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Multidimensional individualised Physical ACTivity (Mi-PACT)--a technology-enabled intervention to promote physical activity in primary care: study protocol for a randomised controlled trial.

ABSTRACT: Low physical activity is a major public health problem. New cost-effective approaches that stimulate meaningful long-term changes in physical activity are required, especially within primary care settings. It is becoming clear that there are various dimensions to physical activity with independent health benefits. Advances in technology mean that it is now possible to generate multidimensional physical activity 'profiles' that provide a more complete representation of physical activity and offer a variety of options that can be tailored to the individual. Mi-PACT is a randomised controlled trial designed to examine whether personalised multidimensional physical activity feedback and self-monitoring alongside trainer-supportive sessions increases physical activity and improves health outcomes in at-risk men and women.We aim to recruit 216 patients from within primary care aged 40 to 70 years and at medium or high risk of cardiovascular disease and/or type II diabetes mellitus. Adopting an unequal allocation ratio (intervention: control) of 2:1, participants will be randomised to one of two groups, usual care or the intervention. The control group will receive usual care from their general practitioner (GP) and standardised messages about physical activity for health. The intervention group will receive physical activity monitors and access to a web-based platform for a 3-month period to enable self-monitoring and the provision of personalised feedback regarding the multidimensional nature of physical activity. In addition, this technology-enabled feedback will be discussed with participants on 5 occasions during supportive one-to-one coaching sessions across the 3-month intervention. The primary outcome measure is physical activity, which will be directly assessed using activity monitors for a 7-day period at baseline, post intervention and at 12 months. Secondary measures (at these time-points) include weight loss, fat mass, and markers of metabolic control, motivation and well-being.Results from this study will provide insight into the effects of integrated physical activity profiling and self-monitoring combined with in-person support on physical activity and health outcomes in patients at risk of future chronic disease.ISRCTN18008011 Trial registration date: 31 July 2013.

SUBMITTER: Peacock OJ

PROVIDER: S-EPMC4552151 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Multidimensional individualised Physical ACTivity (Mi-PACT)--a technology-enabled intervention to promote physical activity in primary care: study protocol for a randomised controlled trial.

Peacock Oliver J OJ Western Max J MJ Batterham Alan M AM Stathi Afroditi A Standage Martyn M Tapp Alan A Bennett Paul P Thompson Dylan D

Trials 20150828

<h4>Background</h4>Low physical activity is a major public health problem. New cost-effective approaches that stimulate meaningful long-term changes in physical activity are required, especially within primary care settings. It is becoming clear that there are various dimensions to physical activity with independent health benefits. Advances in technology mean that it is now possible to generate multidimensional physical activity 'profiles' that provide a more complete representation of physical ...[more]

PMID: 26314577

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Project description:BACKGROUND:Technological progress has enabled the provision of personalised feedback across multiple dimensions of physical activity that are important for health. Whether this multidimensional approach supports physical activity behaviour change has not yet been examined. Our objective was to examine the effectiveness of a novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support in primary care patients identified as at risk of chronic disease. METHODS:MIPACT was a parallel-group, randomised controlled trial that recruited patients at medium (?10 and?<?20%) or high (?20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom. Intervention group participants (n?=?120) received personal multidimensional physical activity feedback using a customised digital system and web-app for 3?months plus five health trainer-led sessions. All participants received standardised information regarding physical activity. Control group participants (n?=?84) received no further intervention. The primary outcome was device-based assessment of physical activity at 12?months. RESULTS:Mean intervention effects were: moderate-vigorous physical activity: -1.1 (95% CI, -?17.9 to 15.7) min/day; moderate-vigorous physical activity in ?10-min bouts: 0.2 (-?14.2 to 14.6) min/day; Physical Activity Level (PAL): 0.00 (-?0.036 to 0.054); vigorous physical activity: 1.8 (-?0.8 to 4.2) min/day; and sedentary time: 10 (-?19.3 to 39.3) min/day. For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID). However, there was profound physical activity multidimensionality, and only a small proportion (5%) of patients had consistently low physical activity across all dimensions. CONCLUSION:In patients at risk of cardiovascular disease and/or type II diabetes, MIPACT did not increase mean physical activity. Using a sophisticated multidimensional digital approach revealed enormous heterogeneity in baseline physical activity in primary care patients, and practitioners may need to screen for low physical activity across dimensions rather than rely on disease-risk algorithms that are heavily influenced by age. TRIAL REGISTRATION:This trial is registered with the ISRCTN registry ( ISRCTN18008011 ; registration date 31 July 2013).

Project description:BackgroundInnovative physical activity monitoring technology can be used to depict rich visual feedback that encompasses the various aspects of physical activity known to be important for health. However, it is unknown whether patients who are at risk of chronic disease would understand such sophisticated personalised feedback or whether they would find it useful and motivating. The purpose of the present study was to determine whether technology-enabled multidimensional physical activity graphics and visualisations are comprehensible and usable for patients at risk of chronic disease.MethodWe developed several iterations of graphics depicting minute-by-minute activity patterns and integrated physical activity health targets. Subsequently, patients at moderate/high risk of chronic disease (n=29) and healthcare practitioners (n=15) from South West England underwent full 7-days activity monitoring followed by individual semi-structured interviews in which they were asked to comment on their own personalised visual feedback Framework analysis was used to gauge their interpretation and of personalised feedback, graphics and visualisations.ResultsWe identified two main components focussing on (a) the interpretation of feedback designs and data and (b) the impact of personalised visual physical activity feedback on facilitation of health behaviour change. Participants demonstrated a clear ability to understand the sophisticated personal information plus an enhanced physical activity knowledge. They reported that receiving multidimensional feedback was motivating and could be usefully applied to facilitate their efforts in becoming more physically active.ConclusionMultidimensional physical activity feedback can be made comprehensible, informative and motivational by using appropriate graphics and visualisations. There is an opportunity to exploit the full potential created by technological innovation and provide sophisticated personalised physical activity feedback as an adjunct to support behaviour change.

Project description:BackgroundMultiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive.Methods/designThis single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life.DiscussionPhysical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS.Trial registrationClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.

Project description:Interventions: The intervention arm will receive a Fitbit to use to monitor physical activity for the duration of the 12-week intervention. Participants who are randomised to the intervention arm will also attend two group sessions which will target goal-setting and action-planning skills. The treatment group will be able to collect the Fitbit post-randomisation. Participants will be able to pick the Fitbit up from the hospital, signing it out upon collection at their first group meeting. They will be asked to wear the Fitbit as much as possible during the 12-week intervention (at least 8 hours per day, preferably all waking hours), and will be encouraged to download Fitbit software that will assist in tracking their physical activity. Use of the Fitbits will provide participants with a practical and convenient method for monitoring their activity. Throughout the 12-week intervention, participants in the treatment group will be required to attend two 1-hour group sessions. The first group session will be held in week 1, and the second in week 4 of the study. Session one will focus on introducing participants to the Fitbit and giving instructions on how to use this device as a self-monitoring tool. Participants will complete goal-setting worksheets (Appendix F - attached to ANZCTR registration form) to set their activity goals for the following 12 weeks. Behaviour change specialists SH and CMS will assist participants with effective action planning, goal-setting and self-monitoring. Session two will attend to support needs and help participants to plan for and overcome barriers to increasing their physical activity level. Participants will also be able to adjust previously established goals, if necessary. This session will also allow for trouble-shooting of any problems or queries that participants encounter regarding Fitbit wear and use. Participants will take all worksheets from the sessions home with them, to assist with achieving their goals. At the end of the Primary outcome(s): Minutes of activity per week as measured by accelerometer wear for 7 days. [12 weeks after baseline];Minutes of sedentary time as measured by accelerometer wear for 7 days.[12 weeks after baseline. ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:BACKGROUND:Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. OBJECTIVE:The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. METHODS:Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients' experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). RESULTS:A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; Pinteraction=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; Pinteraction=.004; effect size of -0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; Pinteraction=.004; effect size of -0.36) remained constant, but deteriorated in UC. CONCLUSIONS:This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. TRIAL REGISTRATION:ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1136/bmjopen-2017-016781.

Project description:BackgroundCurrent practice guidelines emphasize the use of physical activity as the first-line treatment of knee osteoarthritis; however, up to 90% of people with osteoarthritis are inactive.ObjectiveWe aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed diagnosis of knee osteoarthritis or having passed two validated criteria for early osteoarthritis.MethodsWe conducted a proof-of-concept randomized controlled trial. The immediate group received a brief education session by a physical therapist, a Fitbit Flex, and four biweekly phone calls for activity counseling. The delayed group received the same intervention 2 months later. Participants were assessed at baseline (T0) and at the end of 2 months (T1), 4 months (T2), and 6 months (T3). Outcomes included (1) mean time on moderate-to-vigorous physical activity (MVPA ≥3 metabolic equivalents [METs], primary outcome), (2) mean time on MVPA ≥4 METs, (3) mean daily steps, (4) mean time on sedentary activities, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (6) Partners in Health scale. Mixed-effects repeated measures analysis of variance was used to assess five planned contrasts of changes in outcome measures over measurement periods. The five contrasts were (1) immediate T1-T0 vs delayed T1-T0, (2) delayed T2-T1 vs delayed T1-T0, (3) mean of contrast 1 and contrast 2, (4) immediate T1-T0 vs delayed T2-T1, and (5) mean of immediate T2-T1 and delayed T3-T2. The first three contrasts estimate the between-group effects. The latter two contrasts estimate the effect of the 2-month intervention delay on outcomes.ResultsWe recruited 61 participants (immediate: n=30; delayed: n=31). Both groups were similar in age (immediate: mean 61.3, SD 9.4 years; delayed: mean 62.1, SD 8.5 years) and body mass index (immediate: mean 29.2, SD 5.5 kg/m2; delayed: mean 29.2, SD 4.8 kg/m2). Contrast analyses revealed significant between-group effects in MVPA ≥3 METs (contrast 1 coefficient: 26.6, 95% CI 4.0-49.1, P=.02; contrast 3 coefficient: 26.0, 95% CI 3.1-49.0, P=.03), daily steps (contrast 1 coefficient: 1699.2, 95% CI 349.0-3049.4, P=.02; contrast 2 coefficient: 1601.8, 95% CI 38.7-3164.9, P=.045; contrast 3 coefficient: 1650.5, 95% CI 332.3-2968.7; P=.02), KOOS activity of daily living subscale (contrast 1 coefficient: 6.9, 95% CI 0.1-13.7, P=.047; contrast 3 coefficient: 7.2, 95% CI 0.8-13.6, P=.03), and KOOS quality of life subscale (contrast 1 coefficient: 7.4, 95% CI 0.0-14.7, P=.049; contrast 3 coefficient: 7.3, 95% CI 0.1-14.6, P=.048). We found no significant effect in any outcome measures due to the 2-month delay of the intervention.ConclusionsOur counseling program improved MVPA ≥3 METs, daily steps, activity of daily living, and quality of life in people with knee osteoarthritis. These findings are important because an active lifestyle is an important component of successful self-management.Trial registrationClinicalTrials.gov NCT02315664; https://clinicaltrials.gov/ct2/show/NCT02315664 (Archived by WebCite at http://www.webcitation.org/6ynSgUyUC).

Dataset Information

Multidimensional individualised Physical ACTivity (Mi-PACT)--a technology-enabled intervention to promote physical activity in primary care: study protocol for a randomised controlled trial.

Publications

Multidimensional individualised Physical ACTivity (Mi-PACT)--a technology-enabled intervention to promote physical activity in primary care: study protocol for a randomised controlled trial.

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