Prevention of Eating Habits Associated With Obesity

November 27, 2023 updated by: Esther Calvete, University of Deusto

Prevention of Eating Habits Associated With Obesity in Adolescents Through a Wise Intervention

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

591

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48003
        • University of Deusto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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).
Active Comparator: Traditional educational intervention
1 hour traditional educational intervention on nutrition and physical exercise. This will also include reading and writing exercises.
The educational intervention includes information on nutrition and physical exercise. It includes reading and writing exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline scores of healthy and unhealthy food intake using the questionnaire developed by Stok et al. (2015).
Time Frame: Baseline, 1 week, 3 months
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.
Time Frame: Baseline, 3 months
Self-reported height (cm) and weight (kg) for BMI calculation.
Baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Baseline, 1 week, 3 months
It consists of seven items that assess adolescents' interpretation of healthy eating as addressing social justice issues (4 items) and as an assertive behavior expressing autonomy and independence (3 items). Each item is scored 0-4 (0 = not true; 4 = extremely true), yielding a total between 0 and 28.
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).
Time Frame: Baseline, 1 week, 3 months
It consists of three items that assess social attractiveness of healthy eating. Each item is scored 0-4 (0 = not at all agree; 4 = totally agree), yielding a total between 0 and 12.
Baseline, 1 week, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Esther Calvete, PhD, University of Deusto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2023

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw data will be available at OSF when the results of the study are published.

IPD Sharing 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.

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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