Improving Physical Activity Participation in Latinas With Mindfulness

NCT06848335 | Recruiting

• 1 other identifier: 1R01HL171195
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Accelerometer-measured min/week MVPA

  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.

  12 and 18 Months (outcome timepoints)

Secondary Outcomes (2)

• Perceived Stress Scale(PSS)

  Baseline, 6 months, 12 months, 18 months

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

  Baseline, 6, 9, 12 months

Other Outcomes (2)

• Lipid Panel

  Baseline, 6 months, 12 months, 18 months

• HbA1c

  baseline, 6 months, 12 months, 18 months

Study Arms (3)

Remote Physical Activity Intervention

EXPERIMENTAL

Behavioral: Remote Physical Activity Intervention

Mindfulness Enhanced Remote Physical Activity Intervention

ACTIVE COMPARATOR

Behavioral: Mindfulness Enhanced Remote Physical Activity Intervention

Attention Matched Enhanced Remote Physical Activity Intervention

ACTIVE COMPARATOR

Behavioral: Attention Matched Enhanced Remote PA intervention

Interventions

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.

Remote Physical Activity Intervention

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.

Mindfulness Enhanced Remote Physical Activity Intervention

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.

Attention Matched Enhanced Remote Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bess Marcus: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Lifespan/ The Miriam Hospital: collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Bess H Marcus, PhD

CONTACT

(401) 863-6850; bess_marcus@brown.edu

Rachelle Edgar, BS

CONTACT

(401) 863-6850; rachelle_edgar@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Behavioral and Social Sciences

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 27, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication. The duration of preservation and sharing of the data will be a minimum of 7 years after the end of the funding period.
• Access Criteria: Researchers will need to contact the study PI (Dr. Marcus)

Locations

US (1)