Support Your Heart, Phase 1 (SYH)

Support Your Heart: Feasibility Trial of a Cardiovascular Health Intervention for Young Adults, Phase 1

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Sleep; Diet, Healthy; Nicotine; Obesity & Overweight; Cardio Vascular Disease
• Intervention / Treatment: Behavioral: Support Your Heart

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Napolitano, PhD; Phone Number: 202-994-9099; Email: mnapolitano@gwu.edu
• Study Contact Backup: Name: Carmen Ortega-Santos, PhD; Phone Number: 202-994-2757; Email: carmen.ortegasantos@email.gwu.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20052
      • Recruiting
      • GW
      • Contact: Melissa Napolitano, PhD; Phone Number: 202-994-9099; Email: mnapolitano@gwu.edu
      • Principal Investigator: Melissa Napolitano, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Support Your Heart; 12 weeks of telephone-based health coaching	Behavioral: Support Your Heart; 12 weeks of telephone-based health coaching to address Life's Essential 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Melissa Napolitano, PhD, GW

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Life's Essential 8
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Motor Activity
• Other Study ID Numbers: HL175017; R34HL175017 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No