Online Program for Sedentary Lifestyle

(LADIES Online Trial)

Recruiting at 1 trial location

Overseen By Melicia Whitt-Glover, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Gramercy Research Group

Disqualifiers: Physical limitations, Medical conditions, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will identify strategies for modifying a physical activity intervention, previously delivered in a face-to-face format, for online implementation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the online program to promote physical activity for sedentary lifestyles?

Research shows that online exercise programs can improve physical outcomes, such as reducing weight and body fat, and increasing muscle mass in obese patients. Additionally, online physical activity interventions have been effective in changing and maintaining physical activity behavior in healthy inactive adults. ^{1 2 3 4 5}

Is the Online Program for Sedentary Lifestyle generally safe for participants?

Research shows that physical activity programs, like the Online Program for Sedentary Lifestyle, are generally safe for participants. In studies involving over 5,500 people, no serious adverse events were linked to these programs, although some minor injuries like muscle strains were reported. It's important to start slowly and gradually increase activity levels to minimize risks. ^{6 7 8 9 10}

How is the Online Program to Promote Physical Activity different from other treatments for a sedentary lifestyle?

The Online Program to Promote Physical Activity is unique because it uses an online platform to prescribe structured physical exercise, which has been shown to improve weight, body composition, and quality of life in sedentary individuals. This approach allows for easy access and potentially wider reach compared to traditional in-person programs. ^{3 11 12 13 14}

Research Team

Melicia Whitt-Glover, PhD

Principal Investigator

Gramercy Research Group

Robert L Newton, Jr., PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

This trial is for Black/African American women over 18 years old who are not very active, getting less than 150 minutes of moderate exercise per week. Participants must be able to speak and read English, have no physical conditions affected by exercise, and own a device with reliable internet.

Inclusion Criteria

self-identified female

black/African American

self-reported low activity (achieving less than 150 minutes per week of moderate-to-vigorous physical activity)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Solicit input from individuals to inform the translation of the FI curriculum for online use and adapt existing curricula for online use

Varies

Feasibility Testing

Engage the advisory group in feasibility testing of the online curriculum

Varies

Treatment

Participants receive six months of online group-based intervention sessions or self-guided materials

6 months

Follow-up

Participants are monitored for physical activity levels and sedentary behavior using accelerometers and self-reported questionnaires

2 weeks

Treatment Details

Interventions

• Focus group
• Online Program to Promote Physical Activity

Trial Overview The study tests an online program called LADIES aimed at increasing physical activity. It's comparing two versions: the intervention phase (active component) and control phase (possibly informational). The goal is to see if the program can work well online.

Participant Groups

Group I: LADIES online intervention (R33 phase) Experimental Treatment 1 Intervention

Participants will include 30 women who will be randomized to receive six (6) months of online group-based intervention sessions that teach participants how to increase physical activity levels.

Group II: LADIES online control (R33 phase) Placebo Group 1 Intervention

Participants will include 30 women who will be randomized to receive self-guided materials that teach participants how to increase physical activity levels. Placebo comparator participants will receive their materials via the online platform.

Who Is Running the Clinical Trial?

Gramercy Research Group

Lead Sponsor

Trials

3

Recruited

420+

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]

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]

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]

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]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., 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]

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]

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]

A web-based program called Young & Active was developed to increase physical activity among overweight adolescents, incorporating features like self-monitoring, autonomy-supportive counseling, and social support forums, based on theories of self-determination and motivational interviewing.

Usability testing with adolescents aged 12-16 showed that the program was well accepted after iterative adjustments, indicating a strong foundation for further evaluation of its efficacy in a controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and usability testing of an internet intervention to increase physical activity in overweight adolescents. Riiser, K., Løndal, K., Ommundsen, Y., et al.[2021]

The enhanced Internet program (EI) significantly increased physical activity (PA) levels among participants compared to standard Internet resources (SI) after 3 months, with participants in the EI group exercising an average of 186.0 minutes per week versus 57.3 minutes in the SI group.

However, by 6 months, the differences in PA levels between the two groups were no longer significant, indicating that while the EI program was effective in the short term, strategies for maintaining increased PA over the long term need further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial testing an internet physical activity intervention for sedentary adults. Carr, LJ., Dunsiger, SI., Lewis, B., 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. 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]

3. Spain pubmed.ncbi.nlm.nih.gov

[Real-world study of an online platform for the prescription of physical exercise to obese patients - Effect on anthropometric, biochemical parameters and quality of life]. [2022]

4. 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]

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

Can mobile-health applications contribute to long-term increase in physical activity after medical rehabilitation?-A pilot-study. [2023]

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

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

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

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]

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

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

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. Canada pubmed.ncbi.nlm.nih.gov

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

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

12. 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]

13. Canada pubmed.ncbi.nlm.nih.gov

Development and usability testing of an internet intervention to increase physical activity in overweight adolescents. [2021]

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

Randomized controlled trial testing an internet physical activity intervention for sedentary adults. [2022]