Physical Activity Program for Sedentary Lifestyle
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kaiser Permanente
Disqualifiers: Cancer, Heart attack, Arrhythmia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. 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 strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week).
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 data supports the effectiveness of the treatment De Pie Intervention, De Pie y a Movernos for a sedentary lifestyle?
Research shows that using a pedometer (a device that counts steps) in physical activity programs can help people become more active and reduce the time they spend sitting. This approach has been effective in improving physical activity levels and quality of life in people with conditions like COPD and diabetes.12345
Is the Physical Activity Program for Sedentary Lifestyle safe for participants?
Research shows that physical activity programs, like the ones similar to the Physical Activity Program for Sedentary Lifestyle, are generally safe for humans. While minor injuries, mostly related to muscles and joints, can occur, no serious adverse events have been reported. It's important to start slowly and gradually increase activity levels.678910
How is the De Pie Intervention treatment different from other treatments for a sedentary lifestyle?
The De Pie Intervention is unique because it focuses on a physical activity program specifically designed to address sedentary lifestyles, potentially incorporating educational and motivational components to encourage regular movement, unlike other treatments that may focus more on dietary changes or general health advice.1112131415
Eligibility Criteria
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
See 8 more
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.
See 9 more
Trial Timeline
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
Treatment Details
Interventions
- De Pie Intervention (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: De Pie InterventionExperimental Treatment1 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 GroupActive Control1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San DiegoSan Diego, CA
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Who Is Running the Clinical Trial?
Kaiser PermanenteLead Sponsor
University of California, San DiegoCollaborator
References
Long-Term Benefits of Adding a Pedometer to Pulmonary Rehabilitation for COPD: The Randomized Controlled STAR Trial. [2021]This Stay Active after Rehabilitation (STAR) study examined the effects of a pedometer-based behavioral intervention for individuals with COPD during three weeks of inpatient pulmonary rehabilitation (PR) on patients' physical activity levels six weeks and six months after PR, including steps (primary outcome), moderate-intensity physical activity, and sedentary time as well as patient quality of life, symptoms, and other psychological and clinical variables.
The Effect of Changes in Physical Activity on Sedentary Behavior: Results From a Randomized Lifestyle Intervention Trial. [2018]To investigate whether changes in physical activity (PA) have an impact on sedentary behavior (SB) during a lifestyle intervention.
The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. [2022]Effectiveness of a behavioral modification program on physical activity (PA) and sedentary behavior in diabetes patients.
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. [2022]Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD.
The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. [2012]To study the effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation.
Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]To present detailed adverse event (AE) data from a randomized controlled trial (RCT) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner (GP).
Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]Researchers who conduct physical activity (PA) intervention studies provide an invaluable opportunity to further the prevention science knowledge base for implementing and delivering PA programs. Despite recommendations that screening is important to increase patient safety, the specific screening criteria best suited for different community applications are unknown. To add to the limited knowledge base, we examined the screening procedures and the occurrence of adverse events among more than 5,500 participants from 11 diverse PA interventions participating in a trans-National Institutes of Health (NIH) collaborative known as the Behavior Change Consortium (BCC). Numerous adverse events occur in sedentary, chronically ill, or older populations, although few are attributed to activity/exercise interventions. No serious study-related adverse events (SRAEs) were reported across different screening practices, interventions, and/or populations. Relatively few minor SRAEs were reported (primarily musculoskeletal injuries), emphasizing the need to be aware of potential musculoskeletal sequelae during exercise interventions. One common characteristic of these studies is that they recommended "start low and go slow" strategies, with moderate intensity PA as the goal behavior. Recommendations to reframe the meaning and use of screening criteria to initiate PA in the community are discussed. Although we were unable to conduct generalizable quantitative analyses from our data, the combined experience of the BCC studies provides a unique opportunity to examine PA-related screening and safety issues across diverse populations, settings, and intervention programs.
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients.
Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]The objectives of our study were to understand researchers' current practices and perspectives on adverse event (AE) reporting in clinical trials of resistance training (RT) and to identify barriers and facilitators of AE reporting. We conducted web conference or telephone-based one-on-one semistructured interviews with 14 researchers who have published RT studies. We audio-recorded and transcribed the interviews and analyzed the data using the thematic framework method. Four themes were identified: (1) researchers lack guidance and/or motivation for rigorous AE reporting; (2) researchers who undertake AE reporting educate and value participants, use trained personnel, and implement standardized guidelines; (3) suboptimal implementation of existing AE reporting standards and the perception that available guidelines do not apply to exercise trials; and (4) acceptability and feasibility of an exercise-specific guide for AE reporting depend on its content and format. In conclusion, AE reporting methods in the field of exercise science do not align with best practice. Strategies to reduce inconsistent and suboptimal AE reporting in RT trials are urgently needed and could be based on the barriers and facilitators identified in this study.
Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]To evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.
Effect of an educational program on physical activity in individuals undergoing their first percutaneous coronary intervention: A randomized clinical trial. [2023]Educational programs designed for specific populations to improve regular physical activity need to be tested.
[Intensive dietary advice program in primary care]. [2012]A sedentary lifestyle and inappropriate eating habits are the main causes of major diseases (cardiovascular diseases, type 2 diabetes, and certain types of cancers), as well as a high morbidity and mortality. The Dietary Advice program was designed by the Andalusian Health Department to promote healthy habits (i.e. physical exercise and a balanced diet) to prevent secondary diseases. This program is organised in two phases: Basic Dietary Advice and Intensive Dietary Advice. This paper aims to describe the interventions protocol on the intensive dietary phase of the program focused on the promotion on changes in people's lifestyles from a multi-factorial approach. The program consisted of two individual nurse visits, five workshops and nursing follow up clinics. The individual visits ensured that the team learned of each person needs; likewise, the group activities were aimed at improving the transmission of knowledge and the acquisition of skills, abilities and attitudes towards healthier lifestyles.
EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. [2021]To assess the reproducibility of an educational intervention EdAl-2 (Educació en Alimentació) programme in 'Terres de l'Ebre' (Spain), over 22 months, to improve lifestyles, including diet and physical activity (PA).
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. [2022]We investigated the associations of replacing sedentary behavior (SB) with physical activity of different intensities on the physical function of octogenarians living in long-term care facilities.
Development of the 'Sigue la Huella' physical activity intervention for adolescents in Huesca, Spain. [2020]Engaging in physical activity (PA) on a regular and adequate basis generates considerable benefits for health. In developed countries, the time spent doing PA is decreasing, whilst sedentary time (ST) is increasing. A multicomponent school-based intervention programme, called 'Sigue la Huella' (Follow the Footprint), was developed to reduce sedentary lifestyles and increase PA levels. This programme has proven to be effective in increasing the daily levels of moderate to vigorous PA, in decreasing ST and in improving motivational outcomes in secondary education students, in the city of Huesca (Spain). The study design was quasi-experimental, longitudinal and by cohorts, and it was carried out in four schools, two as an experimental group (n = 368) and two as a control group (n = 314). During the 25 months' intervention, this programme adopted a holistic approach aiming to create favourable environments to engage in PA, and the empowerment of students to get actively involved in the design and execution of the activities, assuming responsibility for managing and optimizing their own PA. The programme is theoretically based on the social-ecological model and self-determination theory, and it provided evidence for four actions or components that can be used in school-based PA promotion: tutorial action, Physical Education at school, dissemination of information and participation in institutional programmes and events. The aim of this article is to describe the main characteristics of the intervention programme that have proved to be effective with respect to the objectives proposed.