The World Health Organization (WHO) guidelines for physical activity (PA) state that typical adults should spend a minimum of 150 minutes per week engaged in moderate-intensity PA or 75 minutes engaged in vigorous-intensity PA [9]. One systematic review found that only 9% of individuals with IDs met the WHO´s minimum PA guidelines [4]. Norwegian guidelines are in line with the international guidelines and recommend 150 minutes of moderate- to vigorous-intensity PA per week for adults [10] and 60 minutes per day for children and youths [11]. As high PA is a determinant of health and increased activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important.

Some well-designed studies have not been able to demonstrate improved levels of PA in intervention groups of individuals with IDs after the intervention period has ended. One theory-based randomized controlled study of adults with all types of IDs did not find any significant increases in levels of PA (steps per day) using a walking program [12]. Furthermore, the results of a cluster-randomized study of older adults in the Netherlands showed marginal effects and substantial missing data, despite being well prepared with a published protocol and using day-activity centers for the intervention [13]. Past controlled studies on the effects of PA interventions on individuals with IDs have primarily included adults with mild to moderate IDs, and effect sizes have been small [5,14]. Some studies have reported improved effects on physical fitness indicators such as balance and muscle strength [15], psychological well-being [16], perception of social competence [17], and work routines [14] after increasing levels of PA. One recent study included individuals with severe or profound IDs in a technology-aided program for promotion of PA and found positive results in energy expenditure and independent engagement in light to moderate PA [18], but with a small number of participants. Findings from previous studies indicate that a more flexible approach [19], greater use of theory in intervention design, stronger research design (as there are few randomized controlled studies), and better translation of interventions to community-based settings [20] are needed. Future studies could also have an ecological approach, where the interplay between individual, interpersonal, and environmental factors are considered [1,21]. Motivational issues have been challenging, particularly for approaches that aim for sustainable effects [17], and should be considered when designing future PA interventions.

Mobile health (mHealth) provides a wide range of possibilities for monitoring and motivating individuals in the self-management of chronic illnesses [22-24]. Motion sensor games (exergames) have been explored and have been found to be promising in individuals with IDs [25]. For these solutions to move out of the lab and into actual use, they need to first meet users’ needs [26]. The mobile platform is ubiquitous, and the touch interface has proven to have a low level of cognitive demand and could be used to improve adherence to PA [27]. At present, few mobile apps have incorporated games strategies, such as goal setting or rewards, to increase PA in individuals with various disabilities [28]. To our knowledge, there has been only 1 preliminary report (letter) of a randomized controlled trial using smartphone support to increase motivation for PA in youth and adults with IDs [29].

Methods that could facilitate the development of individualized mHealth support solutions include tailoring, individual goal setting [30], and adjusting communication to meet the specific needs of individuals with IDs [31]. Studies on motivation for PA in the IDs population have shown that predictability with routine and familiarity, communication of purpose, and enjoyable and social activities promote motivation and participation [21,32]. Family and care staff involvement will be central, and we expect the study’s implementation in a natural setting to enhance the effect [33]. We also expect the systematic use of mHealth with rewards and gamification to be beneficial. In Norway, many individuals with IDs have a smartphone or a tablet that they can use for tailored PA interventions. However, this use has not been tested previously. We expect a motivational app for smartphones and tablets to promote adherence to PA in individuals with IDs. According to the World Report on Disability, health promotion efforts targeting this population can improve lifestyle behaviors [34]. The report states that these individuals have the right to be included in all PA programs. Thereby, the present study aims to examine the effectiveness of an individually tailored PA program with motivational mHealth support on everyday levels of PA in youth and adults with IDs, targeting individual, contextual, and interactional factors of PA participation [21]. In addition to higher levels of PA, we expect improvements in psychological health, self-efficacy in activities [32], and social support for physical activity participation [35].

The current study has a randomized controlled clinical design with assessments at baseline, 3 months, and 6 months. Participants will receive either the tailored mHealth-supported PA program or standard care with access to the mHealth support system once the trial is completed. Family and care staff will be involved in the program for support and follow-up.

A total of 60 participants will be recruited into the trial through health care and other related organizations in the municipality of Tromsø in northern Norway. Information about the study will be delivered at meeting places, such as day and activity centers. If the number of included participants is insufficient, more municipalities in Northern Norway will be included, or a multicenter approach will be considered.

Individuals will be included if they have a sedentary lifestyle [1] or a low level of PA, determined with the question, “In how much of your leisure time have you been physically active in the last year?” [8]. The question has 4 response categories and has been used in population-based studies of the general population [36] and in European health indicator studies of individuals with IDs [8]. Individuals with a sedentary lifestyle (eg, primarily engaged in reading, watching television, or other mainly sedentary activities) and a low level of PA (eg, engaged in walking or other light PA for less than 4 hours a week) will be included in the study. Other inclusion criteria will be as follows: (1) diagnosis of ID (mild, moderate, severe, or profound), (2) aged between 16 and 60 years, (3) ability to participate in the intervention, (4) ability to walk with or without support, and (5) able to provide written informed consent or written informed consent can be obtained from a representative. Prior to enrollment, all participants will be screened for readiness, and, if necessary, medical clearance will be obtained. The Physical Activity Readiness Questionnaire [37] will be used for this purpose. Exclusion criteria will be as follows: (1) medical contraindications for participation in programs with increased exercise as advised by the primary care or ID specialist physician, (2) high level of physical activity, and (3) inability to provide written informed consent and written informed consent cannot be obtained from a representative.

This study has been approved by the Regional Committee for Medical and Health Research Ethics in northern Norway (number 2016/1770). The protocol has been registered at ClinicalTrials.gov under the identifier NCT04079439. The project adheres to the Consolidated Standards of Reporting Trials guidelines. Written informed consent will be obtained from each participant, their legal representative, or both prior to inclusion in the study and baseline assessment. If the participant has impaired capability to consent, consent will be sought from the nearest relative or guardian as well as from the individual with IDs, or as representative consent. Ethical issues will be continuously considered. Any adverse events will be recorded.

Participants will be randomized with a computer program to either the PA intervention with mHealth support group or the standard care control group.

Data will be collected at baseline, 3 months, and 6 months, as seen in Figure 3. Baseline data will include baseline PA activity level and will be collected before randomization. Follow-up data will be collected regardless of the participant’s compliance with the study protocol. Participants and assessors will not be blinded. Background data on the participants will be collected at baseline and will include age, gender, educational level, marital status, living condition, employment status, educational status, job-related or day center activities, leisure time activities, smoking habits, level of ID (ie, mild, moderate, severe, or profound), genetic diagnosis, gross motor function classification [42,43], communication level [44], medical history/readiness for the PA intervention, and use of medication. In addition, we will ask questions about barriers for participation in physical activities.