Evaluation of the Strong Hearts Urban Program

NCT ID: NCT06567184

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2023-08-09

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Strong Hearts Urban

A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities

Group Type: EXPERIMENTAL

Strong Hearts Urban

Intervention Type: BEHAVIORAL

A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities

Interventions

Strong Hearts Urban

A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chad D Rethorst, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Texas A&M AgriLife Research

Locations

West Dallas Multipurpose Center

Dallas, Texas, United States

Texas A&M AgriLife Research and Extension Center at Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

IRB2022-0801D

Identifier Type: -

Identifier Source: org_study_id