Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06848335

Improving Physical Activity Participation in Latinas With Mindfulness

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Location status: Recruiting

Location contact

Bess H. Marcus, PhD

PRINCIPAL_INVESTIGATOR

Rachelle Edgar, BS

CONTACT

[email protected]

(401) 863-6850

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Physical Activity Intervention

Behavioral

The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6, with maintenance doses in months 8 and 10. Mailings include motivation-matched physical activity manuals, tip sheets (on stretching, boredom, places to be active, etc.) and computer expert system-tailored PA feedback reports which draw from a bank of over 330 messages addressing psychosocial and environmental factors affecting PA. Participants receive one interactive text message on PA (goal setting and tips for increasing PA) daily for the first 6 months and weekly for months 7-12.

Mindfulness Enhanced Remote Physical Activity Intervention

Behavioral

Women who do not meet the PA guidelines (60% based on our prior work), will be randomized to receive the Attention Matched Enhanced Remote PA intervention or Mindfulness enhanced remote Physical Activity intervention. The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6. In months 7-12, they will receive 4 monthly calls, 11 mailers and daily texts. In months 13-18, they will receive 1 call, weekly texts to self monitor daily PA and meeting goals. For the Mindfulness enhanced remote Physical Activity intervention participants will receive additional messaging and support to manage their stress through incorporating evidence based MBSR and mindful movement into their daily routine.

Attention Matched Enhanced Remote PA intervention

Behavioral

Women who do not meet the PA guidelines (60% based on our prior work), will be randomized to receive the Mindfulness enhanced remote Physical Activity intervention or the Attention Matched Enhanced Remote PA intervention as described here. The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6. In months 7-12, they will receive 4 monthly calls, 11 mailers and daily texts. In months 13-18, they will receive 1 call, weekly texts to self monitor daily PA and meeting goals.

Primary outcomes

  1. Accelerometer-measured min/week MVPA

    Time frame: 12 and 18 Months (outcome timepoints)

    For the week prior to each assessment (baseline, 6, 12, 18-months), all participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure. Data will be used to generate a binary indicator of meeting national PA guidelines (at least 150 min/week MVPA) at each follow-up.

Secondary outcomes

  1. Perceived Stress Scale(PSS)

    Time frame: Baseline, 6 months, 12 months, 18 months

    Measured using a 14-item Perceived Stress Scale(PSS), this self-report measure assesses general perceptions of demands in life exceeding one's capacities to manage them. This scale has shown good reliability and validity in past studies with Spanish speaking Latino participants. The scale score ranges from 0 to 56, with higher scores indicative of higher perceived stress.

  2. Moment to moment self-reported stress evaluated via Ecological momentary assessment (EMA)

    Time frame: Baseline, 6, 9, 12 months

    Participants will be prompted daily (via the wake-up report and random prompts) to respond to : How stressed are you feeling right now? Response options are on a 7-point Likert scale ranging from 0=Not at all to 6=Extremely.

Other outcomes

  1. Lipid Panel

    Time frame: Baseline, 6 months, 12 months, 18 months

    Heart health indicators will be collected at baseline and follow-ups (6, 12 and 18 months), including Total cholesterol, Triglycerides, HDL cholesterol and LDL cholesterol (all measured as mg/dl)

  2. HbA1c

    Time frame: baseline, 6 months, 12 months, 18 months

    HbA1c will be collected at baseline, 6, 12, 18 months and is recorded as a percentage (mmol/mol).

Study contacts

Contact information is provided by the study sponsor or research team.

Bess H Marcus, PhD

CONTACT

[email protected]

(401) 863-6850

Rachelle Edgar, BS

CONTACT

[email protected]

(401) 863-6850

Sponsors and collaborators

Lead sponsor

Bess Marcus

Other

Collaborators

  • Lifespan/ The Miriam Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: Seamos Activas

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.