Obesity, AdolescentNCT05865444
Prevention of Eating Habits Associated With Obesity
A study testing Values alignment wise intervention and Educational traditional intervention in people with Obesity, Adolescent and Eating, Healthy, run by University of Deusto at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Eating, Healthy
- What is being tested?
- Values alignment wise intervention and Educational traditional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 591 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent by the adolescents and their parents.
- To be fluent in Spanish and/or Euskera.
Who cannot join
- Lack of permission by parents and the adolescent.
- Lack of understanding of the instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Adolescent, Eating, Healthy
- Being tested
- Values alignment wise intervention, Educational traditional intervention
- Keywords
- Adolescence, Prevention, Healthy food intake, Unhealthy food intake, Wise intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values alignment wise interventionBehavioural
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).
Educational traditional interventionBehavioural
The educational intervention includes information on nutrition and physical exercise. It includes reading and writing exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Educational traditional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline, 1 week, 3 months
Change from baseline scores of body mass index.
Self-reported height (cm) and weight (kg) for BMI calculation.
Measured: 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).
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.
Measured: 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).
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.
Measured: Baseline, 1 week, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start23 Feb 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Calvete, University of Deusto
- Investigators
- Esther Calvete, PhD, Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865444
- Sponsor's protocol ID
- ETK-43/21-22
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be available at OSF when the results of the study are published.
Publications
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.
PubMed 30979065Bryan 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.
PubMed 30988478Bryan 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.
PubMed 27621440Kobes 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.
PubMed 29671938Stok 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.
PubMed 24940622Walton GM, Wilson TD. Wise interventions: Psychological remedies for social and personal problems. Psychol Rev. 2018 Oct;125(5):617-655. doi: 10.1037/rev0000115.
PubMed 30299141
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Eating Habits Associated With Obesity in Adolescents Through a Wise Intervention
- ClinicalTrials.gov ID
- NCT05865444
- Acronym / sponsor ID
- ETK-43/21-22
- Conditions
- Obesity, Adolescent, Eating, Healthy
- Keywords
- Adolescence, Prevention, Healthy food intake, Unhealthy food intake, Wise intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Values alignment wise intervention | Experimental | Behavioral: Values alignment wise intervention1 hour wise intervention (based on a values alignment approach) consisting on several tasks (online and paper-based tasks) to be completed individually. |
| Traditional educational intervention | Active comparator | Behavioral: Educational traditional intervention1 hour traditional educational intervention on nutrition and physical exercise. This will also include reading and writing exercises. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Informed consent by the adolescents and their parents.
- To be fluent in Spanish and/or Euskera.
Key exclusion criteria (2 listed)
- Lack of permission by parents and the adolescent.
- Lack of understanding of the instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Values alignment wise interventionThe 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). | Behavioural | Values alignment wise intervention |
| Educational traditional interventionThe educational intervention includes information on nutrition and physical exercise. It includes reading and writing exercises. | Behavioural | Traditional educational intervention |
Primary outcome
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".
Change from baseline scores of body mass index.
Time frame: Baseline, 3 months
Self-reported height (cm) and weight (kg) for BMI calculation.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 30979065Ashton 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.
- Background: PubMed 30988478Bryan 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.
- Background: PubMed 27621440Bryan 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.
- Background: PubMed 29671938Kobes 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.
- Background: PubMed 24940622Stok 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.
- Background: PubMed 30299141Walton GM, Wilson TD. Wise interventions: Psychological remedies for social and personal problems. Psychol Rev. 2018 Oct;125(5):617-655. doi: 10.1037/rev0000115.
- Individual participant dataSharing planned: Yes. Raw data will be available at OSF when the results of the study are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Calvete, PhD principal investigator
University of Deusto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Values alignment wise intervention and Educational traditional intervention in people with Obesity, Adolescent and Eating, Healthy, run by University of Deusto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865444, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.