Recruiting

Mindfulness

Sponsor:

Bess Marcus

Code:

NCT06848335

Conditions

Inactivity

Inactivity/Low Levels of Exercise

Inactivity, Physical

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Remote Physical Activity Intervention

Mindfulness Enhanced Remote Physical Activity Intervention

Attention Matched Enhanced Remote PA intervention

Study Details

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.

Conditions

Inactivity

Inactivity/Low Levels of Exercise

Inactivity, Physical

Study ID

NCT06848335

Start date

Mar 21, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remote Physical Activity Intervention

active comparator: Mindfulness Enhanced Remote Physical Activity Intervention

active comparator: Attention Matched Enhanced Remote Physical Activity Intervention

Interventions

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, 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

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

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 outcome measure

  • Accelerometer-measured min/week MVPA [ Time Frame: 12 and 18 Months (outcome timepoints) ]

Central Contacts and Locations

Central contacts

Bess H Marcus, PhD

(401) 863-6850bess_marcus@brown.edu

Rachelle Edgar, BS

(401) 863-6850rachelle_edgar@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Rachelle Edgar, BS

(401) 863-6850rachelle_edgar@brown.edu

Principal Investigator:

Bess H. Marcus, PhD

More Information

Sponsor

Bess Marcus

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bess Marcus on 2026-07-28.