Dietary Reporting in the Amyloidoses

Not Applicable

Recruiting

• Conditions: Amyloidosis
• Interventions: Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)

• Registration Number: NCT05738005
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief Summary

The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis.

The main question it aims to answer is:

Is it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients

Participants will be asked to:

* Download the MyFitnessPal application on their smartphone and view an online tutorial

* After a week of practice, from weeks 2-9, participants will enter daily dietary intake as well as daily herbal/alternative supplement intake into the MyFitnessPal application on their smartphone.

* complete a questionnaire prior to starting the application, after week 2 and at week 10 after starting the application

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-21
• Study Start: 2023-03-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-11-21
• Study Completion: 2025-11-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18 years of age or older
• Diagnosed with any type of amyloidosis
• Speak, read and write in English
• Willing to use the MyFitnessPal app on their own smartphone

Exclusion Criteria

• a planned autologous stem cell transplant or a solid organ transplant in the 12 weeks after enrollment
• cognitive or perceptual disturbances

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)	Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)	MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements.

Primary Outcome Measures

Name	Time	Method
Adherence Rate	56 days	The adherence is defined by the status (yes vs. no) of data recording per day; The adherence rate will be calculated by the ratio of the number of days of adherence to the total number of days of trial (i.e., 56 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.

Secondary Outcome Measures

Name	Time	Method
Subsequent adherence rate	63 days (= 56 days + Week 10)	The subsequent adherence is the status of data recording per day during the third phase (Week 10) of trial participation (i.e., 7 days); The subsequent adherence rate will be calculated by the ratio of the number of days of adherence during the third phase (Week 10) of trial participation (i.e., 7 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.

Trial Locations

Locations (1)

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States