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Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs.
The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs.
The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants’ PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months.
Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities.
We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs.
ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439
PRR1-10.2196/19213
The prevalence of intellectual disabilities (IDs) is estimated to be 1% of the world’s population [
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 [
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 [
Mobile health (mHealth) provides a wide range of possibilities for monitoring and motivating individuals in the self-management of chronic illnesses [
Methods that could facilitate the development of individualized mHealth support solutions include tailoring, individual goal setting [
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 [
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.
This randomized controlled trial is part of our project to develop a tailored mHealth support system that promotes PA in individuals with IDs [
Findings from the qualitative study, discussions in workshops, and creative meetings among developers and researchers showed that many individuals with IDs experience difficulties participating in PA because of individual, interactional, and contextual factors. Some of these factors include individual difficulties in initiating activities; preferences for fun and social activities; and lack of social support, availability of activities, resources and preparation, predictability, and collaboration in activities. After examination of these findings, a prototype of an app was created and presented in one of the workshops. The feedback was promising, and development of the mHealth support system continued. The main emphasis in the app is individually chosen activities, tailored communication, predictability, use of rewards, and involvement of support persons. Activities will be chosen during a goal attainment meeting (using goal attainment scaling) [
In addition, 3 individual exercise apps have been developed as potential alternatives that can be added to Actiplan: (1) an exergame or game-inspired app that promotes outdoor PA; (2) an ergometer bike or outdoor bike placed inside the home, with a mounted screen showing a video or other visually interesting features; and (3) a game-inspired, avatar-based health platform for monitoring PA and motivating users to increase their PA levels [
To explore the participants’ expectations and experiences of the intervention and the mHealth support, a qualitative pilot study recruiting 10 of the first participants in the intervention group will be performed.
Development process of the electronic health support component of the study.
Interface options of the Actiplan app: symbols only, easy-to-read text, or plain text. The app also has read-aloud capabilities.
Participants in the control group will be administered the assessments at baseline, 3 months, and 6 months, and otherwise continue with their standard everyday activities during the study period. They will be invited to use the mHealth support system at the end of the 6-month intervention period.
Data will be collected at baseline, 3 months, and 6 months, as seen in
Consolidated Standards of Reporting Trials flow diagram of the study. mHealth: mobile health.
The primary outcome of this study will be objectively measured PA, as assessed by steps per day measured with a wrist-worn commercial accelerometer (Fitbit Versa; Fitbit Inc). The device will assess level of PA and sedentary time [
Secondary outcome measures will include minutes of moderate PA per day, PA questionnaire, body mass index, blood pressure, physical performance, social support for physical activity, self-efficacy in a PA setting, behavior problems, and goal attainment. See
Summary of outcome measures.
Measurement | Type of outcome | Measure |
Steps per day | Primary outcome | Fitness tracker |
Minutes of moderate activity | Secondary outcome | Fitness tracker |
Body mass index | Secondary outcome | kg/m2 |
Blood pressure | Secondary outcome | Blood pressure monitor |
Physical performance | Secondary outcome | Short Physical Performance Battery [ |
Behavior problems | Secondary outcome | Aberrant Behavior Checklist–Community [ |
Social support for PA and self-efficacy in PA setting | Secondary outcome | The Self-Efficacy/Social Support for Activity for Persons With Intellectual Disability scale [ |
Goal attainment | Method, secondary outcome | Goal attainment scaling [ |
Satisfaction with life | Control for adverse effects | Satisfaction with life scale [ |
The secondary PA outcome is the number of minutes of moderate PA per day, measured with the commercial accelerometer.
In addition, the International Physical Activity Questionnaire-Short Form, adapted to measure PA using proxy respondents, will be used [
Body mass index will be calculated in kg/m2 [
The Short Physical Performance Battery (SPPB) will be used to assess physical performance. The SPPB is a screening test designed to evaluate physical performance and predict disability in older adult populations [
The Aberrant Behavior Checklist—Community (ABC-C) is a questionnaire designed to assess challenging behavior in children, youth, and adults with IDs [
The Self-Efficacy/Social Support for Activity for Persons with Intellectual Disability scale [
Goal attainment scaling [
This study will use the satisfaction with life scale developed by Bergström and Hochwälder [
Patient- or proxy-reported and assessor-reported data are partly captured electronically using Research Electronic Data Capture (REDCap) (Vanderbilt University). REDCap is a web-based system that is compliant with relevant regulations and security requirements. The system has an integrated function for randomization. Questionnaires can be sent electronically to participants or the proxy respondent. Data not captured electronically, such as background information and physical performance test results, are registered at the baseline meeting. The study coordinator will evaluate the data of all participants for completeness. In cases of missing data, respondents will be contacted.
The study will be powered based on the primary outcome of accelerometer-measured steps per day (mean of 4 days) [
The randomized controlled trial includes repeated measures in 2 groups, and linear mixed models will be used in the efficacy analyses of the intervention. In addition to a group variable (treatment or control), follow-up time (3 months and 6 months) and mean steps (with baseline comparison) will be added as covariates. An intention-to-treat approach will be used with a significance level of
The project is approved by the Regional Committee for Medical and Health Research Ethics in northern Norway and is registered at ClinicalTrials.gov. Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. Participant recruitment for the randomized controlled study will be initiated as soon as practical difficulties due to the pandemic situation are solved. Participants will be recruited, randomized, and administered the intervention individually. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about mHealth to support PA in individuals with IDs.
The present trial will investigate how modern technology and mHealth can be used in the promotion of PA in individuals with IDs. A tailored PA program is expected to increase levels of PA, and individuals with IDs and low PA have the greatest chances of improving [
By including individuals with all types of IDs and low levels of PA, we can add to the knowledge on whether mHealth support can be successfully adjusted to individuals with different levels of functioning and whether it can increase levels of PA [
Aberrant Behavior Checklist
Aberrant Behavior Checklist—Community
intellectual disability
mobile health
physical activity
Short Physical Performance Battery
World Health Organization
The study has been and will continue to be conducted with grants from the Northern Norway Regional Health Authority (grant number HNF1353-17) and has received and will continue to receive support from the Department of Clinical Research, University Hospital of North Norway, Tromsø, Norway.
None declared.