Not provided
Not provided
Not provided
Not provided
Not provided
Futility in recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartPhone Intervention | Experimental | Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartPhone app | Behavioral | Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Installation of the Heartphone Application. | Change in the total physical activity volume from baseline to 3 months as measured by the Actigraph GT3XP-BTLE (total activity counts) | 3 months |
| Installation of the Heartphone Application. | Change in the total physical activity volume from baseline to 3 and 6 month as measured by the Actigraph GT3XP-BTLE (total activity counts). | 6 months |
Not provided
Not provided
Inclusion Criteria:
Main Study and Ancillary Study Exclusion Criteria:
Ancillary Study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennsylvania State University | University Park | Pennsylvania | 16802 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HeartPhone Intervention | Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity. HeartPhone app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester: This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HeartPhone Intervention | Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity. HeartPhone app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester: This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Installation of the Heartphone Application. | Change in the total physical activity volume from baseline to 3 months as measured by the Actigraph GT3XP-BTLE (total activity counts) | Only one participant completed 3 month assessment and the study was terminated early due to futility in enrollment. | Posted | Number | Change in average daily activity counts | 3 months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HeartPhone Intervention | Participants install the HeartPhone app on their smartphone. This app presents an image on a splash screen every time they activate their device. The image is randomly drawn from an image bank in the app. Repeated exposure to the image is designed to condition a more favorable automatic affective evaluation of physical activity and lead to increased physical activity. HeartPhone app: Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen) Acetylcholine: Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter Sodium Nitroprusside: Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester: This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David E. Conroy | The Pennsylvania State University | 814-865-7935 | dec9@psu.edu |
Not provided
| 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 | Apr 29, 2019 | May 13, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000109 | Acetylcholine |
| D009599 | Nitroprusside |
| D014106 | Tosylarginine Methyl Ester |
| ID | Term |
|---|---|
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005292 | Ferricyanides |
Not provided
Not provided
Single-group pre-post change
Not provided
Not provided
Not provided
Not provided
| Acetylcholine | Drug | Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter |
|
| Sodium Nitroprusside | Drug | Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor |
|
| L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester | Drug | This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Device-based physical activity volume | Change in the total physical activity volume (expressed as total activity counts) from baseline to 3 and 6 month as measured by the Actigraph device | Study was terminated based on recruitment difficulties. The sample was too small to draw any meaningful inferences and was not analyzed further once futility was established. Specifically, we enrolled two participants who completed the baseline assessment. | Mean | Standard Deviation | Total activity counts (vector magnitude) |
|
|
|
| Primary | Installation of the Heartphone Application. | Change in the total physical activity volume from baseline to 3 and 6 month as measured by the Actigraph GT3XP-BTLE (total activity counts). | Study was terminated prematurely due to futility in recruitment. No participants completed the 6 months assessment. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003486 |
| Cyanides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D006856 | Hydrogen Cyanide |
| D017672 | Nitrogen Compounds |
| D014050 | Toluene |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014105 | Tosyl Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D001120 | Arginine |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |