Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT05746195
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2023-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Use of Text Messages to Increase Whole Grain Consumption in Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial evaluates whether an adaptive text-message intervention is useful in helping survivors of colorectal cancers (CRC) eat more whole grain foods and less refined grain foods. Most CRC survivors don't achieve the recommended intakes of whole grains or fiber, even though there is strong evidence that a high-fiber diet rich in whole grains lowers the risk of death from CRC. Dietary interventions are a promising approach for reducing death from CRC, and text message interventions specifically are a promising tool for reaching diverse populations. This trial evaluates a text-message based dietary intervention that continuously adapts message content to be specifically tailored for the participant for increasing whole grain consumption.
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine the intervention's feasibility and acceptability.
SECONDARY OBJECTIVES:
I. Estimate the effect of the intervention on the percent of grains consumed that are whole.
II. Estimate the effect of the intervention on total fiber intake (grams per day \[g/d\]).
EXPLORATORY OBJECTIVE:
I. Assess convergence of the reinforcement learning (RL) algorithm.
OUTLINE:
Patients receive nutrition education materials and then receive the adaptive text message intervention for 12 weeks on study. Patients who are food insecure also receive resources for food banks, information about meal delivery programs, and support for applying for Supplemental Nutrition Assistance Program (SNAP) benefits.
I. Determine the intervention's feasibility and acceptability.
SECONDARY OBJECTIVES:
I. Estimate the effect of the intervention on the percent of grains consumed that are whole.
II. Estimate the effect of the intervention on total fiber intake (grams per day \[g/d\]).
EXPLORATORY OBJECTIVE:
I. Assess convergence of the reinforcement learning (RL) algorithm.
OUTLINE:
Patients receive nutrition education materials and then receive the adaptive text message intervention for 12 weeks on study. Patients who are food insecure also receive resources for food banks, information about meal delivery programs, and support for applying for Supplemental Nutrition Assistance Program (SNAP) benefits.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-00870 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View | |
| R21CA263539 | NIH | None | https://reporter.nih.gov/quic… | View |