Evaluation of the Strong Hearts Urban Program

Pilot Evaluation of the Strong Hearts Program in an Urban Setting

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Strong Hearts Urban

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75212
      • West Dallas Multipurpose Center
    • Dallas, Texas, United States, 75252
      • Texas A&M AgriLife Research and Extension Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strong Hearts Urban; A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities	Behavioral: Strong Hearts Urban; A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Change in body weight	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit and Vegetable Consumption	Dermal Carotenoid Score. As measured by Veggie Meter using a participant's index finger, the dermal carotenoid score (0-800) reflects a concentration biomarker of fruit and vegetable intake, where a higher score is correlated with higher intake.	12 weeks
Self-reported healthy eating behaviors	Healthy Eating Index (HEI) as measured by Dietary Health Questionnaire (DHQ-III). The DHQ-III is a self-administered, web-based food frequency questionnaire scored 0 to 100, where higher scores indicate closer adherence to the Dietary Guidelines for Americans.	12 weeks
Physical activity - Active Minutes	Objectively measured physical activity by Fitbit activity tracker, counted as Active Minutes	12 weeks
Physical activity - Steps	Objectively measured physical activity by Fitbit activity tracker, counted as steps	12 weeks
Participant Acceptability	Participant feedback from follow-up questionnaires measures acceptability on a 5-point Likert scale, where higher score indicates higher satisfaction	12 weeks
Intervention Engagement	Engagement is assessed by attendance at study activities including intervention classes and data collection appointments	12 weeks

Collaborators and Investigators

• Sponsor: Texas A&M University
• Investigators: Principal Investigator: Chad D Rethorst, Ph.D., Texas A&M AgriLife Research

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): July 29, 2023
• Study Completion (Actual): August 9, 2023

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB2022-0801D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No