Tech-Enhanced Intervention for Sedentary Lifestyle

(I-PASS Trial)

Overseen By Rodney Joseph, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Alzheimer's medications, Antidepressants

Disqualifiers: Mild cognitive impairment, Neurodegenerative, Major psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if technology, such as a special website and virtual coaching, helps older adults who live alone and experience memory issues become more active and socially engaged. It will compare a tech-enhanced program with a basic education program to identify which is more effective at boosting physical activity, social support, and stress resilience. Participants will wear a Garmin device to track activity, set weekly fitness goals, and complete surveys about their mental and social well-being. Those aged 60 or older, living alone, and exercising less than 60 minutes a week may be suitable for this trial. The long-term goal is to discover if these activities can lower the risk of dementia. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance quality of life and reduce dementia risk.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking two or more anti-depression medications or have been prescribed Alzheimer's medications like Donepezil or Memantine.

What prior data suggests that this tech-enhanced intervention is safe for increasing physical activity in older adults?

Research has shown that physical activity is generally safe for most people and helps reduce stress and improve mental well-being. Studies have found that regular exercise can protect against stress-related problems and enhance quality of life. It is also linked to better mental health and can reduce symptoms of depression.

In this trial, participants will use technology like a wearable device and receive virtual coaching to help them be more active. These tools are not known to cause harm and are designed to encourage a more active lifestyle, which is usually well-tolerated.

While specific data on safety concerns for the tech-enhanced approach in this trial is not available, the trial aims to increase physical activity—something generally considered beneficial—indicating it should be safe for participants. Always consult a healthcare professional if specific concerns or health conditions exist before starting any new activity plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a tech-enhanced approach to boost physical activity, social support, and stress resilience, which are crucial for tackling a sedentary lifestyle. Unlike traditional methods that might involve static education materials or face-to-face counseling sessions, this trial leverages a digital platform accessed via a website, soon to be an app, coupled with personalized coaching through Zoom. This innovative combination of technology and personalized guidance offers a more dynamic and accessible way to motivate individuals and foster lasting lifestyle changes.

What evidence suggests that this tech-enhanced intervention is effective for increasing physical activity in older adults?

This trial will compare a tech-enhanced intervention with a control condition to increase physical activity, social support, and stress resilience. Studies have shown that physical activity helps manage stress and improves mental well-being. Being active also links to better mental health and an enhanced ability to recover from stress. Research indicates that regular exercise lowers the risk of stress-related health issues. Walking for just 10 to 15 minutes each day can reduce the risk of heart problems. Overall, staying active boosts both physical and mental health, making it a promising way to improve lifestyle and well-being. ^{1 6 7 8 9}

Who Is on the Research Team?

Molly Maxfield

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

This trial is for older adults who live alone, do less than 60 minutes of moderate to vigorous physical activity per week, and have memory concerns or mild cognitive issues. It's not suitable for those already active or unable to use a wearable device.

Inclusion Criteria

Self-reported decline in cognitive functioning

Engaging in 60 minutes or less per week of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)

Self-reported ownership of/willingness to use a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a wearable activity monitor)

Exclusion Criteria

Incarcerated individuals (i.e., Prisoners)

Score of 9 or higher on the 15-item Geriatric Depression Scale (GDS) at the Baseline Session [scores of 9 and higher are indicative of moderate to severe depression]

Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a 3-month intervention to increase physical activity, social support, and stress resilience. This includes self-monitoring, weekly text reminders, and either basic education or tech-enhanced support with virtual coaching.

12 weeks

Weekly virtual coaching sessions for tech-enhanced group

Follow-up

Participants are monitored for changes in physical activity, social support, stress resilience, and cognitive functioning after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Increasing Physical Activity Through Social Support and Stress Resilience

Trial Overview

The study tests if adding technology like a website and virtual coaching to basic education on physical activity can increase exercise, social support, and stress resilience in sedentary older adults with some memory loss.

How Is the Trial Designed?

Group I: Tech-enhanced condition Experimental Treatment 1 Intervention

Participants in the tech-enhanced condition will receive access to a study specific website (to be developed into an app) and guided use via individual coaching sessions delivered on Zoom. Coaching sessions will align with and reinforce website content, which includes information about the importance of and strategies to increase physical activity, social support, and stress resilience.

Group II: Control condition Active Control 1 Intervention

Participants in the control condition will receive a study-specific manual containing basic education about the importance of and strategies to increase physical activity, social support, and stress resilience.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Fitbit devices are widely used in research to monitor physical activity and promote behavior change, but researchers face significant challenges in their implementation, including technological and logistical issues.

This paper outlines key challenges encountered during the research process with Fitbit trackers and provides empirically tested strategies to help researchers effectively integrate these devices into their studies, ensuring better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Fitbit as an mHealth Intervention Tool to Promote Physical Activity: Potential Challenges and Solutions. Balbim, GM., Marques, IG., Marquez, DX., et al.[2021]

The multicomponent technology intervention significantly reduced daily sedentary time by an average of 58.7 minutes per day among 40 overweight university employees over a 12-week period, indicating its efficacy in promoting physical activity.

Participants engaged well with the intervention, using the provided tools like the pedal machine and online program, which suggests that such technology-based approaches could be effective in reducing sedentary behavior in workplace settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent intervention to reduce daily sedentary time: a randomised controlled trial. Carr, LJ., Karvinen, K., Peavler, M., et al.[2022]

Physical activity interventions are effective in increasing activity levels among healthy inactive adults, with a moderate effect size (d = 0.32) and maintaining behavior change over 6 months (d = 0.21) based on a systematic review of 26 studies involving 2,346 participants.

Sedentary behavior interventions were not effective, and the review identified specific behavior change techniques (BCTs) that contributed to the success of physical activity interventions, such as 'Biofeedback' and 'Action planning', while also noting a significant gap in fidelity measurement across studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are physical activity interventions for healthy inactive adults effective in promoting behavior change and maintenance, and which behavior change techniques are effective? A systematic review and meta-analysis. Howlett, N., Trivedi, D., Troop, NA., et al.[2023]

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