Dietary Tracking App for Amyloidosis

(DRITA Trial)

Overseen By Andrew Kin, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barbara Ann Karmanos Cancer Institute

Disqualifiers: Planned transplants, Cognitive disturbances

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

40 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on tracking dietary and supplement intake using a smartphone app.

What data supports the effectiveness of the treatment using the MyFitnessPal app for dietary tracking in amyloidosis patients?

Research shows that using apps for dietary tracking can be effective in improving nutrition habits. For example, studies on similar apps have shown positive effects in reducing fat intake and increasing fruit and vegetable consumption. Additionally, healthcare professionals find these apps acceptable and useful for patient care. ^{1 2 3 4 5}

Is the Dietary Tracking App for Amyloidosis safe for humans?

Research on nutrition apps, including those for dietary tracking, generally shows positive feedback and good usability among users. These apps are considered safe for use in healthy populations and those trying to lose weight, with no significant safety concerns reported. ^{6 7 8 9 10}

How does the dietary tracking app treatment for amyloidosis differ from other treatments?

The dietary tracking app for amyloidosis is unique because it uses mobile technology to help patients monitor their diet, which can improve adherence to dietary recommendations and potentially impact disease management. Unlike traditional treatments that may focus on medication or other interventions, this app emphasizes self-monitoring and real-time feedback to support dietary changes. ^{4 7 10 11 12}

What is the purpose of this trial?

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

Research Team

Jeffrey A. Zonder

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Eligibility Criteria

This trial is for English-speaking adults over 18 with any type of amyloidosis who are willing to use the MyFitnessPal app on their smartphone. It's not suitable for those with cognitive or perceptual disturbances, or anyone planning a stem cell or organ transplant within 12 weeks after joining.

Inclusion Criteria

I am willing to use the MyFitnessPal app on my smartphone.

I have been diagnosed with amyloidosis.

Speak, read and write in English

Exclusion Criteria

I am scheduled for a stem cell or organ transplant within 3 months after joining.

You have trouble thinking clearly or understanding things.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Practice Phase

Participants download the MyFitnessPal application and view an online tutorial

1 week

1 visit (virtual)

Data Collection

Participants enter daily dietary intake and supplement intake into the MyFitnessPal application

8 weeks

Weekly virtual check-ins

Follow-up

Participants complete a questionnaire and adherence is assessed

1 week

1 visit (virtual)

Treatment Details

Interventions

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

Trial Overview The study tests if it's practical for patients with Amyloidosis to use the MyFitnessPal app to track daily food and supplement intake. Participants will learn how to use the app, record their intake from weeks 2-9, and fill out questionnaires about their experience.

Participant Groups

Group I: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

Findings from Research

Incorporating smartphone apps into the nutrition care process can streamline dietary assessments by automatically converting patient records into nutrient components, allowing dietitians to focus more on education and counseling.

Mobile health apps enhance patient-provider communication through real-time monitoring of progress, making them a valuable tool for improving adherence to dietary changes while still relying on the expertise of dietitians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps and the nutrition care process: Current perspectives and future considerations. Chen, J., Gemming, L., Hanning, R., et al.[2019]

The 'myfood24 Healthcare' app was found to be acceptable for both patients and healthcare professionals in a feasibility study involving 48 participants from weight management and gastroenterology surgery programs.

Compliance with the app was reasonable, with 50% of users recording their dietary intake for four or more days, indicating potential for effective dietary monitoring and support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. Threapleton, DE., Beer, SL., Foley, DJ., et al.[2023]

Between 2005 and 2009, about 75% of studies showed that e-health technologies effectively helped reduce fat intake and increase fruit and vegetable consumption in behavioral nutrition interventions.

By 2010, interventions began to focus more on body weight management and included personalized features like self-monitoring, but there has been limited progress in using objective dietary behavior measures instead of self-reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Nutrition Interventions Using e- and m-Health Communication Technologies: A Narrative Review. Olson, CM.[2019]

A survey of 1001 healthcare professionals revealed that while 45.5% have recommended nutrition and diet (ND) apps to patients, a significant portion (22.5%) are unaware of such apps, indicating a need for better awareness and education about these tools.

Key features that healthcare professionals look for in ND apps include ease of use (87.1%), being free of charge (72.6%), and having validated information (69%), while barriers to adoption include concerns about inaccurate food databases and lack of local food support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Healthcare Professionals Think of "Nutrition & Diet" Apps: An International Survey. Vasiloglou, MF., Christodoulidis, S., Reber, E., et al.[2021]

In a study involving 174 overweight and obese participants, the DietMatePro app showed a higher adherence rate to the Ornish Prevention Diet (43%) compared to a traditional paper food diary (28%), suggesting it may help people stick to their dietary plans better.

While DietMatePro did not provide more accurate dietary data than the paper diary, it still proved beneficial in improving adherence to dietary regimens, indicating its potential as a useful tool for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a PDA-based dietary assessment and intervention program: a randomized controlled trial. Beasley, JM., Riley, WT., Davis, A., et al.[2022]

In a study of 833 participants, adding a smartphone app to traditional counselling for diet and physical activity led to significant reductions in waist circumference and body fat percentage in women after 12 months, indicating the app's effectiveness in supporting weight management.

The beneficial effects of the app were not observed in men, suggesting that the intervention may be more effective for women, highlighting the need for tailored approaches in weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study. Gomez-Marcos, MA., Patino-Alonso, MC., Recio-Rodriguez, JI., et al.[2022]

Mobile nutrition applications can effectively assist individuals in recording their dietary intake, showing moderate to good correlations with traditional methods like 24-hour recall interviews and paper food records, based on a review of 18 studies.

Users of these applications often demonstrate better adherence to self-monitoring and report positive changes in dietary intake and body measurements compared to those using conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary assessment and self-monitoring with nutrition applications for mobile devices. Lieffers, JR., Hanning, RM.[2022]

The mobile Food Record (mFR) method showed a significant correlation between reported energy intake and total energy expenditure, indicating its accuracy in dietary assessment among 45 participants over 7.5 days.

Participants found the mFR easy to use, and it performed comparably to traditional dietary records, with no systematic biases detected in the data collection process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported Energy Intake Accuracy Compared to Doubly Labeled Water and Usability of the Mobile Food Record among Community Dwelling Adults. Boushey, CJ., Spoden, M., Delp, EJ., et al.[2023]

The COCO Nutritionist app, which uses speech recognition technology for dietary assessment, showed no significant difference in energy intake compared to the traditional 24-hour recall method over a 5-day period with 35 participants, indicating its potential accuracy.

This pilot study suggests that COCO could provide a lower-burden, automated approach to self-monitoring dietary intake, making it easier for users to track their nutrition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Natural Spoken Language With Automated Mapping of Self-reported Food Intake to Food Composition Data for Low-Burden Real-time Dietary Assessment: Method Comparison Study. Taylor, S., Korpusik, M., Das, S., et al.[2022]

A comparison of five popular handheld computers used by dietitians revealed significant differences in their features, capabilities, and prices, highlighting the need for careful selection based on individual user needs.

The article provides a strategy for potential buyers to evaluate and choose the most suitable handheld computer for nutrition assessment and support, emphasizing the importance of matching device capabilities with specific requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of handheld computers for nutrition assessment and support. Orta, J., Reinarts, CL.[2019]

In a 12-week pilot study with 39 participants, all groups using self-monitoring (SM) of food intake, whether with or without real-time feedback (FB) or in-person sessions, achieved significant weight loss, averaging around 3% of their body weight.

Adherence to dietary self-monitoring was similar across all groups, indicating that the addition of real-time feedback or in-person sessions did not significantly enhance adherence or weight loss outcomes, suggesting that self-monitoring alone can be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring. Burke, LE., Zheng, Y., Ma, Q., et al.[2022]

In a 6-week study involving 50 participants with a BMI of 23 kg/m2 or above, both a mobile dietary self-monitoring app and a paper-based diary showed no significant differences in weight loss or changes in body measurements, indicating that both methods can be effective for dietary tracking.

Despite both groups reducing their energy intake, there was no significant difference in nutrient intake changes between the app and paper-based diary users, suggesting that the choice of monitoring tool may not impact dietary outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone App for Weight Loss Versus a Paper-Based Dietary Diary in Overweight Adults: Randomized Controlled Trial. Ahn, JS., Lee, H., Kim, J., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Smartphone apps and the nutrition care process: Current perspectives and future considerations. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral Nutrition Interventions Using e- and m-Health Communication Technologies: A Narrative Review. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

What Healthcare Professionals Think of "Nutrition & Diet" Apps: An International Survey. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a PDA-based dietary assessment and intervention program: a randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Dietary assessment and self-monitoring with nutrition applications for mobile devices. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Reported Energy Intake Accuracy Compared to Doubly Labeled Water and Usability of the Mobile Food Record among Community Dwelling Adults. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Use of Natural Spoken Language With Automated Mapping of Self-reported Food Intake to Food Composition Data for Low-Burden Real-time Dietary Assessment: Method Comparison Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of handheld computers for nutrition assessment and support. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Use of a Smartphone App for Weight Loss Versus a Paper-Based Dietary Diary in Overweight Adults: Randomized Controlled Trial. [2021]