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Идёт набор NCT07034352

Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings

Без фазы С лечением Health Promotion Cardiovascular Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Health Impact 360, Usual care - Wait list control.
Кому может быть актуально
Состояния в реестре: Health Promotion, Cardiovascular Health. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

The purpose of this clinical trial is to evaluate an evidence-based intervention, Health Impact 360, toward the promotion of cardiovascular health (CVH), including physical, mental, and social health outcomes, among adults living in marginalized communities. Study hypotheses include: * Participants in the Health Impact 360 intervention arm will have better CVH (i.e., a higher overall LE8 score) at the 16-week endpoint compared to the control. * Participants in the Health Impact 360 intervention arm will report better mental health (i.e., a lower perceived stress score) at the 16-week endpoint compared to the control. * Participants in the Health Impact 360 intervention arm will report better social support and well-being (i.e., higher emotional support and instrumental support scores and reduced social isolation) at the 16-week endpoint compared to control. * Participants with greater intervention engagement (e.g., better session attendance) will experience greater intervention impacts across all primary and secondary outcomes relative to the minimally engaged peers. Researchers will compare outcomes among intervention participants to outcomes among delayed intervention control participants who will be invited to participate in Health Impact 360 once all endpoint measures are collected. Participants will: * Engage in group-based programming twice per week for 8 weeks * Engage in group-based programming once per week for 8 weeks * Participate in survey-based and biometric data collection at two timepoints: baseline and 16-week endpoint * Self-monitor their physical activity via a study-provided pedometer

Вмешательства

  • Поведенческое Health Impact 360
    Participants will be assigned to a team and teams will meet 1-2 times per week for sessions at a local community organization. Sessions will be up to 2 hours long and will include two parts: (1) 30-60 minutes of activities related to physical, mental, social, financial, and community health, and (2) 60-75 minutes of group physical activity (walking), including stretches to warm up and cool down.
  • Другое Usual care - Wait list control
    Participants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks.

Первичные конечные точки

  • Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8) [Срок оценки: Baseline, 16 weeks]
Вторичные конечные точки (4)
  • Change in mental health based on the perceived stress scale [Срок оценки: Baseline, 16 weeks]
  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale [Срок оценки: Baseline, 16 weeks]
  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale [Срок оценки: Baseline, 16 weeks]
  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale [Срок оценки: Baseline, 16 weeks]

Критерии участия

Критерии включения

  • English or Spanish speaking
  • Able to participate in group-based programming

Критерии исключения

\- All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 7 центров
  • Community Health and Social Service Centers (CHASS) — Detroit
  • Eastside Community Network (ECN) — Detroit
  • Detroit Hispanic Development Corporation (DHDC) — Detroit
  • Hasselbringe Senior Center — Flint
  • Spirit of Victory — Flint
  • Flint Development Center — Flint
  • RL Jones Community Center — Flint

Идентификаторы

NCT: NCT07034352 · HUM00256551 · OT2HL158287

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗