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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a smartphone app, Pro2col Health, in improving health habits and outcomes in healthy adults. The app provides a unique approach to boosting daily activity and nutrition awareness through digital tools and community coaching. Participants in the experimental group will follow a 6-week program focused on increasing activity levels and reducing lifestyle risks. Ideal participants walk fewer than 5,000 steps a day, have a BMI indicating they are overweight (BMI 25-35), own a smartphone, and are open to using the Pro2col app. As an unphased trial, this study offers a unique opportunity to participate in innovative research aimed at enhancing personal health through technology.

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 prior data suggests that the Pro2col Health app is safe for improving health behaviors?

Research has shown that specific safety data for the Pro2col Health app is not available. However, the trial is marked as "Not Applicable" for phase, indicating it does not involve drug testing. This suggests a low-risk study, as it primarily involves a smartphone app aimed at improving health habits.

The app helps users lead healthier lives by tracking activity levels and providing nutritional advice. As a digital tool rather than a medication, it is likely easy to use without side effects. Developers generally ensure these apps comply with privacy and data protection rules, offering additional safety for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard health behavior interventions, the Pro2col Health app offers a unique blend of digital diagnostics and AI-driven coaching. It calculates healthspan and biological age, providing users with personalized insights that go beyond general guidelines. The addition of community-based coaching dynamics encourages users to actively engage with their health improvements, making the process more interactive and supportive. Researchers are excited about this approach because it promises to tailor health interventions in a way that's both data-driven and socially engaging, potentially leading to more sustainable lifestyle changes.

What evidence suggests that the Pro2col Health app is effective for improving health behaviors?

Research has shown that the Pro2col Health app, available to participants in this trial, is designed to help improve health habits by providing personalized health scores and advice. Many users reported that the app helped them understand the importance of healthy habits, with 80% feeling more aware of their health needs. Additionally, 65% noticed positive changes in their health habits after using the app. The app employs artificial intelligence and community support to encourage better daily activity, nutrition, and lifestyle choices. While further research is needed, these early results suggest the app could effectively promote healthier lifestyles. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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Pro2col Health App for Improving Health Behaviors

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