Introducing a Plant-Based Diet for Patients With Colorectal Diseases

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:

1. Determine whether an educational intervention is effective in increasing intake of plants
2. Identify barriers and facilitators to adoption of a plant-based diet among patients with colorectal diseases
3. Identify secondary health gains related to adoption of a plant-based diet.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Diet, Healthy
• Intervention / Treatment: Behavioral: Plant-based diet education

Detailed Description

Standard of care: patients with colorectal diseases 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:

1. 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.
2. 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 provide consent

3. 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 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 was created for this study (http://eat2heal.su.domains/). The website features curated information about plant-based diets, and is tailored to patients who had recent colorectal operations and may have a colostomy or an ileostomy. The goal is to recruit 60 patients with colorectal diseases

4. 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cindy Kin, MD; Phone Number: (650) 736-8406; Email: cindykin@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Good English comprehension
• Diagnosis of a colorectal disease
• Must be able to maintain oral nutrition
• Access to Internet and email

Exclusion Criteria:

• Patients who are unable to maintain oral nutrition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Invervention group; Participants will receive an educational intervention about how to incorporate more plant foods into their diet.

Behavioral: Plant-based diet education; Participants 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 66060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No