Clinical trial

Support Your Heart, Phase 1

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07623733

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 39 Years

SexAll

Healthy volunteersAccepted

ConditionCardio Vascular Disease, Obesity & Overweight, Physical Activity, Sleep, Diet, Healthy, Nicotine

Full registry criteria

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)

Treatments and study arms

Support Your Heart

Behavioral

12 weeks of telephone-based health coaching to address Life's Essential 8

Primary outcomes

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 attrition12 weeks

Feasibility metrics will include burden and acceptability, satisfaction, adherence, and retention.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

GW🇺🇸 Washington D.C., District of Columbia, United States

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