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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Attrition rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Current or past diagnosis of an eating disorder (e.g., binge eating disorder, anorexia nervosa, or bulimia nervosa)
- •Pregnant or breastfeeding individuals
研究组 & 干预措施
Intervention group
Participants receiving a newly developed, 12-week pleasure-oriented intervention that promotes the consumption of fruits and vegetables.
干预措施: Eating fruits and vegetables with pleasure! (Behavioral)
Control group
Participants receiving no intervention.
结局指标
主要结局
Attrition rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Simone Lemieux
Full Professor
Laval University