Support Your Heart, Phase 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorGeorge Washington University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-39 at time of enrollment
Living in Washington DC area
not enough sleep
insufficient physical activity
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Support Your Heart
Behavioral12 weeks of telephone-based health coaching to address Life's Essential 8
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Support Your HeartExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 weeksSecondary outcomes
1
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
Time frame
baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
George Washington University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov