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      The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

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          Abstract

          Background

          Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED ( mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions.

          Methods

          A randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity.

          Discussion

          If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth.

          Trial Registration

          ClinicalTrials.gov#: NCTO1280812

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          Most cited references26

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          A 12-Item Short-Form Health Survey

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            Physical fitness and all-cause mortality. A prospective study of healthy men and women.

            We studied physical fitness and risk of all-cause and cause-specific mortality in 10,224 men and 3120 women who were given a preventive medical examination. Physical fitness was measured by a maximal treadmill exercise test. Average follow-up was slightly more than 8 years, for a total of 110,482 person-years of observation. There were 240 deaths in men and 43 deaths in women. Age-adjusted all-cause mortality rates declined across physical fitness quintiles from 64.0 per 10,000 person-years in the least-fit men to 18.6 per 10,000 person-years in the most-fit men (slope, -4.5). Corresponding values for women were 39.5 per 10,000 person-years to 8.5 per 10,000 person-years (slope, -5.5). These trends remained after statistical adjustment for age, smoking habit, cholesterol level, systolic blood pressure, fasting blood glucose level, parental history of coronary heart disease, and follow-up interval. Lower mortality rates in higher fitness categories also were seen for cardiovascular disease and cancer of combined sites. Attributable risk estimates for all-cause mortality indicated that low physical fitness was an important risk factor in both men and women. Higher levels of physical fitness appear to delay all-cause mortality primarily due to lowered rates of cardiovascular disease and cancer.
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              Using pedometers to increase physical activity and improve health: a systematic review.

              Without detailed evidence of their effectiveness, pedometers have recently become popular as a tool for motivating physical activity. To evaluate the association of pedometer use with physical activity and health outcomes among outpatient adults. English-language articles from MEDLINE, EMBASE, Sport Discus, PsychINFO, Cochrane Library, Thompson Scientific (formerly known as Thompson ISI), and ERIC (1966-2007); bibliographies of retrieved articles; and conference proceedings. Studies were eligible for inclusion if they reported an assessment of pedometer use among adult outpatients, reported a change in steps per day, and included more than 5 participants. Two investigators independently abstracted data about the intervention; participants; number of steps per day; and presence or absence of obesity, diabetes, hypertension, or hyperlipidemia. Data were pooled using random-effects calculations, and meta-regression was performed. Our searches identified 2246 citations; 26 studies with a total of 2767 participants met inclusion criteria (8 randomized controlled trials [RCTs] and 18 observational studies). The participants' mean (SD) age was 49 (9) years and 85% were women. The mean intervention duration was 18 weeks. In the RCTs, pedometer users significantly increased their physical activity by 2491 steps per day more than control participants (95% confidence interval [CI], 1098-3885 steps per day, P < .001). Among the observational studies, pedometer users significantly increased their physical activity by 2183 steps per day over baseline (95% CI, 1571-2796 steps per day, P < .0001). Overall, pedometer users increased their physical activity by 26.9% over baseline. An important predictor of increased physical activity was having a step goal such as 10,000 steps per day (P = .001). When data from all studies were combined, pedometer users significantly decreased their body mass index by 0.38 (95% CI, 0.05-0.72; P = .03). This decrease was associated with older age (P = .001) and having a step goal (P = .04). Intervention participants significantly decreased their systolic blood pressure by 3.8 mm Hg (95% CI, 1.7-5.9 mm Hg, P < .001). This decrease was associated with greater baseline systolic blood pressure (P = .009) and change in steps per day (P = .08). The results suggest that the use of a pedometer is associated with significant increases in physical activity and significant decreases in body mass index and blood pressure. Whether these changes are durable over the long term is undetermined.
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                Author and article information

                Journal
                BMC Public Health
                BMC Public Health
                BioMed Central
                1471-2458
                2011
                14 December 2011
                : 11
                : 933
                Affiliations
                [1 ]Institute for Health & Aging, Department of Social and Behavioral Sciences, University of California, San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94143, USA
                [2 ]Institute for Health & Aging, University of San Francisco, San Francisco, CA, USA
                [3 ]Information Services Unit, University of California, San Francisco School of Medicine, San Francisco, CA, USA
                [4 ]Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA
                [5 ]Stanford Prevention Research Center, School of Medicine, Stanford University, Palo Alto, CA, USA
                Article
                1471-2458-11-933
                10.1186/1471-2458-11-933
                3295748
                22168267
                4593f0fe-ef21-4f9d-90d5-ba4aeccb5214
                Copyright ©2011 Fukuoka et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 October 2011
                : 14 December 2011
                Categories
                Study Protocol

                Public health
                Public health

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