Effects of Pro2col Application on Health Outcomes

NCT06738641 | Completed

• 1 other identifier: P083124
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Behavior; Nutrition, Healthy; Activity, Motor

Outcome Measures

Primary Outcomes (6)

• Biological Age

  Assessed via a proprietary algorithm sourced within the application.

  6-weeks

• Muscle Strength-Endurance

  Assessed by performance measures including push-ups to exhaustion, and chair get-ups to exhaustion.

  6-weeks

• Body Composition

  Assessed via a previously validated digital scale.

  6-weeks

• Blood Pressure

  Assessed via an electronic blood pressure cuff.

  6-weeks

• Daily Steps

  Collected via the Apple Health or Google Fit application on the subject's pre-existing personal device.

  6-weeks

• Physical Endurance

  Assessed via a one mile walk time.

  6-weeks

Secondary Outcomes (2)

• Depression

  6-weeks

• Quality of Life (SF-36 Survey)

  6-weeks

Study Arms (2)

Pro2col

EXPERIMENTAL

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.

Behavioral: Pro2col Health

Control

ACTIVE COMPARATOR

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).

Behavioral: Control

Interventions

Pro2col Health BEHAVIORAL

The Pro2col Health application is a smartphone application that provides users with health behavior guidance, personalized feedback, and assessments designed to estimate their current healthspan and biological age.

Pro2col

Control BEHAVIORAL

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).

Control

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 21-60 years.
• A BMI categorized as overweight (≥ 25) but not stage II obesity (≤ 35)
• Daily steps \< 5,000.
• Ownership of a smartphone device with either the Apple Health or Google Fit application.
• Willingness to carry their phone in their pocket or on their person at all times to track steps during study.
• Willing to download the Pro2col application and connect it with either the Apple Health or Google Fit application.
• 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.
• For the experimental group, subjects must be willing to follow the application protocol.
• Able to read, understand, sign and date the informed consent document (English only)
• Able and willing to comply with the scheduled visit(s) and study requirements.

You may not qualify if:

• Currently taking (within the past 30 days) ergogenic dietary supplements including, creatine, protein, amino acids, or stimulants other than caffeine (yohimbe, ephedrine, etc.) Currently taking performance enhancing drugs (testosterone or other anabolic-androgenic steroids), human growth hormone, insulin, etc.
• History or current malignancy
• Receiving chemotherapy agents or radiation treatments
• Musculoskeletal disease (muscular dystrophy, arthritis, etc.)
• Recent (\<3-months) musculoskeletal injuries
• BMI \< 25 or \> 35 kg/m2
• Diagnosis of a terminal illness
• Use of prescription medications that influence body composition (i.e., prescription hormone therapies, etc.)
• History of alcohol abuse
• History or current drug abuse
• History or current diagnosis of depression.
• History or current diagnosis of suicidal thoughts/ideation.
• A score of ≥ 10 arbitrary units on the PHQ-9 during baseline testing.
• History or current cigarette smoke (including vaping) within the past 14 days from the screening visit
• Insulin-dependent diabetes and/or metformin use

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33634, United States

Location

MeSH Terms

Conditions

Health Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open trial.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled parallel study with pre- and post-measures

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 17, 2024
• Study Start: October 6, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)