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Not yet recruitingNCT05526846Updated Mar 28, 2024

Introducing a Plant-Based Diet for Patients With Colorectal Diseases

An interventional study of Plant-based diet education in Diet, Healthy and Colorectal Cancer, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
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:

  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.

02

Conditions studied

  • Diet, Healthy
  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 60 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who are unable to maintain oral nutrition
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Invervention group

    Participants will receive an educational intervention about how to incorporate more plant foods into their diet.

    Behavioral: Plant-based diet education

Interventions

  • BehavioralPlant-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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 weeks after the intervention

Secondary outcomes

  1. 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

    Time frame: 2 weeks after the intervention

  2. 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

    Time frame: 2 weeks after the intervention

  3. 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

    Time frame: 2 weeks after the intervention

07

Study locations

1 site
  • Stanford Health Care
    Stanford, California 94305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05526846
Lead sponsor
Stanford University
Responsible party
Cindy Kin (Assistant Professor of Surgery, Stanford University) — Principal investigator
First posted
Sep 2, 2022
Start date
Dec 2024 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Mar 28, 2024

Study contacts

Cindy Kin, MD
Contact
cindykin@stanford.edu
(650) 736-8406

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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