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Support Your Heart, Phase 1 (SYH)

13 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20052
        • GW

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La 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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Support Your Heart
12 weeks of telephone-based health coaching
Comportemental: Support Your Heart
12 weeks of telephone-based health coaching to address Life's Essential 8

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 12 weeks
Feasibility metrics will include burden and acceptability, satisfaction, adherence, and retention.
12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in the American Heart Association Life's Essential 8 Metric
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

George Washington University

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)

Les enquêteurs

  • Chercheur principal: Melissa Napolitano, PhD, GW

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2026

Achèvement primaire (Estimé)

1 octobre 2026

Achèvement de l'étude (Estimé)

1 novembre 2026

Dates d'inscription aux études

Première soumission

20 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HL175017
  • R34HL175017 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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