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Journal Description

JMIR Formative Research (JFR) (a PubMed-indexed sister journal of J Med Internet Res (JMIR) and JMIR mHealth & uHealth, the leading eHealth and mHealth journals by impact factor) publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research and preliminary results. While the original focus was on the design of medical and health-related research and technology innovations, JFR publishes studies from all areas of medical and health research.

Formative research is research that occurs before a program is designed and implemented, or while a program is being conducted. Formative research can help

  • define and understand populations in need of a intervention or public health program
  • create programs that are specific to the needs of those populations
  • ensure programs are acceptable and feasible to users before launching
  • improve the relationship between users and agencies/research groups
  • demonstrate the feasibility, use, satisfaction with, or problems with a program before large-scale summative evaluation (looking at health outcomes)

Many funding agencies will expect some sort of pilot/feasibility/process evaluation before funding a larger study such as a Randomized Controlled Trial (RCT).

Formative research should be an integral part of developing programs or adapting programs, and should be used while the program is on-going to help refine and improve program activities. Thus, formative evaluation can and should also occur in form of a process evaluation alongside a summative evaluation such as a RCT.

This journal fills an important gap in the academic journals landscape, as it publishes sound and peer-reviewed formative research that is criticial for investigators to apply for further funding, but that is usually not published in outcomes-focussed medical journals aiming for impact and generalizability.

Summative evaluations of programs and apps/software that have undergone a thorough formative evaluation before launch have a better chance to be published in our high-impact flagship journals (JMIR mHealth, J Med Internet Res, JMIR Serious Games), thus we encourage authors to submit - as a first step - their formative evaluations in JMIR Formative Res (and their evaluation protocols in JMIR Res Protoc). 

JMIR Formative Res has been accepted for indexing in PubMed and PubMed Central.


Recent Articles:

  • Source: Pixabay; Copyright: niekverlaan; URL:; License: Licensed by the authors.

    Feasibility and Acceptability of an Interactive Mental Well-Being Intervention for People With Intellectual Disabilities: Pilot Mixed Methods Study


    Background: The availability of both digital and traditional mental well-being interventions is rising, but these interventions typically do not consider people with intellectual disabilities as potential users. Objective: The study aimed to explore the acceptability and feasibility of a new digital intervention, developed with and for people with intellectual disabilities, to improve their subjective well-being. Methods: Using a single-group pre-post design, participants with intellectual disabilities and their caregivers completed the 4-week intervention. Mixed methods questionnaires assessed the acceptability of the intervention, in addition to self-report and proxy-report measures of subjective well-being and behavioral problems. Results: A total of 12 men with mild to moderate intellectual disabilities enrolled in and completed the study alongside 8 caregivers. Participant acceptability of the intervention was high, and feedback covered multiple aspects of the intervention, including (1) program concept and design, (2) program content, and (3) intervention usage. Self-rated mood barometers indicated mood improvements for 5 participants, deteriorations for 2 participants, and no observed changes for the remaining participants. Statistical analyses yielded no difference from pretest (median=79; range 39-86) to posttest (median=79; range 21-96) for subjective well-being in people with intellectual disabilities (W=10.5; P=.17) and for behavioral problems (W=14; P=.05). Conclusions: People with intellectual disabilities and their caregivers are receptive to using digital well-being interventions, and this research shows such interventions to be feasible in routine practice. Given the acceptability of the intervention, its potential efficacy can now be evaluated in people with intellectual disabilities and symptoms of reduced mental well-being.

  • Families playing the Strengthening Families Program online game. Source: Image created by the Authors; Copyright: Jaynie Brown; URL:; License: Creative Commons Attribution (CC-BY).

    Formative Evaluation to Build an Online Parenting Skills and Youth Drug Prevention Program: Mixed Methods Study


    Background: Family-based drug prevention programs that use group-based formats with trained facilitators, such as the Strengthening Families Program (SFP), are effective in preventing underage drinking and youth drug use. However, these programs are resource-intensive and have high costs and logistical demands. Tailoring them for Web-based delivery is more cost-effective and makes it easier to scale these programs for widespread dissemination. This requires the active involvement of all key stakeholders to determine content and delivery format. Objective: The aim was to obtain consumer, agency stakeholder, and expert input into the design of a Web-based parenting skills training and youth drug prevention program. Methods: We conducted 10 focus groups with 85 adults (range 4-10, average 8 per group), 20 stakeholder interviews with family services agency staff, and discussed critical design considerations with 10 prevention scientists and e-learning experts to determine the optimal program content and technology features for SFP Online. Focus group participants also answered survey questions on perceived barriers to use, desired navigational features, preferred course format, desired content, preferred reward structures, course length, interactive components, computer efficacy, and technology use. Descriptive statistics were used to examine consumer characteristics; linear regression was used to examine relations between SFP exposure and four continuous outcome measures, including desired program content, interactive technology, and concerns that may inhibit future use of SFP Online. Logistic regression was used as a binary measure of whether consumers desired fun games in the SFP Online program. Results: Three broad thematic categories emerged from the qualitative interviews enumerating the importance of (1) lesson content, (2) logistics for program delivery, and (3) multimedia interactivity. Among the many significant relations, parents who viewed more SFP lessons reported more reasons to use an online program (beta=1.48, P=.03) and also wanted more interactivity (6 lessons: beta=3.72, P=.01; >6 lessons: beta=2.39, P=.01), parents with less interest in a mixed delivery format (class and online) reported fewer reasons to use the online program (beta=−3.93, P=.01), comfort using computers was negatively associated with concerns about the program (beta=−1.83, P=.01), having mobile phone access was related to fewer concerns about online programs (beta=−1.63, P=.02), willingness to view an online program using a mobile phone was positively associated with wanting more online components (beta=1.95, P=.02), and parents who wanted fun games wanted more interactivity (beta=2.28, P=.01). Conclusions: Formative evaluation based on user-centered approaches can provide rich information that fuels development of an online program. The user-centered strategies in this study lay the foundation for improving SFP Online and provide a means to accommodate user interests and ensure the product serves as an effective prevention tool that is attractive to consumers, engaging, and can overcome some of the barriers to recruitment and retention that have previously affected program outcomes in family-based prevention.

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL:; License: Creative Commons Attribution (CC-BY).

    A Mobile Phone App for the Provision of Personalized Food-Based Information in an Eating-Out Situation: Development and Initial Evaluation


    Background: Increasing pressure from governments, public health bodies, and consumers is driving a need for increased food-based information provision in eating-out situations. Meals eaten outside the home are known to be less healthy than meals eaten at home, and consumers can complain of poor information on the health impact and allergen content of meals eaten out. Objective: This paper aimed to describe the development and early assessment of a mobile phone app that allows the provision of accurate personalized food-based information while considering individual characteristics (allergies, diet type, and preferences) to enable informed consumer choice when eating out. Methods: An app was designed and developed to address these requirements using an agile approach. The developed app was then evaluated at 8 public engagement events using the System Usability Scale (SUS) questionnaire and qualitative feedback. Results: Consideration of the literature and consultation with consumers revealed a need for information provision for consumers in the eating-out situation, including the ability to limit the information provided to that which was personally relevant or interesting. The app was designed to provide information to consumers on the dishes available in a workplace canteen and to allow consumers the freedom to personalize the app and choose the information that they received. Evaluation using the SUS questionnaire revealed positive responses to the app from a range of potential users, and qualitative comments demonstrated broad interest in its use. Conclusions: This paper details the successful development and early assessment of a novel mobile phone app designed to provide food-based information in an eating-out situation in a personalized manner.

  • Source: Unsplash; Copyright: Glenn Carstens-Peters; URL:; License: Licensed by JMIR.

    Web-Based Health Information Seeking Among Students at Kuwait University: Cross-Sectional Survey Study


    Background: Owing to the revolution in technology, the internet has become an important aspect of people’s lives. Modern technology is enabling people from diverse educational backgrounds to use the internet for several purposes, one of which is health information seeking. Recently, Web-based health information has become more popular among patients all over the world and among the general public. Objective: This study aimed to investigate the use of Web-based health resources among undergraduate students at Kuwait University. Methods: The study employed a cross-sectional design with students selected from 8 faculties of Kuwait University, 4 faculties of Literature and 4 faculties of Science. Data were collected using structured questionnaires, and analysis was done using a chi-square test and binary logistic regression to determine the factors associated with seeking health information on the Web. Results: The sample size obtained was 1132 with a response rate of 90.27% (1132/1254). Overall, the prevalence of students seeking Web-based health information was 92.66%. (1049/1132) The most significant factors associated with seeking health information on the Web were age, gender, faculty, year of study, primary source of internet, and level of experience with internet use. In total, 90.0% (325/361) of students who were aged older than 21 years used Web-based health information compared with 82.8% (275/332) of those who were aged 18 years. In addition, female students showed a higher prevalence (829/934, 88.8%) of Web-based health information seeking than males (210/270, 77.8%). All the differences found in the study were significant (P value <.05). Conclusions: The study concluded that many people use the internet for seeking health information. Sociodemographic factors have a significant association with Web-based health information seeking. Therefore, doctors must educate the public about the health information websites that can be trusted.

  • Dr Winkler (Author) demonstrating virtual reality at James A Haley Veterans' Hospital Research Day. Source: Image created by the Authors; Copyright: Dr Sandra L Winkler / The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    Virtual Reality as a Therapy Adjunct for Fear of Movement in Veterans With Chronic Pain: Single-Arm Feasibility Study


    Background: Virtual reality (VR) has demonstrated efficacy for distraction from pain-related thoughts and exposure to feared movements. Little empirical VR research has focused on chronic pain management. Objective: The purpose of this study was to examine the feasibility of VR as an adjunctive intervention for Veterans with chronic pain. We designed a hierarchy ranging from low-intensity pain distraction to high-intensity movement-based exposure for this purpose. VR apps were mapped onto the hierarchy. Methods: Sixteen Veterans receiving inpatient chronic pain rehabilitation participated in daily VR sessions over a 3-week period. Trajectories across the distraction-to-exposure hierarchy and Veteran-reported intensity ratings were described and evaluated over time. Minimum clinically important differences (MCIDs), pre-post effect sizes, and 95% confidence intervals were examined for fear of movement using the Fear of Daily Activities Questionnaire (FDAQ) and Pain Outcomes Questionnaire-VA (POQ-VA; fear scale). This approach was applied to secondary outcomes: POQ-VA (pain intensity, interference, negative affect), Pain Catastrophizing Scale, and Patient-Specific Functioning Scale (PSFS). Session attendance, completion, and VR experiences were described. Results: Ten of 14 Veterans (71%) who participated in three or more VR sessions completed the distraction-to-exposure hierarchy. Only three trajectories emerged more than once. Due to high completion rates, Veterans that completed the hierarchy could self-select nonhierarchy apps. Veterans rated all hierarchy levels (low, medium, high) near medium intensity. Self-selected activities were rated as high intensity. For kinesiophobia, six Veterans (38%) exceeded the MCID on the FDAQ and a small effect size improvement was observed (Cohen d=−0.35). The confidence interval (95% CI −0.71 to 0.01) indicated the possibility of a null effect. The POQ-VA fear scale yielded no effect (Cohen d=0.06, 95% CI −0.43 to 0.54). For secondary outcomes, Veterans exceeding MCID were calculated with complete data: pain intensity (1/15, 7%), pain catastrophizing (5/14, 36%), and patient-specific functioning (10/15, 67%). Effect sizes were large for patient-specific functioning (Cohen d=1.14, 95% CI 0.50-1.78), medium for mobility interference (Cohen d=−0.56, 95% CI −0.96 to −0.16), and small for pain intensity (Cohen d=−0.40, 95% CI −0.69 to −0.12) and catastrophizing (Cohen d=−0.41, 95% CI −0.79 to −0.02). No effects were observed for interference in daily activities (Cohen d=0.10, 95% CI −0.27 to 0.47) and negative affect (Cohen d=0.07, 95% CI −0.26 to 0.40). Veterans attended 85.2% (98/108) of VR sessions and completed 95% (93/96) of sessions attended. Twenty-minute sessions were rated as too short. No significant adverse events were reported. Conclusions: Findings support the feasibility of VR as an adjunct for Veterans with chronic pain. However, the hierarchy will require modification, as evidenced by homogeneous intensity ratings. Veteran-selected activities presented the highest intensity ratings, largest outcome effect size (PSFS), and MCID. This highlights the important role of utilizing Veteran stakeholders in hierarchy modification, design of VR interventions, and outcome selection.

  • Source: Pixabay; Copyright: Pexels / 9152 pictures; URL:; License: Licensed by JMIR.

    Accuracy of a Chatbot (Ada) in the Diagnosis of Mental Disorders: Comparative Case Study With Lay and Expert Users


    Background: Health apps for the screening and diagnosis of mental disorders have emerged in recent years on various levels (eg, patients, practitioners, and public health system). However, the diagnostic quality of these apps has not been (sufficiently) tested so far. Objective: The objective of this pilot study was to investigate the diagnostic quality of a health app for a broad spectrum of mental disorders and its dependency on expert knowledge. Methods: A total of 2 psychotherapists, 2 psychology students, and 2 laypersons each read 20 case vignettes with a broad spectrum of mental disorders. They used a health app (Ada—Your Health Guide) to get a diagnosis by entering the symptoms. Interrater reliabilities were computed between the diagnoses of the case vignettes and the results of the app for each user group. Results: Overall, there was a moderate diagnostic agreement (kappa=0.64) between the results of the app and the case vignettes for mental disorders in adulthood and a low diagnostic agreement (kappa=0.40) for mental disorders in childhood and adolescence. When psychotherapists applied the app, there was a good diagnostic agreement (kappa=0.78) regarding mental disorders in adulthood. The diagnostic agreement was moderate (kappa=0.55/0.60) for students and laypersons. For mental disorders in childhood and adolescence, a moderate diagnostic quality was found when psychotherapists (kappa=0.53) and students (kappa=0.41) used the app, whereas the quality was low for laypersons (kappa=0.29). On average, the app required 34 questions to be answered and 7 min to complete. Conclusions: The health app investigated here can represent an efficient diagnostic screening or help function for mental disorders in adulthood and has the potential to support especially diagnosticians in their work in various ways. The results of this pilot study provide a first indication that the diagnostic accuracy is user dependent and improvements in the app are needed especially for mental disorders in childhood and adolescence.

  • Source: Image created by the Authors; Copyright: The Authors; URL:; License: Licensed by JMIR.

    A Promising Food-Coaching Intervention Program to Achieve Optimal Gestational Weight Gain in Overweight and Obese Pregnant Women: Pilot Randomized Controlled...


    Background: Traditional dietary recommendations for achieving optimal gestational weight gain are ineffective for pregnant women due to the lack of real-time communication and tedious consultation processes. Objective: In this pilot study, we aimed to determine the feasibility of a novel food-coaching smartphone app for controlling gestational weight gain and macronutrient intake among overweight and obese pregnant women. Methods: We designed a randomized controlled trial and recruited 30 overweight and obese pregnant women (1:1 ratio) during 18-20 weeks of gestation and followed them up after 4 and 8 weeks, respectively. Both groups received standard pregnancy dietary orientation at recruitment, while the intervention group received 8 weeks of real-time food coaching via a smartphone app. This food coaching smartphone app (Glycoleap, Holmusk, Singapore) aimed to improve care and outcomes for people with diabetes. Pregnant women using this app were able to upload food images (eg, a picture of a meal, a drink, or a dessert) and received real-time and detailed food-coaching comments and guidance provided by professional dietitians during the day (8 AM to 8 PM). We recorded detailed characteristics during recruitment and examined anthropometry at all visits. We compared the mean differences of the 8-week gestational weight gain and macronutrient intake between the two groups. Results: Upon study completion, three subjects dropped out from the intervention, and one gave birth prematurely in the control group. The acceptance rate of the smartphone app was 90%. More participants achieved optimal gestational weight gain per week in the intervention group (8/12, 67%) than in the control group (5/14, 36%). After the 8-week intervention, women in the intervention group appeared to have lower gestational weight gain (mean difference=–0.08 kg; 95% CI –1.80 to 1.63) and cholesterol intake (mean difference=–31.73 mg; 95% CI –102.91 to 39.45) than those in the control group. Conclusions: Our findings showed that this food-coaching smartphone app is feasible and favorable for weight gain control and cholesterol intake control among overweight and obese pregnant women. Although our results were not significant (perhaps, attributed to the small sample size), it provided proof of concept for the feasibility of applying such technology in future randomized controlled trials with a larger sample size, an earlier intervention onset, and a longer follow-up for overweight and obese pregnant women.

  • Source: picjumbo; Copyright: Viktor Hanacek; URL:; License: Licensed by the authors.

    A Comprehensive Framework to Evaluate Websites: Literature Review and Development of GoodWeb


    Background: Attention is turning toward increasing the quality of websites and quality evaluation to attract new users and retain existing users. Objective: This scoping study aimed to review and define existing worldwide methodologies and techniques to evaluate websites and provide a framework of appropriate website attributes that could be applied to any future website evaluations. Methods: We systematically searched electronic databases and gray literature for studies of website evaluation. The results were exported to EndNote software, duplicates were removed, and eligible studies were identified. The results have been presented in narrative form. Results: A total of 69 studies met the inclusion criteria. The extracted data included type of website, aim or purpose of the study, study populations (users and experts), sample size, setting (controlled environment and remotely assessed), website attributes evaluated, process of methodology, and process of analysis. Methods of evaluation varied and included questionnaires, observed website browsing, interviews or focus groups, and Web usage analysis. Evaluations using both users and experts and controlled and remote settings are represented. Website attributes that were examined included usability or ease of use, content, design criteria, functionality, appearance, interactivity, satisfaction, and loyalty. Website evaluation methods should be tailored to the needs of specific websites and individual aims of evaluations. GoodWeb, a website evaluation guide, has been presented with a case scenario. Conclusions: This scoping study supports the open debate of defining the quality of websites, and there are numerous approaches and models to evaluate it. However, as this study provides a framework of the existing literature of website evaluation, it presents a guide of options for evaluating websites, including which attributes to analyze and options for appropriate methods.

  • Source: Shutterstock; Copyright: Subbotina Anna; URL:; License: Licensed by the authors.

    Internet-Based Cognitive Behavioral Therapy via Videoconference for Patients With Bulimia Nervosa and Binge-Eating Disorder: Pilot Prospective Single-Arm...


    Background: A major problem in providing mental health services is the lack of access to treatment, especially in remote areas. Thus far, no clinical studies have demonstrated the feasibility of internet-based cognitive behavioral therapy (ICBT) with real-time therapist support via videoconference for bulimia nervosa (BN) and binge-eating disorder (BED) in Japan. Objective: The goal of the research was to evaluate the feasibility of ICBT via videoconference for patients with BN or BED. Methods: Seven Japanese subjects (mean age 31.9 [SD 7.9] years) with BN and BED received 16 weekly sessions of individualized ICBT via videoconference with real-time therapist support. Treatment included CBT tailored specifically to the presenting diagnosis. The primary outcome was a reduction in the Eating Disorder Examination Edition 16.0D (EDE 16D) for BN and BED: the combined objective binge and purging episodes, objective binge episodes, and purging episodes. The secondary outcomes were the Eating Disorders Examination Questionnaire, Bulimic Investigatory Test, Edinburgh, body mass index for eating symptoms, Motivational Ruler for motivation to change, EuroQol-5 Dimension for quality of life, 9-item Patient Health Questionnaire for depression, 7-item Generalized Anxiety Disorder scale for anxiety, and Working Alliance Inventory–Short Form (WAI-SF). All outcomes were assessed at week 1 (baseline) and weeks 8 (midintervention) and 16 (postintervention) during therapy. Patients were asked about adverse events at each session. For the primary analysis, treatment-related changes were assessed by comparing participant scores and 95% confidence intervals using the paired t test. Results: Although the mean combined objective binge and purging episodes improved from 47.60 to 13.60 (71% reduction) and showed a medium effect size (Cohen d=–0.76), there was no significant reduction in the combined episodes (EDE 16D –41; 95% CI –2.089 to 0.576; P=.17). There were no significant treatment-related changes in secondary outcomes. The WAI-SF scores remained consistently high (64.8 to 66.0) during treatment. Conclusions: ICBT via videoconference is feasible in Japanese patients with BN and BED. Clinical Trial: University Hospital Medical Information Network Clinical Trials Registry UMIN000029426;

  • Digital sensor used to track inhaler usage and provide feedback to patients with COPD and their providers. Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

    Passive Monitoring of Short-Acting Beta-Agonist Use via Digital Platform in Patients With Chronic Obstructive Pulmonary Disease: Quality Improvement...


    Background: Digital health programs assist patients with chronic obstructive pulmonary disease (COPD) to better manage their disease. Technological and adoption barriers have been perceived as a limitation. Objective: The aim of the research was to evaluate a digital quality improvement pilot in Medicare-eligible patients with COPD. Methods: COPD patients were enrolled in a digital platform to help manage their medications and symptoms as part of their routine clinical care. Patients were provided with electronic medication monitors (EMMs) to monitor short-acting beta-agonist (SABA) use passively and a smartphone app to track use trends and receive feedback. Providers also had access to data collected via a secure website and were sent email notifications if a patient had a significant change in their prescribed inhaler use. Providers then determined if follow-up was needed. Change in SABA use and feasibility outcomes were evaluated at 3, 6, and 12 months. Results: A total of 190 enrolled in the pilot. At 3, 6, and 12 months, patients recorded significant reductions in daily and nighttime SABA use and increases in SABA-free days (all P<.001). Patient engagement, as measured by the ratio of daily active use to monthly active use, was >90% at both 6 and 12 months. Retention at 6 months was 81% (154/190). Providers were sent on average two email notifications per patient during the 12-month program. Conclusions: A digital health program integrated as part of standard clinical practice was feasible and had low provider burden. The pilot demonstrated significant reduction in SABA use and increased SABA-free days among Medicare-eligible COPD patients. Further, patients readily adopted the digital platform and demonstrated strong engagement and retention rates at 6 and 12 months.

  • Elderly woman accessing smartwatch and smartphone for support and monitoring in rehabilitation. Source: Shutterstock; Copyright: Yakobchuk Viacheslav; URL:; License: Creative Commons Attribution (CC-BY).

    Adapting Mobile and Wearable Technology to Provide Support and Monitoring in Rehabilitation for Dementia: Feasibility Case Series


    Background: Mobile and wearable devices are increasingly being used to support our everyday lives and track our behavior. Since daily support and behavior tracking are two core components of cognitive rehabilitation, such personal devices could be employed in rehabilitation approaches aimed at improving independence and engagement among people with dementia. Objective: The aim of this work was to investigate the feasibility of using smartphones and smartwatches to augment rehabilitation by providing adaptable, personalized support and objective, continuous measures of mobility and activity behavior. Methods: A feasibility study comprising 6 in-depth case studies was carried out among people with early-stage dementia and their caregivers. Participants used a smartphone and smartwatch for 8 weeks for personalized support and followed goals for quality of life. Data were collected from device sensors and logs, mobile self-reports, assessments, weekly phone calls, and interviews. This data were analyzed to evaluate the utility of sensor data generated by devices used by people with dementia in an everyday life context; this was done to compare objective measures with subjective reports of mobility and activity and to examine technology acceptance focusing on usefulness and health efficacy. Results: Adequate sensor data was generated to reveal behavioral patterns, even for minimal device use. Objective mobility and activity measures reflecting fluctuations in participants’ self-reported behavior, especially when combined, may be advantageous in revealing gradual trends and could provide detailed insights regarding goal attainment ratings. Personalized support benefited all participants to varying degrees by addressing functional, memory, safety, and psychosocial needs. A total of 4 of 6 (67%) participants felt motivated to be active by tracking their step count. One participant described a highly positive impact on mobility, anxiety, mood, and caregiver burden, mainly as a result of navigation support and location-tracking tools. Conclusions: Smartphones and wearables could provide beneficial and pervasive support and monitoring for rehabilitation among people with dementia. These results substantiate the need for further investigation on a larger scale, especially considering the inevitable presence of mobile and wearable technology in our everyday lives for years to come.

  • Source: Unsplash; Copyright: Bruno Nascimento; URL:; License: Licensed by JMIR.

    Understanding Health Behavior Technology Engagement: Pathway to Measuring Digital Behavior Change Interventions


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  • Machine Learning Approaches to Calibrate Wrist-Worn Accelerometry for Physical Activity Assessment in Preschoolers

    Date Submitted: Oct 17, 2019

    Open Peer Review Period: Oct 17, 2019 - Dec 12, 2019

    Background: Physical activity (PA) level is associated with multiple health benefits during early childhood. However, inconsistency remains in the quantification of PA levels in preschoolers. Objectiv...

    Background: Physical activity (PA) level is associated with multiple health benefits during early childhood. However, inconsistency remains in the quantification of PA levels in preschoolers. Objective: The present study used machine learning (ML) approaches to develop PA intensity cut-points for wrist-worn accelerometry to assess PA in preschoolers. Methods: Wrist- and hip-worn accelerometer data were collected simultaneously from 34 preschoolers for three consecutive preschool days. Two supervised ML models, receiver operating characteristic curve (ROC) and ordinal logistic regression (OLR), and one unsupervised ML model, k-means cluster analysis, were applied to establish wrist-worn accelerometer vector magnitude (VM) cut-points to classify accelerometer counts into sedentary behavior (SED), light PA (LPA), moderate PA (MPA), and vigorous PA (VPA). PA intensity levels identified by hip-worn accelerometer VM cut-points were used as the reference to train the supervised ML models. VM counts were classified by intensity based on three newly established wrist methods and the hip reference to examine classification accuracy. Estimates of PA were compared to the hip reference at daily level. Results: 3600 epochs with matched hip- and wrist-worn accelerometer VM counts were analyzed. All ML approaches performed differently on developing PA intensity cut-points for wrist-worn accelerometers. Among the three ML models, K-means cluster analysis derived cut-points, which were: ≤ 2556 cpm for SED, 2557-7064 cpm for LPA, 7065-14532 for MPA, and ≥ 14533 cpm for VPA, had the highest classification accuracy, with more than 70% of the total epochs being classified into the correct PA categories as examined by the hip reference. K-means cut-points also exhibited the most accurate estimates on SED, LPA, and VPA as the hip reference, whereas none of the three wrist methods were able to accurately assess MPA. Conclusions: This study demonstrates the potential of ML approaches on establishing cut-points for wrist-worn accelerometry to assess PA in preschoolers. Based on the findings from this study, warrant additional validation studies of wrist-worn accelerometry for PA assessment in preschoolers, and the feasibility of using the k-means cluster analysis derived cut-points to assess PA in a larger sample. Clinical Trial: ClinicalTrials.Gov (NCT03590834) July 18, 2018