes in adolescent attitudes and dietary choices. Therefore, the general objective of this project is to adapt the values alignment intervention to improve obesity-related eating habits in Spanish adolescents and evaluates its effectiveness. It is therefore a highly innovative project with great potential for social impact in the field of health promotion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Adolescent Eating, Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Allocation will be concealed to the participants and teachers. Assessment will be done online through self-reports.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Values alignment wise intervention

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

Group Type EXPERIMENTAL

Values alignment wise intervention

Intervention Type 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).

Traditional educational intervention

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

Group Type ACTIVE_COMPARATOR

Educational traditional intervention

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Values alignment wise intervention

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).

Intervention Type BEHAVIORAL

Educational traditional intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Lack of permission by parents and the adolescent.
* Lack of understanding of the instructions.
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Deusto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Esther Calvete

Principal Investigator, Deusto Stress Research Team

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esther Calvete, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Deusto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Deusto

Bilbao, Vizcaya, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30979065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30988478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27621440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29671938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24940622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30299141 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ETK-43/21-22

Identifier Type: -

Identifier Source: org_study_id