Clinical trial NCT06567184: Evaluation of the Strong Hearts Urban Program
Official title: Pilot Evaluation of the Strong Hearts Program in an Urban Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, American Heart Association's Life's Essential 8 (AHA Essential 8), and health behaviors among Black/African American and/or Hispanic/Latinx urban residents with overweight or obesity.

Detailed description: Cultural adaptation of effective health behavior interventions holds the potential to improve health behaviors and ultimately health outcomes among underserved populations. The Strong Hearts (SH) Urban Intervention will adapt the existing SH curriculum for delivery in urban Dallas communities to improve weight status and Life's Essential 8 score for ideal cardiovascular health. Despite declines in heart disease mortality in the United States since 2000, it remains the leading cause of mortality in both men and women-accounting for about one-third of all deaths in the U.S. Costs related to cardiovascular disease (CVD) place a substantial financial burden on the health care system, accounting for an estimated $320 billion in 2016. Although most obesity or CVD prevention programs target only the individual level, the US Centers for Disease Control and Prevention recognizes that health is affected by factors at multiple levels: individual (e.g., behaviors, knowledge, attitudes, skills, psychological factors), social (e.g., influences from one's social network on health-related behaviors), and environmental (e.g., safe places to walk, food choices at workplaces, availability of affordable fruits and vegetables), and recommends integrating approaches to make changes beyond the individual level to support long-term, sustainable behavior change. Providing individuals with the motivation, skills, and opportunity to change behaviors may be less effective if their social or community environment makes it difficult to adopt or maintain these behaviors

SH is a multilevel, multicomponent community-based program, in which an experiential learning focus is combined with social and environmental components, including civic engagement activities related to local resource awareness and enhancement. There is limited knowledge about how programs and services can move beyond commonly used individual-level approaches, which have limitations in terms of cost, impact, reach, and sustainability, to effectively reduce CVD health disparities using an integrated, multi-level, community-engaged approach. This pilot study will provide needed data on the feasibility and preliminary effectiveness of such approaches in urban and underserved communities.

Eligibility criteria: Inclusion Criteria:

1. Women aged 18 or older
2. Overweight or obese (BMI≥25)
3. Less than 150 minutes of moderate physical activity per week
4. Black/African American race and/or Hispanic/Latinx ethnicity

Exclusion Criteria:

1. Pregnancy, or intent to become pregnant during the study duration
2. Unable to read and communicate in English
3. Planning to participate in another health behavior change program in the next three months
4. Unable/unwilling to provide informed consent

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Fruit and Vegetable Consumption
timeFrame: 12 weeks
measure: Self-reported healthy eating behaviors
timeFrame: 12 weeks
measure: Physical activity - Active Minutes
timeFrame: 12 weeks
measure: Physical activity - Steps
timeFrame: 12 weeks
measure: Participant Acceptability
timeFrame: 12 weeks
measure: Intervention Engagement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: West Dallas Multipurpose Center
state: Texas
city: Dallas
country: United States
facility: Texas A&M AgriLife Research and Extension Center at Dallas
state: Texas
Study officials:
affiliation: Texas A&M AgriLife Research
name: Chad D Rethorst, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: