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Completed

NCT Number: NCT06567184

Evaluation of the Strong Hearts Urban Program

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M AgriLife Research and Extension Center at Dallas, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strong Hearts Urban

Behavioral

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

Primary outcomes

  1. Body Weight

    Time frame: 12 weeks

    Change in body weight

Secondary outcomes

  1. Fruit and Vegetable Consumption

    Time frame: 12 weeks

    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.

  2. Self-reported healthy eating behaviors

    Time frame: 12 weeks

    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.

  3. Physical activity - Active Minutes

    Time frame: 12 weeks

    Objectively measured physical activity by Fitbit activity tracker, counted as Active Minutes

  4. Physical activity - Steps

    Time frame: 12 weeks

    Objectively measured physical activity by Fitbit activity tracker, counted as steps

  5. Participant Acceptability

    Time frame: 12 weeks

    Participant feedback from follow-up questionnaires measures acceptability on a 5-point Likert scale, where higher score indicates higher satisfaction

  6. Intervention Engagement

    Time frame: 12 weeks

    Engagement is assessed by attendance at study activities including intervention classes and data collection appointments

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

Pilot Evaluation of the Strong Hearts Program in an Urban Setting

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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