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

Trial Summary

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 data supports the effectiveness of the treatment Increasing Physical Activity Through Social Support and Stress Resilience?

Research shows that interventions aimed at increasing physical activity are effective in changing and maintaining behavior in inactive adults, especially when techniques like action planning and self-reward are used. Additionally, higher social support is linked to improvements in physical activity levels. ^{1 2 3 4 5}

Is the tech-enhanced intervention for sedentary lifestyle safe for humans?

The research articles do not provide specific safety data for the tech-enhanced intervention for sedentary lifestyle, but they do discuss the use of physical activity trackers like Fitbit, which are generally considered safe for monitoring and promoting physical activity. ^{6 7 8 9 10}

How is the treatment 'Increasing Physical Activity Through Social Support and Stress Resilience' different from other treatments for sedentary lifestyle?

This treatment is unique because it combines social support and stress resilience strategies with technology to increase physical activity, unlike many existing options that do not integrate these elements. It leverages digital tools and social connections to motivate and sustain behavior change, which is not commonly found in traditional interventions. ^{3 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience. The primary questions are to determine whether * the tech-enhanced condition lead to greater physical activity over time? * the tech-enhanced condition lead to social support and stress resilience over time? * social support and stress resilience mediate the relationship between the study condition and physical activity? All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience. Participants will: * Use a Garmin wearable device to monitor their physical activity * Be randomly assigned to a basic education condition or tech-enhanced condition * Set achievable goals for weekly physical activity, with incremental increases to achieve 150 minutes per week by the end of the study * Respond to surveys to monitor their social support, stress resilience, quality of life, and depression. The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.

Research Team

Molly Maxfield

Principal Investigator

Arizona State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2023]

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

Patient and practitioner perspectives on reducing sedentary behavior at an exercise-based cardiac rehabilitation program. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Multicomponent intervention to reduce daily sedentary time: a randomised controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of Two Web-Based Interventions and Mediating Mechanisms on Stage of Change Regarding Physical Activity in Older Adults. [2021]

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

Dietary Barriers Appear to Influence the Effects of a Dyadic Web-Based Lifestyle Intervention on Caloric Intake and Adiposity: A Mediation Analysis of the DUET Trial. [2023]

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

The role of improved social support for healthy eating in a lifestyle intervention: Texercise Select. [2023]

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

Everyday stress components and physical activity: examining reactivity, recovery and pileup. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Everyday stress response targets in the science of behavior change. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

REAL-TIME SUBJECTIVE ASSESSMENT OF PSYCHOLOGICAL STRESS: ASSOCIATIONS WITH OBJECTIVELY-MEASURED PHYSICAL ACTIVITY LEVELS. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Using Fitbit as an mHealth Intervention Tool to Promote Physical Activity: Potential Challenges and Solutions. [2021]

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

Desired features of smartphone applications promoting physical activity. [2022]

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

Can a 'rewards-for-exercise app' increase physical activity, subjective well-being and sleep quality? An open-label single-arm trial among university staff with low to moderate physical activity levels. [2022]

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

A Mixed Methods Study on Engagement and Satisfaction with a Digitally-Enhanced Pilot Intervention Among African American and Hispanic Women. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Adaptive Goals and Reinforcement Timing to Increase Physical Activity in Adults: A Factorial Randomized Trial. [2023]