A Blended Web-Based Gaming Intervention on Changes in Physical Activity for Overweight and Obese Employees: Influence and Usage in an Experimental Pilot Study

Background Addressing the obesity epidemic requires the development of effective interventions aimed at increasing physical activity (PA). eHealth interventions with the use of accelerometers and gaming elements, such as rewarding or social bonding, seem promising. These eHealth elements, blended with face-to-face contacts, have the potential to help people adopt and maintain a physically active lifestyle. Objective The aim of this study was to assess the influence and usage of a blended Web-based gaming intervention on PA, body mass index (BMI), and waist circumference among overweight and obese employees. Methods In an uncontrolled before-after study, we observed 52 health care employees with BMI more than 25 kg/m2, who were recruited via the company’s intranet and who voluntarily participated in a 23-week Web-based gaming intervention, supplemented (blended) with non-eHealth components. These non-eHealth components were an individual session with an occupational health physician involving motivational interviewing and 5 multidisciplinary group sessions. The game was played by teams in 5 time periods, aiming to gain points by being physically active, as measured by an accelerometer. Data were collected in 2014 and 2015. Primary outcome was PA, defined as length of time at MET (metabolic equivalent task) ≥3, as measured by the accelerometer during the game. Secondary outcomes were reductions in BMI and waist circumference, measured at baseline and 10 and 23 weeks after the start of the program. Gaming elements such as “compliance” with the game (ie, days of accelerometer wear), “engagement” with the game (ie, frequency of reaching a personal monthly target), and “eHealth teams” (ie, social influence of eHealth teams) were measured as potential determinants of the outcomes. Linear mixed models were used to evaluate the effects on all outcome measures. Results The mean age of participants was 48.1 years; most participants were female (42/51, 82%). The mean PA was 86 minutes per day, ranging from 6.5 to 223 minutes, which was on average 26.2 minutes per day more than self-reported PA at baseline and remained fairly constant during the game. Mean BMI was reduced by 1.87 kg/m2 (5.6%) and waist circumference by 5.6 cm (4.8%). The univariable model showed that compliance, engagement, and eHealth team were significantly associated with more PA, which remained significant for eHealth team in the multivariable model. Conclusions This blended Web-based gaming intervention was beneficial for overweight workers in becoming physically active above the recommended activity levels during the entire intervention period, and a favorable influence on BMI and waist circumference was observed. Promising components in the intervention, and thus targets for upscaling, are eHealth teams and engagement with the game. Broader implementation and long-term follow-up can provide insights into the sustainable effects on PA and weight loss and into who benefits the most from this approach.

Do you want to be acknowledged (with your name and affilitation) in the CONSORT-EHEALTH publication? * (provided you make contributions below. Please refer to the last question if you also wish to be a co-author of the Elaboration manuscript) yes no Your role/experience with ehealth-trials Which of the following describes you (multiple may apply) I have experience with conducting ehealth studies myself, but no RCTs I have conducted ehealth RCTs I have read many ehealth RCT/evaluation reports I have experience mainly from a consumer/patient point of view I have experience mainly from a policy/implementation/decision-maker point of view

Other guidelines
Are you aware of any other guidelines that should be cited? (give references and provide a short description)   TITLE AND ABSTRACT 1a) Identification as a randomized trial in the title 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internetbased" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

2 3 4 5 subitem not at all important essential
Comment on subitem 1a-ii)   "blended" is mentioned in the title.

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 1 2 3 4 5 subitem not at all important essential   overweight and obese employees are our target group.
Add a subitem under CONSORT item 1a   1b) Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the abstract
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms.
1 2 3 4 5 subitem not at all important essential Comment on subitem 1b-i)   overweight and obese employees recieved a blended webbased gaming intervention, which was directed at increasing PA and reducing body mass index (BMI) and waist circumference

1b-ii) Level of human involvement in the abstract
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any).
1 2 3 4 5 subitem not at all important essential Page 4 of 36 CONSORT-EHEALTH (Draft V 1.5 2011-04-04)    the program is administered in a blended care approach, meaning that eHealth-elements were blended with face-to-face contacts. These non-eHealth components were an individual session with an occupational health physician by the method of motivational interviewing and five multidisciplinary groupsessions.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in abstract Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in abstract: Mention how participants were recruited (online vs. offline), e.g., from an open access website (open trial) or from a clinic or other closed user group (closed trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials).

2 3 4 5 subitem not at all important essential
Comment on subitem 1b-iii)   Participants were recruited via the company's web. "Primary outcome was PA, defined as amount of time at MET≥3, as measured by an accelerometer during the game. Secondary outcomes were reductions in BMI and waist circumference, measured at baseline, and 10 and 23 weeks after the start of the program. " 1b-iv) Results in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons.   This blended web-based gaming intervention was beneficial for overweight workers in being physically active above the recommended activity levels during the entire interventionperiod, and a beneficial influence on BMI and waist circumference was seen. Promising components in the intervention are eHealth-teams and engagement with the game. Broader implementation and long-term follow-up can provide insights into the remaining effects on PA and weight loss and into who benefits the most from this approach.  "Aiming for a both effective and efficient intervention with the blended usage of eHealth components and non-eHealth, we constructed our program and implemented it in a pilot setting. The results of this pilot will inform us whether broader implementation with longer follow-up is useful for this target population. "

2a-ii) Scientific background, rationale
Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this specific study, from which stakeholder viewpoint is the study performed, potential impact of findings [2]. Briefly justify the choice of the comparator.

 
Therefore, the aims of this study were to analyze the sustainability of PA during the game, and to assess changes in body mass index (BMI) and waist circumference. In addition, we aimed to assess the influence of compliance, engagement and eHealth-teams on these outcomes.

METHODS
3a) Description of trial design (such as parallel, factorial) including allocation ratio (no EHEALTH-specific subitems under CONSORT item 3a) Comment below to suggest a subitem   This pilot study evaluates a blended web-based gaming intervention for overweight and obese employees to become more physically active and adopt a healthy diet in a way that suits their personal preferences and abilities, and ultimately, to lose weight. The program consists of a face-to-face intake-session with the occupational health physician (OP), five group-sessions, and a 20-week movement-game, which is played real-life using accelerometers.
3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc.

 
Because of the web-based approach, affinity with computers was desirable, but only computer-accessibility was required.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant.
In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.

2 3 4 5 subitem not at all important essential
Comment on subitem 4a-ii)

 
The way of recruitment, how many participants were recruited, and in of which company is stated in the 'materials and methods'-part of the manuscript.

4a-iii) Information giving durnig recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.    This is not specifically addressed in manuscript: the study was completely performed by the hospital they were employed at.

Add a subitem under CONSORT item 4b
  5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section).

2 3 4 5 subitem not at all important essential
Comment on subitem 5-i)   "Registration of PA was performed by the Activ8 system, which is a small 3D-accelerometer that is worn in the pocket of any pants or with a leg-strap on the upper leg [31]. The gamecoach handed out instructions on installing the Activ8-software to the computer, and assisted if necessary."Participants could actually see the name of the system on the device and also this brand when uploading the device. Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

2 3 4 5 subitem not at all important essential
Comment on subitem 5-ii)   "The main idea was developed and tested in 2010, and upgraded to the current version in 2013, which was tested by a test-group before implementation in our study population"

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

2 3 4 5 subitem not at all important essential
Comment on subitem 5-iii)   not applicable, as the intervention was used in full version.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.   "Confidentiality of users was ensured by only using first names in the game. To ensure security of content and users, the game used password-protected accounts, encrypted password storage, encrypted login details, and secure external servers. " The brand of the scale is mentioned, and waist circumference was always measured by the same OP according to guidelines. 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi). In the methods section is clearly stated how much was paid by the participants, and how and when the accessed the online platform.

 
The mode of delivery is divided in three items: the session with the OP, the group-sessions and the movement-game.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use)

 
"During the game, the Activ8 needed to be worn at all times, except during swimming and sleeping. "

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered" [6]. It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).   "the sessions were alternately given by a physician, a dietician, a physical therapist, and a psychologist. " "An independent 'game-coach' randomly divided the participants "

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc [1]. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21generalizability).

2 3 4 5 subitem not at all important essential
Comment on subitem 5-xi)   "Every two weeks, an automatic e-mail was sent to the participants, providing general information on multiple lifestyle aspects related to the upcoming continent. If participants failed to log on to the game-website for more than two weeks, an e-mail reminder was sent by the game-coach" Describe any co-interventions (incl. training/support): Clearly state any "interventions that are provided in addition to the targeted eHealth intervention" [1], as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21generalizability.

 
Online questionnaires were not used for this intervention. Our primary outcome physical activity was measured by a 3D accelerometer, BMI was measured by a calibrated scale, and waist circumference was measured by the same OP at all times.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained
Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

2 3 4 5 subitem not at all important essential
Comment on subitem 6a-iii)   Not applicable for out outcomes. We will use focus groups before implementation at a larger scale.  In this clinical pilot study we analyzed data based on four actual programs, in order to gain information on working elements of our intervention.

9)
Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned (no EHEALTH-specific subitems under CONSORT item 9) Comment below to suggest a subitem   not applicable 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions (no EHEALTH-specific subitems under CONSORT item 10) Comment below to suggest a subitem   not applicable 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).  11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator". 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

2 3 4 5 subitem not at all important essential
Comment on subitem 12a-i)   "We excluded data of one participant because of pregnancy. " "Univariable and multivariable analyses were performed using linear mixed models to account for the within-subject correlations due to intra-team effects and, in the case of BMI and waist circumference, for repeated measurements. "By the multivariable mixed models, any missing independent variables were automatically imputed.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center (no EHEALTH-specific subitems under CONSORT item 13a) Comment below to suggest a subitem   "In total, 52 employees participated in this program, of whom one was excluded from analyses because of pregnancy. " "On average, the accelerometer was worn for more than 10 hours per day on 89% of the available days, ranging from 44% to 100%. This percentage was above 80% in all 5 continents of the game. " 13b) For each group, losses and exclusions after randomisation, together with reasons 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) [5] or other figures or tables demonstrating usage/dose/engagement.

Add a subitem under CONSORT item 14a
Page 25 of 36 CONSORT-EHEALTH (Draft V 1.5 2011-04-04)  16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).  Table 3 shows our multivariable association between baseline characteristics and program-usage, and our primary outcome 'physical activity' in 51 participants, showing separate models using linear mixed models.

 
Add a subitem under CONSORT item 16   17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).  Comment below to suggest a subitem   Engagement is presented as a binary outcome, and is analyzed being a determinant of the primary and secondary outcomes. Beta's and 95% confidence intervals are presented.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

 
This was not subject of study for this manuscript, but users will be asked to join a focus group as part of future upgrading of this intervention.
Add a subitem under CONSORT item 19   DISCUSSION 22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group 22-i) Restate study questions and summarize the answers suggested by the data [2], starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data [2], starting with primary outcomes and process outcomes (use). In this clinical pilot-study in an overweight or obese working population, we evaluated the levels of PA during a web-based gaming intervention using a 3D-accelerometer and we assessed changes in BMI and waist circumference versus baseline. We found that levels of PA remained high during our intervention, and in addition, reductions in BMI and waist circumference were achieved. Key components for success were social interaction by eHealth-teams and the level of engagement. "
1 2 3 4 5   -broader implementation of a web-based gaming intervention with focus on eHealth-teams and engagement will be beneficial for overweight and obese individuals, and long-term effects should be studied. -more research is needed to find out how and by whom social support should be delivered and to predict for whom this could work.

Add a subitem under CONSORT item 22
  20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Nevertheless, this compact setting provided enough information to suggest broader implementation along with a follow-up study including more individuals in a randomized controlled setting.
-gaming elements in our intervention were mainly focused on PA. -the follow-up time of half a year is insufficient to determine the effectiveness of weight loss maintenance and to ignore potential seasonal variations