Dietary Reporting in the Amyloidoses

NCT05738005 | Recruiting

• 1 other identifier: 2022-067
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Adherence Rate

  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.

  56 days

Secondary Outcomes (1)

• Subsequent adherence rate

  63 days (= 56 days + Week 10)

Study Arms (1)

Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)

OTHER

MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements.

Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)

Interventions

Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) OTHER

Amyloidosis patients will use MyFitnessPal application to track dietary intake and use of herbal/alternative supplements in from week 2-9. Patient's usage of the application and questionnaires completed by the patient at the start, Week 2 and Week 10 will determine feasibility.

Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Amyloidosis

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey Zonder, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Zonder, MD

CONTACT

313-576-8732; zonderj@karmanos.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Multiple Myeloma Multidisciplinary team leader, M.D.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 21, 2023
• Study Start: March 2, 2023
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)