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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06250738
Enrollment
24
Registered
2024-02-09
Start date
2024-02-17
Completion date
2024-04-27
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Syndrome, Psychological Distress

Keywords

Mindfulness-based Stress reduction programs, Cardiometabolic outcomes, Psychological well-being, Health behaviors

Brief 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

Detailed 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

Interventions

BEHAVIORALMindfulness-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.

BEHAVIORALHome exercises

Following each virtual session, participants will be given home exercises like practicing awareness of breathing, awareness of thoughts, and awareness of eating.

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rates of Recruitment and RetentionBaseline, week 4, week 8Number of participants at the beginning of the study versus the number of participants at the end of the study.
Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home4 weeksThe frequency of self-reported completed home practice was assessed at post-intervention assessments. Participants will answer the question Usually, how often did you practice the at-home exercises of the program?. Response options include: never, \<1/week 1-2/week, 3-4/week, 5-6/week, every day.
Adherence to the Program: Number of 4-week MBSR Sessions Joined4 weeksMeasured by the number of sessions joined. This is tracked by session attendance done by research staff. Data entered will be 0 sessions, 1 session, 2 sessions, 3 sessions or 4 sessions
Ratings of Satisfaction (Overall)Week 4Ratings of program satisfaction, also assessed by survey in post-intervention assessments, will be measured with aseveral questions on, including one that reads Overall, how satisfied were you with the stress reduction program
Ratings of Satisfaction Pre and Post InterventionBaseline, week 4Satisfaction with the ability to manage stress in life before and after the 4-week MBSR intervention

Secondary

MeasureTime frameDescription
Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)Baseline, week 4, 2 month follow upThe FFMQ-15 is a 15-item tool assessing mindfulness across five dimensions: observing, describing, awareness, non-judging, and non-reacting. Higher scores indicate greater mindfulness, linked to better emotional regulation and well-being. Average scores are obtained by adding up the responses and dividing by the total number of items, reflecting the overall agreement with each item (1 = rarely true, 5 = always true). Higher scores suggest a greater level of mindfulness in daily life.
Change in Depression Symptoms: CSED-10 ScoresBaseline, week 4, 2 month follow upThe CESD-10 is a shortened version of the 20-item CES-D, designed to assess depressive symptoms. It includes 10 questions rated on a 4-point Likert scale (0-3), with higher scores indicating greater symptom severity. The scale covers both negative (e.g., loneliness, sadness) and positive (e.g., hopefulness, happiness) experiences. A total score ranges from 0 to 30, with a score of 10 or higher often indicating significant depressive symptoms and a potential risk for Major Depressive Disorder (MDD).
Change in Psychological Flexibility: Acceptance and Action Questionnaire - IIBaseline, week 4, 2 month follow upThe AAQ-II measures psychological flexibility, or the ability to accept negative emotions and take value-driven actions. Higher scores indicate greater flexibility, associated with better emotional resilience and well-being. Includes seven statements that participants rate using a 7-point Likert scale, from 1 (Never true) to 7 (Always true). The total score is obtained by adding the ratings for all items (ranging from 7- 49). Higher scores reflect lower psychological flexibility, whereas lower scores indicate greater flexibility
Change in Anxiety Symptoms: GAD-7 ScoresBaseline, week 4, 2 month follow upThe GAD-7 is a seven-item screening tool for generalized anxiety disorder. Each item is rated on a 0-3 scale, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, with 10 or higher suggesting possible GAD. Severity levels range from minimal (0-4) to severe (15-21).
Change in PTSD Symptoms: Civilian Abbreviated ScaleBaseline, week 4, 2 month follow upTwo symptoms of PTSD experienced in the previous month were assessed with the PTSD Civilian Abbreviated Scale. One item measured disturbing memories of any adverse event, and the second item measured feelings of distress due to these memories. Response options to both items were on a 5-point scale and ranged from 0 'not at all' to 4 'extremely'. Response options to both items were summed (Lowest score: 0, highest score: 8), with higher scores indicating greater PTSD symptomatology.
Change in Perceived Stress (Perceived Stress Scale)Baseline, week 4, 2 month follow upThe PSS-4 is a short tool measuring perceived stress based on feelings of unpredictability and overwhelm. Scores range from 0 to 16, with higher scores indicating greater stress.
Shift-and-persist (Chen et al)Baseline, week 4, 2 month follow upIt includes 8 items: 4 measuring shift and 4 measuring persist. Response options for all items were on a 4-point Likert scale (from a score of 1 for 'not at all' to a score of 4 for 'a lot'). Total scores were calculated by summing each subscale's items, and possible scores range from 8 to 32, with higher scores indicating greater shift and persist

Countries

United States

Participant flow

Recruitment details

Participants were recruited through social media pages and email blasts at academic institutions. Participant enrollment began on February 17, 2024, and all 2 months follow-up assessments were completed by April 27, 2024

Participants by arm

ArmCount
Study Population
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.
24
Total24

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up1

Baseline characteristics

CharacteristicStudy Population
Age, Continuous25.7 years
STANDARD_DEVIATION 3.1
Education level
Graduate
10 Participants
Education level
High school graduate-some college
6 Participants
Education level
Undergraduate
8 Participants
Employment status
Other
1 Participants
Employment status
Student
11 Participants
Employment status
Working full/part time
12 Participants
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 24
other
Total, other adverse events
0 / 24
serious
Total, serious adverse events
0 / 24

Outcome results

Primary

Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home

The frequency of self-reported completed home practice was assessed at post-intervention assessments. Participants will answer the question Usually, how often did you practice the at-home exercises of the program?. Response options include: never, \<1/week 1-2/week, 3-4/week, 5-6/week, every day.

Time frame: 4 weeks

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Study PopulationAdherence to the Program: Frequency of Daily Mindfulness Practice Exercises at HomeNever0 Participants
Study PopulationAdherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home< 1/week4 Participants
Study PopulationAdherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home1-2/week8 Participants
Study PopulationAdherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home3-4/week8 Participants
Study PopulationAdherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home5-6/week3 Participants
Study PopulationAdherence to the Program: Frequency of Daily Mindfulness Practice Exercises at HomeEveryday1 Participants
Primary

Adherence to the Program: Number of 4-week MBSR Sessions Joined

Measured by the number of sessions joined. This is tracked by session attendance done by research staff. Data entered will be 0 sessions, 1 session, 2 sessions, 3 sessions or 4 sessions

Time frame: 4 weeks

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Study PopulationAdherence to the Program: Number of 4-week MBSR Sessions Joined0 sessions0 Participants
Study PopulationAdherence to the Program: Number of 4-week MBSR Sessions Joined1 session0 Participants
Study PopulationAdherence to the Program: Number of 4-week MBSR Sessions Joined2 sessions2 Participants
Study PopulationAdherence to the Program: Number of 4-week MBSR Sessions Joined3 sessions2 Participants
Study PopulationAdherence to the Program: Number of 4-week MBSR Sessions Joined4 sessions20 Participants
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.

Time frame: Baseline, week 4, week 8

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Study PopulationRates of Recruitment and RetentionWeek 424 Participants
Study PopulationRates of Recruitment and RetentionBaseline24 Participants
Study PopulationRates of Recruitment and RetentionWeek 823 Participants
Primary

Ratings of Satisfaction (Overall)

Ratings of program satisfaction, also assessed by survey in post-intervention assessments, will be measured with aseveral questions on, including one that reads Overall, how satisfied were you with the stress reduction program

Time frame: Week 4

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Study PopulationRatings of Satisfaction (Overall)Very satisfied19 Participants
Study PopulationRatings of Satisfaction (Overall)Somewhat satisfied4 Participants
Study PopulationRatings of Satisfaction (Overall)Somewhat dissatisfied1 Participants
Study PopulationRatings of Satisfaction (Overall)Very Dissatisfied0 Participants
Primary

Ratings of Satisfaction Pre and Post Intervention

Satisfaction with the ability to manage stress in life before and after the 4-week MBSR intervention

Time frame: Baseline, week 4

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Study PopulationRatings of Satisfaction Pre and Post InterventionPost-interventionVery satisfied17 Participants
Study PopulationRatings of Satisfaction Pre and Post InterventionPre-interventionVery dissatisfied3 Participants
Study PopulationRatings of Satisfaction Pre and Post InterventionPre-interventionDissatisfied16 Participants
Study PopulationRatings of Satisfaction Pre and Post InterventionPre-interventionSatisfied4 Participants
Study PopulationRatings of Satisfaction Pre and Post InterventionPre-interventionVery satisfied1 Participants
Study PopulationRatings of Satisfaction Pre and Post InterventionPost-interventionVery dissatisfied0 Participants
Study PopulationRatings of Satisfaction Pre and Post InterventionPost-interventionDissatisfied1 Participants
Study PopulationRatings of Satisfaction Pre and Post InterventionPost-interventionSatisfied6 Participants
Secondary

Change in Anxiety Symptoms: GAD-7 Scores

The GAD-7 is a seven-item screening tool for generalized anxiety disorder. Each item is rated on a 0-3 scale, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, with 10 or higher suggesting possible GAD. Severity levels range from minimal (0-4) to severe (15-21).

Time frame: Baseline, week 4, 2 month follow up

Population: 1 subject was lost to followup

ArmMeasureGroupValue (MEAN)Dispersion
Study PopulationChange in Anxiety Symptoms: GAD-7 Scores2 month Follow up5.5 score on a scaleStandard Deviation 4.6
Study PopulationChange in Anxiety Symptoms: GAD-7 ScoresBaseline9.0 score on a scaleStandard Deviation 3.4
Study PopulationChange in Anxiety Symptoms: GAD-7 ScoresWeek 46.0 score on a scaleStandard Deviation 4.1
Secondary

Change in Depression Symptoms: CSED-10 Scores

The CESD-10 is a shortened version of the 20-item CES-D, designed to assess depressive symptoms. It includes 10 questions rated on a 4-point Likert scale (0-3), with higher scores indicating greater symptom severity. The scale covers both negative (e.g., loneliness, sadness) and positive (e.g., hopefulness, happiness) experiences. A total score ranges from 0 to 30, with a score of 10 or higher often indicating significant depressive symptoms and a potential risk for Major Depressive Disorder (MDD).

Time frame: Baseline, week 4, 2 month follow up

Population: 1 subject was lost to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
Study PopulationChange in Depression Symptoms: CSED-10 ScoresBaseline13.4 score on a scaleStandard Deviation 5.4
Study PopulationChange in Depression Symptoms: CSED-10 ScoresWeek 48.3 score on a scaleStandard Deviation 6.2
Study PopulationChange in Depression Symptoms: CSED-10 Scores2 month Follow up8.8 score on a scaleStandard Deviation 6.8
Secondary

Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)

The FFMQ-15 is a 15-item tool assessing mindfulness across five dimensions: observing, describing, awareness, non-judging, and non-reacting. Higher scores indicate greater mindfulness, linked to better emotional regulation and well-being. Average scores are obtained by adding up the responses and dividing by the total number of items, reflecting the overall agreement with each item (1 = rarely true, 5 = always true). Higher scores suggest a greater level of mindfulness in daily life.

Time frame: Baseline, week 4, 2 month follow up

Population: 1 subject was lost to followup

ArmMeasureGroupValue (MEAN)Dispersion
Study PopulationChange in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)Week 43.4 score on a scaleStandard Deviation 0.6
Study PopulationChange in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)2 month Follow up3.5 score on a scaleStandard Deviation 0.7
Study PopulationChange in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)Baseline3.1 score on a scaleStandard Deviation 0.5
Secondary

Change in Perceived Stress (Perceived Stress Scale)

The PSS-4 is a short tool measuring perceived stress based on feelings of unpredictability and overwhelm. Scores range from 0 to 16, with higher scores indicating greater stress.

Time frame: Baseline, week 4, 2 month follow up

Population: 1 subject was lost to followup

ArmMeasureGroupValue (MEAN)Dispersion
Study PopulationChange in Perceived Stress (Perceived Stress Scale)Week 46.0 score on a scaleStandard Deviation 3
Study PopulationChange in Perceived Stress (Perceived Stress Scale)Baseline8.7 score on a scaleStandard Deviation 1.9
Study PopulationChange in Perceived Stress (Perceived Stress Scale)2 month Follow up5.7 score on a scaleStandard Deviation 3.1
Secondary

Change in Psychological Flexibility: Acceptance and Action Questionnaire - II

The AAQ-II measures psychological flexibility, or the ability to accept negative emotions and take value-driven actions. Higher scores indicate greater flexibility, associated with better emotional resilience and well-being. Includes seven statements that participants rate using a 7-point Likert scale, from 1 (Never true) to 7 (Always true). The total score is obtained by adding the ratings for all items (ranging from 7- 49). Higher scores reflect lower psychological flexibility, whereas lower scores indicate greater flexibility

Time frame: Baseline, week 4, 2 month follow up

Population: 1 subject was lost to followup

ArmMeasureGroupValue (MEAN)Dispersion
Study PopulationChange in Psychological Flexibility: Acceptance and Action Questionnaire - II2 month Follow up18.1 score on a scaleStandard Deviation 10.1
Study PopulationChange in Psychological Flexibility: Acceptance and Action Questionnaire - IIBaseline24.0 score on a scaleStandard Deviation 9.5
Study PopulationChange in Psychological Flexibility: Acceptance and Action Questionnaire - IIWeek 417.9 score on a scaleStandard Deviation 8.9
Secondary

Change in PTSD Symptoms: Civilian Abbreviated Scale

Two symptoms of PTSD experienced in the previous month were assessed with the PTSD Civilian Abbreviated Scale. One item measured disturbing memories of any adverse event, and the second item measured feelings of distress due to these memories. Response options to both items were on a 5-point scale and ranged from 0 'not at all' to 4 'extremely'. Response options to both items were summed (Lowest score: 0, highest score: 8), with higher scores indicating greater PTSD symptomatology.

Time frame: Baseline, week 4, 2 month follow up

Population: 1 subject was lost to followup

ArmMeasureGroupValue (MEAN)Dispersion
Study PopulationChange in PTSD Symptoms: Civilian Abbreviated ScaleBaseline6.6 score on a scaleStandard Deviation 2
Study PopulationChange in PTSD Symptoms: Civilian Abbreviated ScaleWeek 44.8 score on a scaleStandard Deviation 1.6
Study PopulationChange in PTSD Symptoms: Civilian Abbreviated Scale2 month Follow up4.3 score on a scaleStandard Deviation 1.6
Secondary

Shift-and-persist (Chen et al)

It includes 8 items: 4 measuring shift and 4 measuring persist. Response options for all items were on a 4-point Likert scale (from a score of 1 for 'not at all' to a score of 4 for 'a lot'). Total scores were calculated by summing each subscale's items, and possible scores range from 8 to 32, with higher scores indicating greater shift and persist

Time frame: Baseline, week 4, 2 month follow up

Population: 1 subject was lost to followup

ArmMeasureGroupValue (MEAN)Dispersion
Study PopulationShift-and-persist (Chen et al)Baseline24.0 score on a scaleStandard Deviation 4.7
Study PopulationShift-and-persist (Chen et al)Week 426.5 score on a scaleStandard Deviation 4.9
Study PopulationShift-and-persist (Chen et al)2 month Follow up26.6 score on a scaleStandard Deviation 4.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026