The Health for Hearts United Collaborative
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health, Health for Hearts United Delivery of Health, Health for Hearts United Comparison Group Health Ministry Development.
- Who it may be relevant to
- Registry conditions: Cardiovascular Disease Risk Reduction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral 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. - Behavioral 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. - Behavioral 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). - Other 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.
Primary outcome measures
- Participant Reach [Time frame: 12 months]
- Intervention Adoption [Time frame: 12 months]
- Intervention Implementation [Time frame: 12 months]
- Intervention Maintenance [Time frame: 12 months]
Secondary outcome measures (11)
- Food choice [Time frame: 12 months]
- Fruit and vegetable intake [Time frame: 12 months]
- Fat intake [Time frame: 12 months]
- Self-report Physical activity [Time frame: 12 months]
- Objective physical activity [Time frame: 12 months]
- Blood pressure [Time frame: 12 months]
- Weight [Time frame: 12 months]
- Height [Time frame: 12 months]
- Hip circumference [Time frame: 12 months]
- Waist circumference [Time frame: 12 months]
- Abdomen circumference [Time frame: 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Center on Better Health and Life for Underserved Populations — Tallahassee
Publications
- 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
Identifiers
NCT: NCT05259150 · STUDY00000409