Study Summary
This trial will test whether two possible strategies for the Health for Hearts United Collaborative can reduce cardiovascular disease risk in African Americans.
Eligible Conditions
- Cardiovascular Disease Risk Reduction
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 11 Secondary · Reporting Duration: 12 months
12 months
Abdomen circumference
Blood pressure
Cost of Intervention
Fat intake
Food choice
Fruit and vegetable intake
Height
Hip circumference
Intervention Adoption
Intervention Implementation
Intervention Maintenance
Objective physical activity
Participant Reach
Self-report Physical activity
Waist circumference
Weight
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Comparison Group Strategy
1 of 3
Expert Professional (EP) Strategy
1 of 3
Internal Champion (IC) Strategy
1 of 3
Active Control
Experimental Treatment
225 Total Participants · 3 Treatment Groups
Primary Treatment: Health for Hearts United Planning for Health · No Placebo Group · N/A
Expert Professional (EP) StrategyExperimental Group · 3 Interventions: Health for Hearts United Delivery of Health, Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health · Intervention Types: Behavioral, Behavioral, Behavioral
Internal Champion (IC) StrategyExperimental Group · 3 Interventions: Health for Hearts United Delivery of Health, Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health · Intervention Types: Behavioral, Behavioral, Behavioral
Comparison Group Strategy
Other
ActiveComparator Group · 1 Intervention: Health for Hearts United Comparison Group Health Ministry Development · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
University of GeorgiaOTHER
86 Previous Clinical Trials
30,368 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,371 Previous Clinical Trials
3,930,459 Total Patients Enrolled
Florida State UniversityLead Sponsor
163 Previous Clinical Trials
27,393 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a life expectancy of at least 18 years.
You are not hospitalized or having a clinically significant medical condition in the past six months.
References
- Hu, Frank B, Eric Rimm, Stephanie A Smith-Warner, Diane Feskanich, Meir J Stampfer, Albert Ascherio, Laura Sampson, and Walter C Willett. 1999. “Reproducibility and Validity of Dietary Patterns Assessed with a Food-frequency Questionnaire”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/69.2.243.
- WILLETT, WALTER C., LAURA SAMPSON, MEIR J. STAMPFER, BERNARD ROSNER, CHRISTOPHER BAIN, JELIA WITSCHI, CHARLES H. HENNEKENS, and FRANK E. SPEIZER. 1985. “Reproducibility and Validity of A Semiquantitative Food Frequency Questionnaire”. American Journal of Epidemiology. Oxford University Press (OUP). doi:10.1093/oxfordjournals.aje.a114086.
- 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.
- 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.
- Penny Ralston 2022. "The Health for Hearts United Collaborative". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05259150.
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Conditions
Cancer Related
Treatments