Pro2col Health App for Improving Health Behaviors

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Applied Science & Performance Institute

Must not be taking: Ergogenic supplements, Anabolic steroids

Disqualifiers: Cancer, Musculoskeletal disease, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain supplements, performance-enhancing drugs, or medications that affect body composition. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Pro2col Health?

The research suggests that using mobile health technologies to collect patient-reported outcomes (PROs) can improve care by providing detailed information for clinical decision-making. This approach has been shown to enhance symptom management and quality of life in patients with chronic illnesses and cancer, indicating potential benefits for the Pro2col Health treatment. ^{1 2 3 4 5}

Is the Pro2col Health App safe for use in humans?

The available research does not provide specific safety data for the Pro2col Health App, but it highlights general concerns about mobile health apps, such as data privacy and security issues, which are important to consider for safe use. ^{6 7 8 9 10}

How is the Pro2col Health App treatment different from other treatments for improving health behaviors?

The Pro2col Health App is unique because it focuses on personalizing health behavior changes through a mobile application, offering features like goal setting, progress monitoring, and personalized feedback, which are not typically found in traditional treatments. This app aims to engage users by providing a more interactive and tailored approach to improving health behaviors. ^{6 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to test the effectiveness of a novel smartphone application (Pro2col Health) in regard to multiple health outcomes and health behaviors in healthy middle-aged adults.

Eligibility Criteria

This trial is for healthy middle-aged adults (21-60 years) who are slightly overweight, can perform physical tasks, and own a smartphone. They must be willing to use the Pro2col app connected to Apple Health or Google Fit and track their steps. Excluded are those with serious illnesses, drug abuse history, mental health issues, certain medication use, recent injuries or surgeries.

Inclusion Criteria

Willingness to complete physical tasks including a timed one-mile walk/run, regular or modified push-ups to exhaustion, and chair get-ups to exhaustion

I am willing to follow the study's treatment plan.

My BMI is between 25 and 35, making me overweight but not obese.

Exclusion Criteria

History or current drug abuse

I do not have serious health issues like uncontrolled diabetes, heart problems, or severe mental health conditions.

A family member of the investigator or an employee of the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline and Enrollment

Baseline measurements and enrollment of participants into the study

1 week

1 visit (in-person)

Intervention

Participants follow a 6-week protocol with either the Pro2col application or control materials

6 weeks

Weekly monitoring (virtual)

Post-testing

Post-testing to assess health outcomes after the intervention

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pro2col Health

Trial Overview The study tests the effectiveness of the Pro2col Health smartphone application on improving health behaviors and motor skills in adults. Participants will follow the app's protocol while their activity is tracked via smartphone sensors to measure changes in nutrition habits and physical abilities.

Participant Groups

Group I: Pro2col Experimental Treatment 1 Intervention

The experimental group will be enrolled in the Prime Health Technologies software (Pro2col), which provides a digital diagnostic score to calculate healthspan and biological age, along with AI and group community-based coaching dynamics. Subjects will be assigned a 6 week progressive protocol targeting improvements in daily activity levels, nutritional awareness, and overall lifestyle risk factors.

Group II: Control Active Control 1 Intervention

The control group will receive subject-facing materials depicting current general activity recommendations as published by the American Heart Association (AHA) and current dietary guidelines provided by the United States Department of Agriculture (USDA).

Who Is Running the Clinical Trial?

Applied Science & Performance Institute

Lead Sponsor

Trials

17

Recruited

1,200+

Findings from Research

Patient-reported outcomes (PROs) are increasingly recognized as valuable data for evaluating product safety, effectiveness, and quality of care, reflecting a shift towards more patient-centered healthcare practices.

Integrating PROs into electronic health records and patient portals can improve care delivery and communication, although challenges such as implementation costs and data standardization need to be addressed for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. Basch, E.[2014]

The Wellness Diary (WD) mobile application is designed to help users track and change their behaviors to manage chronic conditions, and it has been found acceptable and useful for long-term use.

However, WD currently lacks engaging features to ensure users remain motivated and committed over time, highlighting the need for improvements in personalization and feedback to enhance user experience and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering citizens for well-being and chronic disease management with wellness diary. Mattila, E., Korhonen, I., Salminen, JH., et al.[2018]

A systematic evaluation of seven DASH diet apps revealed that only two apps, NOOM and DASH To TEN, met both quality and data security standards, making them suitable for supporting self-management of the DASH diet.

While three apps scored high in quality across various domains, most apps exhibited significant shortcomings in quality and data privacy, highlighting the need for better app development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. Alnooh, G., Alessa, T., Noorwali, E., et al.[2023]

The Wellness App developed in the Smart Health 2.0 project serves as a personal trainer, providing tailored recommendations based on users' physical parameters and lifestyle to enhance well-being.

A pilot study in Calabria showed high usability (average score of 77.16) and navigability (average score of 76.87) of the app, along with significant improvements in users' Wellness Index (95% significance) and Mediterranean Adequacy Index (99% significance).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wellness Mobile Application for Smart Health: Pilot Study Design and Results. Sannino, G., Forastiere, M., De Pietro, G.[2018]

References

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New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. [2014]

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Empowering citizens for well-being and chronic disease management with wellness diary. [2018]

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Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. [2023]

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