Eating Fruits and Vegetables With Pleasure!

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaval University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Current or past diagnosis of an eating disorder (e.g., binge eating disorder, anorexia nervosa, or bulimia nervosa)

Pregnant or breastfeeding individuals

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eating fruits and vegetables with pleasure!

    Behavioral

    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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of the 12-week intervention
2

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.

Time frame
At the beginning and at the end of the 12-week intervention
3

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.

Time frame
From enrollment to the end of the 12-week intervention.
4

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.

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).

Secondary outcomes

1

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.

Time frame
At the beginning and at the end of the 12-week intervention
2

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

Time frame
At the beginning and at the end of the 12-week intervention
3

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.

Time frame
At the beginning and at the end of the 12-week intervention
4

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.

Time frame
At the beginning and at the end of the 12-week intervention

Other outcomes

1

Sociodemographic Data

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.

Time frame
At the beginning of the 12-week intervention

Sponsors and contacts

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Laval University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

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