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App-technology to improve lifestyle behaviors among working adults - the Health Integrator study, a randomized controlled trial.
Bonn, SE, Löf, M, Östenson, CG, Trolle Lagerros, Y
BMC public health. 2019;19(1):273
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Lifestyle is the single most important factor to improve health and decrease premature death. Digital solutions for implementing lifestyle change and tracking different types of health data are becoming popular preventative initiatives. The main aim of this study was to evaluate whether a digital platform (The Health Integrator) accessible via a smartphone-app offering lifestyle intervention, with and without additional health coach guidance, can be used to make lifestyle changes and improve health related quality of life in gainfully employed persons. The Health Integrator intervention study is a three-arm parallel randomized controlled trial. Participants were randomized to 1 of 3 groups: 1) intervention using Health Integrator and a monthly telephone session with the health coach during the 3 months of follow-up or 2) intervention using Health Integrator without extra health coach sessions or 3) control group which is not given any lifestyle advise during the intervention period. The study is still ongoing. However, mobile Health has been suggested as one way to take global action as it has the potential to make treatment and prevention widely accessible at a fraction of the current cost. In fact, Health Integrator was developed on the basis of previous research. Current literature shows that multi-component interventions including for example face-to-face counselling or provision of physical activity equipment in addition to an app, were more successful than a stand-alone app intervention.
Abstract
BACKGROUND Mobile health, mHealth is recognized as a strategy to improve lifestyle behaviors. Research targeting specific lifestyle behaviors has shown that interventions using smartphones can be effective. However, few studies have evaluated solutions with multicomponent interventions, tailoring the intervention to the specific needs of the participant using a combination of mHealth and conventional treatment. To accomplish this, we developed Health Integrator, an mHealth platform with services and offers in the areas of diet, physical activity, sleeping habits, stress, alcohol and tobacco use. In the system, the user selects an area of intervention together with a health coach and set weekly goals. This study protocol presents the design and methodology of the Health Integrator Study, a randomized controlled trial to promote improved lifestyle behaviors. METHODS A three-arm parallel randomized controlled trial (1:1:1) is conducted in the Stockholm County, Sweden. In total, 209 employees at a four different companies representing both white and blue collar workers, have been recruited. Participants are randomized to either a control group or to one of two intervention groups receiving a 3-month lifestyle behavior change program including either 1) use of Health Integrator and monthly health coaching sessions or 2) only Health Integrator. At baseline and follow-up after 3- and 6-months, all participants answer questionnaires assessing lifestyle behaviors and quality of life. At baseline and the 3-month follow-up (end of intervention period), weight, height, waist circumference and blood pressure are measured, and all participants wear an Actigraph accelerometer for 7 days to assess physical activity. Blood lipid profile and HbA1c are measured among all participants at baseline. If baseline measures fall outside the normal range, a second measurement is done after 3 months. DISCUSSION The Health Integrator Intervention Study will evaluate if a personalized intervention combining mHealth and conventional programs for lifestyle change, with or without additional health coach sessions, can improve lifestyle behaviors and quality of life. Based on the results from this trial, Health Integrator can easily be implemented within a broad public. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03579342 . Retrospectively registered, first submitted May 8, 2018.
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Influence of combined functional resistance and endurance exercise over 12 weeks on matrix metalloproteinase-2 serum concentration in persons with relapsing-remitting multiple sclerosis - a community-based randomized controlled trial.
Proschinger, S, Joisten, N, Rademacher, A, Schlagheck, ML, Walzik, D, Metcalfe, AJ, Oberste, M, Warnke, C, Bloch, W, Schenk, A, et al
BMC neurology. 2019;19(1):314
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Multiple Sclerosis (MS) is a degenerative autoimmune neuroinflammatory disease where the blood-brain barrier is compromised, causing inflammation. Regular exercise has been shown to support psychomotor symptoms and improve mobility. This trial examines the effects of resistance and endurance exercise in 64 patients, aged 18-45 years, with relapsing-remitting MS (RRMS). The patients are divided into an exercise group and a passive group. The exercise group will perform 60 min of combined functional resistance and endurance exercises 3x per week over a period of 12 weeks. Blood samples will be taken to measure proteolytic matrix metalloproteinases (MMP) as an indicator of neurological inflammation. Secondary measures will also be taken to evaluate patient-reported outcomes regarding gait, sleep, depression, anxiety, fatigue, and quality of life. The study is currently ongoing, so the results are not yet published. From an ethical perspective the passive group will also be offered the opportunity to perform the same exercises at the end of the trial.
Abstract
BACKGROUND The relevance of regular moderate to intense exercise for ameliorating psychomotor symptoms in persons with multiple sclerosis (pwMS) is becoming increasingly evident. Over the last two decades, emerging evidence from clinical studies and animal models indicate immune regulatory mechanisms in both periphery and the central nervous system that may underlie these beneficial effects. The integrity of the blood-brain barrier as the main structural interface between periphery and brain seems to play an important role in MS. Reducing the secretion of proteolytic matrix metalloproteinases (MMP), i.e. MMP-2, as disruptors of blood-brain barrier integrity could have profound implications for MS. METHODS In this two-armed randomized controlled trial 64 participants with relapsing-remitting MS (RRMS) (EDSS 0-4.0) will be allocated to either an intervention group or a passive wait list control group. The intervention group will perform 60 min of combined functional resistance and endurance exercises 3x per week over a period of 12 weeks in a community-based and publicly available setting. Changes in serum concentration of MMP-2 will be the primary outcome. Secondary outcomes are numbers of immune cell subsets, soluble (anti-) inflammatory factors, physical capacity, cognitive performance, physical activity behavior, gait performance, and patient-reported outcomes. All outcome measures will be assessed at baseline and after week 12 with an additional blood sampling before, during and immediately after a single training session in week 6. DISCUSSION To our knowledge, this will be the first RCT to investigate both the acute and chronic effects of a community-based intense functional resistance and endurance exercise regimen in persons with RRMS. Combining analysis of biological and cognitive or psychological outcomes may provide a better understanding of the MS-specific symptomology. TRIAL REGISTRATION DRKS00017091; 05th of April, 2019; International Clinical Trials Registry Platform.
