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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app can effectively track the dietary intake of individuals with amyloidosis, a condition where abnormal proteins accumulate in tissues. Researchers seek to find out if this low-cost method provides detailed information about patients' calorie consumption. Participants will use the MyFitnessPal app to log their daily food and supplement intake over several weeks. This trial suits English-speaking adults diagnosed with any type of amyloidosis who can use a smartphone app. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance dietary tracking for amyloidosis patients.

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 prior data suggests that this dietary tracking app is safe for use in Amyloidosis patients?

Research shows that using the MyFitnessPal app to track food and supplement intake is generally safe. This app, popular for monitoring nutrition, has helped many people track their eating habits. Studies have found that it can accurately estimate calorie and nutrient consumption. However, some research highlights inconsistencies in details like saturated fats and cholesterol. These issues do not affect safety but may reduce precision.

Overall, MyFitnessPal is user-friendly. No reports indicate problems from using the app itself. Participants in similar studies have used it without safety concerns. In this study, participants will use the app to log eating and supplement habits, a safe process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a dietary tracking app like MyFitnessPal for amyloidosis because it offers a new way to manage the condition by focusing on diet and supplement intake. Unlike traditional treatments that might involve medication or invasive procedures, this approach empowers patients to actively monitor and potentially modify their lifestyle choices, which could have a positive impact on their health. The app's easy-to-use interface allows for precise tracking of daily dietary intake and alternative supplements, giving patients and healthcare providers valuable insights into potential correlations between diet and disease management.

What evidence suggests that this dietary tracking app is effective for monitoring nutrition in Amyloidosis patients?

Research has shown that using MyFitnessPal to track food intake can help individuals adhere to diet goals. For example, one study found that people who logged their meals with the app were 32% more likely to follow their diet plans. This trial will involve participants using the MyFitnessPal app to track dietary and supplement intake, potentially aiding in the development of healthy eating habits. However, some studies have found that the app's accuracy can vary depending on the user and the situation. While it might not always be perfect, it remains a useful tool for monitoring food intake and making healthier choices. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeffrey A. Zonder

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05738005

NCT05738005 | Dietary Reporting in the Amyloidoses 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 ...

2. ctv.veeva.com ctv.veeva.com/study/dietary-reporting-in-the-amyloidoses

Dietary Reporting in the Amyloidoses - ClinicalTrials.Veeva MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements. Treatment: Other: Tracking Dietary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11221275/

relative validity and intercoder reliability among dietitians ... Results of this study showed MyFitnessPal to have poor construct validity and poor relative validity among Filipinos with obesity but with good ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7333076/

Rethinking the Use of Mobile Apps for Dietary Assessment ... In this paper, we describe the purposes of collecting dietary data in medical research and outline the main considerations for using mobile dietary assessment ...

5. prnewswire.com prnewswire.com/news-releases/the-power-of-tracking-new-preliminary-data-underscores-how-myfitnesspal-supports-weight-management-goals-302338087.html

The Power of Tracking: New Preliminary Data Underscores ... Participants who track their meals with MyFitnessPal were 32% more likely to adhere to their GLP-1 treatment compared to those who were not ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39233588/

Reliability Issues of Mobile Nutrition Apps for ... The findings reveal substantial inaccuracies and inconsistencies in diet-tracking apps' reporting of saturated fats and cholesterol.

7. myfitnesspal.com myfitnesspal.com/

MyFitnessPal: Calorie Tracker & BMR Calculator to Reach ... MyFitnessPal simplifies nutrition and calorie tracking, provides the data you want, and helps you make sense of it all.