Mindfulness for Physical Inactivity

(Seamos Activas Trial)

Overseen By Rachelle Edgar, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Bess Marcus

Must not be taking: Beta blockers

Disqualifiers: Heart disease, Stroke, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

258 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have asthma, high blood pressure, or diabetes, you may need your doctor's approval to participate.

What data supports the effectiveness of this treatment for physical inactivity?

Research shows that internet-based and remote physical activity programs, especially those that are individually tailored and include coaching or feedback, can effectively increase physical activity levels in various groups, including older adults and cancer survivors. ^{1 2 3 4 5}

Is the Mindfulness for Physical Inactivity treatment safe for humans?

The remote physical activity programs, including those for individuals after stroke, have been shown to be safe, with participants reporting no significant issues like falls, pain, or dizziness during exercises. ^{4 5 6 7 8}

How does the Mindfulness Enhanced Remote Physical Activity Intervention treatment differ from other treatments for physical inactivity?

This treatment is unique because it combines mindfulness (paying attention to the present moment with acceptance) with physical activity, delivered remotely via audio recordings or text messages. This approach is designed to increase motivation and adherence to exercise by making the experience more engaging and satisfying, which is different from traditional exercise programs that do not incorporate mindfulness. ^{1 9 10 11 12}

Eligibility Criteria

This trial is for inactive Latina women aged 18 to 65 looking to improve their exercise habits. Participants must be able to engage in a remote physical activity program and have access to the necessary technology. There are no specific exclusion criteria provided, but typically those with health conditions that prevent safe exercise would not qualify.

Inclusion Criteria

Own a cell phone capable of sending and receiving text messages

Planning on living in the area for the next 18 months

Required to have reliable access to the Internet via a computer or mobile device

Exclusion Criteria

BMI greater than 45

I have a heart condition or am receiving treatment for one.

Non-insulin dependent diabetes without physician approval to participate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

All participants receive an evidence-based physical activity intervention for 6 months

6 months

Remote monitoring

Adaptive Treatment

Participants are assessed for meeting exercise guidelines; those who meet continue the standard program, others receive enhanced programs

6 months

Remote monitoring

Follow-up

Participants are monitored for physical activity levels, stress, and heart health indicators

6 months

Remote monitoring

Treatment Details

Interventions

• Attention Matched Enhanced Remote PA intervention
• Mindfulness Enhanced Remote Physical Activity Intervention
• Remote Physical Activity Intervention

Trial Overview The study tests how effective a mindfulness-based physical activity program is compared to an attention-matched enhanced remote program in helping participants reach at least 150 minutes of moderate intensity activity per week. It's conducted remotely over 18 months, with progress checks and potential adjustments after the first six months.

Participant Groups

Group I: Remote Physical Activity Intervention Experimental Treatment 1 Intervention

Group II: Mindfulness Enhanced Remote Physical Activity Intervention Active Control 1 Intervention

Group III: Attention Matched Enhanced Remote Physical Activity Intervention Active Control 1 Intervention

Who Is Running the Clinical Trial?

Bess Marcus

Lead Sponsor

Trials

1

Recruited

260+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Lifespan/ The Miriam Hospital

Collaborator

Trials

1

Recruited

260+

Findings from Research

A 12-week study involving 170 inactive older adults showed that both a standard pedometer intervention and an individually tailored, Internet-mediated pedometer significantly increased walking behavior compared to a control group.

The individually tailored intervention resulted in a greater increase in step count than the standard pedometer approach, highlighting the effectiveness of personalized feedback in promoting physical activity among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Individually Tailored, Internet-Mediated Physical Activity Intervention in Older Adults: A Randomized Controlled Trial. Rowley, TW., Lenz, EK., Swartz, AM., et al.[2022]

Interventions using activity trackers during and after inpatient care can significantly increase physical activity levels in patients, with a small positive effect size (SMD = 0.34) observed in 13 studies involving 1435 patients.

However, these increases in physical activity did not lead to significant improvements in physical functioning, indicating that while activity trackers can motivate patients to move more, they may not directly enhance overall physical capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. de Leeuwerk, ME., Bor, P., van der Ploeg, HP., et al.[2022]

The Internet-based physical activity support program (IPAS) did not show significant improvements in moderate-to-vigorous physical activity (MVPA) or secondary outcomes among 137 cancer survivors compared to a control group after 6 months.

Blended care, which included physiotherapist telephone counseling, received better satisfaction scores than online-only support, but overall adherence to the program was low, indicating a need for improved accessibility and support in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of and Lessons Learned from an Internet-Based Physical Activity Support Program (with and without Physiotherapist Telephone Counselling) on Physical Activity Levels of Breast and Prostate Cancer Survivors: The PABLO Randomized Controlled Trial. van de Wiel, HJ., Stuiver, MM., May, AM., et al.[2021]

A systematic review of 24 studies found that remote feedback in home-based physical activity interventions for older adults can enhance physical activity levels, with varying effectiveness depending on the frequency of contact; non-frequent and direct contact strategies showed stronger positive effects.

Adherence to these remote feedback interventions was similar or better than traditional treatment or exercise control groups, suggesting that remote feedback could be a viable alternative to supervised exercise, especially as older adults become more comfortable with technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of remote feedback in home-based physical activity interventions for older adults: a systematic review. Geraedts, H., Zijlstra, A., Bulstra, SK., et al.[2022]

The study involves 288 adults aged 20 to 65 years, comparing the effectiveness of a remote physical activity promotion program with three different approaches over 6 months: minimal intervention with written advice, coaching sessions, and coaching with SMS prompts.

The primary goal is to assess self-reported physical activity levels, while secondary outcomes include objective activity measures, psychosocial factors, well-being, BMI, and adherence, which will help identify the most effective components for promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall). Fischer, X., Donath, L., Zwygart, K., et al.[2020]

A 16-week randomized controlled trial with 41 healthy older adults showed that a home-based training program delivered via videoconference was as effective as face-to-face training in reducing body weight and fat mass, and improving cardiorespiratory fitness and lower limb strength.

While videoconferencing training was effective for many fitness measures, it was less effective than face-to-face training for improving certain strength metrics like handgrip and trunk extension strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-inferiority of a home-based videoconference physical training program in comparison with the same program administered face-to-face in healthy older adults: the MOTION randomised controlled trial. Langeard, A., Bigot, L., Maffiuletti, NA., et al.[2022]

A study involving 30 healthy middle-aged adults showed that a face-to-face physical activity (PA) intervention significantly reduced body weight, body fat mass, and waist circumference, with further reductions observed after a remote follow-up intervention.

The remote PA follow-up intervention appears to effectively maintain and enhance the benefits of the initial face-to-face program, suggesting it could be a valuable addition to physical activity promotion strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Remote Physical Activity Follow-Up Intervention after the Face-to-Face Program for Healthy Middle-Aged Adults: A Randomized Trial Using ICT and Mobile Technology. Yamatsu, K., Narazaki, K.[2022]

The remote physical exercise program for stroke survivors had a high adherence rate of 86%, indicating that many participants were willing to engage with the program despite the challenges posed by remote delivery.

However, the actual attendance was low, with participants attending only 8 out of 44 sessions, primarily due to barriers like lack of motor skills and the absence of exercise companions, highlighting the need for tailored support in remote exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Rate, Barriers to Attend, Safety, and Overall Experience of a Remote Physical Exercise Program During the COVID-19 Pandemic for Individuals After Stroke. Torriani-Pasin, C., Palma, GCDS., Makhoul, MP., et al.[2021]

A pilot study involving 50 physically underactive adults found that an audio-recorded mindfulness-based intervention for exercise was both acceptable and feasible, suggesting it could be easily implemented.

Participants who used the mindfulness intervention reported an increase of 67.16 minutes in moderate-to-vigorous physical activity compared to the control group, indicating that this approach can significantly enhance physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study. Sala, M., Geary, B., Baldwin, AS.[2021]

This study aims to evaluate whether incorporating mindfulness practices can improve adherence to physical activity on prescription (PAP) among 90 sedentary individuals aged 40-65 in Sweden, with participants randomized into three groups: PAP only, mindfulness plus PAP, and mindfulness only.

The study will measure physical activity levels using an activity monitor at baseline and after 3 and 6 months, assessing the feasibility of the design and the impact of mindfulness on motivation and satisfaction with physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol. Nymberg, P., Ekvall Hansson, E., Stenman, E., et al.[2019]

Daily text prompts for mindfulness significantly increased the amount of aerobic physical activity among adults aged 50 and older, as shown in a 4-week randomized trial.

Participants who practiced mindfulness not only engaged in more physical activity but also reported higher intrinsic motivation compared to those in the control group, suggesting mindfulness can enhance motivation for exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial Influence of Mindfulness Training Promoted by Text Messages on Self-Reported Aerobic Physical Activity in Older Adults: A Randomized Controlled Study. Robin, N., Toussaint, L., Sinnapah, S., et al.[2023]

A systematic review of 40 studies found that mindfulness-based approaches can positively influence physical activity levels, particularly through psychological factors like stress and psychological flexibility.

Mindfulness interventions were more effective when they specifically targeted physical activity and addressed psychological aspects related to exercise, highlighting the need for more rigorous research to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of mindfulness in physical activity: a systematic review. Schneider, J., Malinowski, P., Watson, PM., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of an Individually Tailored, Internet-Mediated Physical Activity Intervention in Older Adults: A Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of and Lessons Learned from an Internet-Based Physical Activity Support Program (with and without Physiotherapist Telephone Counselling) on Physical Activity Levels of Breast and Prostate Cancer Survivors: The PABLO Randomized Controlled Trial. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Effects of remote feedback in home-based physical activity interventions for older adults: a systematic review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall). [2020]

6. England pubmed.ncbi.nlm.nih.gov

Non-inferiority of a home-based videoconference physical training program in comparison with the same program administered face-to-face in healthy older adults: the MOTION randomised controlled trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of the Remote Physical Activity Follow-Up Intervention after the Face-to-Face Program for Healthy Middle-Aged Adults: A Randomized Trial Using ICT and Mobile Technology. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence Rate, Barriers to Attend, Safety, and Overall Experience of a Remote Physical Exercise Program During the COVID-19 Pandemic for Individuals After Stroke. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Beneficial Influence of Mindfulness Training Promoted by Text Messages on Self-Reported Aerobic Physical Activity in Older Adults: A Randomized Controlled Study. [2023]

12. England pubmed.ncbi.nlm.nih.gov

The role of mindfulness in physical activity: a systematic review. [2019]