Support Your Heart, Phase 1

NCT07623733 | Recruiting

• 2 other identifiers: HL175017R34HL175017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Life's Essential 8

Outcome Measures

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.

  12 weeks

Secondary Outcomes (1)

• Change in the American Heart Association Life's Essential 8 Metric

  baseline and 12 weeks

Study Arms (1)

Support Your Heart

EXPERIMENTAL

12 weeks of telephone-based health coaching

Behavioral: Support Your Heart

Interventions

Support Your Heart BEHAVIORAL

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

Support Your Heart

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• at time of enrollment
• Living in Washington DC area
• At least two risk factors for cardiovascular disease:
• not enough sleep
• insufficient physical activity
• tobacco and nicotine product use
• elevated body mass index
• poor diet
• high cholesterol
• high blood pressure; and/or
• elevated HbA1c.

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• George Washington University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

GW

Washington D.C., District of Columbia, 20052, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Melissa Napolitano, PhD

  GW

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Napolitano, PhD

CONTACT

202-994-9099; mnapolitano@gwu.edu

Carmen Ortega-Santos, PhD

CONTACT

202-994-2757; carmen.ortegasantos@email.gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

US (1)