Compared to the general population, individuals with intellectual disability (ID) have more sedentary lifestyles, poor health, and greater barriers for participation in physical activity (PA), and consequently lower levels of PA [1-6]. PA is beneficial for cardiovascular and muscular capacity and psychological well-being and can reduce the burden of chronic disease for individuals with ID [1,7-9]. A systematic review by Hassan et al [10] investigated the efficacy of randomized controlled PA interventions, and the results showed inconsistent evidence, with only 3 intervention studies showing a prolonged effect of the intervention [8,10-12]. It is clear that new approaches and further investigations are needed to develop effective interventions for PA in this group.

Including individuals with ID in clinical intervention trials can be challenging, since there are several barriers in all aspects of the research process [13,14]. Struggling to inform the individual with ID about the research, difficulties in obtaining informed consent, finding transport to research sites, and following instructions are common challenges in clinical trials involving individuals with ID [3,15,16]. It is, therefore, particularly important to carefully plan intervention studies for this group, and performing pilot trials or feasibility studies can improve the quality of research [17].

Recent studies have shown measurable benefits from the use of mobile technologies in health care and the use of technology in everyday life has been explored and deemed promising for individuals with ID [18-21]. Although some studies have explored the possibility of using mobile technologies for promoting PA for individuals with ID, there has been only one preliminary report of a randomized controlled trial (RCT) using smartphone support to increase motivation for PA in youths and adults with ID [22-25]. In Norway, many individuals with ID have a smartphone or a tablet device they can use for tailored PA interventions and this use has not been tested. A previous study in this research project showed that individuals with ID are motivated to participate in PA and evince an interest in technology [26,27]. According to the World Report on Disability 2011 [28], health promotion efforts targeting this population can improve lifestyle behaviors. The report states that these individuals have the right to be included in all PA programs.

The primary objective of this pilot study is to assess feasibility and acceptability of study procedures for a future RCT. We also aim to explore the experience of participants and their caregivers regarding the intervention, focusing on success factors, problems, and reasons for dropout, and to understand how the use of technology can influence motivation for PA for this group.

This pilot study is part of a larger project, which aims to develop and test tailored mobile health (mHealth) support systems that promote PA in individuals with ID. We have previously conducted a qualitative study on motivation for participation in PA for such individuals, held workshops and collaborated with developers, and performed usability tests [26,29]. The results from this study will be used in the planning of a larger RCT with 60 participants. See Michalsen et al [27] for more detailed information regarding the RCT.

This protocol describes a mixed methods pilot study of an intervention arm in a planned RCT [27].

Eligible participants will be identified through their participation in a larger study on health indicators for individuals with ID, the Norwegian Health in Intellectual Disability (NOHID) study, and through staff leaders at municipality levels who have identified potential participants [30]. Overall, 10 participants with ID as well as caregivers and support persons (ie, staff) will be included if they have a sedentary lifestyle or low levels of PA. A sedentary lifestyle is defined as primarily engaging in reading, watching TV, or other mainly sedentary activities. A low level of PA is defined as mainly walking or other light PA for less than 4 hours a week. The number of participants is chosen on the basis of assumptions about sufficient variation for the investigation of feasibility and acceptability of the pilot study [23]. Data saturation of qualitative data collected will be evaluated continually and there will be scope for flexibility to achieve this during the data collection period.

The inclusion criteria are as follows: (1) low levels of PA, (2) diagnosis of ID (mild, moderate, severe, or profound), (3) aged between 16 and 60 years, (4) ability to participate in the pilot study, (5) capable of walking with or without support, and (6) can provide written informed consent or consent can be obtained from a legal representative. Prior to enrollment, all participants will be screened for readiness, and, if necessary, medical clearance will be obtained. The Physical Activity Readiness Questionnaire will be used for this purpose [31]. Exclusion criteria are as follows: (1) medical contraindications for participation in programs with increased exercise, as advised by the primary care or ID specialist physician; (2) high levels of PA; and (3) inability to provide written informed consent or consent cannot be obtained from a legal representative.

All participants and their caregivers will receive information about the purpose and procedures for the study. Informed consent will be obtained from the individuals with ID, as far as possible, if the person has decision-making capability to provide consent. In addition, or in case the person with ID cannot provide consent, a caregiver will provide informed consent on behalf of the person with ID. The definite trial and the pilot study have been approved by the Regional Committees for Medical and Health Research Ethics in Norway (2016/1770) and the data protection officer at the University Hospital of North Norway.

The final app is named Active Leisure (Aktiv Fritid) and consists of an advanced activity planner based on the platform developed by the nonprofit organization Smart Cognition AS (Smart Cognition AS). The app offers various interface options (symbols only, easy-to-read text, plain text, and read aloud). See Multimedia Appendix 1 for interface options for the Active Leisure app. The activity planner will mostly be used by an individual with ID and a support person (caregiver or health care provider). Participants will have different levels of functioning and will require different proximity of support persons, which will be considered when delivering the intervention. After completing an activity, a simple reward is available (eg, a smiling face or to share a picture with other users of the app). All activities that go into the activity planner are added through a web application. For this project, the principal author (HM) will be responsible for adding personalized activities into the activity planner for each participant. The use of tailored communication [32] through personalization (the use of the individual’s first name in the activity planner), adaptation (individually chosen activities, adjusted communication, including symbols, easy-to-read text, or plain text), preparation and planning, and feedback (rewarding and positive feedback after activities have been performed) are expected to increase motivation and thereby lead to higher levels of PA.

An individual mHealth exercise app has also been developed as a potential alternative that can be added to the Active Leisure planner; this app is called Sorterius (see Multimedia Appendix 2) [33] and is an augmented reality game, inspired by the popular game Pokémon Go. In this app, individuals can use the camera on their phone to look for virtual waste on the ground. Virtual waste will appear as they walk and can be sorted into correct waste bins, depending on the level of difficulty chosen (easy=1 waste bin, medium=2 waste bins, difficult=4 waste bins). When a set number of items has been collected, the individual will receive a virtual reward (stars and positive feedback). It is possible to add goals for steps per day and a weekly goal, which can be tailored to each individual’s interest.

In this pilot study, a possible main finding will be the large variations in the quality of the collected data. Many intervention studies including individuals with ID have recruitment problems [13], report that data are missing [12], and have a low participation rate, particularly for individuals with severe ID [5,6]. Conducting pilot trials is, therefore, important when planning RCTs since it offers the possibility to address feasibility issues, improve procedures, and prevent wastage of resources in future trials [52]. This knowledge can guide future development of technology-based PA programs and help improve future intervention studies aiming to improve levels of PA.

We expect that this pilot trial will uncover possible challenges in using technological devices for interventions aiming at PA promotion for individuals with ID. This pilot study will show how the use of a technological tool, such as mHealth, can be tested in research involving individuals with ID. The use of technology as a means of improving health has been explored to some extent in this population [20,21,55-57], but limited studies have investigated the use of mHealth for improving levels of PA for individuals with ID [25,58].

The quantitative measurements at baseline and follow-up may reveal differences in PA levels, self-efficacy of PA or in other psychosocial variables. In addition, we expect to find goal achievement among the participants by follow-up. We do not expect to detect any effects of the trial as it is a pilot study [59]. In addition, we expect a possible finding to be that the use of 2 activity trackers, Fitbit and Axivity, will strengthen the quality of activity data. We will gain experience in using one commercial and one research-friendly activity tracker. This experience can be useful in future trials.

In this pilot study, we expect that the use of the mHealth tool will rely on the caregivers or staffs’ involvement. The study will, therefore, offer insight into the inclusion of support persons in the planning of PA using mHealth tools, as previous research has shown a greater motivation for PA in individuals with ID if support persons are engaged and included in the activity [26]. It will also explore how the use of goal attainment for adults with ID can be used in a research project on PA promotion [60]. The influence of the use of technology on motivation for PA is being investigated through qualitative methods.

This study will have several limitations. The sample size will be small, which will influence the representativeness of the quantitative data. For the qualitative data, a sample of 10 participants is expected to be of good quality if data saturation is achieved. Another limitation in the data collection can be that having 2 activity trackers might not be accepted by participants, resulting in no measurement if the participants stop using them. Participants or caretakers who agree to be included in the pilot study might be interested or engaged in PA promotion and the variation in the included participants regarding interest in PA might be scarce.

The study has potentially important implications for both individuals with ID and their support networks. The study will be presented at conferences and published in recognized international peer-reviewed journals.

This pilot study will evaluate the feasibility and acceptability of study procedures of the intervention arm of a planned RCT. This can, in turn, address feasibility issues, improve study procedures, and estimate effectiveness of the study measures. We will investigate how technology can be used to influence motivation for PA, which can help guide and improve future PA interventions involving the use of technology. Investigating new ways of enhancing PA for individuals with ID is important to ensure better health and quality of life for this group.