- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387289
Eating Fruits and Vegetables With Pleasure! (PLAISIR)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simone Lemieux, Ph.D.
- Phone Number: 403637 1 418 656-2131
- Email: simone.lemieux@fsaa.ulaval.ca
Study Contact Backup
- Name: Alexandra Bédard, Ph.D.
- Email: alexandra.bedard@fsaa.ulaval.ca
Study Locations
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Quebec
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Québec, Quebec, Canada, G1V 0A6
- Institut sur la nutrition et les aliments fonctionnels (INAF), Université Laval
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Contact:
- Katherine Coulombe
- Phone Number: 1 418 656-2645
- Email: katherine.coulombe@vrr.ulaval.ca
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Contact:
- Najat Aattouri
- Phone Number: 1 418 656-2659
- Email: najat.aattouri@vrr.ulaval.ca
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Principal Investigator:
- Simone Lemieux, Ph.D.
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Sub-Investigator:
- Catherine Bégin, Ph.D.
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Sub-Investigator:
- Ariane Bélanger-Gravel, Ph.D.
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Sub-Investigator:
- Sophie Desroches, Ph.D.
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Sub-Investigator:
- Andréanne Michaud, Ph.D.
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Sub-Investigator:
- Véronique Provencher, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current or past diagnosis of an eating disorder (e.g., binge eating disorder, anorexia nervosa, or bulimia nervosa)
- Pregnant or breastfeeding individuals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants receiving a newly developed, 12-week pleasure-oriented intervention that promotes the consumption of fruits and vegetables.
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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.
|
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No Intervention: Control group
Participants receiving no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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From enrollment to the end of the 12-week intervention
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Adherence rate
Time Frame: At the beginning and at the end of the 12-week intervention
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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.
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At the beginning and at the end of the 12-week intervention
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Participation rate
Time Frame: From enrollment to the end of the 12-week intervention.
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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:
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From enrollment to the end of the 12-week intervention.
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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).
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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.
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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).
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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).
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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.
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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).
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Achievement of change objectives targeted by the intervention, assessed using a structured questionnaire
Time Frame: At the end of the 12-week intervention
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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.
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At the end of the 12-week intervention
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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.
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At the beginning and at the end of the 12-week intervention
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Eating pleasure assessed using the Eating Pleasure Questionnaire
Time Frame: At the beginning and at the end of the 12-week intervention
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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.
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At the beginning and at the end of the 12-week intervention
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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
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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.
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At the beginning and at the end of the 12-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diet quality
Time Frame: At the beginning and at the end of the 12-week intervention
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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.
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At the beginning and at the end of the 12-week intervention
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Eating behaviors assessed using the Dutch Eating Behavior Questionnaire
Time Frame: At the beginning and at the end of the 12-week intervention
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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
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At the beginning and at the end of the 12-week intervention
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Attitudes and beliefs about weight
Time Frame: At the beginning and at the end of the 12-week intervention
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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.
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At the beginning and at the end of the 12-week intervention
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Intuitive eating behaviors assessed using the Intuitive Eating Scale-3
Time Frame: At the beginning and at the end of the 12-week intervention
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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.
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At the beginning and at the end of the 12-week intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic Data
Time Frame: At the beginning of the 12-week intervention
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A questionnaire on sociodemographic and medical data-documenting age, gender, income, education level, ethnicity, and obesity-related comorbidities-will be completed by participants prior to the intervention in both groups.
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At the beginning of the 12-week intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Simone Lemieux, Ph.D., Laval University
Publications and helpful links
General Publications
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- Demos KE, McCaffery JM, Thomas JG, Mailloux KA, Hare TA, Wing RR. Identifying the mechanisms through which behavioral weight-loss treatment improves food decision-making in obesity. Appetite. 2017 Jul 1;114:93-100. doi: 10.1016/j.appet.2017.03.013. Epub 2017 Mar 15.
- Briers B, Huh YE, Chan E, Mukhopadhyay A. The unhealthy = tasty belief is associated with BMI through reduced consumption of vegetables: A cross-national and mediational analysis. Appetite. 2020 Jul 1;150:104639. doi: 10.1016/j.appet.2020.104639. Epub 2020 Feb 22.
- Fardet A, Boirie Y. Associations between food and beverage groups and major diet-related chronic diseases: an exhaustive review of pooled/meta-analyses and systematic reviews. Nutr Rev. 2014 Dec;72(12):741-62. doi: 10.1111/nure.12153. Epub 2014 Nov 18.
- Sofi F, Macchi C, Abbate R, Gensini GF, Casini A. Mediterranean diet and health status: an updated meta-analysis and a proposal for a literature-based adherence score. Public Health Nutr. 2014 Dec;17(12):2769-82. doi: 10.1017/S1368980013003169. Epub 2013 Nov 29.
- Schwingshackl L, Bogensberger B, Hoffmann G. Diet Quality as Assessed by the Healthy Eating Index, Alternate Healthy Eating Index, Dietary Approaches to Stop Hypertension Score, and Health Outcomes: An Updated Systematic Review and Meta-Analysis of Cohort Studies. J Acad Nutr Diet. 2018 Jan;118(1):74-100.e11. doi: 10.1016/j.jand.2017.08.024. Epub 2017 Oct 27.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-480
- PJT-175185 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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