Cardio Vascular Disease, Diet, Healthy, Nicotine, Obesity & Overweight, Physical Activity, Sleep
Conditions
Keywords
Life's Essential 8
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSupport Your Heart
12 weeks of telephone-based health coaching to address Life's Essential 8
Sponsors
George Washington University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-39 at time of enrollment 2. Living in Washington DC area 3. At least two risk factors for cardiovascular disease: 1. not enough sleep 2. insufficient physical activity 3. tobacco and nicotine product use 4. elevated body mass index 5. poor diet 6. high cholesterol 7. high blood pressure; and/or 8. elevated HbA1c.
Exclusion criteria
* 1\. Major medical condition or chronic disease that would impede physical activity or increase the risk of the intervention (e.g., reported type 1 or type 2 diabetes, cerebrovascular accident, systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg, renal disease, pulmonary disease dependent on oxygen, recent orthopedic injury, significant surgery within the last 6 months, HbA1c \>6.5%, total cholesterol \>240 mg/dL); 2. Plan to become pregnant during study duration; 3. Psychiatric hospitalization, psychosis or suicide attempt within the last 12 months; 4. Alcohol or substance use disorder; 5. An eating disorder; 6. Conditions or behaviors that are likely to interfere with the conduct of the trial (e.g., inability to communicate with study staff, unwillingness to accept any of the three treatment assignments by randomization, current participation in another physical activity or lifestyle intervention research program)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks | Feasibility metrics will include burden and acceptability, satisfaction, adherence, and retention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the American Heart Association Life's Essential 8 Metric | baseline and 12 weeks | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMelissa Napolitano, PhD
GW
Outcome results
None listed