Online Exercise Promotion for Sedentary Lifestyle

Overseen By Paul G Ritvo, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: York University

Disqualifiers: Bipolar, Borderline, OCD, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program designed to help individuals who exercise infrequently become more active. It features weekly phone counseling, an online platform with health tips and videos, and a Fitbit for step tracking. The goal is to discover more effective methods to encourage physical activity and improve health. Individuals who regularly attend church, have a BMI between 27 and 33, and can walk for 30 minutes without pain may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for enhancing physical activity and overall well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this online intervention is safe for increasing physical activity?

Research shows that digital health tools, like the one in this study, are generally safe. Studies have found that online platforms and wearable devices help people sit less and move more without causing harm.

These tools have been tested in numerous studies aimed at increasing physical activity. They often include online resources and devices like Fitbits, which track steps and activity. Research has found these tools easy to use, allowing people to use them without major issues.

No reports of serious side effects have emerged from using these digital methods. Therefore, the online exercise program in this study is expected to be safe based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it integrates technology and personalized support to tackle sedentary lifestyles. Unlike traditional exercise recommendations that might involve self-guided programs or in-person classes, this approach uses a combination of phone-based counseling and an online platform called Nex J Connected Wellness. Participants receive a Fitbit to track their activity, which allows counselors to provide tailored feedback and encouragement through text messages. This method aims to make exercise promotion more engaging and accessible, leveraging personal data to motivate and guide participants towards a more active lifestyle.

What evidence suggests that this online intervention is effective for increasing physical activity in a sedentary lifestyle?

Research has shown that digital health tools can help people sit less and move more. One study found that online programs reduce the time people spend sitting. Another study showed that mobile health tools, such as apps, increase activity by sending reminders and tracking progress. These tools often feature text messages and access to helpful health information. In this trial, participants in the experimental arm will receive both counseling and online tools, which have shown promise in promoting increased activity. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for sedentary individuals aged 25-55 who regularly attend church, are willing to wear a Fitbit daily, and can walk for 30 minutes without pain. They must be fluent in English, have a BMI of 27-33, and get doctor's approval to start walking exercises. People with certain mental health conditions or those already moderately active are excluded.

Inclusion Criteria

Self-identification as a regular church attendee

Willingness to complete the Big Five Inventory (BFI)

BMI between 27 and 33

Exclusion Criteria

Individuals with a self-reported co-morbid illness or condition that could be negatively affected by walking exercise

Individuals who self-report a past or present diagnosis of Bipolar Disorder, Borderline Personality Disorder, Obsessive-Compulsive Disorder, Schizophrenia, Substance Abuse/Addiction in the past three months

Suicidal ideation or attempted suicide in the past six months prior to the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 16-week online Christian-based CBT-PA intervention with phone-based counseling and access to an online platform

16 weeks

16 phone sessions (1 per week), ongoing online platform access

Follow-up

Participants are monitored for changes in physical activity and other health measures post-intervention

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Online intervention

Trial Overview

The study tests an online intervention designed to increase physical activity among conscientious Christians leading a sedentary lifestyle. Participants will use a Fitbit Versa 2 and follow the program for 16 weeks while their activity levels are monitored.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Sixteen weeks of phone-based counselling at a rate of 1 session/week and ongoing access to a online platform (Nex J Connected Wellness) that has health promotion text and videos readily accessed in combination with text messaging exchanges between counselor and participant. Participants receive a Fitbit which is connected to the Nex J Connected Wellness such that counselors can monitor steps/day.

Group II: Wait list control Active Control 1 Intervention

Participants wait for 16 weeks.

Who Is Running the Clinical Trial?

York University

Lead Sponsor

Trials

64

Recruited

521,000+

Published Research Related to This Trial

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., 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]

An online supervised exercise program significantly reduced fasting blood sugar and body mass index (BMI) in 70 older patients with Type 2 diabetes over a 6-week period.

While both supervised and unsupervised exercise groups showed improvements in psychological resilience and quality of life, the online supervised group demonstrated greater benefits, suggesting it may be a valuable treatment option for older adults unable to attend in-person rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an online-supervised exercise program in older people with diabetes on fasting blood sugar, psychological resilience and quality of life: A double blind randomised controlled trial. Terkes, N., Aksu, NT., Yamac, SU.[2023]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

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