Diet, HealthyNCT05526846
Introducing a Plant-Based Diet for Patients With Colorectal Diseases
A study testing Plant-based diet education in people with Diet, Healthy and Colorectal Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Colorectal Cancer
- What is being tested?
- Plant-based diet education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good English comprehension
- Diagnosis of a colorectal disease
- Must be able to maintain oral nutrition
- Access to Internet and email
Who cannot join
- Patients who are unable to maintain oral nutrition
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diet, Healthy, Colorectal Cancer
- Being tested
- Plant-based diet education
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based diet educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Invervention group | Experimental | Participants will receive an educational intervention about how to incorporate more plant foods into their diet. Receives: Behavioral: Plant-based diet education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks after the intervention
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 2 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Kin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526846
- Sponsor's protocol ID
- 66060
- Status last verified
- Mar 2024
- First submitted
- 31 Aug 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing a Plant-Based Diet for Patients With Colorectal Diseases
- ClinicalTrials.gov ID
- NCT05526846
- Acronym / sponsor ID
- 66060
- Conditions
- Diet, Healthy, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invervention group | Experimental | Behavioral: Plant-based diet educationParticipants will receive an educational intervention about how to incorporate more plant foods into their diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good English comprehension
- Diagnosis of a colorectal disease
- Must be able to maintain oral nutrition
- Access to Internet and email
Key exclusion criteria (1 listed)
- Patients who are unable to maintain oral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based diet educationParticipants 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. | Behavioural | Invervention group |
Primary outcome
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
3 secondary outcomes
Effect of the intervention on participant's Quality of Life
Time frame: 2 weeks after the intervention
Barriers and facilitators to transitioning to a healthier diet
Time frame: 2 weeks after the intervention
Secondary health gains associated with adopting a plant-based diet
Time frame: 2 weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet education in people with Diet, Healthy and Colorectal Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy Kin, MD ((650) 736-8406, cindykin@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the intervention on participant's Healthy Plant-Based Diet Index (time frame: 2 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.