NCT07387289

Brief 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. 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 19, 2026

Last Update Submit

January 27, 2026

Conditions

Keywords

FruitsVegetablesAdultsHigher weightNutritional interventionFeasibility study

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

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

Secondary Outcomes (4)

  • Diet quality

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

  • Eating behaviors assessed using the Dutch Eating Behavior Questionnaire

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

  • Attitudes and beliefs about weight

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

  • Intuitive eating behaviors assessed using the Intuitive Eating Scale-3

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

Other Outcomes (1)

  • Sociodemographic Data

    At the beginning of the 12-week intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receiving a newly developed, 12-week pleasure-oriented intervention that promotes the consumption of fruits and vegetables.

Behavioral: Eating fruits and vegetables with pleasure!

Control group

NO INTERVENTION

Participants receiving no intervention.

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut sur la nutrition et les aliments fonctionnels (INAF), Université Laval

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (33)

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MeSH Terms

Interventions

Vegetables

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Simone Lemieux, Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Bédard, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations