Introducing a Plant-Based Diet for Patients With Colorectal Diseases

Colorectal Cancer Clinical Trial

Official title:

Introducing a Plant-Based Diet for Patients With Colorectal Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05526846
• Other study ID #: 66060
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Cindy Kin, MD
• Phone: (650) 736-8406
• Email: cindykin[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Diet, Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	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