Faith-based Mind-body Intervention for Psychosocial Health

Overseen By Scherezade Mama, DRPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Yoga, Pregnancy, Moving, others

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

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called Harmony & Health, which combines yoga with Christian spirituality, to determine if it encourages participants to become more active. It involves two groups: one participating in Harmony & Health sessions and another attending health education classes. The trial seeks Black or African American individuals who exercise less than 90 minutes a week and sit for at least 6 hours a day. Participants should also have a body mass index (BMI) of 25 or higher, typically indicating being overweight. As an unphased trial, this study provides a unique opportunity to explore a holistic approach to enhancing physical activity and well-being.

Do I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

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 is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Harmony & Health program, which combines yoga and Christian spirituality, is both feasible and well-received in other studies. Participants generally found it approachable and manageable. Although specific safety details are not mentioned, the program's emphasis on mind-body activities suggests it is unlikely to cause harm. Activities like yoga are typically safe and well-tolerated by most people. However, as with any new program, participants should pay attention to their bodies and consult the study team if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Harmony & Health intervention because it takes a unique faith-based, mind-body approach to improving psychosocial health. Unlike traditional treatments that may focus on medication or therapy alone, this intervention combines group-based sessions held in faith settings, which can enhance community support and personal empowerment. By incorporating spiritual and holistic elements, this approach aims to address the mind, body, and spirit, offering a comprehensive path to well-being that traditional methods might not fully cover.

What evidence suggests that this trial's treatments could be effective for improving exercise habits?

Research has shown that the Harmony & Health program, which participants in this trial may receive, can reduce stress and improve mental well-being for rural churchgoers, at least in the short term. Studies found that participants experienced less emotional distress related to mental health after joining the program. The program combines yoga with aspects of Christian spirituality, creating a sense of peace and lifting overall mood. While more research is needed to fully understand its benefits, these early results are promising for those interested in enhancing their mental health through spiritual and physical activities. ^{1 2 3 4 6}

Who Is on the Research Team?

Scherezade Mama, DRPH

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for Black or African American adults who are over 18, have a BMI of at least 25, do less than 90 minutes of exercise per week, and sit for more than 6 hours a day. They must be able to consent, read, speak and write in English. Those who are pregnant or planning to move away from the study areas within six months cannot join.

Inclusion Criteria

Self-identify as Black or African American

I am cleared by a doctor to engage in physical activities.

Self-report doing <90 minutes/week of physical activity

Exclusion Criteria

I sit for less than 6 hours a day.

I am under 18 years old.

Practicing yoga or enrolled in another program targeting physical activity, sitting time, or weight loss

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Harmony & Health intervention or the attention control group, attending sessions twice a week for 8 weeks

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for retention and adherence, and interviews are conducted to assess acceptance and refine protocols

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Fitbit
• Harmony & Health Intervention

Trial Overview

The Harmony & Health program is being tested; it's a mix of yoga and Christian spirituality aimed at increasing physical activity among participants. The study will also use Fitbits to monitor activity levels compared with an attention control group.

How Is the Trial Designed?

Group I: Harmony & Health Intervention (Group 1) Experimental Treatment 2 Interventions

Participants randomized to the Harmony and Health intervention group will attend group-based in-person intervention sessions at FOP or COGIC. on.

Group II: Attention Control (Group 2) Experimental Treatment 2 Interventions

Participants randomized to the attention control condition will participate in in-person group-based health education sessions twice a week for 8 weeks with a trained interventionist and will receive 4 monthly newsletters (20 total contacts).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

A review of 36 studies on faith-based interventions (FBIs) from 2007 to 2017 showed that these studies had moderate and inconsistent integration of faith concepts with health outcomes, indicating a need for better measurement of faith-related factors.

Despite the inconsistent integration of faith, the interventions still led to beneficial outcomes, suggesting that FBIs can be effective, but further research is needed to clarify how faith integration impacts these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a faith-based integration tool to assess mental and physical health interventions. Saunders, DM., Leak, J., Carver, ME., et al.[2022]

The study developed the '3R' model to create religiously-tailored health messages aimed at improving mammography intentions among Muslim women, based on insights from focus groups and interviews with 25 participants.

The model addresses negative beliefs about health behaviors by reframing, reprioritizing, and reforming these beliefs within a religious context, highlighting both the potential benefits and ethical considerations of using faith-based approaches in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing religiously-tailored health messages for behavioral change: Introducing the reframe, reprioritize, and reform ("3R") model. Padela, AI., Malik, S., Vu, M., et al.[2018]

Transformative practices from various religious traditions, such as meditation and yoga, have been shown to enhance psychological and physical well-being, according to several well-designed studies.

Despite the challenges in defining and quantifying 'transformation,' there is a growing need for randomized trials to better understand and validate the health benefits of these spiritual practices in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transformative practices for integrating mind-body-spirit. Luskin, F.[2019]

In a study of 168 participants with chronic medical conditions and a healthy control group, it was found that physical health is positively related to the frequency of attending religious services, suggesting that better health may enable individuals to participate more in their faith communities.

Spiritual beliefs, particularly the belief in a loving higher power and maintaining a positive worldview, are associated with better health outcomes, supporting theories that link psychological and spiritual well-being to physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining relationships between physical health and spiritual experience, religious practices, and congregational support in a heterogeneous medical sample. Campbell, JD., Yoon, DP., Johnstone, B.[2021]

The RHIBS Taxonomy is the first comprehensive classification system for religious components in health interventions, developed through a systematic review of 12,337 papers and consensus from 19 international experts, resulting in 82 defined components across 22 categories.

This taxonomy aims to enhance the clarity and consistency of religious health interventions, facilitating better replication, implementation, and evidence synthesis in healthcare research and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of the Religious Health Interventions in Behavioural Science (RHIBS) Taxonomy: a scientific classification of religious practices in health. Patel, R., Jong, J., Worthington, EL., et al.[2023]

In a study of 250 patients followed for nine months after hospital admission, 79% reported some form of spiritual belief, but those with stronger beliefs were 2.3 times more likely to have a poor clinical outcome, indicating a potential negative impact of strong spiritual beliefs on recovery.

The research found that stronger spiritual beliefs were a more significant predictor of poor health outcomes than both physical condition and self-reported psychological state at the time of admission, suggesting that spiritual beliefs may influence recovery in unexpected ways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spiritual beliefs on outcome from illness. King, M., Speck, P., Thomas, A.[2019]

Mind-body medicine (MBM) leverages the connection between the brain, mind, body, and behavior to promote health, focusing on techniques like exercise, relaxation, and nutrition, and is well-established in the US healthcare system.

MBM is effective in addressing chronic lifestyle-related diseases by enhancing individual resilience and reducing stress, and it operates on principles similar to the placebo effect, making it a valuable approach for self-healing and self-care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-healing in health-care: Using the example of mind-body medicine]. Esch, T.[2020]

The Fit Body and Soul intervention, adapted from a successful diabetes prevention program, aims to promote healthy lifestyle changes within African American communities through faith-based initiatives.

This 12-session program incorporates church missions and biblical scripture, leveraging the strong participation of African Americans in faith communities to influence health behaviors and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit body and soul: a church-based behavioral lifestyle program for diabetes prevention in African Americans. Dodani, S., Kramer, MK., Williams, L., et al.[2022]

A community-based participatory research (CBPR) intervention in 74 African Methodist Episcopal churches involving 1257 members led to significant increases in self-reported moderate- to vigorous-intensity physical activity (MVPA) after 15 months, indicating the intervention's effectiveness in promoting physical health.

The intervention also positively impacted self-reported fruit and vegetable consumption, suggesting that faith-based approaches can successfully encourage healthier lifestyle choices in ethnic minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Faith, Activity, and Nutrition program: a randomized controlled trial in African-American churches. Wilcox, S., Parrott, A., Baruth, M., et al.[2022]

Faith-based weight management interventions (WMIs) targeting African American women show promise in addressing obesity, but there is a lack of systematic evaluation of these programs, highlighting the need for better assessment criteria.

The review emphasizes the importance of robust research methodologies, including randomization and appropriate intervention design, to ensure the effectiveness and feasibility of faith-based WMIs in church settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review and evaluation of faith-based weight management interventions that target African American women. Timmons, SM.[2022]

The 'Harmony & Health' (HH) intervention, a mind-body program adapted for rural churchgoers, was found to be feasible and acceptable, effectively reducing perceived stress, depressive symptoms, and negative affect after an 8-week program involving overweight or obese adults.

Participants in the study, primarily women with a mean age of 49, showed significant improvements in mental health outcomes, indicating that integrating spirituality with mind-body practices can enhance psychosocial well-being in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A faith-based mind-body intervention to improve psychosocial well-being among rural adults. Mama, SK., Bhuiyan, N., Bopp, MJ., et al.[2022]

The Building a Health Temple (BHT) diabetes self-management education support (DSMES) program is being tested in a cluster-randomized trial involving 360 participants from 18 churches, aiming to improve diabetic outcomes through faith-based interventions.

The primary goal of the study is to assess changes in Hemoglobin A1c (HbA1c) levels, with additional outcomes including body mass index, diabetes distress, and self-care behaviors, highlighting the potential of church settings to enhance diabetes management among Hispanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a Healthy Temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial. Wilmoth, S., Carrillo, L., Correa, L., et al.[2021]

Patients often view their spiritual health as equally important as their physical health, and addressing spiritual needs can lead to better health outcomes, including improved coping skills and quality of life during illness.

Research indicates that religious involvement and spirituality are linked to positive health effects, such as reduced anxiety and depression, and that supporting patients' spiritual needs can enhance their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Religious involvement, spirituality, and medicine: implications for clinical practice. Mueller, PS., Plevak, DJ., Rummans, TA.[2022]

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