Health BehaviorNCT06738641
Effects of Pro2col Application on Health Outcomes
A study testing Pro2col Health in people with Health Behavior and Nutrition, Healthy, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Nutrition, Healthy, Activity, Motor
- What is being tested?
- Pro2col Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
- Chronic kidney or liver disease
- Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such conditions might be aggravated as a result of treatment
- The investigator feels that for any reason the subject is not eligible to participate in the study
- History of uncontrolled cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements
- A family member of the investigator or an employee of the investigator
- Participation in any other investigational study within 30 days prior to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science and Performance Institute
Tampa, Florida, 33634
About this study
Official title: The Effects of a Digital Customized Healthy Habit Software (Pro2col Health) on Health-Related Habits, Healthspan, and Biological Age
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.
Read the detailed description
This is a non-blinded randomized controlled pilot trial conducted over up to 8 weeks. Week 0 will involve baseline measurements and enrollment, Weeks 1-6 constitute the intervention, and Week 7 to 8 is reserved for post-testing. The study will enroll up to 200 participants, with a minimum of 50 participants who meet the inclusion criteria, and a minimum target of 20 participants completing the study in each group (experimental and control).
Following baseline testing and enrollment in the study, participants will be randomly assigned to either the control (CON) or experimental (PRO) group. 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). 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. Both groups will then be monitored by study staff throughout the duration of the intervention period with post-testing taking place following the last week of the experiment.
- Conditions
- Health Behavior, Nutrition, Healthy, Activity, Motor
- Being tested
- Pro2col Health, Control
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro2col HealthBehavioural
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.
ControlBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Age
Assessed via a proprietary algorithm sourced within the application.
Measured: 6-weeks
Muscle Strength-Endurance
Assessed by performance measures including push-ups to exhaustion, and chair get-ups to exhaustion.
Measured: 6-weeks
Body Composition
Assessed via a previously validated digital scale.
Measured: 6-weeks
Blood Pressure
Assessed via an electronic blood pressure cuff.
Measured: 6-weeks
Daily Steps
Collected via the Apple Health or Google Fit application on the subject's pre-existing personal device.
Measured: 6-weeks
Physical Endurance
Assessed via a one mile walk time.
Measured: 6-weeks
Secondary outcomes (2)
Depression
Assessed by the previously validated Patient Health Questionnaire 9 (PHQ-9) subjective questionnaire. Scores from each question are summed for a total of 0 to 27 points, with higher scores representing more symptoms of depression.
Measured: 6-weeks
Quality of Life (SF-36 Survey)
Assessed by the previously validated Short Form 36 (SF-36) subjective questionnaire. This questionnaire houses 8 unique domains of quality of life measures, and each domain is scored from 0-100 based on subject responses (higher scores represent better quality of life). Scores from all 8 domains are then averaged to provide an aggregate score for the SF-36.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start6 Oct 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled parallel study with pre- and post-measures
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738641
- Sponsor's protocol ID
- P083124
- Status last verified
- Sep 2025
- First submitted
- 10 Dec 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Digital Customized Healthy Habit Software (Pro2col Health) on Health-Related Habits, Healthspan, and Biological Age
- ClinicalTrials.gov ID
- NCT06738641
- Acronym / sponsor ID
- P083124
- Conditions
- Health Behavior, Nutrition, Healthy, Activity, Motor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-blinded randomized controlled pilot trial conducted over up to 8 weeks. Week 0 will involve baseline measurements and enrollment, Weeks 1-6 constitute the intervention, and Week 7 to 8 is reserved for post-testing. The study will enroll up to 200 participants, with a minimum of 50 participants who meet the inclusion criteria, and a minimum target of 20 participants completing the study in each group (experimental and control).
Following baseline testing and enrollment in the study, participants will be randomly assigned to either the control (CON) or experimental (PRO) group. 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). 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. Both groups will then be monitored by study staff throughout the duration of the intervention period with post-testing taking place following the last week of the experiment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled parallel study with pre- and post-measures
| Arm | Type | Receives |
|---|---|---|
| Pro2col | Experimental | Behavioral: Pro2col HealthThe 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. |
| Control | Active comparator | Behavioral: ControlThe 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 may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro2col HealthThe 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. | Behavioural | Pro2col |
| ControlThe 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). | Behavioural | Control |
Primary outcome
Biological Age
Time frame: 6-weeks
Assessed via a proprietary algorithm sourced within the application.
Muscle Strength-Endurance
Time frame: 6-weeks
Assessed by performance measures including push-ups to exhaustion, and chair get-ups to exhaustion.
Body Composition
Time frame: 6-weeks
Assessed via a previously validated digital scale.
Blood Pressure
Time frame: 6-weeks
Assessed via an electronic blood pressure cuff.
Daily Steps
Time frame: 6-weeks
Collected via the Apple Health or Google Fit application on the subject's pre-existing personal device.
Physical Endurance
Time frame: 6-weeks
Assessed via a one mile walk time.
2 secondary outcomes
Depression
Time frame: 6-weeks
Quality of Life (SF-36 Survey)
Time frame: 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro2col Health in people with Health Behavior and Nutrition, Healthy, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Age (time frame: 6-weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.