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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL175017 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a pilot feasibility study designed to establish the feasibility and acceptability of the "Support Your Heart" (SYH) study's phone-based protocols regarding AHA's LE8, social isolation, loneliness, and stress.
The age range for this intervention is 18-39, which is intended to reflect the transitional life period from adolescence to adulthood. Participants must also display at least two LE8 risk factors for cardiovascular disease (e.g., not enough sleep or physical activity; tobacco/nicotine product use; elevated body mass index; high cholesterol, high blood pressure, elevated HbA1c , and/or poor diet).
Participants will receive weekly calls (averaging around 20-30 minutes each) from a SYH health coach in order to review key concepts, give personalized progress, and provide consistent feedback over the course of 12 weeks. SYH staff will measure improvement in AHA metrics as well as participant burden, acceptability, satisfaction, adherence, and retention. This research has the potential to create substantial public health impact by addressing cardiovascular health, social isolation, loneliness, and stress, all of which represent significant burdens to individual health.
This is a pilot feasibility study designed to establish the feasibility and acceptability of the telephone-based protocols of the "Support Your Heart" (SYH) intervention, a health-coach-delivered program for young adults with suboptimal cardiovascular health.
More specifically, the Support Your Heart intervention utilizes evidence-based health coaching to address cardiovascular health as moderated by social isolation, loneliness, stress, and other lifestyle behaviors. Including goal setting, mindfulness, relaxation training, thought restructuring, and establishing new hobbies. The age range for this intervention is 18-39, which is intended to reflect the transitional life period from adolescence to adulthood. Participants must also display at least two LE8 risk factors for cardiovascular disease (e.g., not enough sleep or physical activity; tobacco/nicotine product use; elevated body mass index; high cholesterol, high blood pressure, elevated HbA1c, and/or poor diet).
Participants will receive weekly calls (averaging around 20-30 minutes each) from a SYH health coach in order to review key concepts, give personalized progress, and provide consistent feedback over the course of 12 weeks. SYH staff will measure improvement in AHA metrics as well as participant burden, acceptability, satisfaction, adherence, and retention.
Participants will complete an interest form to express their intention to join this study, then they will be contacted by a SYH staff member who can provide more information and provide them with a means of completing an online screening questionnaire and scheduling an in-person screening visit. Participants would be officially enrolled in the study if deemed eligible following this visit. Once enrolled, they would complete a baseline survey before beginning the SYH health coaching. Follow-ups will be conducted at the 4-week, 8-week, and 12-week marks.
This research has the potential to create substantial public health impact by addressing cardiovascular health, social isolation, loneliness, and stress, all of which comprise significant burdens to individual health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Support Your Heart | Experimental | 12 weeks of telephone-based health coaching |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support Your Heart | Behavioral | 12 weeks of telephone-based health coaching to address Life's Essential 8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who report low intervention burden and high acceptability, high levels of satisfaction with the program and the health coach, good adherence to the protocol and low attrition | Feasibility metrics will include burden and acceptability, satisfaction, adherence, and retention. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the American Heart Association Life's Essential 8 Metric | Life's Essential 8 (LE8) cardiovascular health metric will be assessed according to the American Heart Association Presidential Advisory definition and scoring algorithm described by Lloyd-Jones et al. 2022 The LE8 components include diet, physical activity, nicotine exposure, sleep health, body mass index (BMI), blood lipids, blood glucose, and systolic/diastolic blood pressure. Individual component scores (0-100) will be calculated using standardized criteria and averaged to derive an overall LE8 cardiovascular health score. Reference: Lloyd-Jones DM, Allen NB, Anderson CAM, et al. Life's Essential 8: updating and enhancing the American Heart Association's construct of cardiovascular health: a presidential advisory from the American Heart Association. Circulation. 2022;146(5):e18-e43. doi:10.1161/CIR.000000000000107 |
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Inclusion Criteria:
18-39 at time of enrollment
Living in Washington DC area
At least two risk factors for cardiovascular disease:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Napolitano, PhD | Contact | 202-994-9099 | mnapolitano@gwu.edu | |
| Carmen Ortega-Santos, PhD | Contact | 202-994-2757 | carmen.ortegasantos@email.gwu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Napolitano, PhD | GW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GW | Recruiting | Washington D.C. | District of Columbia | 20052 | United States |
Quantitative and qualitative data from 20 young adults (ages 18-39) in Phase 1. De-identified questionnaire data, as well as anthropometric, biomarker, and weight data. Qualitative data will include deidentified transcripts from structured interviews and focus groups. Only de-identified data will be preserved to ensure the confidentiality of participants.
Deidentified data that support the findings of this study will be made available to the scientific community at the end of the grant or upon manuscript acceptance of the primary results whichever is earlier. We will follow standard NIH/NHLBI BioData Catalyst (BDC) workflows for data requests.
Scientific data will be made available as public use data. To request access for general research purposes users will follow standard BDC registration and access workflows and agree to the Terms of Use.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| baseline and 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |