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

BackgroundAs 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/designThe 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.DiscussionUsing a peer led implementation strategy to deliver a multi-level community based PA program can enhance program adoption, implementation, and sustainment.Trial registrationClinicalTrials.gov, USA ( NCT02405325 ). Date of registration, March 20, 2015. This website also contains all items from the World Health Organization Trial Registration Data Set

A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care : study protocol

Background: The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs) and Healthcare Assistants (HCAs) to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design: This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour), and to help people translate their “good” intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm), who will be trained by the research team to deliver the selfregulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA). This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socioeconomic status, and clinical condition. A mediation analysis will investigate the extent to which changes in constructs specified by the Theory of Planned Behaviour lead to changes in objectively assessed walking behaviour. Discussion: This trial addresses the current lack of evidence for interventions that are effective at increasing walking and that can be offered to patients in primary care. The intervention being evaluated has demonstrated efficacy, and has been through an extensive process of adaptation to ensure acceptability to both provider and recipient, thus optimising fidelity of intervention delivery and treatment receipt. It therefore provides a strong test of the hypothesis that a self-regulation intervention can help primary care patients increase their walking

Effects of a Tailored Follow-Up Intervention on Health Behaviors, Beliefs, and Attitudes

Background: The high rates of relapse that tend to occur after short-term behavioral interventions indicate the need for maintenance programs that promote long-term adherence to new behavior patterns. Computer-tailored health messages that are mailed to participants or given in brief telephone calls offer an innovative and time-efficient alternative to ongoing face-to-face contact with healthcare providers. Methods: Following a 1-year behavior change program, 22 North Carolina health departments were randomly assigned to a follow-up intervention or control condition. Data were collected from 1999 to 2001 by telephone-administered surveys at preintervention and postintervention for 511 low-income, midlife adult women enrolled in the Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program at local North Carolina health departments. During the year after the behavior change program, intervention participants were mailed six sets of computer-tailored health messages and received two computer-tailored telephone counseling sessions. Main outcomes of dietary and physical activity behaviors, beliefs, and attitudes were measured. Results: Intervention participants were more likely to move forward into more advanced stages of physical activity change (p = 0.02); control participants were more likely to increase their level of dietary social support at follow-up (p = 0.05). Both groups maintained low levels of reported saturated fat and cholesterol intake at follow-up. No changes were seen in physical activity in either group. Conclusions: Mailed computer-tailored health messages and telephone counseling calls favorably modified forward physical activity stage movement but did not appreciably affect any other psychosocial or behavioral outcomes

Study protocol: The Adherence and Intensification of Medications (AIM) study - a cluster randomized controlled effectiveness study

Abstract Background Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. Methods In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. Discussion Integration of the three intervention elements - proactive identification, adherence counseling and medication intensification - is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. Trial Registration The ClinicalTrials.gov registration number is NCT00495794.http://deepblue.lib.umich.edu/bitstream/2027.42/78258/1/1745-6215-11-95.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78258/2/1745-6215-11-95.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/78258/3/1745-6215-11-95-S1.DOCPeer Reviewe

Theory-based predictors of multiple clinician behaviors in the management of diabetes

Peer reviewedPostprin

Walk well:a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

Background - Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design - This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion - Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities