NCT05526846

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

August 31, 2022

Last Update Submit

March 26, 2024

Conditions

Outcome Measures

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

    2 weeks after the intervention

Secondary Outcomes (3)

  • Effect of the intervention on participant's Quality of Life

    2 weeks after the intervention

  • Barriers and facilitators to transitioning to a healthier diet

    2 weeks after the intervention

  • Secondary health gains associated with adopting a plant-based diet

    2 weeks after the intervention

Study Arms (1)

Invervention group

EXPERIMENTAL

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

Behavioral: Plant-based diet education

Interventions

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.

Invervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who are unable to maintain oral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations