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

NCT06250738 | Completed Results

• 2 other identifiers: STUDY000067528K12AR084234
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Psychological Distress; Cardiometabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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, week 8

• 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.

  4 weeks

• 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

  4 weeks

• 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

  Week 4

• Ratings of Satisfaction Pre and Post Intervention

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

  Baseline, week 4

Secondary Outcomes (7)

• Change in Depression Symptoms: CSED-10 Scores

  Baseline, week 4, 2 month follow up

• Change in Anxiety Symptoms: GAD-7 Scores

  Baseline, week 4, 2 month follow up

• Change in PTSD Symptoms: Civilian Abbreviated Scale

  Baseline, week 4, 2 month follow up

• Change in Perceived Stress (Perceived Stress Scale)

  Baseline, week 4, 2 month follow up

• Shift-and-persist (Chen et al)

  Baseline, week 4, 2 month follow up

Study Arms (1)

Study population

EXPERIMENTAL

Behavioral: Mindfulness-based Stress reduction program: Virtual; Behavioral: Home exercises

Interventions

Mindfulness-based Stress reduction program: Virtual BEHAVIORAL

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.

Study population

Home exercises BEHAVIORAL

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

Study population

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: * Reporting female sex at birth * Not identifying as a man, trans man, or trans woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Rollins School of Public Helath

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Psychological Well-Being; Health Behavior

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Personal Satisfaction; Behavior

Results Point of Contact

• Title: Dr. Andrea Lopez-Cepero
• Organization: Rollins School of Public Health

andrea.a.lopez-cepero@emory.edu

404-727-3956

Study Officials

• Andrea Lopez-Cepero, PhD

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 17, 2024
• Primary Completion: April 27, 2024
• Study Completion: April 27, 2024
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 06/2024 - 06/2028
• Access Criteria: Investigators interested in conducting analyses will need to submit a manuscript proposal to be reviewed by the PI. Data and study files will be shared upon positive review.

Locations

US (1)