Clinical trial NCT04156919: The Impact of a Health Video Game on User-Game Engagement and Dietary Choices
Official title: Playful Gameplay Broadens Thought-Action Repertoires: Effects of Playfulness on Meaningful Engagement in Health Games
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Nutrition Knowledge
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Tati Siding Primary School
name: FriendsLearn
First posted: 2019-11-08
Enrollment: 89
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pediatric obesity is one of the most serious public health challenges of the 21st century. It is a serious problem that is expected to create lifelong health challenges and potentially overwhelm the ability of healthcare providers to manage the consequences. While many factors contribute to pediatric obesity, dietary choices are the leading cause. A key concern is how to inculcate healthy dietary habits early among young children. Over the past 20 years, there has been significant scientific interest in examining the potential learning consequences of playing video games given children's interests in such games. This study investigates the impact of a health video game on children's nutritional knowledge and dietary choices.

Detailed description: Brief Overview of the Study Protocol

Study Design, Participants and Recruitment

A cluster randomized controlled trial with three data collection periods-baseline, post one, and post two- will be adopted for this study. We will collaborate with a primary school in the North-East District of Botswana. Recruitment will be done with the help of the school with which we are collaborating. The children will be sent home with consent forms to obtain parental consent. Before participation, eligible parents will provide informed consent and child assent. To ensure sufficient power of 0.8 with a medium effect size, 120 participants will be recruited to participate in the experiment.

Procedures

Following baseline assessment, the children will be randomly assigned to one of three groups: playfulness condition, non-playfulness condition, and control condition. The playfulness and non-playfulness conditions will vary in terms of the climate such that children in the playfulness condition will have a relaxed, play-oriented context while those in the non-playfulness condition will have a more formal work-oriented context. The children in the control condition will play a video game that is unrelated to diet and lifestyle choices. Randomization will be done at the class/cluster level to avoid contamination between the experimental conditions (Puffer et al. 2005). The baseline survey, including demographics and family environment, gaming experience/ frequency of gameplay, nutrition knowledge, social cognitive factors (i.e., attitude, intention, and health locus of control), will be administered after obtaining consent. Since the administration of a pre-test survey may change the way that participants interact with the game (during the experiment) and/or suggest to the participants that there is a socially desirable way to respond to outcome measures, the pre-test survey will be administered a week before the actual experiment. Post 1 experiment data collection will occur immediately upon completion of the experiment. The study will be conducted from November 2019 to May 2020. Post 2 experiment data collection will occur three months after the experiments.

Experimental Setup

Taking into account the malleability of the engagement construct (Boekaerts 2016), we ensured that our setup does not use invasive equipment. The chosen setup thus results from a trade-off between sensitivity and practical requirements. We will use the Tobii pro nano eye tracker that captures gaze data at 60Hz. Skin conductance will be measured using the shimmer 3 GSR kit. It was selected because of its small size and lightweight (28g).

All the experiments will be conducted individually as follows. The participants will sit in a non-swiveling chair in front of an IPAD with an eye tracker. An eye tracker will be attached to the IPAD. The experimenter will begin the session by describing the procedure to the participant. The experimenter will then place physiological feedback sensors to measure skin conductance on the participants' non-dominant hand. The non-dominant hand will be chosen to allow participants free access to the video game touch screen with the dominant hand (Jensen et al. 2016). The participant will be given 6 minutes to feel comfortable, and, at that time, any necessary technical adjustments will be made. We will exclude children who report that they are not comfortable and/or depict symptoms of discomfort. After the participant is comfortable, a survey will be administered to capture their mood. Next, the experimenter will record baseline GSR and gaze data for 2 minutes. To initiate the calibration process for eye gaze data, participants will be required to trace an on-screen object with their eyes (Jensen et al. 2016). Participants will play eight levels of the mobile health game. Based on our pre-tests, the completion of eight levels should take about 20 minutes. This duration was chosen because to prevent myopia, children are advised not to play with handheld devices for more than 30 minutes at a stretch.

After the game, a post-test questionnaire will be administered to capture 1) nutritional knowledge acquisition, 2) subjective emotional responses, 3) social cognitive factors, and 4) perceived game complexity. After completing the post hoc survey, participants will choose four actual food items under the pretext of a parting gift. The following instruction will be used: "thank you for your time. You may now pick what you like from these options. You can eat your choice now or later. It is entirely up to you." The choice will serve as an objective measure of on-site behavior. Following the experiments, we will conduct a follow-up data collection after three months.

Eligibility criteria: Inclusion Criteria:

* children in primary level 4 between the ages of 8-11
* children fluent in English
* children who have a parent fluent in English who is willing to participate in the study

Exclusion Criteria:

* children with a history of photosensitive epilepsy
* children with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators
* underweight children

Primary outcomes:
measure: Dietary Choice
timeFrame: 1 day
measure: Objective Nutrition Knowledge (ONK)
timeFrame: 1 day
measure: Subjective Nutrition Knowledge (SNK)
timeFrame: 1 day
measure: Subjective Experiences of Discrete Emotions
timeFrame: 1 day
Secondary outcomes:
measure: Health locus of control
timeFrame: 1 day
measure: Dietary Intention
timeFrame: 1 day
Other outcomes:
Locations:
city: Tati Siding
country: Botswana
facility: Tati Siding Primary School
state: North East
Study officials:
References: