Introducing a Plant-Based Diet for Patients Recovering From Colorectal Surgery

Study Overview
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Brief Summary
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Dietary patterns are a potentially modifiable risk factor for colon cancer recurrence, flares in inflammatory bowel diseases, and for chronic diseases. Nutritional counseling is rarely brought up during medical appointment. As a result, patients are often left confused regarding which specific dietary recommendation to follow after surgical treatment. A plant-based diet is naturally high in fiber and is beneficial to long-term health, especially for patients with colorectal diseases. The aims of this study are to: Determine whether an educational intervention is effective in increasing intake of plants Identify barriers and facilitators to adoption of a plant-based diet among patients recovering from colorectal surgery. Identify secondary health gains related to adoption of a plant-based diet.

Detailed Description
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Standard of care: patients recovering from colorectal surgery are sometimes advised to eat healthfully before and after to surgery. They are also encouraged to increase fiber intake and to take fiber supplements, but not particularly encouraged to eat more plants. Research Activities: Screening: eligible patients will be identified through screening the clinic schedules. Participants that might be eligible will be asked if they are interested in being contacted by the research team. Enrollment: in person or remotely, if the patient demonstrates interest in participating, the research team will explain details about the study. If the patient agrees, they will be asked to sign the consent form Intervention: at baseline, data will be collected regarding clinical information of the patients (age, body mass index, comorbidities, medications or supplements, physical activity level), and baseline dietary pattern, which will be evaluated through a validated shortened Food Frequency Questionnaire. Patients will be assessed regarding their stage of change according to the transtheoretical model. A Food Choice Questionnaire will be administered to understand what drives their food choices. A Quality of Life questionnaire for patients recovering from surgery will also be administered. The intervention proposed is a 6-week challenge, in which participants will be encouraged to make at least one change towards a plant-based diet per week. They will attend a virtual kick-off introductory session, and will receive weekly emails with information about plant-based diets and a goal/task for each week. There will be a 'core curriculum' that will be sent to all participants, as well as additional information according to the participant's stage of change and food choice preferences. All information will be available on a website that will be created for this study. The website will feature curated information about plant-based diets, that is tailored to patients who had recent colorectal operations and may have a colostomy or an ileostomy. Bi-weekly office hours will be held for patients to have the opportunity to discuss questions or concerns that may arise. Before launching, the intervention will be tested with 10-20 healthy volunteers, recruited from the colorectal surgery care provider team, former patients, and others in the community. The rationale is that the colorectal surgery care providers must be familiar with the intervention proposed, and that they agree with the recommendations given. We also believe that former patients who have fully recovered from surgery at least one year ago will have valuable perspective on the post-operative experience, and their feedback will be critical to ensuring that this is a patient-centered intervention. Semi-structured interviews with the healthcare team, former patients, and community members will be conducted at the end of the intervention to obtain feedback about the intervention and allow for iterations. Closeout: At the end of the intervention period, the quality of life and food frequency questionnaires will be re-administered. Semi-structured interviews will be conducted at the end of the intervention period to identify areas for improvement, barriers and facilitators to adopt a plant-based diet, and other health attitudes that may have changed as a result of the intervention.

Official Title
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Introducing a Plant-Based Diet for Patients Recovering From Colorectal Surgery

Conditions
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Colorectal Disorders, Diet, Healthy

Intervention / Treatment
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* Behavioral: Plant-based diet education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking patients recovering from colorectal surgery in the past 6 months Must be able to maintain oral nutrition Exclusion Criteria: Patients who are unable to maintain oral nutrition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant-based diet education<br>Participants will receive an educational intervention about how to incorporate more plant foods into their diet. The intervention will last 6 weeks | Behavioral: Plant-based diet education<br>* Participants will attend a virtual kick-off introductory session and will receive weekly emails with information about plant-based diets and a goal/task for each week. There will be a 'core curriculum' that will be sent to all participants, as well as additional information according to the participant's stage of change and food choice preferences. All information will be available on a website that will be created for this study. The website will feature curated information about plant-based diets, that is tailored to patients who had recent colorectal operations and may have a colostomy or an ileostomy. Bi-weekly office hours will be held for patients to have the opportunity to discuss questions or concerns that may arise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the intervention on participant's Healthy Plant-Based Diet Index | The Healthy Plant-Based Diet Index will be calculated from a standardized Food Frequency Questionnaire, which will be administered upon enrollment and 2 weeks after the end of the intervention | 2 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the intervention on participant's Quality of Life | Quality of life will be assessed through a validated Quality of Life Questionnaire that will be administered upon enrollment and 2 weeks after the end of the intervention | 2 weeks after the intervention | 
| Barriers and facilitators to transitioning to a healthier diet | A semi-structured interview will be performed to identify barriers and facilitators to transitioning to a healthier diet | 2 weeks after the intervention | 
| Secondary health gains associated with adopting a plant-based diet | A semi-structured interview will be performed to identify secondary health gains that may be expected by adopting a plant-based diet | 2 weeks after the intervention |