Clinical trial NCT06848335: Improving Physical Activity Participation in Latinas With Mindfulness
Official title: Improving Physical Activity Participation in Latinas With Mindfulness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inactivity
Inactivity/Low Levels of Exercise
Inactivity, Physical
Keywords: Physical Activity
Latinas
Spanish-Language
Text-Message
Exercise
Mindfulness
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Lifespan/ The Miriam Hospital
First posted: 2025-02-27
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The current study is an innovative adaptive intervention tested on inactive Latinas aged 18-65 (n=258). During the initial 6 month phase, all participants will receive our evidence based physical activity (PA) intervention. At 6 months, participants who meet national PA guidelines (at least 150 mins/week of at least moderate intensity PA) will continue to receive the standard PA intervention for another 6 months. Participants who do not meet the PA guidelines, will be randomized to continue intensive PA counseling or receive attention matched PA counseling incorporating the most potent components from Mindfulness-Based Stress Reduction (MBSR) adapted for PA. Participants in all 3 arms will be followed and compared over 18 months. The investigators will also rigorously evaluate stress as a mechanism for meeting PA guidelines using multiple measures (objective and self-report), including using wearable technology and Ecological Momentary Assessment (EMA). Finally, heart health indicators will be collected to assess long term benefits of PA.

Eligibility 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

Primary outcomes:
measure: Accelerometer-measured min/week MVPA
timeFrame: 12 and 18 Months (outcome timepoints)
Secondary outcomes:
measure: Perceived Stress Scale(PSS)
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Moment to moment self-reported stress evaluated via Ecological momentary assessment (EMA)
timeFrame: Baseline, 6, 9, 12 months
Other outcomes:
measure: Lipid Panel
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: HbA1c
timeFrame: baseline, 6 months, 12 months, 18 months
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References: