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Background: During the recent decade presence of digital media, especially handheld devices, in everyday life, has been increasing. Survey data suggests that children and adults spend much of their leisure on screen media, including use of social media and video services. Despite much public debate on possible harmful effects of such behavioral shifts, evidence from rigorously conducted randomized controlled trials in free-living settings, investigating the efficacy of reducing screen media use on physical activity, sleep, and physiological stress, is still lacking. Therefore, a family and home-based randomized controlled trial - the SCREENS trial - is being conducted. Here we describe in detail the rationale and protocol of this study.Methods: The SCREENS pilot trial was conducted during the fall of 2018 and spring of 2019. Based on experiences from the pilot study, we developed a protocol for a parallel group randomized controlled trial. The trial is being conducted from May 2019 to ultimo 2020 in 95 families with children 4-14 years recruited from a population-based survey. As part of the intervention family members must handover most portable devices for a 2-week time frame, in exchange for classic mobile phones (not smartphones). Also, entertainment-based screen media use during leisure must be limited to no more than 3 hours/week/person. At baseline and follow-up, 7-day 24-h physical activity will be assessed using two triaxial accelerometers; one at the right hip and one the middle of the right thigh. Sleep duration will be assessed using a single channel EEG-based sleep monitor system. Also, to assess physiological stress (only assessed in adults), parameters of 24-h heart rate variability, the cortisol awakening response and diurnal cortisol slope will be quantified using data sampled over three consecutive days. During the study we will objectively monitor the families' screen media use via different software and hardware monitoring systems.Discussion: Using a rigorous study design with state-of-the-art methodology to assess outcomes and intervention compliance, analyses of data from the SCREENS trial will help answer important causal questions of leisure screen media habits and its short-term influence on physical activity, sleep, and other health related outcomes among children and adults.Trial Registration: NCT04098913 at https://clinicaltrials.gov [20-09-2019, retrospectively registered]. [ABSTRACT FROM AUTHOR]

Background: Physical activity can decrease the risk of complications related to diabetes type 2. Feasible and scalable strategies to implement support for a healthy lifestyle for patients in primary care are needed. The aim of the DiaCert-study is to evaluate a digital healthcare platform and the effect of a 12-week long smartphone-app physical activity intervention aiming at increasing physical activity (primary outcome) and improve levels of HbA1c (glycated hemoglobin), blood lipids, blood pressure, body composition, as well as other lifestyle factors and overall health in patients with diabetes type 2.Methods/design: The DiaCert-study is a two-arm, randomized controlled trial that will include 250 patients with diabetes type 2. At baseline, participants are randomized 1:1 to intervention, i.e. use of the smartphone-app, during 12 weeks, or to a control group receiving only standard care. Physical activity and sedentary behavior, is objectively measured using the Actigraph GT3X. Biomarkers including HbA1c and blood lipids are measured in fasting blood samples. Anthropometrics include height, weight, waist circumference and body composition, and a number of lifestyle factors including sleep, diet, self-efficacy, and quality of life, are assessed through an extensive questionnaire. Measurements are made at baseline and at follow-up after 3, 6 and 12 months.Discussion: Using new technology, is one way to bridge the gap between what patients need and what health care can offer. This study evaluates a new digital health care platform and will show if use of a smartphone-app to promote daily steps is an effective and feasible method to increase physical activity and improve clinical markers in patients with diabetes type 2.Trial Registration: ClinicalTrials.gov Identifier: NCT03053336 ; 7 Feb, 2017. [ABSTRACT FROM AUTHOR]

Background: Coordinated, multi-component school-based interventions can improve health behaviors in children, as well as parents, and impact the weight status of students. By leveraging a unique collaboration between Texas AgriLife Extension (a federal, state and county funded educational outreach organization) and the University of Texas School of Public Health, the Texas Grow! Eat! Go! Study (TGEG) modeled the effectiveness of utilizing existing programs and volunteer infrastructure to disseminate an enhanced Coordinated School Health program. The five-year TGEG study was developed to assess the independent and combined impact of gardening, nutrition and physical activity intervention(s) on the prevalence of healthy eating, physical activity and weight status among low-income elementary students. The purpose of this paper is to report on study design, baseline characteristics, intervention approaches, data collection and baseline data.Methods: The study design for the TGEG study consisted of a factorial group randomized controlled trial (RCT) in which 28 schools were randomly assigned to one of 4 treatment groups: (1) Coordinated Approach to Child Health (CATCH) only (Comparison), (2) CATCH plus school garden intervention [Learn, Grow, Eat & Go! (LGEG)], (3) CATCH plus physical activity intervention [Walk Across Texas (WAT)], and (4) CATCH plus LGEG plus WAT (Combined). The outcome variables include student's weight status, vegetable and sugar sweetened beverage consumption, physical activity, and sedentary behavior. Parents were assessed for home environmental variables including availability of certain foods, social support of student health behaviors, parent engagement and behavior modeling.Results: Descriptive data are presented for students (n = 1369) and parents (n = 1206) at baseline. The sample consisted primarily of Hispanic and African American (53 % and 18 %, respectively) and low-income (i.e., 78 % eligible for Free and Reduced Price School Meals program and 43 % food insecure) students. On average, students did not meet national guidelines for vegetable consumption or physical activity. At baseline, no statistical differences for demographic or key outcome variables among the 4 treatment groups were observed.Conclusions: The TGEG study targets a population of students and parents at high risk of obesity and related chronic conditions, utilizing a novel and collaborative approach to program formulation and delivery, and a rigorous, randomized study design. [ABSTRACT FROM AUTHOR]

Background: The aims of this report were 1) to describe the duration of moderate to vigorous physical activity (MVPA) and the proportion of participants meeting the recommended criterion of at least 150 min of MVPA per week as measured by the 7 Day Physical Activity Recall Questionnaire (7D-PAR) and accelerometer among women who were enrolled in the mPED trial; 2) to assess the level of agreement of the two measures using a Bland-Altman plot; and 3) to describe the positive and negative predictive values (PPV and NPV, respectively) of meeting the guidelines by calculating the percentage of women meeting the physical activity recommendation by the 7D-PAR who also met this recommendation based on data from the accelerometer.Methods: Baseline data on duration of MVPA from the mPED trial were analyzed for 215 women. Among the women who met the recommended criterion by the 7D-PAR (self-report), we calculated the proportion of individuals who also met it by the accelerometer (objective measure). A Bland Altman Plot was used to assess concordance between the two measures.Results: The mean age was 52.4 (±11.2) years; 54.4 % were white; and 48.8 % were single or divorced. While median MVPA was 160 min/week by the 7D-PAR, it was only 24 min/week in the accelerometer. A total of 117 women met the 150-min criterion by the 7D-PAR. Of these, only 18 also met the criterion by the objective measure (PPV 15.4 %, 95 % CI 9.4-23.2 %). Among the 98 women who did not meet the criterion by the 7D-PAR, none met it by the accelerometer (NPV 100 %). A Bland Altman plot showed the mean difference of +145 min between the two measures with a 95 % limit of agreement at + 471 to -181 min.Conclusions: The large discrepancy between the self-reported and objective measures of MVPA meeting the 150-min criterion suggests that self-reported physical activity measures should be used with caution in intervention studies. While our data suggest that self-report could be used to identify a physically inactive sample, it would be likely to over-estimate the proportions of women who become active in one or both arms of trials of interventions promoting MVPA.Trial Registration: ClinicalTrials.gov NCT01280812. [ABSTRACT FROM AUTHOR]

Background: After-school programs represent a promising opportunity to assist adolescent girls' in attaining adequate physical activity. Although evaluating the process of intervention implementation is important for determining if an intervention was delivered and received as intended, comprehensive information about process evaluation methods and results are rarely reported. The purpose of this article was to evaluate the reach, dose, and fidelity of a 90-minute after-school physical activity club offered 3 days a week. The club is 1 of 3 components included in a 17-week intervention designed for 5th-8th grade girls, the majority of whom were of minority and/or low socioeconomic status.Methods: A total of 24 schools (12 intervention; 12 control) and 56-67 girls per school (total N = 1519 girls) were included in the Girls on the Move group randomized controlled trial. At the beginning of each of 3 academic years (2012-2015), 8 schools per year were randomized to receive either the intervention (n = 4) or control condition (n = 4). To evaluate the club, data collected via surveys from girls, club coaches and managers, and process evaluators were analyzed. To evaluate the opportunity for physical activity provided by the coaches and managers, process evaluators used an observation tool based on the System for Observing Fitness Instruction Time and Academic Learning Time - Physical Education. Girls wore accelerometers every other week during the club time.Results: Mean attendance was 41 % with the average attendance in year 3 being higher than rates for years 1 or 2. Mean moderate-to-vigorous physical activity time was 21.85 minutes measured via accelerometry and 21.81 minutes observed by process evaluators. Satisfaction with the intervention was high. For the most part, process evaluators perceived the club was delivered as planned and reflected constructs of the Health Promotion Model and Self-Determination Theory. Areas contributing to success included using incentives and offering a variety of activities. Issues negatively impacting implementation included managing behavioral problems, having limited space for moderate-to-vigorous physical activity, dealing with inclement weather, and getting coaches to actively participate in all physical activities with the girls.Conclusions: This process evaluation provides important information to guide future school-based physical activity intervention delivery. Barriers to implementation have been identified. Ways to overcome them warrant consideration when designing physical activity interventions. Research is needed to test innovative approaches for enhancing attendance and increasing girls' moderate-to-vigorous physical activity in after-school programs.Trial Registration: ClinicalTrials.gov Identifier NCT01503333 . Registered 23 December, 2011. [ABSTRACT FROM AUTHOR]

Background: Sedentary behaviour is an independent risk factor for mortality and morbidity, especially for type 2 diabetes. Since office work is related to long periods that are largely sedentary, it is of major importance to find ways for office workers to engage in light intensity physical activity (LPA). The Inphact Treadmill study aims to investigate the effects of installing treadmill workstations in offices compared to conventional workstations. Methods/Design: A two-arm, 13-month, randomized controlled trial (RCT) will be conducted. Healthy overweight and obese office workers (n = 80) with mainly sedentary tasks will be recruited from office workplaces in Umeå, Sweden. The intervention group will receive a health consultation and a treadmill desk, which they will use for at least one hour per day for 13 months. The control group will receive the same health consultation, but continue to work at their regular workstations. Physical activity and sedentary time during workdays and non-workdays as well as during working and non-working hours on workdays will be measured objectively using accelerometers (Actigraph and activPAL) at baseline and after 2, 6, 10, and 13 months of follow-up. Food intake will be recorded and metabolic and anthropometric variables, body composition, stress, pain, depression, anxiety, cognitive function, and functional magnetic resonance imaging will be measured at 3–5 time points during the study period. Interviews with participants from the intervention group will be performed at the end of the study. Discussion: This will be the first long-term RCT on the effects of treadmill workstations on objectively measured physical activity and sedentary time as well as other body functions and structures/morphology during working and non-working hours among office workers. This will provide further insight on the effects of active workstations on our health and could fill in some of the knowledge gaps regarding how we can reduce sedentary time in office environments. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) is recognized as a systemic illness with significant extra-pulmonary features, such as exercise intolerance and muscle weakness. Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD. However, limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care. Furthermore, it is unknown if improved exercise capacity translates into enhanced daily physical activities. The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD. Methods/design: In this randomized controlled trial situated in the primary care setting, 102 patients with mild to moderate airflow obstruction (FEV1 ≥ 50% of predicted), dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group. The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice, which includes exercise training, resistance training, breathing exercises and advises on how to increase the level of physical activity. The control group receives usual care, i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected. Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance. Secondary outcomes include peripheral muscle strength, physical activity in daily life, health related quality of life, Medical Research Council (MRC) dyspnoea score and patients' perceived effectiveness. Follow-up measurement will take place at 6 months after baseline. Discussion: This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care. The results of this trial may give a unique insight into the potential of the implementation of an easy, close-to-home rehabilitation programme. [ABSTRACT FROM AUTHOR]

Background: Exercise may be a promising target for depression interventions. However, evidence for a beneficial effect of exercise interventions on the prevention of depression differs substantially across different studies.Methods: A systematic search was performed up to July 2018 using PubMed, Embase, PsycINFO, and Cochrane. Articles were included if a meta-analysis of randomized controlled trials was performed that examined the effect of exercise interventions on the onset of depression or depressive symptoms in the general population. Meta-analyses focusing on treatment of diagnosed depression were excluded. Two authors independently screened the articles and graded the quality of included meta-analyses using AMSTAR 2.Results: Eight meta-analyses were included that showed little overlap in 134 included studies. All meta-analyses reported on depressive symptoms rather than onset of depression. Five of these were rated as moderate quality and three of low quality. Six meta-analyses found significant effects, and two found non-significant effects of exercise interventions in reducing depressive symptoms in children, adolescents, adults and the elderly (effect sizes ranging from - 0.10 to - 0.81). Scarce evidence did not allow to draw conclusions about the role of sex and characteristics of exercise on depression. However, some findings suggest that low intensity exercise was as effective as high intensity exercise. Heterogeneity among primary studies was high, likely caused by differences in study quality and exercise characteristics.Conclusions: The evidence from this study suggests that exercise interventions have a beneficial effect on depressive symptoms in the general population across a wide age-range. [ABSTRACT FROM AUTHOR]

Background: WOPAP is a theoretically-grounded workplace physical activity intervention that aims to reduce work-related burnout and to improve vigor at work and other work-related outcomes. Using a randomized controlled trial, we investigate whether a 10-week program including two Nordic walking sessions per week is effective in improving employee well-being at work, in comparison with another attractive leisure activity (Theatre condition) or a waiting list control condition. The design of the study makes it possible to test the effect on burnout and vigor of the instructor's style during physical activity (i.e., traditional vs. need-supportive style). Finally, this study is also interested in several possible psychological (i.e., detachment, relaxation, mastery, control, relatedness, and positive affects experiences) and physiological (i.e., cardiorespiratory fitness) mechanisms through which the practice of physical activity in the intervention could influence burnout and vigor.Methods: Employees of the authors' University (N = 140) will be recruited via email, leaflets, and posters. Participants will be randomized to one of the four arms of the trial: (1) Physical Activity Traditional Style, (2) Physical Activity Need-Supportive Style, (3) Theatre condition, and (4) Waiting List Control. The experimental phase will last 10 weeks, followed by a six-month follow-up. During the ten weeks of the intervention, all groups - except the waiting list control - will carry out two activity sessions per week. Primary outcomes are burnout and vigor, secondary outcomes are work motivation, job satisfaction, work performance and work ability. These variables will be assessed before and after the intervention, and at three and six months after the end of the intervention. Moreover, burnout, vigor, needs satisfaction at work and psychological mediators will be assessed weekly throughout the intervention period.Discussion: If effective, this study will provide evidence for the promotion of workplace physical activity interventions including a need-supportive climate to improve employee well-being. Results could be used to design new research protocols, but also to implement more efficient programs in the workplace.Trial Registration: ISRCTN12725337 . Registered 21 March 2018. Registered retrospectively. [ABSTRACT FROM AUTHOR]