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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-weeks |
| Quality of Life (SF-36 Survey) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Science and Performance Institute | Tampa | Florida | 33634 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2024 | Dec 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Randomized controlled parallel study with pre- and post-measures
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This is an open trial.
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| 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). |
|
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. |
| 6-weeks |