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Support Your Heart, Phase 1 (SYH)

13 juli 2026 uppdaterad av: George Washington University

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

20

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • District of Columbia
      • Washington D.C., District of Columbia, Förenta staterna, 20052
        • GW

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Support Your Heart
12 weeks of telephone-based health coaching
Beteende: Support Your Heart
12 weeks of telephone-based health coaching to address Life's Essential 8

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 12 weeks
Feasibility metrics will include burden and acceptability, satisfaction, adherence, and retention.
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the American Heart Association Life's Essential 8 Metric
Tidsram: 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
baseline and 12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

George Washington University

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

Utredare

  • Huvudutredare: Melissa Napolitano, PhD, GW

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2026

Primärt slutförande (Beräknad)

1 oktober 2026

Avslutad studie (Beräknad)

1 november 2026

Studieregistreringsdatum

Först inskickad

20 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HL175017
  • R34HL175017 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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