Improving Physical Activity Participation in Latinas With Mindfulness

ConditionsInactivity Inactivity/Low Levels of Exercise Inactivity, Physical

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-65

SponsorBess Marcus

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

258 Participants

are divided into 3 treatment groups

Group A: Remote Physical Activity InterventionExperimental treatment 1 intervention

Group B: Mindfulness Enhanced Remote Physical Activity InterventionActive comparator 1 intervention

Group C: Attention Matched Enhanced Remote Physical Activity InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

12 and 18 Months (outcome timepoints)

Secondary outcomes

Perceived Stress Scale(PSS)

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.

Time frame

Baseline, 6 months, 12 months, 18 months

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

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.

Time frame

Baseline, 6, 9, 12 months

Other outcomes

Lipid Panel

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)

Time frame

Baseline, 6 months, 12 months, 18 months

HbA1c

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

Time frame

baseline, 6 months, 12 months, 18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bess Marcus

Lead sponsor

Brown University

Sponsor institution

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Lifespan/ The Miriam Hospital

Collaborator

Source ClinicalTrials.gov

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