The Health for Hearts United Collaborative

Обзор

This proposed project will determine the effectiveness of Health for Hearts United Collaborative (HHUC) implementation strategies in relation to process outcomes and reducing cardiovascular disease (CVD) risk in African Americans (AAs),examining two possible strategies.

Подробное описание

This project will determine the effectiveness of HHUC implementation strategies in relation to process outcomes and reducing CVD risk in AAs, guided by ecological theory, the Consolidated Framework for Implementation Research (CFIR), and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. The HHUC model currently includes three components: governance structure, annual events, and basic support. The investigators propose adding a fourth component that includes one of two possible implementation strategies: 1) an internal champions (IC)-driven strategy that includes two features (leadership development, culturally-tailored planning approaches) or 2) an external change agent (external professionals \[EP\])-driven strategy without these features. The investigators will pilot and refine the IC and EP-driven implementation strategies using health leaders from four churches in the two-county area by determining feasibility and acceptability. Following the pilot, the investigators will use an effectiveness implementation hybrid Type 3 design to evaluate the IC and EP implementation strategies in relation to process outcomes. The study will be conducted in a two-county area in North Florida, using congregants ((18 years of age and older, n=225) in nine churches: three IC treatment, three EP treatment, and three comparison with delayed comparable activities.

Вмешательства

• Поведенческое Health for Hearts United Planning for Health
  Participants (health leaders) receive trainings (three entitled Take Charge of Your Health, Eat Better, \& Move Around More) and plan for their health ministry and cardiovascular health program to congregants.
• Поведенческое Health for Hearts United Preparing for Health
  Research participants (church congregants) receive cardiovascular health programming prepared by health leaders that includes the following best practices: Individual Goal Setting, Training, Culturally-tailored Materials, Monitoring Tool \& Recognition.
• Поведенческое Health for Hearts United Delivery of Health
  The Organization (church) uses best practices to implement Heart Health activities (annual plans, achievements, plans for the year and practices).
• Другое Health for Hearts United Comparison Group Health Ministry Development
  Participants (health leaders) have meetings to develop the health ministry. Research participants (church congregants) do not receive cardiovascular health program.

Первичные конечные точки

• Participant Reach [Срок оценки: 12 months]
• Intervention Adoption [Срок оценки: 12 months]
• Intervention Implementation [Срок оценки: 12 months]
• Intervention Maintenance [Срок оценки: 12 months]

Вторичные конечные точки (11)

• Food choice [Срок оценки: 12 months]
• Fruit and vegetable intake [Срок оценки: 12 months]
• Fat intake [Срок оценки: 12 months]
• Self-report Physical activity [Срок оценки: 12 months]
• Objective physical activity [Срок оценки: 12 months]
• Blood pressure [Срок оценки: 12 months]
• Weight [Срок оценки: 12 months]
• Height [Срок оценки: 12 months]
• Hip circumference [Срок оценки: 12 months]
• Waist circumference [Срок оценки: 12 months]
• Abdomen circumference [Срок оценки: 12 months]

Критерии участия

Критерии включения

• African American,
• 18 years of age and older,
• not pregnant in the last six months,
• not hospitalized or having a clinically significant medical condition in the past six months

Критерии исключения

• not being African American,
• under the age of 18,
• pregnant in the last six months,
• hospitalized or having a clinically significant medical condition in the past six months.

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Center on Better Health and Life for Underserved Populations — Tallahassee

Публикации

• Hu FB, Rimm E, Smith-Warner SA, Feskanich D, Stampfer MJ, Ascherio A, Sampson L, Willett WC. Reproducibility and validity of dietary patterns assessed with a food-frequency questionnaire. Am J Clin Nutr. 1999 Feb;69(2):243-9. doi: 10.1093/ajcn/69.2.243. PMID 9989687
• Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985 Jul;122(1):51-65. doi: 10.1093/oxfordjournals.aje.a114086. PMID 4014201

Идентификаторы

NCT: NCT05259150 · STUDY00000409

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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