Online Program for Sedentary Lifestyle

(LADIES Online Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to move a physical activity program online, enabling more people to participate and become active. It focuses on assisting women, specifically Black or African American women, who currently engage in minimal exercise. Participants will either join online group sessions or receive self-guided materials to help increase their physical activity. A suitable candidate for this trial is a woman who identifies as Black or African American, exercises less than 150 minutes a week, and has a smartphone or computer with internet access. As an unphased trial, this study offers a unique opportunity to contribute to research that could make physical activity more accessible to many.

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 prior data suggests that this online program is safe for promoting physical activity?

Research has shown that online programs designed to increase physical activity are generally safe. Studies have found that these digital tools can boost activity levels without causing harm. For instance, one study on a remote program for office workers showed it effectively increased their activity, with no major side effects reported.

Another study tested web-based health programs and found them safe and useful for improving fitness. Participants did not report any serious issues from using these programs. Overall, evidence suggests that online programs to encourage physical activity are well-tolerated and safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative approach to tackling a sedentary lifestyle through an online program. Unlike traditional methods that may involve in-person fitness coaching or gym memberships, this program brings the intervention directly to participants' homes via digital platforms. The trial features two key components: a group-based online intervention and a self-guided module, both designed to increase physical activity levels. This digital delivery method could offer a more accessible and flexible option for busy individuals, particularly women, who might struggle to fit physical activity into their daily routines. By making fitness guidance easily accessible online, the trial aims to assess whether these digital interventions can effectively motivate and sustain healthier lifestyle changes.

What evidence suggests that this online program is effective for promoting physical activity?

Research has shown that digital programs can help people who don't exercise much become more active. One study found that online programs led to an increase in self-reported exercise. Another study demonstrated that smartphone apps encouraged more movement. Reviews of multiple studies also support the idea that digital health tools can help reduce sedentary behavior. In this trial, participants will be randomized to receive either an online group-based intervention or self-guided materials, both designed to promote physical activity. Overall, this evidence suggests that an online program might help participants become more active. ^{2 6 7 8 9}

Who Is on the Research Team?

Melicia Whitt-Glover, PhD

Principal Investigator

Gramercy Research Group

Robert L Newton, Jr., PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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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