- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05526846
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:
- 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 with colorectal diseases
- Identify secondary health gains related to adoption of a plant-based diet.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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 provide consent
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
- 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cindy Kin, MD
- Phone Number: (650) 736-8406
- Email: cindykin@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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.
|
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
Time Frame: 2 weeks after the intervention
|
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
Time Frame: 2 weeks after the intervention
|
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
Time Frame: 2 weeks after the intervention
|
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
Time Frame: 2 weeks after the intervention
|
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 66060
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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