Clinical trial NCT05865444: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Eating, Healthy
Keywords: Adolescence
Prevention
Healthy food intake
Unhealthy food intake
Wise intervention
Lead sponsor: University of Deusto
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 591
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change from baseline scores of healthy and unhealthy food intake using the questionnaire developed by Stok et al. (2015).
timeFrame: Baseline, 1 week, 3 months
measure: Change from baseline scores of body mass index.
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: 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).
timeFrame: Baseline, 1 week, 3 months
measure: Change from baseline scores of the social attractiveness of healthy eating using a questionnaire developed by Bryan et al. (2019).
timeFrame: Baseline, 1 week, 3 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: University of Deusto
state: Vizcaya
Study officials:
affiliation: University of Deusto
name: Esther Calvete, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.