Mindfulness-based program to boost exercise in inactive Latina women
Improving Physical Activity Participation in Latinas With Mindfulness
This study tests if a mindfulness program can help inactive Latina women get more active and improve their exercise habits over 18 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Brown University Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06848335 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a mindfulness-based physical activity program aimed at improving exercise habits among 258 inactive Latina women aged 18 to 65. Over an 18-month period, participants will initially engage in a standard exercise program for six months, after which their activity levels will be assessed. Those meeting exercise guidelines will continue with the program, while those who do not will be randomly assigned to either enhanced physical activity support or a mindfulness-based intervention. The study will utilize various measures, including wearable technology, to evaluate stress and heart health indicators as outcomes.
Who should consider this trial
Good fit: Ideal candidates are sedentary Hispanic or Latina women aged 18 to 65 who can read and write in Spanish and have access to a cell phone and the internet.
Not a fit: Patients with a BMI greater than 45 or those unable to walk independently may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance physical activity levels and overall health in inactive Latina women.
How similar studies have performed: Other studies have shown promise in using mindfulness techniques to enhance physical activity, making this approach both innovative and supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent) * 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) * Hispanic or Latina (self-identified) * Must be able to read and write in Spanish fluently * 18 - 65 years of age * Planning on living in the area for the next 18 months * Own a cell phone capable of sending and receiving text messages * Required to have reliable access to the Internet via a computer or mobile device * Must be able to receive materials in the mail, either at your own home or at a mailbox Exclusion Criteria: * BMI greater than 45 * Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise * Exercise is against advice of doctor * Inability to walk independently * Current or planned pregnancy in the next 12 months * Heart disease/treatment * Heart murmur * Angina/chest pain or Angina/chest pain with exertion * Palpitations * Stroke/Transient Ischemic Attacks * Peripheral Vascular Disease * Diabetes that requires insulin * Non-insulin dependent diabetes without physician approval to participate * Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval * Chronic liver disease * Cystic Fibrosis * Abnormal EKG on last EKG performed * Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease * Seizure in past year * Surgery in past year on heart, lung, joint, orthopedic surgery * Surgery pending in next year on lung, joint, orthopedic surgery * Unusual/concerning shortness of breath * Asthma (may be able to participate with physician consent) * High blood pressure/high blood pressure medication (may be able to participate with physician consent) * Use of Beta Blockers or medicines not approved by doctor. * Abnormal Medical Stress Test in the last 12 months * Musculoskeletal problems * Fainting/dizziness more than 3 times in past year OR which interferes with daily activities OR causes loss of balance * Cancer treatment in past 3 months * Hospitalized for psychiatric disorder in past 3 years or suicidal * Participation in prior Seamos Activas II study or participant in other research study about exercise currently or within the last 6 months ago
Where this trial is running
Providence, Rhode Island
- Brown University — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Bess H Marcus, PhD
- Email: bess_marcus@brown.edu
- Phone: (401) 863-6850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.