Trial Outcomes & Findings for Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico (NCT NCT06250738)
NCT ID: NCT06250738
Last Updated: 2025-06-27
Results Overview
Number of participants at the beginning of the study versus the number of participants at the end of the study.
COMPLETED
NA
24 participants
Baseline, week 4, week 8
2025-06-27
Participant Flow
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
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Lost to Follow-up
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1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Age, Continuous
|
25.7 years
STANDARD_DEVIATION 3.1 • n=24 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
|
Education level
High school graduate-some college
|
6 Participants
n=24 Participants
|
|
Education level
Undergraduate
|
8 Participants
n=24 Participants
|
|
Education level
Graduate
|
10 Participants
n=24 Participants
|
|
Employment status
Student
|
11 Participants
n=24 Participants
|
|
Employment status
Working full/part time
|
12 Participants
n=24 Participants
|
|
Employment status
Other
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4, week 8Number of participants at the beginning of the study versus the number of participants at the end of the study.
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Rates of Recruitment and Retention
Baseline
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24 Participants
|
|
Rates of Recruitment and Retention
Week 4
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24 Participants
|
|
Rates of Recruitment and Retention
Week 8
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23 Participants
|
PRIMARY outcome
Timeframe: 4 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.
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home
Never
|
0 Participants
|
|
Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home
< 1/week
|
4 Participants
|
|
Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home
1-2/week
|
8 Participants
|
|
Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home
3-4/week
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8 Participants
|
|
Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home
5-6/week
|
3 Participants
|
|
Adherence to the Program: Frequency of Daily Mindfulness Practice Exercises at Home
Everyday
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1 Participants
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PRIMARY outcome
Timeframe: 4 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
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Adherence to the Program: Number of 4-week MBSR Sessions Joined
1 session
|
0 Participants
|
|
Adherence to the Program: Number of 4-week MBSR Sessions Joined
2 sessions
|
2 Participants
|
|
Adherence to the Program: Number of 4-week MBSR Sessions Joined
3 sessions
|
2 Participants
|
|
Adherence to the Program: Number of 4-week MBSR Sessions Joined
4 sessions
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20 Participants
|
|
Adherence to the Program: Number of 4-week MBSR Sessions Joined
0 sessions
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0 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Ratings of Satisfaction (Overall)
Very satisfied
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19 Participants
|
|
Ratings of Satisfaction (Overall)
Somewhat satisfied
|
4 Participants
|
|
Ratings of Satisfaction (Overall)
Somewhat dissatisfied
|
1 Participants
|
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Ratings of Satisfaction (Overall)
Very Dissatisfied
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4Satisfaction with the ability to manage stress in life before and after the 4-week MBSR intervention
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Ratings of Satisfaction Pre and Post Intervention
Post-intervention · Dissatisfied
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1 Participants
|
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Ratings of Satisfaction Pre and Post Intervention
Post-intervention · Satisfied
|
6 Participants
|
|
Ratings of Satisfaction Pre and Post Intervention
Post-intervention · Very satisfied
|
17 Participants
|
|
Ratings of Satisfaction Pre and Post Intervention
Pre-intervention · Very dissatisfied
|
3 Participants
|
|
Ratings of Satisfaction Pre and Post Intervention
Pre-intervention · Dissatisfied
|
16 Participants
|
|
Ratings of Satisfaction Pre and Post Intervention
Pre-intervention · Satisfied
|
4 Participants
|
|
Ratings of Satisfaction Pre and Post Intervention
Pre-intervention · Very satisfied
|
1 Participants
|
|
Ratings of Satisfaction Pre and Post Intervention
Post-intervention · Very dissatisfied
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 4, 2 month follow upPopulation: 1 subject was lost to follow up.
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).
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Change in Depression Symptoms: CSED-10 Scores
Baseline
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13.4 score on a scale
Standard Deviation 5.4
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Change in Depression Symptoms: CSED-10 Scores
Week 4
|
8.3 score on a scale
Standard Deviation 6.2
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Change in Depression Symptoms: CSED-10 Scores
2 month Follow up
|
8.8 score on a scale
Standard Deviation 6.8
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SECONDARY outcome
Timeframe: Baseline, week 4, 2 month follow upPopulation: 1 subject was lost to followup
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).
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Change in Anxiety Symptoms: GAD-7 Scores
Baseline
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9.0 score on a scale
Standard Deviation 3.4
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Change in Anxiety Symptoms: GAD-7 Scores
Week 4
|
6.0 score on a scale
Standard Deviation 4.1
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Change in Anxiety Symptoms: GAD-7 Scores
2 month Follow up
|
5.5 score on a scale
Standard Deviation 4.6
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SECONDARY outcome
Timeframe: Baseline, week 4, 2 month follow upPopulation: 1 subject was lost to followup
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.
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Change in PTSD Symptoms: Civilian Abbreviated Scale
Baseline
|
6.6 score on a scale
Standard Deviation 2.0
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Change in PTSD Symptoms: Civilian Abbreviated Scale
Week 4
|
4.8 score on a scale
Standard Deviation 1.6
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Change in PTSD Symptoms: Civilian Abbreviated Scale
2 month Follow up
|
4.3 score on a scale
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Baseline, week 4, 2 month follow upPopulation: 1 subject was lost to followup
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.
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Change in Perceived Stress (Perceived Stress Scale)
Baseline
|
8.7 score on a scale
Standard Deviation 1.9
|
|
Change in Perceived Stress (Perceived Stress Scale)
Week 4
|
6.0 score on a scale
Standard Deviation 3.0
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Change in Perceived Stress (Perceived Stress Scale)
2 month Follow up
|
5.7 score on a scale
Standard Deviation 3.1
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SECONDARY outcome
Timeframe: Baseline, week 4, 2 month follow upPopulation: 1 subject was lost to followup
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
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Shift-and-persist (Chen et al)
Baseline
|
24.0 score on a scale
Standard Deviation 4.7
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Shift-and-persist (Chen et al)
Week 4
|
26.5 score on a scale
Standard Deviation 4.9
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Shift-and-persist (Chen et al)
2 month Follow up
|
26.6 score on a scale
Standard Deviation 4.7
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SECONDARY outcome
Timeframe: Baseline, week 4, 2 month follow upPopulation: 1 subject was lost to followup
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.
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)
Baseline
|
3.1 score on a scale
Standard Deviation 0.5
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Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)
Week 4
|
3.4 score on a scale
Standard Deviation 0.6
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Change in Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ-15)
2 month Follow up
|
3.5 score on a scale
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: Baseline, week 4, 2 month follow upPopulation: 1 subject was lost to followup
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
Outcome measures
| Measure |
Study Population
n=24 Participants
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.
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|---|---|
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Change in Psychological Flexibility: Acceptance and Action Questionnaire - II
Baseline
|
24.0 score on a scale
Standard Deviation 9.5
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|
Change in Psychological Flexibility: Acceptance and Action Questionnaire - II
Week 4
|
17.9 score on a scale
Standard Deviation 8.9
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Change in Psychological Flexibility: Acceptance and Action Questionnaire - II
2 month Follow up
|
18.1 score on a scale
Standard Deviation 10.1
|
Adverse Events
Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrea Lopez-Cepero
Rollins School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place