Faith-Based Physical Activity Programs for Cardiovascular Health

Overseen By Elva Arredondo, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Health condition, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

677 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost physical activity among adult Latinas to help prevent cardiovascular disease through church-based programs. It compares three approaches: a standard program (Faith in Action), an enhanced version with tailored support from church leaders (Faith in Action+), and a further enhanced version with added community support to sustain efforts (Faith in Action++). The trial seeks to determine which approach best increases and maintains physical activity over time. Women who identify as Latina, attend church regularly, and currently engage in less than 50 minutes of leisure physical activity per week might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance community health programs and improve cardiovascular health for Latinas.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing physical activity among participants.

What prior data suggests that these faith-based physical activity programs are safe for cardiovascular health?

Research has shown that Faith in Action, a program designed to increase physical activity among Latinas, is safe and well-received. A study on the program's long-term effects found that it successfully encourages more physical activity without causing significant side effects. Participants engage in activities tailored to their community, helping them safely become more active.

The program avoids medication or direct medical treatments, resulting in very low risks. Instead, it relies on community support, education, and motivation to promote healthier habits. Previous participants have not reported any major safety issues, indicating that the program is a safe way to boost physical activity and overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Faith-Based Physical Activity Programs because they uniquely integrate spiritual support with physical health initiatives, targeting cardiovascular health in a holistic way. Unlike traditional treatments that focus solely on medical interventions or lifestyle changes, these programs leverage community and faith-based activities to encourage sustained physical activity. The "Enhanced Condition" adds organizational strategies to the standard program, while the "Enhanced + Sustainment condition" further includes maintenance strategies to ensure long-term adherence. This approach not only aims to improve heart health but also fosters a supportive community environment, making it a promising avenue for lasting lifestyle changes.

What evidence suggests that this trial's treatments could be effective for improving physical activity among Latinas?

Research has shown that the Faith in Action program, one of the programs studied in this trial, helps Latinas become more physically active. Over two years, participants significantly increased their moderate to vigorous exercise during their free time. This increase is important because more activity can lower the risk of heart disease and other long-term health problems like cancer. Other studies have found that church-based programs like this one can effectively address health issues in communities with high disease rates. These programs are promising because they are part of the church community, which is central to many Latinas' lives. This trial will compare different versions of the Faith in Action program, including the Enhanced Condition and Enhanced + Sustainment condition, to evaluate their effectiveness in promoting physical activity. ^{1 2 3 5 6}

Who Is on the Research Team?

Elva Arredondo, PhD

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for Latina women aged 18-65 who plan to attend their church regularly for the next 18 months, engage in less than 50 minutes of moderate-to-vigorous physical activity (MVPA) per week, and have no health issues that limit physical activity. Those with cognitive impairments or other health conditions that prevent PA are excluded.

Inclusion Criteria

Self-identifying as Latina

Planning on attending the FBO for the next 18 months

Low self-reported leisure-time MVPA (<50 min of weekly leisure MVPA)

Exclusion Criteria

I do not have any cognitive issues that prevent me from participating.

Attending other churches besides the church of recruitment

I cannot complete the informed consent in English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of Faith in Action program with organizational-level strategies in churches

12 months

Baseline, 6 months, 12 months

Sustainment Follow-up

Additional support provided to Enhanced + Sustainment group to examine program and participant PA sustainment

6 months

18 months post-baseline

Follow-up

Participants are monitored for maintenance of physical activity and organizational outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Faith in Action
• Faith in Action+
• Faith in Action++

Trial Overview The study tests three versions of a program called Faith in Action aimed at increasing physical activity to prevent cardiovascular disease among Latinas. Churches will implement either the standard program, an enhanced version with tailored messaging and leader training, or an enhanced version plus strategies to help sustain the program long-term.

How Is the Trial Designed?

Group I: Standard EBI Condition Experimental Treatment 1 Intervention

Faith in Action as originally implemented

Group II: Enhanced Condition Experimental Treatment 1 Intervention

Standard condition + organizational-level implementation strategies

Group III: Enhanced + Sustainment condition Experimental Treatment 1 Intervention

Enhanced implementation condition + maintenance strategies

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

The Faith in Action program, aimed at increasing physical activity among Latina women in churches, highlights the importance of community engagement and the role of church leaders in implementing health interventions.

Interviews with 22 pastors and church staff revealed key barriers such as lack of knowledge about physical activity and competing priorities, while also identifying effective strategies like health behavior training and tailored messaging to enhance program implementation and support scale-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying barriers, facilitators, and implementation strategies for a faith-based physical activity program. Haughton, J., Takemoto, ML., Schneider, J., et al.[2022]

The faith-based physical activity intervention involving 418 African-American adults from 20 churches did not lead to significant changes in physical activity behavior after one year, indicating limited efficacy of the program.

While there was a marginal increase in instrumental support from churches, the study found no significant psychosocial mediators that could explain changes in physical activity, suggesting that the intervention did not effectively target the intended factors influencing behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial mediators of a faith-based physical activity intervention: implications and lessons learned from null findings. Baruth, M., Wilcox, S., Blair, S., et al.[2022]

A systematic review of 38 faith-based interventions aimed at improving healthy eating and physical activity found that while most showed positive changes in health behaviors, none fully reported all necessary elements for effective implementation and dissemination.

The overall reporting quality was low across key intervention domains, indicating a need for future studies to provide more comprehensive data to enhance the potential for broad public health impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Eating and Physical Activity Interventions in Faith-Based Settings: A Systematic Review Using the Reach, Effectiveness/Efficacy, Adoption, Implementation, Maintenance Framework. Dunn, CG., Wilcox, S., Saunders, RP., et al.[2022]

Physical activity interventions delivered in faith-based organizations can effectively increase physical activity levels and improve health and fitness measures among participants, as shown in a review of 18 studies predominantly involving female participants in the U.S.

Despite the positive outcomes, the overall quality of the evidence was very low, highlighting the need for more rigorous randomized clinical trials to better evaluate the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Interventions in Faith-Based Organizations: A Systematic Review. Tristão Parra, M., Porfírio, GJM., Arredondo, EM., et al.[2019]

The pilot faith-based physical activity intervention significantly increased awareness of health benefits and knowledge of physical activity recommendations among Latino participants, with 66% of intervention participants citing health reasons for participation compared to only 36% in the comparison group.

The study highlighted both successes and challenges in implementation, indicating that while the intervention was effective in improving knowledge, there were communication issues and difficulties in reaching a broader audience within the church community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A faith-based physical activity intervention for Latinos: outcomes and lessons. Bopp, M., Fallon, EA., Marquez, DX.[2021]

The 'Hearts To God' project is a cardiovascular health promotion program specifically designed for women, integrating spirituality and health education to address the gap in knowledge about cardiovascular disease.

Participants reported that the program was relevant and useful, as it provided tools for women to assess and create personalized heart health plans, promoting behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and implementing a Healthy Heart program for women in a parish setting. Ruesch, AC., Gilmore, GD.[2019]

The Strong for Life exercise program was successfully implemented with 105 frail, homebound older adults, showing high satisfaction rates of 100% among volunteers and 98.6% among participants after 4 months.

Participants engaged in exercise an average of 2.2 times per week, with over half exercising 2 to 4 times weekly, leading to significant improvements in social functioning without any serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of implementing the Strong for Life program in community settings. Etkin, CD., Prohaska, TR., Harris, BA., et al.[2019]

Out of 773 U.S. Islamic centers analyzed, 206 (about 27%) advertised physical activity programs, with youth programs being the most common (44%) and sports programs the least common (23%).

Most advertised activities were led by men and primarily targeted a male audience, indicating a need for more inclusive programming, especially for women, and better promotion of these activities on their websites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Programming Advertised on Websites of U.S. Islamic Centers: A Content Analysis. Kahan, D.[2019]

Citations

1. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-022-01329-6

Two-year outcomes of Faith in Action/Fe en Acción This study evaluated the 24-month impact of a faith-based PA intervention targeting Latinas. Methods The study is a cluster randomized controlled trial.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4770876/

Fe en Accion/Faith in Action: Design and implementation of a ... Findings from the current study will address gaps in research by showing the long term effectiveness of multi-level faith-based interventions promoting physical ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5463215/

Promoting Physical Activity Among Churchgoing Latinas This low level of physical activity among Latinas may explain, in part, their high rates of cardiovascular disease and other chronic diseases such as cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S000296292301203X

Systematic review and meta-analysis of church-based ... Church-based interventions have been shown to reduce cardiovascular disease (CVD) risk factors and could reduce health disparities in groups with a high ...

5. researchgate.net researchgate.net/publication/362364258_Two-year_outcomes_of_Faith_in_ActionFe_en_Accion_a_randomized_controlled_trial_of_physical_activity_promotion_in_Latinas

(PDF) Two-year outcomes of Faith in Action/Fe en Acción Results After adjusting for sociodemographic factors, a mixed effects analysis found significant increases in self-reported leisure time MVPA ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01776632

Promoting Physical Activity in Churchgoing Latinas | ... Fe en Accion/Faith in Action: Design and implementation of a church-based randomized trial to promote physical activity and cancer screening among ...