Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico

Psychological Distress Clinical Trial

Official title:

Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico: A Pilot of a Mindfulness-based Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06250738
• Other study ID #: STUDY00006752
• Secondary ID: 8K12AR084234
• Status: Completed
• Phase: N/A
• Start date: February 17, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the feasibility and acceptability of a 4-week mindfulness program among young women in Puerto Rico with elevated stress. The main questions it aims to answer are:

• how feasible and acceptable is a s a 4-week mindfulness program among participants with elevated stress

• what are the changes in psychological resilience, psychological distress, health behaviors, and cardiometabolic markers

Participants will be asked to

• attend 4 weekly virtual sessions and daily mindfulness exercises at home

• complete online study questionnaires

Description:

Cardiometabolic diseases among women in Puerto Rico. The 1.7 million women residing in Puerto Rico experience a great load of cardiometabolic diseases (i.e., adiposity, type 2 diabetes, hypertension, and hyperlipidemia). It is estimated that, among women in PR, the prevalence of overweight and obesity is 67.1%, hypertension 39.2%, hyperlipidemia 36.8%, and type 2 diabetes 16.3%, with estimates of obesity and type 2 diabetes being higher than in men. With cardiometabolic diseases driving the majority of deaths and disability in Puerto Rico -including women, the steep societal and individual cost of these diseases-particularly in the context of Puerto Rico's financial crisis, it is imperative to understand modifiable factors influencing women's cardiometabolic health and guide early prevention efforts.

Psychological well-being and cardiometabolic health. Psychological well-being has gained attention as a protective factor against cardiovascular disease. This is of particular importance to women in Puerto Rico as they report greater psychological distress than Puerto Rican men. The protective effect of psychological well-being on cardiometabolic health is believed to partially occur by buffering the effects of stress on health. This is of particular importance to women in Puerto Rico given that stress is detrimental to Latinx cardiometabolic health. Puerto Ricans in the mainland US have lower psychological well-being, as measured by optimism, than other Latinx heritage groups.

Mindfulness-based Stress reduction programs (MBSR). The high burden of cardiometabolic diseases among women in Puerto Rico, their disproportionate exposure to stressors, and potentially low psychological well-being highlight the need for effective behavioral interventions. The American Heart Association has issued a call to action for studies testing mindfulness-based interventions for cardiometabolic health. At its core, this program empowers participants to develop a profound awareness of the present moment, fostering a deeper understanding of their thoughts, emotions, and bodily sensations. Through mindfulness meditation and a series of carefully crafted exercises, MBSR equips individuals with powerful tools to manage stress, reduce anxiety, and enhance their overall well-being. MBSR consists of an 8-week program with weekly sessions (usually lasting 2.5 hours), daily practice exercises (of 45 minutes duration each), and an end-of-program day-long retreat. MBSR has been shown to improve psychological well-being, with studies documenting greater intervention effectiveness and acceptability for women than men. Additionally, studies have shown that mindfulness-based interventions reduce adiposity and hypertension. However, there is limited data on MBSR in Latinx women-less in Puerto Rico. The Puerto Rican population has unique socio-cultural values and norms that merit MBSR to be tested in this group.

MBSR interventions have critical pitfalls, such as time and transportation barriers, that need to be addressed to improve implementation. The only study in Puerto Rico evaluating an MBSR reported time commitment and lack of transportation as barriers to participation. A study done at UMass Medical School did some preliminary work to address these limitations. The researchers at UMass have adapted the original MBSR to use shortened weekly sessions (1.5- 1hr) and home practice exercises (5-15min). The researchers also selected 4 sessions out of the original 8-week MBSR sessions to shorten the program. This responds to preliminary data from our focus group discussions among young women in Puerto Rico documenting that an 8-week long program with weekly sessions was a burden and would hinder participation.

The Investigator took these modifications and further made adaptations to make the 4-week MBSR program be delivered virtually. The original 4-week protocol by Rosal and Camrody was already available in English and Spanish. In the present study, we will test the feasibility and acceptability of the Spanish version 4-week MBSR program among young women (18-29yr) with elevated stress residing in Puerto Rico and will explore changes in resilience, stress, health behavior, and cardiometabolic outcomes. Testing the Spanish 4-week MBSR protocol in young women in Puerto Rico is needed to evaluate novel strategies that may be feasible and acceptable for this group

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 30, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• Individuals residing in Puerto Rico

• Spanish speaking

• Elevated stress (defined as a score >6 in the Perceived Stress Scale (PSS-4)34)

• Willing to undergo research activities (focus group discussions).

Exclusion Criteria:

• Currently pregnant

• Previous participation in an 8-week MBSR program

• Experiencing moderately severe or severe depressive symptoms (PHQ-9>15)35)

• Have active suicidal ideation (PHQ-9 item #9)35

• Self-report history of cognitive and psychiatric conditions

• Lack of access to the internet/phone (mode of focus group discussions-via Zoom)

• Prisoners

• Cognitively impaired or Individuals with Impaired Decision-Making Capacity

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome
• Psychological Distress

Intervention

Behavioral:
• Mindfulness-based Stress reduction program: Virtual
Through mindfulness meditation and a series of carefully crafted exercises, MBSR equips individuals with powerful tools to manage stress, reduce anxiety, and enhance their overall well-being. Participants will complete 4 weekly virtual sessions covering topics like introduction to stress and its consequences, awareness of sensations, and thoughts, mindful eating, and mindful walking.
• Home exercises
Following each virtual session, participants will be given home exercises like practicing awareness of breathing, awareness of thoughts, and awareness of eating.

Locations

Country	Name	City	State
United States	Rollins School of Public Helath	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of recruitment and retention	Number of participants at the beginning of the study versus the number of participants at the end of the study.	Baseline, week 4
Primary	Adherence to the program	Measured by the number of phone sessions attended and the frequency of self-reported completed home practice, both assessed at post-intervention assessments	Baseline, week 4
Primary	Ratings of satisfaction	Ratings of satisfaction, also assessed by survey in post-intervention assessments, will be measured with several questions, including one that reads "Overall, how satisfied were you with the stress reduction program", "How satisfied are you NOW (after the stress reduction program) with your ability to manage the stress in your life?"	Baseline, week 4
Secondary	Change in cardiometabolic markers: Weight	-Baseline and post-intervention secondary outcome data on cardiometabolic markers (adiposity and blood pressure) will be assessed during clinic visits or by self-report when visit to the clinic is not possible	Baseline, week 4
Secondary	Change in cardiometabolic markers: Waist Circumference	-Baseline and post-intervention secondary outcome data on cardiometabolic markers (adiposity and blood pressure) will be assessed during clinic visits or by self-report when visit to the clinic is not possible	Baseline, week 4
Secondary	Change in cardiometabolic markers: Blood Pressure	-Baseline and post-intervention secondary outcome data on cardiometabolic markers (adiposity and blood pressure) will be assessed during clinic visits or by self-report when visit to the clinic is not possible	Baseline, week 4