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Prevention of Eating Habits Associated With Obesity

Primary Purpose

Obesity, Adolescent, Eating, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Values alignment wise intervention
Educational traditional intervention
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Adolescent focused on measuring Adolescence, Prevention, Healthy food intake, Unhealthy food intake, Wise intervention

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of DeustoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Values alignment wise intervention

Traditional educational intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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".
Change from baseline scores of body mass index.
Self-reported height (cm) and weight (kg) for BMI calculation.

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2023
Last Updated
May 9, 2023
Sponsor
University of Deusto
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1. Study Identification

Unique Protocol Identification Number
NCT05865444
Brief Title
Prevention of Eating Habits Associated With Obesity
Official Title
Prevention of Eating Habits Associated With Obesity in Adolescents Through a Wise Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Deusto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent, Eating, Healthy
Keywords
Adolescence, Prevention, Healthy food intake, Unhealthy food intake, Wise intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Allocation will be concealed to the participants and teachers. Assessment will be done online through self-reports.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Values alignment wise intervention
Arm Type
Experimental
Arm Description
1 hour wise intervention (based on a values alignment approach) consisting on several tasks (online and paper-based tasks) to be completed individually.
Arm Title
Traditional educational intervention
Arm Type
Active Comparator
Arm Description
1 hour traditional educational intervention on nutrition and physical exercise. This will also include reading and writing exercises.
Intervention Type
Behavioral
Intervention Name(s)
Values alignment wise intervention
Intervention Description
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
Intervention Name(s)
Educational traditional intervention
Intervention Description
The educational intervention includes information on nutrition and physical exercise. It includes reading and writing exercises.
Primary Outcome Measure Information:
Title
Change from baseline scores of healthy and unhealthy food intake using the questionnaire developed by Stok et al. (2015).
Description
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".
Time Frame
Baseline, 1 week, 3 months
Title
Change from baseline scores of body mass index.
Description
Self-reported height (cm) and weight (kg) for BMI calculation.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Baseline, 1 week, 3 months
Title
Change from baseline scores of the social attractiveness of healthy eating using a questionnaire developed by Bryan et al. (2019).
Description
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.
Time Frame
Baseline, 1 week, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Calvete, PhD
Phone
0034 944139 000
Ext
2847
Email
esther.calvete@deusto.es
First Name & Middle Initial & Last Name or Official Title & Degree
Liria Fernández-González, PhD
Phone
0034 944139 000
Ext
2800
Email
liria.fernandez@deusto.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Calvete, PhD
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Deusto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Calvete, PhD
Phone
944139000
Ext
2847
Email
esther.calvete@deusto.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30979065
Citation
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.
Results Reference
background
PubMed Identifier
30988478
Citation
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.
Results Reference
background
PubMed Identifier
27621440
Citation
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.
Results Reference
background
PubMed Identifier
29671938
Citation
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.
Results Reference
background
PubMed Identifier
24940622
Citation
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.
Results Reference
background
PubMed Identifier
30299141
Citation
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.
Results Reference
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Prevention of Eating Habits Associated With Obesity

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