Remote Physical Activity Interventions for Sedentary Lifestyle

(WHISH EnCore Trial)

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Nursing home, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

232 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help older women become more active using remote technology. It compares two groups: one receiving a program called Our Voice citizen science, which helps identify and tackle barriers to physical activity, and another receiving general health education. The goal is to determine if these programs can improve physical and mental health in older women who don't get enough exercise. Women who aren't very active, can walk around their neighborhood, and use a smartphone might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance health and well-being for older women.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on physical activity, so it's likely you can continue your medications, but please confirm with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the "Our Voice" program, which uses citizen science to boost physical activity, has been safely implemented by older adults. One study found that participants aged 65 and older acted as citizen scientists to evaluate and improve their neighborhood environments, with no negative effects reported. This suggests the program is well-received by this age group.

For the remote physical activity education program, studies have found it effectively encourages more physical activity in various groups, including office workers. The studies available report no safety issues, indicating the program is generally safe.

Both programs aim to promote physical activity without involving medications or invasive procedures, which typically reduces the risk of side effects. Current research suggests these methods are safe for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they offer a fresh approach to tackling sedentary lifestyles using remote strategies. Unlike traditional exercise programs that often require in-person attendance, these interventions utilize a "light touch" physical activity education program combined with citizen science, empowering participants to identify and address barriers to physical activity in their environment. This method not only promotes physical activity but also fosters community engagement and personal empowerment. By using remote technology, these interventions have the potential to reach a broader audience, making physical activity more accessible and adaptable to individual needs and environments.

What evidence suggests that this trial's treatments could be effective for promoting physical and cognitive health in older women?

Research shows that the Our Voice citizen science program, which participants in this trial may receive, helps people become more active by involving them in identifying and solving barriers to exercise. This method has proven effective in creating healthier environments and improving key health habits, such as regular exercise. Similarly, remote physical activity education programs, another component of this trial, have consistently encouraged increased activity. These programs use online tools to inspire and educate participants, resulting in higher activity levels. Both strategies aim to make staying active easier and more enjoyable for older adults, focusing on their specific needs. ^{1 2 3 6 7}

Who Is on the Research Team?

Abby C King, Ph.D

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for older women who are not very active physically, enrolled in the WHISH trial, can use a smartphone, and willing to wear a pedometer. They should be able to walk moderately and stay in the area for a year. It's not for those living in nursing homes or with dementia or conditions preventing moderate physical activity.

Inclusion Criteria

No plans to move from the area over the 1 year study period

Willing to be randomized and engage in study assessments

Willing to wear the study pedometer

Exclusion Criteria

I do not live in a nursing home and do not have dementia or conditions preventing me from moderate physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a remote 'light-touch' physical activity education program combined with either the Our Voice citizen science program or additional health education information

12 months

Follow-up

Participants are monitored for changes in physical activity, cognitive function, and sedentary behavior

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Our Voice citizen science
• PA Education

Trial Overview The study tests if adding 'Our Voice', which uses technology to tackle barriers to being active outdoors, improves physical and cognitive health when combined with an existing remote education program on physical activity versus just the education program plus human/planetary health awareness.

How Is the Trial Designed?

Group I: PA Education plus Our Voice citizen science Experimental Treatment 2 Interventions

Participants will receive the remote "light touch" physical activity education program in combination with the remote Our Voice citizen science program aimed at identifying and addressing physical and social environmental barriers to and enablers of regular physical activity.

Group II: PA Education plus human and planetary health information Active Control 1 Intervention

Participants will continue to receive the remote "light touch" physical activity education program that they have been receiving for the past several years along with additional remote health education information to control for nonspecific factors (staff attention, participant time).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A 12-month randomized controlled trial in The Netherlands showed that a video-based computer-tailored intervention significantly reduced energy intake in adults compared to a control group, with a notable decrease of 205.40 calories after 6 months and 128.14 calories after 12 months.

The effectiveness of the video intervention on energy intake was consistent across different educational levels and BMI categories, indicating its broad applicability for preventing overweight and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Video-Versus Text-Based Computer-Tailored Intervention for Obesity Prevention after One Year: A Randomized Controlled Trial. Cheung, KL., Schwabe, I., Walthouwer, MJL., et al.[2022]

In a 10-week study involving 30 older women with an average age of 76, the use of a telephone-based interactive voice response (IVR) system significantly increased physical activity by an average of 79 minutes per week (p < .001).

Participants found the IVR coaching and accompanying Go4Life® materials helpful, with 70% reporting that the technology was easy to use, indicating that IVR could be an effective and acceptable tool for promoting physical activity in older women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study combining Go4Life® materials with an interactive voice response system to promote physical activity in older women. Saquib, J., King, AC., Castro, CM., et al.[2017]

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]

The study evaluated two remotely delivered physical activity interventions over seven weeks in 53 children, showing that both interventions significantly increased moderate-to-vigorous physical activity (MVPA) levels, with no additional benefit from including family supports.

Approximately 90% of caregivers found the family support content acceptable, indicating that while family involvement is valued, it did not enhance the effectiveness of the intervention compared to the classroom-based approach alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Family Digital Supports to Classroom-Based Physical Activity Interventions to Target In- and Out-of-School Activity: An Evaluation of the Stay Active Intervention during the COVID-19 Pandemic. Forseth, B., Ortega, A., Hibbing, PR., et al.[2023]

The study demonstrated that using voice-controlled intelligent personal assistants (VIPAs) to deliver a home-based exercise program to 15 older adults was safe and feasible, with a 100% retention rate over 12 weeks.

Participants showed excellent adherence to the exercise regimen, completing 115% of the prescribed exercises without any reported adverse events, indicating that VIPAs can effectively support independent exercise in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of Home-Based Exercise Interventions in Older Adults Facilitated by Amazon Alexa: A 12-week Feasibility Trial. Jansons, P., Dalla Via, J., Daly, RM., et al.[2022]

The fully automated physical activity counseling system (TLC-PA) significantly increased the likelihood of participants meeting physical activity recommendations at 3 months compared to a healthy eating intervention, with 26% of TLC-PA participants meeting the guidelines versus 19.6% in the comparison group.

Participants using TLC-PA reported higher daily energy expenditure and greater motivational readiness for physical activity, but these positive effects were not sustained at 6 months, likely due to a decrease in system usage over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a computer-based, telephone-counseling system on physical activity. Pinto, BM., Friedman, R., Marcus, BH., et al.[2019]

A study involving 12,287 physically inactive adults found that access to a website providing tailored feedback on increasing physical activity did not lead to significant improvements in overall physical activity levels compared to a control group.

While only a small percentage of participants actively used the website, those who did showed improvements in their physical activity levels, suggesting that more engaging and sophisticated interventions are needed to motivate unmotivated users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Web-based intervention to promote physical activity and improve health among physically inactive adults: a population-based randomized controlled trial. Hansen, AW., Grønbæk, M., Helge, JW., et al.[2022]

An 8-week randomized trial involving 655 university staff found no significant overall increase in physical activity from either a print or a web-based intervention, indicating that both methods may be equally ineffective in increasing activity levels.

However, the print program was effective for participants who were inactive at the start, showing a significant increase in physical activity, while the web program led to a notable decrease in sitting time, suggesting different impacts based on the delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Print versus website physical activity programs: a randomized trial. Marshall, AL., Leslie, ER., Bauman, AE., et al.[2019]

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]

Videoconferencing exercise interventions for people with chronic diseases have been found to be effective in improving both exercise capacity and quality of life, based on a systematic review of 32 trials.

The studies showed small to moderate positive effects favoring videoconferencing compared to both non-exercising and exercising comparators, with no serious adverse events reported, indicating that this method is safe and feasible for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of exercise via telehealth for chronic disease: a systematic review and meta-analysis of exercise interventions delivered via videoconferencing. Brown, RC., Coombes, JS., Jungbluth Rodriguez, K., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8453124/

The Steps for Change Randomized Controlled Trial Design ... The Steps for Change Trial represents the first randomized, controlled study to test whether the addition of the Our Voice citizen science model can complement ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36429494/

The "Our Voice" Method: Participatory Action Citizen Science ... Exemplary health equity-focused outcomes include key health behaviors (e.g., healthy eating or physical activity) and community-level changes ( ...

3. med.stanford.edu med.stanford.edu/ourvoice.html

Our Voice: Citizen Science Promoting Health for All The Our Voice Initiative activates the power of people as change agents to build healthier and more vibrant communities.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03041415

Citizen Science to Promote Sustained Physical Activity in ... Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

5. med.stanford.edu med.stanford.edu/ourvoice/publications-featuredarticles/publications-physicalactivity.html

Publications | Our Voice: Citizen Science Promoting Health for ... Testing the effectiveness of community-engaged citizen science to promote physical activity, foster healthier neighborhood environments, and advance health ...

6. researchgate.net researchgate.net/publication/329257699_Older_Adults_Using_Our_Voice_Citizen_Science_to_Create_Change_in_Their_Neighborhood_Environment

(PDF) Older Adults Using Our Voice Citizen Science to ... This exploratory study engaged a small sample (N = 8) of adults aged 65 or older as citizen scientists to assess and then work to improve their ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714421002627

The Steps for Change randomized controlled trial design ... The Steps for Change Trial represents the first randomized, controlled study to test whether the addition of the Our Voice citizen science model can complement ...