Health effects and cost-effectiveness of a multilevel physical activity intervention in low-income older adults; results from the PEP4PA cluster randomized controlled trial.

BACKGROUND: Older adults are the least active population in the U.S. Low-income communities have fewer physical activity (PA) resources, contributing to less PA and increased chronic disease risk. This study assessed the effect of the multilevel, peer-led, Peer Empowerment Program 4 Physical Activity (PEP4PA) on moderate-to-vigorous PA (MVPA) and health outcomes, over 2 years of follow up. METHODS: In a cluster-randomized controlled trial, 12 senior or community centers serving low-income older adults were assigned to a PA intervention (n = 6) or usual programming (n = 6) condition. PEP4PA included self-monitoring, health coaching, group walks, social support, and community advocacy to improve walking conditions. The primary outcome was daily minutes of MVPA (7-day accelerometer). Secondary outcomes included Perceived Quality of Life (PQoL), 6-Minute Walk Test (6-MWT), blood pressure (BP), and depressive symptoms at baseline, 6, 12, 18 and 24 months. Mixed effects regression models estimated the effects on outcomes between groups over time and included random effects for repeated measures and center clustering. Effect modification by sex and income status was assessed. We calculated the incremental cost per daily minute of MVPA gained in the intervention group relative to the control group to assess cost effectiveness. RESULTS: We enrolled 476 older adults (50 + years). Participants were on average 71 years old, 76% female, 60% low income, and 38% identified as racial or ethnic minorities. Compared to the control group, intervention participants sustained roughly a 10 min/day increase in MVPA from baseline at all time points and increased mean PQoL scores from unsatisfied at baseline to satisfied at 12, 18 and 24 months. Males and higher-income groups had greater improvements in MVPA. No significant effects were observed for 6-MWT or depressive symptoms, and BP results were mixed. The incremental cost per minute MVPA gained per person was $0.25, $0.09, $0.06, and $0.05 at 6, 12, 18 and 24 months, respectively. CONCLUSIONS: PEP4PA achieved increases in MVPA and PQoL in low-income older adults, over 2 years of follow up. The peer-led, community-based intervention provides a sustainable and cost-effective model to improve health behaviors in underserved, aging populations. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02405325 ) March 20, 2015.

Participants' Perceptions on the Use of Wearable Devices to Reduce Sitting Time: Qualitative Analysis.

BACKGROUND: Recent epidemiological evidence indicates that, on average, people are sedentary for approximately 7.7 hours per day. There are deleterious effects of prolonged sedentary behavior that are separate from participation in physical activity and include increased risk of weight gain, cancer, metabolic syndrome, diabetes, and heart disease. Previous trials have used wearable devices to increase physical activity in studies; however, additional research is needed to fully understand how this technology can be used to reduce sitting time. OBJECTIVE: The purpose of this study was to explore the potential of wearable devices as an intervention tool in a larger sedentary behavior study through a general inductive and deductive analysis of focus group discussions. METHODS: We conducted four focus groups with 15 participants to discuss 7 different wearable devices with sedentary behavior capabilities. Participants recruited for the focus groups had previously participated in a pilot intervention targeting sedentary behavior over a 3-week period and were knowledgeable about the challenges of reducing sitting time. During the focus groups, participants commented on the wearability, functionality, and feedback mechanism of each device and then identified their two favorite and two least favorite devices. Finally, participants designed and described their ideal or dream wearable device. Two researchers, who have expertise analyzing qualitative data, coded and analyzed the data from the focus groups. A thematic analysis approach using Dedoose software (SocioCultural Research Consultants, LLC version 7.5.9) guided the organization of themes that reflected participants' perspectives. RESULTS: Analysis resulted in 14 codes that we grouped into themes. Three themes emerged from our data: (1) features of the device, (2) data the device collected, and (3) how data are displayed. CONCLUSIONS: Current wearable devices for increasing physical activity are insufficient to intervene on sitting time. This was especially evident when participants voted, as several participants reported using a "process of elimination" as opposed to choosing favorites because none of the devices were ideal for reducing sitting time. To overcome the limitations in current devices, future wearable devices designed to reduce sitting time should include the following features: waterproof, long battery life, accuracy in measuring sitting time, real time feedback on progress toward sitting reduction goals, and flexible options for prompts to take breaks from sitting.

Implementation-effectiveness trial of an ecological intervention for physical activity in ethnically diverse low income senior centers.

BACKGROUND: As the US population ages, there is an increasing need for evidence based, peer-led physical activity programs, particularly in ethnically diverse, low income senior centers where access is limited. METHODS/DESIGN: The Peer Empowerment Program 4 Physical Activity' (PEP4PA) is a hybrid Type II implementation-effectiveness trial that is a peer-led physical activity (PA) intervention based on the ecological model of behavior change. The initial phase is a cluster randomized control trial randomized to either a peer-led PA intervention or usual center programming. After 18 months, the intervention sites are further randomized to continued support or no support for another 6 months. This study will be conducted at twelve senior centers in San Diego County in low income, diverse communities. In the intervention sites, 24 peer health coaches and 408 adults, aged 50 years and older, are invited to participate. Peer health coaches receive training and support and utilize a tablet computer for delivery and tracking. There are several levels of intervention. Individual components include pedometers, step goals, counseling, and feedback charts. Interpersonal components include group walks, group sharing and health tips, and monthly celebrations. Community components include review of PA resources, walkability audit, sustainability plan, and streetscape improvements. The primary outcome of interest is intensity and location of PA minutes per day, measured every 6 months by wrist and hip accelerometers and GPS devices. Secondary outcomes include blood pressure, physical, cognitive, and emotional functioning. Implementation measures include appropriateness & acceptability (perceived and actual fit), adoption & penetration (reach), fidelity (quantity & quality of intervention delivered), acceptability (satisfaction), costs, and sustainability. DISCUSSION: Using a peer led implementation strategy to deliver a multi-level community based PA program can enhance program adoption, implementation, and sustainment. TRIAL REGISTRATION: ClinicalTrials.gov, USA ( NCT02405325 ). Date of registration, March 20, 2015. This website also contains all items from the World Health Organization Trial Registration Data Set.

Engaging research participants to inform the ethical conduct of mobile imaging, pervasive sensing, and location tracking research.

Researchers utilize mobile imaging, pervasive sensing, social media, and location tracking (MISST) technologies to observe and intervene with participants in their natural environment. The use of MISST methods and tools introduces unique ethical issues due to the type and quantity of data, and produces raising new challenges around informed consent, risk assessment, and data management. Since MISST methods are relatively new in behavioral research, there is little documented evidence to guide institutional review board (IRB) risk assessment and inform appropriate risk management strategies. This study was conducted to contribute the participant perspectives when considering ethical and responsible practices. Participants (n = 82) enrolled in an observational study where they wore several MISST devices for 1 week completed an exit survey. Survey items focused on the following: 1-device comfort, 2-informed consent, 3-privacy protections, and 4-bystander engagement. The informed consent process reflected participant actual experience. Device comfort and privacy were raised as concerns to both the participants and bystanders. While the majority of the participants reported a positive experience, it is important to note that the participants were volunteers who were not mandated to wear tracking devices and that persons who are mandated may not have a similar response. Findings support strategies proposed in the Kelly et al. (2013) ethical framework, which emphasizes procedures to improve informed consent, protect privacy, manage data, and respect bystander rights when using a wearable camera.

Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults.

BACKGROUND: Excessive sitting has been linked to poor health. It is unknown whether reducing total sitting time or increasing brief sit-to-stand transitions is more beneficial. We conducted a randomized pilot study to assess whether it is feasible for working and non-working older adults to reduce these two different behavioral targets. METHODS: Thirty adults (15 workers and 15 non-workers) age 50-70 years were randomized to one of two conditions (a 2-hour reduction in daily sitting or accumulating 30 additional brief sit-to-stand transitions per day). Sitting time, standing time, sit-to-stand transitions and stepping were assessed by a thigh worn inclinometer (activPAL). Participants were assessed for 7 days at baseline and followed while the intervention was delivered (2 weeks). Mixed effects regression analyses adjusted for days within participants, device wear time, and employment status. Time by condition interactions were investigated. RESULTS: Recruitment, assessments, and intervention delivery were feasible. The 'reduce sitting' group reduced their sitting by two hours, the 'increase sit-to-stand' group had no change in sitting time (p < .001). The sit-to-stand transition group increased their sit-to-stand transitions, the sitting group did not (p < .001). CONCLUSIONS: This study was the first to demonstrate the feasibility and preliminary efficacy of specific sedentary behavioral goals. TRIAL REGISTRATION: clinicaltrials.gov NCT02544867.