RECRUITING

Improving Physical Activity Participation in Latinas with Mindfulness

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, the investigators are exploring how a mindfulness-based physical activity program can help improve exercise habits and overall health among 258 inactive Latina women aged 18 to 65. The study will be conducted entirely remotely over and 18 month period. During the first 6 months, all participants will receive an exercise program that has previously been tested by our research team. After 6 months, the investigators will check if participants are meeting the recommended exercise guidelines of at least 150 minutes/week of at least moderate intensity activity. Participants who meet the guidelines will continue with the successful exercise program for another 6 months. For participants who do not meet the guidelines (are exercising less than 150 minutes/week), they will receive one of two enhanced programs, which will be randomly assigned. One program offers additional physical activity support, and the other incorporates stress management through mindfulness techniques. For all participants, over 18 months, the investigators will track physical activity levels, stress, and heart health indicators.

Official Title

Improving Physical Activity Participation in Latinas with Mindfulness

Quick Facts

Study Start:2025-03-01
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06848335

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)
  3. * Sedentary (defined as participating in MVPA for 60 minutes or less per week and engaging in muscle-strengthening exercise on less than 2 days per week)
  4. * Hispanic or Latina (self-identified)
  5. * Must be able to read and write in Spanish fluently
  6. * 18 - 65 years of age
  7. * Planning on living in the area for the next 18 months
  8. * Own a cell phone capable of sending and receiving text messages
  9. * Required to have reliable access to the Internet via a computer or mobile device
  10. * Must be able to receive materials in the mail, either at your own home or at a mailbox
  1. * BMI greater than 45
  2. * Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
  3. * Exercise is against advice of doctor
  4. * Inability to walk independently
  5. * Current or planned pregnancy in the next 12 months
  6. * Heart disease/treatment
  7. * Heart murmur
  8. * Angina/chest pain or Angina/chest pain with exertion
  9. * Palpitations
  10. * Stroke/Transient Ischemic Attacks
  11. * Peripheral Vascular Disease
  12. * Diabetes that requires insulin
  13. * Non-insulin dependent diabetes without physician approval to participate
  14. * Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval
  15. * Chronic liver disease
  16. * Cystic Fibrosis
  17. * Abnormal EKG on last EKG performed
  18. * Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
  19. * Seizure in past year
  20. * Surgery in past year on heart, lung, joint, orthopedic surgery
  21. * Surgery pending in next year on lung, joint, orthopedic surgery
  22. * Unusual/concerning shortness of breath
  23. * Asthma (may be able to participate with physician consent)
  24. * High blood pressure/high blood pressure medication (may be able to participate with physician consent)
  25. * Use of Beta Blockers or medicines not approved by doctor.
  26. * Abnormal Medical Stress Test in the last 12 months
  27. * Musculoskeletal problems
  28. * Fainting/dizziness more than 3 times in past year OR which interferes with daily activities OR causes loss of balance
  29. * Cancer treatment in past 3 months
  30. * Hospitalized for psychiatric disorder in past 3 years or suicidal
  31. * Participation in prior Seamos Activas II study or participant in other research study about exercise currently or within the last 6 months ago

Contacts and Locations

Study Contact

Bess H Marcus, PhD
CONTACT
(401) 863-6850
bess_marcus@brown.edu
Rachelle Edgar, BS
CONTACT
(401) 863-6850
rachelle_edgar@brown.edu

Study Locations (Sites)

Brown University
Providence, Rhode Island, 02912
United States

Collaborators and Investigators

Sponsor: Bess Marcus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2029-07-31

Terms related to this study

Keywords Provided by Researchers

  • Physical Activity
  • Latinas
  • Spanish-Language
  • Text-Message
  • Exercise
  • Mindfulness

Additional Relevant MeSH Terms

  • Inactivity
  • Inactivity/low Levels of Exercise
  • Inactivity, Physical