Healthy EatingPLAISIRNCT07387289
Eating Fruits and Vegetables With Pleasure!
A study testing Eating fruits and vegetables with pleasure! in people with Healthy Eating, run by Laval University at 1 site in Canada.
Trial summary
The objective of this interventional study is to pilot test a newly evidence-based intervention integrating different dimensions of eating pleasure to promote the consumption of fruits et vegetables. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Eating
- What is being tested?
- Eating fruits and vegetables with pleasure!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years
- Presenting with higher body weight, defined in this study as a body mass index (BMI) ≥ 30 kg/m²
- Fluent in French, as the nutritional intervention is conducted in this language
- Able to travel to Laval University to take part in the nutritional intervention
Who cannot join
- Current or past diagnosis of an eating disorder (e.g., binge eating disorder, anorexia nervosa, or bulimia nervosa)
- Pregnant or breastfeeding individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra Bédard, Ph.D. contact
Canada1 site
Institut sur la nutrition et les aliments fonctionnels (INAF), Université Laval
Québec, Quebec, G1V 0A6
Katherine Coulombe, 1 418 656-2645, katherine.coulombe@vrr.ulaval.ca
Najat Aattouri, 1 418 656-2659, najat.aattouri@vrr.ulaval.ca
About this study
Official title: Eating Fruits and Vegetables With Pleasure! A Pilot Randomized Controlled Feasibility and Acceptability Assessment of a Nutritional Intervention Integrating Eating Pleasure to Promote Healthy Eating in Higher-Weight Adults
The objective of this interventional study is to pilot test a newly evidence-based intervention integrating different dimensions of eating pleasure to promote the consumption of fruits et vegetables. The target population for this study is men and women, aged 18-65 years old, living with a higher weight.The main hypothesis is that this newly pleasure-oriented intervention is feasible and acceptable for the target population. Participants will be randomized in two groups, a first group receiving the newly, 12-week pleasure-oriented intervention (intervention group) and a second group receiving no intervention (control group).
Participants will:
- Complete a battery of online questionnaires at home before and after the 12-week nutritional intervention (both intervention and control groups);
- For participants assigned to the intervention group only: take part in a 12-week nutritional intervention consisting of 10 group sessions held at Laval University (approximately 2 hours each) and an individual follow-up by phone (30 to 45 minutes). After each session, participants will complete a short questionnaire assessing their appreciation of the session (5 to 10 minutes), as well as a comprehensive appreciation questionnaire at the end of the 12-week intervention (25 to 30 minutes).
Read the detailed description
Research Problem and Hypothesis The health impact of several nutrients, foods, and certain dietary patterns is well documented. Despite this knowledge, food choices within the population remain suboptimal. Furthermore, attempting to promote healthy eating by focusing on the nutritional quality of foods can present certain pitfalls. Indeed, some studies have suggested that there is a persistent perception across different populations-particularly among individuals with higher body weight - that foods considered "healthy" are necessarily less tasty than "unhealthy" foods. This perception may undermine efforts to adhere to healthy eating, given the importance of taste and the pleasure of eating in everyday food choices. In this context, an approach that leverages the pleasure of eating as a driver for healthy eating could be highly relevant. Interestingly, there is growing evidence that eating pleasure can be used to promote healthy eating. Nevertheless, no systematically developed, evidence-based intervention integrating eating pleasure to encourage healthier food choices has yet been described in the literature. To address this gap, the investigators designed an intervention aimed at increasing fruit and vegetable consumption among adults with higher body weight by incorporating eating pleasure into intervention strategies. The research team is now at the stage of assessing its feasibility and acceptability. The choice of this target population (i.e., adults with higher body weight) is based on the fact that these individuals are more likely to seek nutritional advice and benefit from improvements in their dietary intake and behaviors. The main hypothesis is that the proposed intervention will be considered feasible and acceptable by this population.
Objectives and Methodological Approach This intervention was developed using Intervention Mapping, a widely used protocol in behavioral science for designing effective, theory-based, evidence-informed interventions that place the needs and perspectives of the target population at the center of the development process.
In accordance with the Intervention Mapping protocol, four specific objectives were formulated:
- Assess how the target population adheres to the different dimensions of eating pleasure;
- Explore dietitians' perspectives on the elements to consider to maximize the relevance, feasibility, and applicability of using eating pleasure to promote healthy eating by conducting in-depth interviews exploring how the different dimensions of eating pleasure are used to encourage healthy eating, the challenges , and the themes and activities that should be integrated into the intervention;
- Develop the intervention in terms of performance and change objectives, theory-based methods and strategies, and intervention components;
- Conduct a pilot study of the intervention to assess its feasibility and acceptability. To do so, five indicators of feasibility and acceptability will be evaluated: (1) attrition rate, (2) adherence rate, (3) participation rate, (4) perceived acceptability, and (5) implementation fidelity. Performance and change objectives targeted by the intervention will also be measured to identify effective components and those requiring improvement. Measures related to eating pleasure will also be collected, as eating pleasure is considered a key driver of change in this intervention. Dietary quality will be assessed before and after the intervention, as it is the primary outcome of the planned full-scale randomized controlled trial. Finally, certain eating behaviors will also be measured before and after the intervention to ensure that improvements in dietary intake are accompanied by healthy eating behaviors. Similarly, attitudes and beliefs about weight will be assessed to evaluate the impact of the intervention on these variables.
The present application concerns specific objective 4. The intervention will last 12 weeks and include 10 group sessions as well as an individual follow-up.
Participants and Recruitment A total of 88 participants will be recruited and randomly assigned to one of two study groups: a control group (no intervention, n = 44) and an intervention group (n = 44). Allocation will ensure equitable gender representation, with an equal number of men and women in each group. Participants identifying as "other" gender will also be evenly distributed between the two groups. Half of the participants in each group will be aged 18-42 years, and the other half will be aged 43-65 years (42 years being the median age of the 18-65 population in Quebec).
Inclusion criteria are: (1) aged 18-65 years; (2) presenting with higher body weight, defined in this study as a body mass index (BMI) ≥ 30 kg/m²; (3) able to come to INAF (Laval University) if randomized to the intervention group; and (4) to be fluent in French, as the nutrition intervention will be conducted in this language. Participants without Internet access will be able to come to Laval University to complete their online questionnaires, reducing recruitment bias associated with socioeconomic status. Individuals currently suffering from or with a history of eating disorders (e.g., binge eating disorder, anorexia, or bulimia), as well as pregnant or breastfeeding, will be excluded from this study, as these conditions may significantly influence perceptions related to eating pleasure and healthy eating.
Participants will be recruited through mailing lists of the research institute (INAF) and Laval University (students and staff), as well as via social media (e.g., Facebook, Instagram), the INAF website, and certain community collaborators and affiliated centers of the co-investigators. Interested individuals will be invited to contact the research team and provide their phone number. A team member will then call them to present the study and ask a few questions to assess eligibility. Once eligibility is confirmed, the consent form will be presented via the secure FANI platform. If participants have questions, they will be invited to contact the research team. They will have as much time as needed to consider participation. Those wishing to take part in the study will be asked to indicate their consent in the online consent form.
Randomization Men and women from the two age subgroups described above will be evenly distributed between two groups: one group will receive the intervention, and the other will receive no intervention (control group). It has been suggested that, in pilot studies, a no-treatment control group may be preferable to avoid prematurely discarding a potentially promising intervention. The intervention will be facilitated by one or more dietitians involved in the steering committee responsible for developing the intervention. To minimize bias, the randomization sequence for participants will be generated by a computer algorithm using random numbers, taking into account participants' gender and age.
Steering Committee As recommended in the Intervention Mapping process, a steering committee was established at the beginning of the project to provide support, guidance, and oversight at key stages. This committee includes the researchers and the student involved in the project, three dietitians working with the target population, and two individuals from the target population (one man and one woman).
Statistical Analyses Quantitative data related to feasibility and acceptability measures will be presented as means and percentages. For qualitative data, an inductive thematic content analysis will be conducted independently by two team members using NVivo software. Sociodemographic data (e.g., age, gender, income, education level, ethnicity or cultural background) will be entered as attributes to determine whether they influence expressed feedback.
Changes in dependent variables (HEFI-2019, HEFI-FV, IES-3 and DEBQ scales, performance objectives, eating pleasure scales, FAAT) will be compared between intervention and control groups using the PROC MIXED procedure for repeated measures in SAS software (Cary, NC). Confounding variables (e.g., age, gender, income, education level, ethnicity/cultural background, obesity-related comorbidities) and their interactions with the intervention effect will be tested and included as covariates in the models.
Contribution to Knowledge Advancement This study will make a significant contribution to advancing knowledge in healthy eating promotion by leveraging eating pleasure as an innovative driver. The surveys with individuals with higher body weight and dietitians revealed new ways in which eating pleasure can be used to support healthy eating. This intervention will then systematically determine the best way to integrate these findings and other available evidence into practice by health professionals. This project will also provide a new example of collaboration between researchers, clinicians, and the public in generating knowledge that can be rapidly applied.
Perspectives and Knowledge Mobilization Plan This project will help better understand how to use eating pleasure to promote healthy eating among individuals with higher body weight. It will be followed by a randomized controlled trial to evaluate the intervention's effectiveness. Ultimately, an online training workshop for dietitians could be developed to ensure dissemination and sustainability of the intervention, with complementary research to monitor implementation.
Given the significant intercultural differences in food perceptions, the intervention will need to be adapted if researchers or health professionals wish to use it in populations outside Quebec. To this end, a detailed report on the intervention's development on the Open Science Framework platform will be published, and the intervention manual will be available upon request. Thanks to this methodology used in this study, the intervention can be appropriately adapted using effective strategies.
Finally, new knowledge generated by this project will be disseminated through peer-reviewed scientific publications and conference presentations. As a member of the advisory committee established by Health Canada for developing a tool to measure adherence to Canada's Food Guide recommendations, Dr. Lemieux will use the results of this research to contribute to defining the measurement of the recommendation "Enjoy your food" and, eventually, to developing strategies to promote adherence.
- Conditions
- Healthy Eating
- Being tested
- Eating fruits and vegetables with pleasure!
- Keywords
- Fruits, Vegetables, Adults, Higher weight, Nutritional intervention, Feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating fruits and vegetables with pleasure!Behavioural
A newly developed 12-week, pleasure-oriented intervention that promotes the consumption of fruits and vegetables. The program was designed using the Intervention Mapping framework. It includes 10 group sessions along with an individual follow-up throughout the 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants receiving a newly developed, 12-week pleasure-oriented intervention that promotes the consumption of fruits and vegetables. Receives: Behavioral: Eating fruits and vegetables with pleasure! |
| Control group | No intervention | Participants receiving no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition rate
The attrition rate, defined as the percentage of participants who do not complete the study, will be calculated in both groups (considered acceptable if below 20%). Reasons for dropout will be documented by the research team to identify potential barriers to participation and the timing of withdrawal.
Measured: From enrollment to the end of the 12-week intervention
Adherence rate
Adherence rates will be measured by completion of pre- and post-intervention questionnaires in both groups (considered successful if questionnaire completion exceeds 70%). Reasons for non-completion will be documented when applicable.
Measured: At the beginning and at the end of the 12-week intervention
Participation rate
To assess participation rates, attendance at each intervention session will be recorded by the research team in the intervention group (considered successful if attendance exceeds 70%). This rate are calculated at two levels:
- For each participant (attending at least 70% of sessions on average);
- For each session (at least 70% of participants present). Attendance trends and reasons for absences will be also documented.
Measured: From enrollment to the end of the 12-week intervention.
Acceptability
Regarding acceptability, after each session, participants in the intervention group will complete a questionnaire assessing perceived usefulness and appreciation of the activities (considered acceptable if the average score exceeds 7/10). This questionnaire will also include questions on the understanding of the session content, its credibility, session length, and intention to apply learned concepts. Participants will be invited to indicate what they liked and disliked, suggest improvements, and state whether they would recommend the session to others. At the end of the pilot study, an additional questionnaire will explore overall appreciation of the intervention, including general satisfaction, relevance of the intervention, perceived feasibility of maintaining changes, and willingness to continue or participate in a similar program. Open-ended questions will identify the most liked and disliked aspects, encountered obstacles, and suggested improvements to increase acceptability.
Measured: Weekly during the 10 weekly group sessions (Weeks 1-10), and at the individual session conducted at the end of the 12-week intervention (Week 12).
Implementation fidelity
Implementation fidelity will be assessed by the dietitian facilitating the sessions using a structured observation checklist to document adherence to the protocol, including content delivery, adaptations made and their rationale, and encountered difficulties. Sessions will be recorded so the research team can review them and provide feedback to the dietitian.
Measured: Weekly during the 10 weekly group sessions (Weeks 1-10), and at the individual session conducted at the end of the 12-week intervention (Week 12).
Achievement of change objectives targeted by the intervention, assessed using a structured questionnaire
The achievement of change objectives identified through the Intervention Mapping process will be assessed using a structured questionnaire developed for this study. The questionnaire includes items reflecting key determinants targeted by the intervention. Participants in both groups will report their level of attainment of each change objective. Each item assesses a specific change objective and will be analyzed individually to inform refinement and optimization of the intervention. In addition, item responses may be aggregated to compute a composite score summarizing overall achievement of the change objectives.
Measured: At the end of the 12-week intervention
Achievement of intervention performance objectives assessed using a structured questionnaire
The achievement of performance objectives identified through the Intervention Mapping process will be assessed using a structured questionnaire developed for this study. The questionnaire includes items reflecting key targeted behavioral objectives addressed by the intervention. Participants in both groups will rate their level of attainment of each performance objective. Each item assesses a specific performance objective and will be analyzed individually to inform refinement and optimization of the intervention. In addition, item responses may be aggregated to compute a composite score summarizing overall achievement of the performance objectives.
Measured: At the beginning and at the end of the 12-week intervention
Eating pleasure assessed using the Eating Pleasure Questionnaire
The Eating Pleasure Questionnaire will be completed to assess whether eating pleasure evolves following participation. This questionnaire will be completed in both groups. Total and subscale scores will be calculated (min:0, max:3), with higher scores indicating greater levels of eating pleasure.
Measured: At the beginning and at the end of the 12-week intervention
Perceived Impact of Eating Pleasure on Healthy Eating assessed using the Perceived Impact of Eating Pleasure on Healthy Eating questionnaire
The Perceived Impact of Eating Pleasure on Healthy Eating questionnaire will be assessed in both groups to assess whether this concept evolves following participation. Total and subscale scores will be calculated (min:1, max:5). A score > 3 indicates that participants perceived eating pleasure as supporting healthy eating, whereas a score < 3 indicated that it is seen as hindering healthy eating.
Measured: At the beginning and at the end of the 12-week intervention
Secondary outcomes (4)
Diet quality
Since this intervention aims to improve participants' dietary quality, the HEFI-2019 score, a global indicator of adherence to the 2019 Canada's Food Guide recommendations, will be measured before and after the intervention in both groups. In addition to the overall score (min:0, max:80), the score for each component will be also calculated to better capture changes in participants' diets. Because the intervention seeks to promote fruit and vegetable consumption, special attention will be given to the fruit and vegetable component (HEFI-FV; min:0, max:20). These scores will be calculated from three validated web-based 24-hour dietary recalls, completed on three unannounced days (two weekdays and one weekend day), randomly selected by a computer algorithm during the week preceding and following the intervention. Higher scores indicate higher diet quality.
Measured: At the beginning and at the end of the 12-week intervention
Eating behaviors assessed using the Dutch Eating Behavior Questionnaire
Participants in both groups will complete the Dutch Eating Behavior Questionnaire (DEBQ), a tool used for measuring restrictive eating, emotional eating, and external eating behaviors. The Dutch Eating Behavior Questionnaire consists of 33 items rated on a 5-point Likert scale (1 = never to 5 = very often). Subscale scores are typically calculated as the mean of their respective items, yielding scores ranging from 1 to 5, with higher scores indicating greater levels of restrained, emotional, or external eating
Measured: At the beginning and at the end of the 12-week intervention
Attitudes and beliefs about weight
Two subscales (" Body acceptance " et " Critical health ") of the Fat Attitudes Assessment Toolkit (FAAT) will be completed by participants in both groups to determine whether attitudes and beliefs about weight influence response to the intervention and whether they change as a result of the intervention. The Body Acceptance and Critical Health subscales of the Fat Attitudes Assessment Toolkit are scored as the mean of their respective items, yielding scores ranging from 1 to 7, with higher scores indicating greater body acceptance and more critical health-related attitudes toward weight.
Measured: At the beginning and at the end of the 12-week intervention
Intuitive eating behaviors assessed using the Intuitive Eating Scale-3
Participants in both groups will complete the Intuitive Eating Scale-3, a validated questionnaire designed to assess intuitive eating. Items of the Intuitive Eating Scale-3 are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total and subscale scores (Unconditional Permission to Eat, Eating for Physical Rather than Emotional Reasons, Reliance on Hunger and Satiety Cues, and Body-Food Choice Congruence) are calculated as the mean of their respective items, resulting in scores ranging from 1 to 5, with higher scores indicating greater intuitive eating.
Measured: At the beginning and at the end of the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Healthy EatingStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Simone Lemieux, Laval University
- Investigators
- Simone Lemieux, Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387289
- Sponsor's protocol ID
- 2025-480
- Other IDs
- PJT-175185
- Acronym
- PLAISIR
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data underlying the findings are not publicly available because the original approval by the Research Ethics Committee of Laval University and the informed consent from the subjects participating in the studies did not include such a direct, free access. Data can be requested from the principal investigator at simone.lemieux@fsaa.ulaval.ca for researchers who meet the criteria for access to confidential data.
Publications
Cain, P., Donaghue, N., & Ditchburn, G. (2022). Development and validation of the Fat Attitudes Assessment Toolkit (FAAT): A multidimensional nonstigmatizing measure of contemporary attitudes toward fatness and fat people. Journal of Applied Social Psychology, 52, 1121-1145. https://doi.org/10.1111/jasp.12882
van Strien, T., Frijters, J. E. R., Bergers, G. P. A., & Defares, P. B. (1986). The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders, 5(2), 295-315. https://doi.org/10.1002/1098-108X(198602)5:2<295::AID-EAT2260050209>3.0.CO;2-T
Tylka TL, Maiano C, Fuller-Tyszkiewicz M, Linardon J, Burnette CB, Todd J, Swami V. The Intuitive Eating Scale-3: Development and psychometric evaluation. Appetite. 2024 Aug 1;199:107407. doi: 10.1016/j.appet.2024.107407. Epub 2024 May 9.
PubMed 38729580Brassard D, Elvidge Munene LA, St-Pierre S, Gonzalez A, Guenther PM, Jessri M, Vena J, Olstad DL, Vatanparast H, Prowse R, Lemieux S, L'Abbe MR, Garriguet D, Kirkpatrick SI, Lamarche B. Evaluation of the Healthy Eating Food Index (HEFI)-2019 measuring adherence to Canada's Food Guide 2019 recommendations on healthy food choices. Appl Physiol Nutr Metab. 2022 May;47(5):582-594. doi: 10.1139/apnm-2021-0416. Epub 2022 Jan 14.
PubMed 35030069Brassard D, Elvidge Munene LA, St-Pierre S, Guenther PM, Kirkpatrick SI, Slater J, Lemieux S, Jessri M, Haines J, Prowse R, Olstad DL, Garriguet D, Vena J, Vatanpatast H, L'Abbe MR, Lamarche B. Development of the Healthy Eating Food Index (HEFI)-2019 measuring adherence to Canada's Food Guide 2019 recommendations on healthy food choices. Appl Physiol Nutr Metab. 2022 May;47(5):595-610. doi: 10.1139/apnm-2021-0415. Epub 2022 Jan 14.
PubMed 35030038Bédard, A., Pitre, C., Grégoire, L.-M., Lévy-Ndejuru, J., Desroches, S., Provencher, V., Bélanger-Gravel, A., Bégin, C., & Lemieux, S. (2025). The Perceived Impact of Eating Pleasure on Healthy Eating: Development and Validation of a Questionnaire for the French-Speaking Québec Adult Population. Dietetics, 4(2), 22. https://doi.org/10.3390/dietetics4020022
Gregoire LM, Bedard A, Desroches S, Provencher V, Belanger-Gravel A, Begin C, Lemieux S. Development and validation of a questionnaire assessing eating pleasure dimensions in the adult French-speaking population of the province of Quebec, Canada. Appetite. 2022 May 1;172:105966. doi: 10.1016/j.appet.2022.105966. Epub 2022 Feb 11.
PubMed 35151684Mohr DC, Spring B, Freedland KE, Beckner V, Arean P, Hollon SD, Ockene J, Kaplan R. The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychother Psychosom. 2009;78(5):275-84. doi: 10.1159/000228248. Epub 2009 Jul 11.
PubMed 19602916Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.
PubMed 26146089Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
PubMed 24993581Statistics Canada (2016). Âge et sexe - Faits saillants en tableaux, Recensement de 2016 [cited October 2 2025]. Available from: https://www12.statcan.gc.ca/census-recensement/2016/dp-pd/hlt-fst/as/index-fra.cfm.
Bartholomew Eldredge LK, Markham CM, Ruiter RAC, Fernandez ME, Kok G , Parcel GS. Planning health promotion programs : an intervention mapping approach. San Francisco, CA: Jossey-Bass & Pfeiffer Imprints, Wiley; 2016.
Wharton S, Lau DCW, Vallis M, Sharma AM, Biertho L, Campbell-Scherer D, Adamo K, Alberga A, Bell R, Boule N, Boyling E, Brown J, Calam B, Clarke C, Crowshoe L, Divalentino D, Forhan M, Freedhoff Y, Gagner M, Glazer S, Grand C, Green M, Hahn M, Hawa R, Henderson R, Hong D, Hung P, Janssen I, Jacklin K, Johnson-Stoklossa C, Kemp A, Kirk S, Kuk J, Langlois MF, Lear S, McInnes A, Macklin D, Naji L, Manjoo P, Morin MP, Nerenberg K, Patton I, Pedersen S, Pereira L, Piccinini-Vallis H, Poddar M, Poirier P, Prud'homme D, Salas XR, Rueda-Clausen C, Russell-Mayhew S, Shiau J, Sherifali D, Sievenpiper J, Sockalingam S, Taylor V, Toth E, Twells L, Tytus R, Walji S, Walker L, Wicklum S. Obesity in adults: a clinical practice guideline. CMAJ. 2020 Aug 4;192(31):E875-E891. doi: 10.1503/cmaj.191707. No abstract available.
PubMed 32753461Brown J CC, Johnson Stoklossa C, Sievenpiper J. : Canadian Adult Obesity Clinical Practice Guidelines: Medical Nutrition Therapy in Obesity Management. https://obesitycanada.ca/guidelines/nutrition. Accessed [10/09/2020]. 2020.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Fruits and Vegetables With Pleasure! A Pilot Randomized Controlled Feasibility and Acceptability Assessment of a Nutritional Intervention Integrating Eating Pleasure to Promote Healthy Eating in Higher-Weight Adults
- ClinicalTrials.gov ID
- NCT07387289
- Acronym / sponsor ID
- PLAISIR / 2025-480
- Conditions
- Healthy Eating
- Keywords
- Fruits, Vegetables, Adults, Higher weight, Nutritional intervention, Feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (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.
The objective of this interventional study is to pilot test a newly evidence-based intervention integrating different dimensions of eating pleasure to promote the consumption of fruits et vegetables. The target population for this study is men and women, aged 18-65 years old, living with a higher weight.The main hypothesis is that this newly pleasure-oriented intervention is feasible and acceptable for the target population. Participants will be randomized in two groups, a first group receiving the newly, 12-week pleasure-oriented intervention (intervention group) and a second group receiving no intervention (control group).
Participants will:
- Complete a battery of online questionnaires at home before and after the 12-week nutritional intervention (both intervention and control groups);
- For participants assigned to the intervention group only: take part in a 12-week nutritional intervention consisting of 10 group sessions held at Laval University (approximately 2 hours each) and an individual follow-up by phone (30 to 45 minutes). After each session, participants will complete a short questionnaire assessing their appreciation of the session (5 to 10 minutes), as well as a comprehensive appreciation questionnaire at the end of the 12-week intervention (25 to 30 minutes).
Detailed description
Research Problem and Hypothesis The health impact of several nutrients, foods, and certain dietary patterns is well documented. Despite this knowledge, food choices within the population remain suboptimal. Furthermore, attempting to promote healthy eating by focusing on the nutritional quality of foods can present certain pitfalls. Indeed, some studies have suggested that there is a persistent perception across different populations-particularly among individuals with higher body weight - that foods considered "healthy" are necessarily less tasty than "unhealthy" foods. This perception may undermine efforts to adhere to healthy eating, given the importance of taste and the pleasure of eating in everyday food choices. In this context, an approach that leverages the pleasure of eating as a driver for healthy eating could be highly relevant. Interestingly, there is growing evidence that eating pleasure can be used to promote healthy eating. Nevertheless, no systematically developed, evidence-based intervention integrating eating pleasure to encourage healthier food choices has yet been described in the literature. To address this gap, the investigators designed an intervention aimed at increasing fruit and vegetable consumption among adults with higher body weight by incorporating eating pleasure into intervention strategies. The research team is now at the stage of assessing its feasibility and acceptability. The choice of this target population (i.e., adults with higher body weight) is based on the fact that these individuals are more likely to seek nutritional advice and benefit from improvements in their dietary intake and behaviors. The main hypothesis is that the proposed intervention will be considered feasible and acceptable by this population.
Objectives and Methodological Approach This intervention was developed using Intervention Mapping, a widely used protocol in behavioral science for designing effective, theory-based, evidence-informed interventions that place the needs and perspectives of the target population at the center of the development process.
In accordance with the Intervention Mapping protocol, four specific objectives were formulated:
- Assess how the target population adheres to the different dimensions of eating pleasure;
- Explore dietitians' perspectives on the elements to consider to maximize the relevance, feasibility, and applicability of using eating pleasure to promote healthy eating by conducting in-depth interviews exploring how the different dimensions of eating pleasure are used to encourage healthy eating, the challenges , and the themes and activities that should be integrated into the intervention;
- Develop the intervention in terms of performance and change objectives, theory-based methods and strategies, and intervention components;
- Conduct a pilot study of the intervention to assess its feasibility and acceptability. To do so, five indicators of feasibility and acceptability will be evaluated: (1) attrition rate, (2) adherence rate, (3) participation rate, (4) perceived acceptability, and (5) implementation fidelity. Performance and change objectives targeted by the intervention will also be measured to identify effective components and those requiring improvement. Measures related to eating pleasure will also be collected, as eating pleasure is considered a key driver of change in this intervention. Dietary quality will be assessed before and after the intervention, as it is the primary outcome of the planned full-scale randomized controlled trial. Finally, certain eating behaviors will also be measured before and after the intervention to ensure that improvements in dietary intake are accompanied by healthy eating behaviors. Similarly, attitudes and beliefs about weight will be assessed to evaluate the impact of the intervention on these variables.
The present application concerns specific objective 4. The intervention will last 12 weeks and include 10 group sessions as well as an individual follow-up.
Participants and Recruitment A total of 88 participants will be recruited and randomly assigned to one of two study groups: a control group (no intervention, n = 44) and an intervention group (n = 44). Allocation will ensure equitable gender representation, with an equal number of men and women in each group. Participants identifying as "other" gender will also be evenly distributed between the two groups. Half of the participants in each group will be aged 18-42 years, and the other half will be aged 43-65 years (42 years being the median age of the 18-65 population in Quebec).
Inclusion criteria are: (1) aged 18-65 years; (2) presenting with higher body weight, defined in this study as a body mass index (BMI) ≥ 30 kg/m²; (3) able to come to INAF (Laval University) if randomized to the intervention group; and (4) to be fluent in French, as the nutrition intervention will be conducted in this language. Participants without Internet access will be able to come to Laval University to complete their online questionnaires, reducing recruitment bias associated with socioeconomic status. Individuals currently suffering from or with a history of eating disorders (e.g., binge eating disorder, anorexia, or bulimia), as well as pregnant or breastfeeding, will be excluded from this study, as these conditions may significantly influence perceptions related to eating pleasure and healthy eating.
Participants will be recruited through mailing lists of the research institute (INAF) and Laval University (students and staff), as well as via social media (e.g., Facebook, Instagram), the INAF website, and certain community collaborators and affiliated centers of the co-investigators. Interested individuals will be invited to contact the research team and provide their phone number. A team member will then call them to present the study and ask a few questions to assess eligibility. Once eligibility is confirmed, the consent form will be presented via the secure FANI platform. If participants have questions, they will be invited to contact the research team. They will have as much time as needed to consider participation. Those wishing to take part in the study will be asked to indicate their consent in the online consent form.
Randomization Men and women from the two age subgroups described above will be evenly distributed between two groups: one group will receive the intervention, and the other will receive no intervention (control group). It has been suggested that, in pilot studies, a no-treatment control group may be preferable to avoid prematurely discarding a potentially promising intervention. The intervention will be facilitated by one or more dietitians involved in the steering committee responsible for developing the intervention. To minimize bias, the randomization sequence for participants will be generated by a computer algorithm using random numbers, taking into account participants' gender and age.
Steering Committee As recommended in the Intervention Mapping process, a steering committee was established at the beginning of the project to provide support, guidance, and oversight at key stages. This committee includes the researchers and the student involved in the project, three dietitians working with the target population, and two individuals from the target population (one man and one woman).
Statistical Analyses Quantitative data related to feasibility and acceptability measures will be presented as means and percentages. For qualitative data, an inductive thematic content analysis will be conducted independently by two team members using NVivo software. Sociodemographic data (e.g., age, gender, income, education level, ethnicity or cultural background) will be entered as attributes to determine whether they influence expressed feedback.
Changes in dependent variables (HEFI-2019, HEFI-FV, IES-3 and DEBQ scales, performance objectives, eating pleasure scales, FAAT) will be compared between intervention and control groups using the PROC MIXED procedure for repeated measures in SAS software (Cary, NC). Confounding variables (e.g., age, gender, income, education level, ethnicity/cultural background, obesity-related comorbidities) and their interactions with the intervention effect will be tested and included as covariates in the models.
Contribution to Knowledge Advancement This study will make a significant contribution to advancing knowledge in healthy eating promotion by leveraging eating pleasure as an innovative driver. The surveys with individuals with higher body weight and dietitians revealed new ways in which eating pleasure can be used to support healthy eating. This intervention will then systematically determine the best way to integrate these findings and other available evidence into practice by health professionals. This project will also provide a new example of collaboration between researchers, clinicians, and the public in generating knowledge that can be rapidly applied.
Perspectives and Knowledge Mobilization Plan This project will help better understand how to use eating pleasure to promote healthy eating among individuals with higher body weight. It will be followed by a randomized controlled trial to evaluate the intervention's effectiveness. Ultimately, an online training workshop for dietitians could be developed to ensure dissemination and sustainability of the intervention, with complementary research to monitor implementation.
Given the significant intercultural differences in food perceptions, the intervention will need to be adapted if researchers or health professionals wish to use it in populations outside Quebec. To this end, a detailed report on the intervention's development on the Open Science Framework platform will be published, and the intervention manual will be available upon request. Thanks to this methodology used in this study, the intervention can be appropriately adapted using effective strategies.
Finally, new knowledge generated by this project will be disseminated through peer-reviewed scientific publications and conference presentations. As a member of the advisory committee established by Health Canada for developing a tool to measure adherence to Canada's Food Guide recommendations, Dr. Lemieux will use the results of this research to contribute to defining the measurement of the recommendation "Enjoy your food" and, eventually, to developing strategies to promote adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Eating fruits and vegetables with pleasure!Participants receiving a newly developed, 12-week pleasure-oriented intervention that promotes the consumption of fruits and vegetables. |
| Control group | No intervention | –Participants receiving no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 65 years
- Presenting with higher body weight, defined in this study as a body mass index (BMI) ≥ 30 kg/m²
- Fluent in French, as the nutritional intervention is conducted in this language
- Able to travel to Laval University to take part in the nutritional intervention
Key exclusion criteria (2 listed)
- Current or past diagnosis of an eating disorder (e.g., binge eating disorder, anorexia nervosa, or bulimia nervosa)
- Pregnant or breastfeeding individuals
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 |
|---|---|---|
| Eating fruits and vegetables with pleasure!A newly developed 12-week, pleasure-oriented intervention that promotes the consumption of fruits and vegetables. The program was designed using the Intervention Mapping framework. It includes 10 group sessions along with an individual follow-up throughout the 12-week period. | Behavioural | Intervention group |
Primary outcome
Attrition rate
Time frame: From enrollment to the end of the 12-week intervention
The attrition rate, defined as the percentage of participants who do not complete the study, will be calculated in both groups (considered acceptable if below 20%). Reasons for dropout will be documented by the research team to identify potential barriers to participation and the timing of withdrawal.
Adherence rate
Time frame: At the beginning and at the end of the 12-week intervention
Adherence rates will be measured by completion of pre- and post-intervention questionnaires in both groups (considered successful if questionnaire completion exceeds 70%). Reasons for non-completion will be documented when applicable.
Participation rate
Time frame: From enrollment to the end of the 12-week intervention.
To assess participation rates, attendance at each intervention session will be recorded by the research team in the intervention group (considered successful if attendance exceeds 70%). This rate are calculated at two levels: * For each participant (attending at least 70% of sessions on average); * For each session (at least 70% of participants present). Attendance trends and reasons for absences will be also documented.
Acceptability
Time frame: Weekly during the 10 weekly group sessions (Weeks 1-10), and at the individual session conducted at the end of the 12-week intervention (Week 12).
Regarding acceptability, after each session, participants in the intervention group will complete a questionnaire assessing perceived usefulness and appreciation of the activities (considered acceptable if the average score exceeds 7/10). This questionnaire will also include questions on the understanding of the session content, its credibility, session length, and intention to apply learned concepts. Participants will be invited to indicate what they liked and disliked, suggest improvements, and state whether they would recommend the session to others. At the end of the pilot study, an additional questionnaire will explore overall appreciation of the intervention, including general satisfaction, relevance of the intervention, perceived feasibility of maintaining changes, and willingness to continue or participate in a similar program. Open-ended questions will identify the most liked and disliked aspects, encountered obstacles, and suggested improvements to increase acceptability.
Implementation fidelity
Time frame: Weekly during the 10 weekly group sessions (Weeks 1-10), and at the individual session conducted at the end of the 12-week intervention (Week 12).
Implementation fidelity will be assessed by the dietitian facilitating the sessions using a structured observation checklist to document adherence to the protocol, including content delivery, adaptations made and their rationale, and encountered difficulties. Sessions will be recorded so the research team can review them and provide feedback to the dietitian.
Achievement of change objectives targeted by the intervention, assessed using a structured questionnaire
Time frame: At the end of the 12-week intervention
The achievement of change objectives identified through the Intervention Mapping process will be assessed using a structured questionnaire developed for this study. The questionnaire includes items reflecting key determinants targeted by the intervention. Participants in both groups will report their level of attainment of each change objective. Each item assesses a specific change objective and will be analyzed individually to inform refinement and optimization of the intervention. In addition, item responses may be aggregated to compute a composite score summarizing overall achievement of the change objectives.
Achievement of intervention performance objectives assessed using a structured questionnaire
Time frame: At the beginning and at the end of the 12-week intervention
The achievement of performance objectives identified through the Intervention Mapping process will be assessed using a structured questionnaire developed for this study. The questionnaire includes items reflecting key targeted behavioral objectives addressed by the intervention. Participants in both groups will rate their level of attainment of each performance objective. Each item assesses a specific performance objective and will be analyzed individually to inform refinement and optimization of the intervention. In addition, item responses may be aggregated to compute a composite score summarizing overall achievement of the performance objectives.
Eating pleasure assessed using the Eating Pleasure Questionnaire
Time frame: At the beginning and at the end of the 12-week intervention
The Eating Pleasure Questionnaire will be completed to assess whether eating pleasure evolves following participation. This questionnaire will be completed in both groups. Total and subscale scores will be calculated (min:0, max:3), with higher scores indicating greater levels of eating pleasure.
Perceived Impact of Eating Pleasure on Healthy Eating assessed using the Perceived Impact of Eating Pleasure on Healthy Eating questionnaire
Time frame: At the beginning and at the end of the 12-week intervention
The Perceived Impact of Eating Pleasure on Healthy Eating questionnaire will be assessed in both groups to assess whether this concept evolves following participation. Total and subscale scores will be calculated (min:1, max:5). A score > 3 indicates that participants perceived eating pleasure as supporting healthy eating, whereas a score < 3 indicated that it is seen as hindering healthy eating.
4 secondary outcomes
Diet quality
Time frame: At the beginning and at the end of the 12-week intervention
Eating behaviors assessed using the Dutch Eating Behavior Questionnaire
Time frame: At the beginning and at the end of the 12-week intervention
Attitudes and beliefs about weight
Time frame: At the beginning and at the end of the 12-week intervention
Intuitive eating behaviors assessed using the Intuitive Eating Scale-3
Time frame: At the beginning and at the end of the 12-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- BackgroundCain, P., Donaghue, N., & Ditchburn, G. (2022). Development and validation of the Fat Attitudes Assessment Toolkit (FAAT): A multidimensional nonstigmatizing measure of contemporary attitudes toward fatness and fat people. Journal of Applied Social Psychology, 52, 1121-1145. https://doi.org/10.1111/jasp.12882
- Backgroundvan Strien, T., Frijters, J. E. R., Bergers, G. P. A., & Defares, P. B. (1986). The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders, 5(2), 295-315. https://doi.org/10.1002/1098-108X(198602)5:2<295::AID-EAT2260050209>3.0.CO;2-T
- Background: PubMed 38729580Tylka TL, Maiano C, Fuller-Tyszkiewicz M, Linardon J, Burnette CB, Todd J, Swami V. The Intuitive Eating Scale-3: Development and psychometric evaluation. Appetite. 2024 Aug 1;199:107407. doi: 10.1016/j.appet.2024.107407. Epub 2024 May 9.
- Background: PubMed 35030069Brassard D, Elvidge Munene LA, St-Pierre S, Gonzalez A, Guenther PM, Jessri M, Vena J, Olstad DL, Vatanparast H, Prowse R, Lemieux S, L'Abbe MR, Garriguet D, Kirkpatrick SI, Lamarche B. Evaluation of the Healthy Eating Food Index (HEFI)-2019 measuring adherence to Canada's Food Guide 2019 recommendations on healthy food choices. Appl Physiol Nutr Metab. 2022 May;47(5):582-594. doi: 10.1139/apnm-2021-0416. Epub 2022 Jan 14.
- Background: PubMed 35030038Brassard D, Elvidge Munene LA, St-Pierre S, Guenther PM, Kirkpatrick SI, Slater J, Lemieux S, Jessri M, Haines J, Prowse R, Olstad DL, Garriguet D, Vena J, Vatanpatast H, L'Abbe MR, Lamarche B. Development of the Healthy Eating Food Index (HEFI)-2019 measuring adherence to Canada's Food Guide 2019 recommendations on healthy food choices. Appl Physiol Nutr Metab. 2022 May;47(5):595-610. doi: 10.1139/apnm-2021-0415. Epub 2022 Jan 14.
- BackgroundBédard, A., Pitre, C., Grégoire, L.-M., Lévy-Ndejuru, J., Desroches, S., Provencher, V., Bélanger-Gravel, A., Bégin, C., & Lemieux, S. (2025). The Perceived Impact of Eating Pleasure on Healthy Eating: Development and Validation of a Questionnaire for the French-Speaking Québec Adult Population. Dietetics, 4(2), 22. https://doi.org/10.3390/dietetics4020022
- Background: PubMed 35151684Gregoire LM, Bedard A, Desroches S, Provencher V, Belanger-Gravel A, Begin C, Lemieux S. Development and validation of a questionnaire assessing eating pleasure dimensions in the adult French-speaking population of the province of Quebec, Canada. Appetite. 2022 May 1;172:105966. doi: 10.1016/j.appet.2022.105966. Epub 2022 Feb 11.
- Background: PubMed 19602916Mohr DC, Spring B, Freedland KE, Beckner V, Arean P, Hollon SD, Ockene J, Kaplan R. The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychother Psychosom. 2009;78(5):275-84. doi: 10.1159/000228248. Epub 2009 Jul 11.
- Background: PubMed 26146089Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6.
- Background: PubMed 20053272Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
- Background: PubMed 24993581Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
- BackgroundStatistics Canada (2016). Âge et sexe - Faits saillants en tableaux, Recensement de 2016 [cited October 2 2025]. Available from: https://www12.statcan.gc.ca/census-recensement/2016/dp-pd/hlt-fst/as/index-fra.cfm.
- Individual participant dataSharing planned: No. The data underlying the findings are not publicly available because the original approval by the Research Ethics Committee of Laval University and the informed consent from the subjects participating in the studies did not include such a direct, free access. Data can be requested from the principal investigator at simone.lemieux@fsaa.ulaval.ca for researchers who meet the criteria for access to confidential data.
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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.
Alexandra Bédard, Ph.D. contact
Simone Lemieux, Ph.D. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating fruits and vegetables with pleasure! in people with Healthy Eating, run by Laval University at 1 site in Canada.
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 4 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Lemieux, Ph.D. (1 418 656-2131 ext. 403637, simone.lemieux@fsaa.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition rate (time frame: From enrollment to the end of the 12-week intervention). The study lists 9 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 NCT07387289, which also lists 33 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 4 Feb 2026.