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RECRUITING
NCT06848335
NA

Improving Physical Activity Participation in Latinas With Mindfulness

Sponsor: Bess Marcus

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

258

Start Date

2025-03-21

Completion Date

2029-07-31

Last Updated

2025-04-25

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (1)

Brown University

Providence, Rhode Island, United States