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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Given the importance of reducing mortality-morbidity, more effective Physical Activity (PA) interventions are important, and the recently observed stabilizations of PI levels suggest that novel methods must be explored (Ozemek et al., 2019). This study aims to provide a select sedentary subpopulation with a customized intervention hypothesized to increase their PA adoption. Novel recruiting methods are used to identify a target subpopulation (based on multiple characteristics) that can be contacted in multiple sections of North America. We will intervene online and rigorously test the theoretical formulations that identify the subpopulation and the customized intervention.

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 data supports the effectiveness of the treatment Online intervention for promoting exercise in sedentary individuals?

Research shows that online exercise programs can improve physical activity levels and maintain behavior change over time. Specifically, online-supervised exercise programs are more effective than unsupervised ones, and structured internet-delivered exercise recommendations can enhance aerobic capacity and reduce cardiovascular risk in sedentary individuals. ^{1 2 3 4 5}

Is online exercise promotion safe for sedentary individuals?

Research shows that physical activity interventions, including online ones, are generally safe for sedentary individuals, with few minor injuries reported, mostly related to muscles and joints. No serious adverse events were linked to these interventions, especially when starting with low intensity and gradually increasing. ^{6 7 8 9 10}

How does the online intervention treatment for sedentary lifestyle differ from other treatments?

The online intervention for promoting exercise in sedentary individuals is unique because it leverages the Internet to provide motivationally-tailored feedback and real-time prompts, making it more accessible and personalized compared to traditional print-based methods. This approach can reach a larger audience and adapt to individual needs, potentially increasing its effectiveness in encouraging physical activity. ^{8 11 12 13 14}

Eligibility Criteria

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

I agree to wear a Fitbit Versa 2 daily for 16 weeks.

Willingness to complete the Big Five Inventory (BFI)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. England 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. [2023]

2. 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]

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

An internet-delivered exercise intervention for workplace health promotion in overweight sedentary employees: a randomized trial. [2018]

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

Home-exercise Childhood Obesity Intervention: A Randomized Clinical Trial Comparing Print Versus Web-based (Move It) Platforms. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support for inactive adults with chronic health conditions: the e-coachER trial. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

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

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

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

Step into Motion: a randomized trial examining the relative efficacy of Internet vs. print-based physical activity interventions. [2015]

9. United States 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. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Can self-monitoring mobile health apps reduce sedentary behavior? A randomized controlled trial. [2021]

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

The effectiveness of e-& mHealth interventions to promote physical activity and healthy diets in developing countries: A systematic review. [2022]

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

eHealth promotion: the use of the Internet for health promotion. [2022]

14. Australia pubmed.ncbi.nlm.nih.gov

Project Energise: Using participatory approaches and real time computer prompts to reduce occupational sitting and increase work time physical activity in office workers. [2019]