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      Digital interventions to promote physical activity among inactive adults: A study protocol for a hybrid type I effectiveness-implementation randomized controlled trial

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          Abstract

          Introduction

          Physical inactivity is the fourth leading risk factor for global mortality, and inactive adults have a higher risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy of fitness technologies and other digital interventions for physical activity (PA) promotion. Intervention studies are needed to test the effectiveness and implementation of innovative PA promotion strategies.

          Methods and analysis

          The ONWARDS study is a hybrid type I effectiveness-implementation randomized control trial aiming at an inactive and presumably high-risk population living in Northern Norway. One hundred and eighty participants will be assigned to 3 groups in a 1:1:1 ratio and participate for 18 months. Participants in group A will be provided an activity tracker with the personalized metric Personal Activity Intelligence (PAI). Participants in group B will be provided with both an activity tracker with the personalized metric PAI and access to online training videos (Les Mills+) to perform home-based training. Participants in group C will be provided an activity tracker with the personalized metric PAI, home-based online training and additional peer support via social media. The primary objective is to test which combination of interventions is more effective in increasing PA levels and sustaining long-term exercise adherence. Secondary objectives include: proportion of participants reaching PA recommendations; exercise adherence; physical fitness; cardiovascular risk; quality of life; perceived competence for exercise; self-efficacy; social support; usability; users' perspectives on implementation outcomes (adoption, acceptability, adherence, sustainability). The study design will allow testing the effectiveness of the interventions while gathering information on implementation in a real-world situation.

          Discussion

          This study can contribute to reduce disparities in PA levels among inactive adults by promoting PA and long-term adherence. Increased PA might, in turn, result in better prevention of lifestyle diseases. Digital interventions delivered at home can become an alternative to training facilities, making PA accessible and feasible for inactive populations and overcoming known barriers to PA. If effective, such interventions could potentially be offered through national health portals to citizens who do not meet the minimum recommendations on PA or prescribed by general practitioners or specialists.

          Trial registration

          https://clinicaltrials.gov/ct2/show/NCT04526444, Registered 23 April 2021, identifier: NCT04526444.

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          Most cited references51

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          World Health Organization 2020 guidelines on physical activity and sedentary behaviour

          Objectives To describe new WHO 2020 guidelines on physical activity and sedentary behaviour. Methods The guidelines were developed in accordance with WHO protocols. An expert Guideline Development Group reviewed evidence to assess associations between physical activity and sedentary behaviour for an agreed set of health outcomes and population groups. The assessment used and systematically updated recent relevant systematic reviews; new primary reviews addressed additional health outcomes or subpopulations. Results The new guidelines address children, adolescents, adults, older adults and include new specific recommendations for pregnant and postpartum women and people living with chronic conditions or disability. All adults should undertake 150–300 min of moderate-intensity, or 75–150 min of vigorous-intensity physical activity, or some equivalent combination of moderate-intensity and vigorous-intensity aerobic physical activity, per week. Among children and adolescents, an average of 60 min/day of moderate-to-vigorous intensity aerobic physical activity across the week provides health benefits. The guidelines recommend regular muscle-strengthening activity for all age groups. Additionally, reducing sedentary behaviours is recommended across all age groups and abilities, although evidence was insufficient to quantify a sedentary behaviour threshold. Conclusion These 2020 WHO guidelines update previous WHO recommendations released in 2010. They reaffirm messages that some physical activity is better than none, that more physical activity is better for optimal health outcomes and provide a new recommendation on reducing sedentary behaviours. These guidelines highlight the importance of regularly undertaking both aerobic and muscle strengthening activities and for the first time, there are specific recommendations for specific populations including for pregnant and postpartum women and people living with chronic conditions or disability. These guidelines should be used to inform national health policies aligned with the WHO Global Action Plan on Physical Activity 2018–2030 and to strengthen surveillance systems that track progress towards national and global targets.
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            SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

            High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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              Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda

              An unresolved issue in the field of implementation research is how to conceptualize and evaluate successful implementation. This paper advances the concept of “implementation outcomes” distinct from service system and clinical treatment outcomes. This paper proposes a heuristic, working “taxonomy” of eight conceptually distinct implementation outcomes—acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability—along with their nominal definitions. We propose a two-pronged agenda for research on implementation outcomes. Conceptualizing and measuring implementation outcomes will advance understanding of implementation processes, enhance efficiency in implementation research, and pave the way for studies of the comparative effectiveness of implementation strategies.
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                Author and article information

                Contributors
                Journal
                Front Public Health
                Front Public Health
                Front. Public Health
                Frontiers in Public Health
                Frontiers Media S.A.
                2296-2565
                21 October 2022
                2022
                : 10
                : 925484
                Affiliations
                [1] 1Norwegian Centre for E-health Research, University Hospital of North Norway , Tromsø, Norway
                [2] 2Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway , Tromsø, Norway
                [3] 3School of Sport Sciences, UiT The Arctic University of Norway , Tromsø, Norway
                [4] 4Memento U , Trondheim, Norway
                [5] 5Norwegian National Advisory Unit on Exercise Training as Medicine for Cardiopulmonary Condition, St. Olavs Hospital , Trondheim, Norway
                [6] 6K.G. Jebsen Center for Exercise in Medicine - CERG, Norwegian University of Science and Technology , Trondheim, Norway
                [7] 7Les Mills International , Auckland, New Zealand
                [8] 8Faculty of Nursing, Université Laval , Québec, QC, Canada
                [9] 9SINTEF Digital , Oslo, Norway
                Author notes

                Edited by: Victor Zuniga Dourado, Federal University of São Paulo, Brazil

                Reviewed by: Alana D. Steffen, University of Illinois at Chicago, United States; Letizia Leocani, San Raffaele Hospital (IRCCS), Italy; Chao-Yu Guo, National Yang Ming Chiao Tung University, Taiwan

                *Correspondence: Paolo Zanaboni paolo.zanaboni@ 123456ehealthresearch.no

                This article was submitted to Digital Public Health, a section of the journal Frontiers in Public Health

                Article
                10.3389/fpubh.2022.925484
                9634084
                36339169
                d6736069-33d8-4cc8-bb99-702fb51ab498
                Copyright © 2022 Zanaboni, Manskow, Sagelv, Morseth, Edvardsen, Aamot, Nes, Hastings, Gagnon and Antypas.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 21 April 2022
                : 07 October 2022
                Page count
                Figures: 2, Tables: 1, Equations: 0, References: 51, Pages: 10, Words: 6780
                Funding
                Funded by: Helse Nord RHF, doi 10.13039/501100007137;
                Award ID: HNF1428-18
                Categories
                Public Health
                Study Protocol

                physical activity,digital interventions,e-health,mobile health,lifestyle diseases,randomized controlled trial

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