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Clinical Trials/NCT06567184
NCT06567184
Completed
Not Applicable

Pilot Evaluation of the Strong Hearts Program in an Urban Setting

Texas A&M University2 sites in 1 country51 target enrollmentJanuary 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Texas A&M University
Enrollment
51
Locations
2
Primary Endpoint
Body Weight
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2023
End Date
August 9, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Body Weight

Time Frame: 12 weeks

Change in body weight

Secondary Outcomes

  • Physical activity - Steps(12 weeks)
  • Self-reported healthy eating behaviors(12 weeks)
  • Participant Acceptability(12 weeks)
  • Fruit and Vegetable Consumption(12 weeks)
  • Physical activity - Active Minutes(12 weeks)
  • Intervention Engagement(12 weeks)

Study Sites (2)

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