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      A Self-Directed Mobile Intervention (WaznApp) to Promote Weight Control Among Employees at a Lebanese University: Protocol for a Feasibility Pilot Randomized Controlled Trial

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          Abstract

          Background

          Overweight and obesity have become major health problems globally with more than 1.9 billion overweight adults. In Lebanon, the prevalence of obesity and overweight is 65.4% combined. Risk factors of obesity and overweight are preventable and can be addressed by modifications in the environment and in an individual’s lifestyle. Mobile technologies are increasingly used in behavioral, self-directed weight management interventions, providing users with additional opportunities to attain weight control (weight loss, weight gain prevention, etc). Mobile apps may allow for the delivery of Just-in-Time Adaptive Interventions (JITAIs), which provide support through skill building, emotional support, and instrumental support, following the participants’ progress. A few commercially available apps offer JITAI features, but no studies have tested their efficacy.

          Objective

          The primary objective of this study is to examine the feasibility of a self-directed weight loss intervention, targeting employees of an academic institution, using a virtual coaching app with JITAI features (Lark) and a self-help calorie-counting app (MyFitnessPal). The secondary objective is to estimate the effects of the intervention on main study outcomes.

          Methods

          This study is a single-center, parallel, randomized controlled trial with 2 study arms (intervention and control). Participants will be randomly allocated in equal proportions to the intervention (Lark) and control groups (MyFitnessPal). To be eligible for this study, participants must be employed full- or part-time at the university or its medical center, able to read English, have a smartphone, and be interested in controlling their weight. Recruitment strategies entail email invitations, printed posters, and social media postings. We will assess quantitative rates of recruitment, adherence, and retention, self-reported app quality using the user version of the Mobile App Rating Scale. We will also assess changes in weight-related outcomes (absolute weight and waist circumference), behavioral outcomes (physical activity and diet), and cognitive factors (motivation to participate in the trial and to manage weight).

          Results

          WaznApp was funded in June 2017, and recruitment started in March 2018.

          Conclusions

          This study will provide information as to whether the selected mobile apps offer a feasible solution for promoting weight management in an academic workplace. The results will inform a larger trial whose results might be replicated in similar workplaces in Lebanon and the Middle East and North Africa region, and will be used as a benchmark for further investigations in other settings and similar target groups.

          Trial Registration

          ClinicalTrials.gov NCT03321331; https://clinicaltrials.gov/ct2/show/NCT03321331 (Archived by WebCite at http://www.webcitation.org/6ys9NOLo5)

          Registered Report Identifier

          RR1-10.2196/9793

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          Most cited references46

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          Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM.

          Reliability, the consistency of a test or measurement, is frequently quantified in the movement sciences literature. A common metric is the intraclass correlation coefficient (ICC). In addition, the SEM, which can be calculated from the ICC, is also frequently reported in reliability studies. However, there are several versions of the ICC, and confusion exists in the movement sciences regarding which ICC to use. Further, the utility of the SEM is not fully appreciated. In this review, the basics of classic reliability theory are addressed in the context of choosing and interpreting an ICC. The primary distinction between ICC equations is argued to be one concerning the inclusion (equations 2,1 and 2,k) or exclusion (equations 3,1 and 3,k) of systematic error in the denominator of the ICC equation. Inferential tests of mean differences, which are performed in the process of deriving the necessary variance components for the calculation of ICC values, are useful to determine if systematic error is present. If so, the measurement schedule should be modified (removing trials where learning and/or fatigue effects are present) to remove systematic error, and ICC equations that only consider random error may be safely used. The use of ICC values is discussed in the context of estimating the effects of measurement error on sample size, statistical power, and correlation attenuation. Finally, calculation and application of the SEM are discussed. It is shown how the SEM and its variants can be used to construct confidence intervals for individual scores and to determine the minimal difference needed to be exhibited for one to be confident that a true change in performance of an individual has occurred.
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            Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support

            Background The just-in-time adaptive intervention (JITAI) is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual’s changing internal and contextual state. The availability of increasingly powerful mobile and sensing technologies underpins the use of JITAIs to support health behavior, as in such a setting an individual’s state can change rapidly, unexpectedly, and in his/her natural environment. Purpose Despite the increasing use and appeal of JITAIs, a major gap exists between the growing technological capabilities for delivering JITAIs and research on the development and evaluation of these interventions. Many JITAIs have been developed with minimal use of empirical evidence, theory, or accepted treatment guidelines. Here, we take an essential first step towards bridging this gap. Methods Building on health behavior theories and the extant literature on JITAIs, we clarify the scientific motivation for JITAIs, define their fundamental components, and highlight design principles related to these components. Examples of JITAIs from various domains of health behavior research are used for illustration. Conclusions As we enter a new era of technological capacity for delivering JITAIs, it is critical that researchers develop sophisticated and nuanced health behavior theories capable of guiding the construction of such interventions. Particular attention has to be given to better understanding the implications of providing timely and ecologically sound support for intervention adherence and retention We clarify the scientific motivation for the Just-In-Time Adaptive Interventions, define its fundamental components, and discuss key design principles for each component.
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              Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors.

              Nearly 40% of mortality in the United States is linked to social and behavioral factors such as smoking, diet and sedentary lifestyle. Autonomous self-regulation of health-related behaviors is thus an important aspect of human behavior to assess. In 1997, the Behavior Change Consortium (BCC) was formed. Within the BCC, seven health behaviors, 18 theoretical models, five intervention settings and 26 mediating variables were studied across diverse populations. One of the measures included across settings and health behaviors was the Treatment Self-Regulation Questionnaire (TSRQ). The purpose of the present study was to examine the validity of the TSRQ across settings and health behaviors (tobacco, diet and exercise). The TSRQ is composed of subscales assessing different forms of motivation: amotivation, external, introjection, identification and integration. Data were obtained from four different sites and a total of 2731 participants completed the TSRQ. Invariance analyses support the validity of the TSRQ across all four sites and all three health behaviors. Overall, the internal consistency of each subscale was acceptable (most alpha values >0.73). The present study provides further evidence of the validity of the TSRQ and its usefulness as an assessment tool across various settings and for different health behaviors.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                May 2018
                16 May 2018
                : 7
                : 5
                : e133
                Affiliations
                [1] 1 Department of Health Promotion and Community Health Faculty of Health Sciences American University of Beirut Beirut Lebanon
                [2] 2 Department of Family Medicine Faculty of Medicine American University of Beirut Beirut Lebanon
                Author notes
                Corresponding Author: Marco Bardus marco.bardus@ 123456gmail.com
                Author information
                http://orcid.org/0000-0002-0707-7196
                http://orcid.org/0000-0001-9625-5531
                http://orcid.org/0000-0003-0826-2104
                http://orcid.org/0000-0002-1327-8242
                Article
                v7i5e133
                10.2196/resprot.9793
                5981057
                29769174
                d4c94ee3-f563-421b-9a4c-399bcb6c09df
                ©Marco Bardus, Ghassan Hamadeh, Bouchra Hayek, Rawan Al Kherfan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.05.2018.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 7 January 2018
                : 22 February 2018
                : 18 March 2018
                : 31 March 2018
                Categories
                Protocol
                Protocol

                mobile apps,weight loss,physical activity,healthy diet,workplace,mhealth,randomized controlled trial

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