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

Trial Summary

What is the purpose of this trial?

While older women are disproportionately affected by chronic diseases and conditions associated with aging, including both physical and cognitive impairments, that can be alleviated or delayed by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. This research aims to evaluate, in insufficiently active older women from the national WHISH pragmatic trial, the effects of a technology-driven "citizen science" approach to environmental physical activity barriers called Our Voice plus the ongoing "light-touch" remote physical activity educational program, compared to the "light-touch" remote physical activity educational program plus a control educational intervention that creates awareness around human and planetary health. This study will add important information on the benefits and trade-offs of combining these remotely delivered and practical behavioral health approaches to promote physical and cognitive health for the fast-expanding demographic group of U.S. 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.

What data supports the idea that Remote Physical Activity Interventions for Sedentary Lifestyle is an effective treatment?

The available research shows that remote physical activity interventions, like those in the Movingcall study, can be effective. This study found that personalized coaching and regular reminders helped increase physical activity levels more than just giving written advice. Additionally, the MOTION trial demonstrated that home-based exercise programs delivered through video calls were just as effective as in-person sessions for older adults. These findings suggest that remote interventions can successfully encourage people to be more active, even without face-to-face contact. ^{1 2 3 4 5}

What safety data exists for remote physical activity interventions?

The provided research abstracts do not directly address safety data for remote physical activity interventions like 'Our Voice' or similar programs. They focus on the effectiveness and feasibility of various remote interventions, such as telephone counseling, video-based programs, and web-based interventions, in promoting physical activity. However, none of the studies explicitly mention safety outcomes or adverse events related to these interventions. ^{1 2 6 7 8}

Is the treatment Our Voice citizen science, PA Education a promising treatment for a sedentary lifestyle?

Yes, the Our Voice citizen science, PA Education treatment is promising because remote physical activity programs can effectively reach many people and increase activity levels. These programs can be tailored to individual needs and use technology like websites, emails, and even voice assistants to encourage more physical activity. They have been shown to be effective in both short-term and long-term scenarios, making them a valuable option for promoting a more active lifestyle. ^{1 3 9 10 11}

Research Team

Abby C King, Ph.D

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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 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]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a computer-based, telephone-counseling system on physical activity. [2019]

3. 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]

4. England 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. [2022]

5. 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]

6. Switzerland 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A pilot study combining Go4Life® materials with an interactive voice response system to promote physical activity in older women. [2017]

8. Canada 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. [2022]

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

Print versus website physical activity programs: a randomized trial. [2019]

10. France pubmed.ncbi.nlm.nih.gov

Delivery of Home-Based Exercise Interventions in Older Adults Facilitated by Amazon Alexa: A 12-week Feasibility Trial. [2022]

11. United States 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. [2023]