Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
ID06848335

Improving Physical Activity Participation in Latinas With Mindfulness

Led by Bess Marcus · Updated on 2025-04-25

258

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Bess Marcus

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how a mindfulness-based physical activity program can help improve exercise habits and overall health among inactive Latina women aged 18 to 65. This study involves 258 participants and is conducted entirely remotely over 18 months. The goal is to see if the program helps women meet recommended exercise guidelines and to assess the impact on stress and heart health. All participants will receive a physical activity program during the first 6 months, which has been previously tested by the research team. After 6 months, those who meet the guidelines of at least 150 minutes per week of moderate-intensity activity will continue with the same program for another 6 months. Participants not meeting the guidelines will be randomly assigned to one of two enhanced programs: one with additional physical activity support and another that adds mindfulness-based stress reduction techniques. The study compares these three groups over 18 months. Participants will be involved in goal-setting sessions via Zoom and receive support through phone calls, mailings, and text messages throughout the study. Physical activity levels will be measured using accelerometers, and stress will be assessed through various self-reports and wearable technology. Heart health indicators will also be collected to evaluate long-term benefits. The study monitors progress regularly over the full 18-month period.

CONDITIONS

Brief Title

Improving Physical Activity Participation in Latinas With Mindfulness

Who Can Participate

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Generally healthy (controlled asthma, high blood pressure, or type II diabetes allowed with physician consent)
  • Sedentary: doing moderate to vigorous physical activity 60 minutes or less per week and muscle-strengthening less than 2 days per week
  • Hispanic or Latina (self-identified)
  • Fluent in reading and writing Spanish
  • Aged 18 to 65 years
  • Planning to live in the area for the next 18 months
  • Own a cell phone that can send and receive text messages
  • Have reliable internet access via computer or mobile device
  • Able to receive study materials by mail at home or mailbox
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) over 45
  • Unable to walk continuously for 30 minutes or limited ability to exercise
  • Exercise advised against by a doctor
  • Unable to walk independently
  • Current or planned pregnancy within 12 months
  • History of heart disease, heart murmur, angina, palpitations, stroke, or peripheral vascular disease
  • Diabetes requiring insulin or uncontrolled diabetes without doctor approval
  • Chronic infectious diseases like HIV or Hepatitis C without doctor approval
  • Chronic liver disease or cystic fibrosis
  • Abnormal EKG or medical stress test within the last year
  • Lung diseases such as emphysema, chronic bronchitis, or COPD
  • Seizure in the past year
  • Recent or pending surgery on heart, lung, joints, or orthopedic areas
  • Unusual or concerning shortness of breath
  • Asthma or high blood pressure without doctor approval
  • Use of beta blockers or unapproved medications
  • Musculoskeletal problems
  • Frequent fainting or dizziness interfering with daily activities
  • Cancer treatment in past 3 months
  • Psychiatric hospitalization in past 3 years or suicidal
  • Participation in related exercise studies recently or currently ongoing

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Treatment

Duration - Up to 18 months

Participants receive a physical activity intervention remotely through goal setting sessions, phone calls, mailings, and text messages. After 6 months, participants who meet physical activity guidelines continue the standard intervention, while those who do not are randomized to either continued intensive counseling or mindfulness-enhanced counseling, with ongoing remote support for up to 18 months.

1 baseline Zoom goal setting session; phone calls at week 1 and months 1, 2, 3, 9; weekly and then less frequent mailings and daily to weekly text messages over the study period

Trial Site Locations

Total: 1 location

1

Brown University

Providence, Rhode Island, United States, 02912

Actively Recruiting

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Research Team

B

Bess H Marcus, PhD

R

Rachelle Edgar, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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