Clinical trial NCT05259150: The Health for Hearts United Collaborative
Official title: The Health for Hearts United Collaborative
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiovascular Disease Risk Reduction
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Georgia
First posted: 2022-02-28
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: effectiveness implementation hybrid Type 3 design
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Participant Reach
timeFrame: 12 months
measure: Intervention Adoption
timeFrame: 12 months
measure: Intervention Implementation
timeFrame: 12 months
measure: Intervention Maintenance
timeFrame: 12 months
Secondary outcomes:
measure: Food choice
timeFrame: 12 months
measure: Fruit and vegetable intake
timeFrame: 12 months
measure: Fat intake
timeFrame: 12 months
measure: Self-report Physical activity
timeFrame: 12 months
measure: Objective physical activity
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Weight
timeFrame: 12 months
measure: Height
timeFrame: 12 months
measure: Hip circumference
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: Abdomen circumference
timeFrame: 12 months
Other outcomes:
measure: Cost of Intervention
timeFrame: 12 months
Locations:
city: Tallahassee
country: United States
facility: Center on Better Health and Life for Underserved Populations
state: Florida
Study officials:
References:
citation: 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.
citation: 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.