Physical Activity Program for Sedentary Lifestyle

Recruiting at 1 trial location

Overseen By Julie B Cooper, MPA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Cancer, Heart attack, Arrhythmia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 12-week, culturally adapted program called De Pie can encourage Hispanic/Latino adults over 55 to become more active and enjoy exercise. Participants will either join the De Pie program, which focuses on reducing sitting time and increasing movement, or a comparison group that learns about brain health. The trial is ideal for those who are currently sedentary, can walk a block without assistance, and are open to using a smartphone for study activities. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance community health and personal 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 seems focused on physical activity, so it's likely you can continue your medications, but you should confirm with the study team.

What prior data suggests that the De Pie intervention is safe for promoting physical activity?

Research has shown that the De Pie program, a physical activity plan, is safe and easy for older adults to follow. This program reduces sitting time and encourages more movement throughout the day. Participants will add more structured exercise only if a safety check, including a blood pressure test, confirms it is safe.

Previous studies have not reported any serious side effects. The program adapts to fit different cultures, making participation easier and more comfortable, which can also enhance safety. Unlike typical clinical trials that test new drugs, this trial focuses on how well the program increases physical activity, suggesting it should be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the De Pie Intervention because it offers a fresh approach to tackling a sedentary lifestyle by focusing on reducing sitting time and encouraging movement throughout the day. Unlike typical recommendations that might simply advise more physical activity, this intervention strategically incorporates two steps: first, reducing sedentary behavior and, second, integrating structured exercise into daily routines, pending a safety check. This dual-focus approach is designed to be more comprehensive and adaptable, potentially making it more effective and appealing for individuals who struggle with maintaining regular physical activity.

What evidence suggests that the De Pie intervention is effective for promoting physical activity?

Research shows that the De Pie program, which participants in this trial may receive, is designed to encourage more movement by reducing sitting time and promoting daily activity. Previous studies suggest this program can boost confidence, build strong habits, increase social support, and make physical activity more enjoyable for older Hispanic/Latino adults. Tailored to fit cultural needs, the program is offered online, making it easy to access and potentially more engaging for participants. Although specific results from this trial are not yet available, the program's emphasis on building good habits and social support appears promising for helping people maintain recommended activity levels. Another group in this trial will participate in the HALT-AD program, which focuses on preventing cognitive decline through lifestyle behaviors other than physical activity. ^{1 3 4 5 6}

Who Is on the Research Team?

Dori E Rosenberg, PhD, MPH

Principal Investigator

Kaiser Permanente

Zvinka Z Zlatar, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino adults over age 55 living in Southern California who do not have dementia. Participants should be leading a sedentary lifestyle and are interested in increasing their physical activity to meet moderate-intensity guidelines.

Inclusion Criteria

Willing to follow study procedures depending on program assignment

I am available for calls on weekdays from 8am to 5pm.

Able to participate for up to 20 weeks in the study

Exclusion Criteria

Unable to hear phone conversation, even with a hearing aid

Had a fall in the last year that resulted in hospitalization

I am willing to get an email address if I don't already have one.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the culturally adapted De Pie y a Movernos intervention or the HALT-AD active comparison program for 12 weeks

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for changes in physical activity and psychosocial mediators after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• De Pie Intervention

Trial Overview The study compares two programs: the De Pie intervention, which encourages physical activity, and HALT-AD, focusing on brain health education. The goal is to see if De Pie can boost self-efficacy and enjoyment of exercise over a period of 12 weeks.

How Is the Trial Designed?

Group I: De Pie Intervention Experimental Treatment 1 Intervention

The De Pie intervention program receives a sedentary behavior reduction and physical activity promotion intervention centered on two steps: Step 1) reduce sitting time and move more throughout the day; Step 2) if cleared by a safety assessment and blood pressure check, participants can work towards adding structured bouts of exercise into their day.

Group II: HALT-AD Active Comparison Group Active Control 1 Intervention

Those randomized to HALT-AD (Healthy Actions and Lifestyles to Avoid Dementia) will receive one phone call to introduce them to preventing cognitive decline through various lifestyle behaviors (e.g. stress reduction, healthy diet, healthy sleep) other than physical activity. They will be encouraged by the Health Coach upon randomization to complete one module approximately every week (there are 10 modules in total).

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

An educational program focused on physical activity significantly improved habitual physical activity levels and self-efficacy in patients after their first percutaneous coronary intervention, compared to usual care, in a study involving 109 participants.

The program's effectiveness was measured 5 to 7 months post-discharge, showing a mean score increase of 0.89 for physical activity and 2.30 for self-efficacy, with no significant differences in anxiety and depression symptoms between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an educational program on physical activity in individuals undergoing their first percutaneous coronary intervention: A randomized clinical trial. Pitta, NC., Furuya, RK., Freitas, NO., et al.[2023]

The 'Sigue la Huella' program effectively increased moderate to vigorous physical activity levels and reduced sedentary time among secondary education students in Huesca, Spain, involving 368 students in the experimental group and 314 in the control group over a 25-month period.

The intervention utilized a holistic approach based on the social-ecological model and self-determination theory, empowering students to take an active role in their physical activity, which contributed to its success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the 'Sigue la Huella' physical activity intervention for adolescents in Huesca, Spain. Murillo Pardo, B., Julián Clemente, JA., García González, L., et al.[2020]

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 study involving 327 patients with COPD, both a pedometer-based behavioral intervention group and a control group showed significant increases in daily steps and improvements in quality of life six weeks and six months after a three-week inpatient pulmonary rehabilitation program.

However, the addition of the pedometer intervention did not lead to statistically significant greater increases in physical activity levels compared to the control group, indicating that standard rehabilitation alone was effective in enhancing activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Benefits of Adding a Pedometer to Pulmonary Rehabilitation for COPD: The Randomized Controlled STAR Trial. Geidl, W., Carl, J., Schuler, M., et al.[2021]

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 randomized trial with 204 participants, those who increased their physical activity (iPA) managed to exercise 14 more minutes per day and reduced their sedentary behavior by 18 minutes per day, showing a clear link between increased activity and decreased sitting time.

Participants who focused on reducing sedentary leisure time (dSED) did not show significant changes in physical activity or sedentary behavior, indicating that actively increasing exercise may be more effective than simply trying to cut down on screen time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Changes in Physical Activity on Sedentary Behavior: Results From a Randomized Lifestyle Intervention Trial. Siddique, J., de Chavez, PJ., Craft, LL., et al.[2018]

In a study involving 21 COPD patients, those who received lifestyle physical activity counseling and used a pedometer increased their daily steps by 1,430 steps/day (69% increase), compared to a 455 steps/day (19% increase) in the control group, suggesting that the intervention may enhance physical activity levels.

While the primary outcome of increased daily steps was significant, secondary outcomes such as physical fitness and quality of life did not show notable differences, indicating that while the intervention is effective for increasing activity, it may not directly improve other health metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. de Blok, BM., de Greef, MH., ten Hacken, NH., et al.[2012]

In a study of 427 octogenarians in long-term care, replacing sedentary behavior with light-intensity or moderate to vigorous physical activity significantly improved various measures of physical function, including strength and mobility.

Participants who engaged in more physical activity showed notable increases in chair stand cycles, peak force, grip strength, and faster times in mobility tests, highlighting the importance of physical activity for enhancing the quality of life in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacing Sedentary Behavior With Physical Activity of Different Intensities: Implications for Physical Function, Muscle Function, and Disability in Octogenarians Living in Long-Term Care Facilities. Del Pozo-Cruz, J., Irazusta, J., Rodriguez-Larrad, A., 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]

The Dietary Advice program by the Andalusian Health Department aims to combat diseases linked to sedentary lifestyles and poor eating habits through a structured two-phase approach, focusing on both individual and group interventions.

The intensive dietary phase includes personalized nurse visits and workshops designed to equip participants with the knowledge and skills necessary to adopt healthier lifestyles, potentially reducing the risk of major diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intensive dietary advice program in primary care]. Sánchez-Robles, R., Gea-Lázaro, ML.[2012]

The EdAl-2 educational intervention program successfully increased after-school physical activity among boys, with a 15% higher participation rate in the intervention group compared to controls, but did not lead to changes in obesity prevalence or BMI after 22 months.

While the program improved some lifestyle habits, such as reducing screen time for boys, it did not have a significant impact on overall obesity rates or BMI in the participating children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. Llauradó, E., Tarro, L., Moriña, D., et al.[2021]

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]

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]

A 24-week behavioral modification program using pedometers and telephone support significantly increased physical activity by an average of 2744 steps per day and reduced sedentary behavior by 23 minutes per day in type 2 diabetes patients.

These positive changes in physical activity and reduced sedentary time were still evident one year later, with an increase of 1872 steps per day and a decrease of 12 minutes in sedentary behavior, demonstrating the program's lasting impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. De Greef, KP., Deforche, BI., Ruige, JB., et al.[2022]

The study involves 239 Veterans with chronic obstructive pulmonary disease (COPD) participating in a randomized controlled trial to test the effectiveness of an Internet-mediated walking program called Taking Healthy Steps, which aims to increase physical activity and improve health outcomes.

Participants in the intervention group receive personalized feedback and support through a pedometer and online community, while the control group waits a year for their intervention, highlighting the potential for remote programs to engage older Veterans with significant health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease. Martinez, CH., Moy, ML., Nguyen, HQ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12154937/

Feasibility and Cultural Adaptation of a Community-Engaged ... The De Pie ya Movernos intervention aims to reduce barriers to participation in clinical research by culturally adapting a remotely based PA intervention.

2. trial.medpath.com trial.medpath.com/clinical-trial/59ecf0c9d21c7471/nct06362824-de-pie-y-a-movernos-study

Promoting Physical Activity in Older Hispanic/Latino(a) Adults The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit ...

3. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06362824

Promoting Physical Activity in Older Hispanic/Latino(a) Adults The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit ...

4. withpower.com withpower.com/trial/phase-physical-inactivity-5-2024-b4ce6

Physical Activity Program for Sedentary Lifestyle The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit ...

5. kpwashingtonresearch.org kpwashingtonresearch.org/index.php/our-research/our-scientists/rosenberg-dori-e?ccm_paging_p=5

Dori Rosenberg, PhD, MPH The De Pie y a Movernos Study. Dr. Rosenberg and colleagues are co-designing a sedentary behavior reduction and physical activity promotion intervention ...

6. kpwashingtonresearch.org kpwashingtonresearch.org/index.php/our-research/our-scientists/rosenberg-dori-e?ccm_paging_p=9

Dori Rosenberg, PhD, MPH The De Pie y a Movernos Study. Dr. Rosenberg and colleagues are co-designing a sedentary behavior reduction and physical activity promotion intervention for ...