Wheels lifestyle intervention study.

An active lifestyle is known to be beneficial for a person*s health. This seems
even more important for wheelchair users because it also influences their level
of functioning. Physical inactivity, obesity and low vitality are, however,
common among such users with spinal cord injury (SCI) or lower limb amputation
(LLA), and are risk factors for secondary health problems and a reduced quality
of life. It is, therefore, important that wheelchair users are being encouraged
to achieve and maintain an active lifestyle during and after inpatient
rehabilitation. Despite encouragement during inpatient rehabilitation, it is
difficult for wheelchair users with SCI or LLA to maintain the adopted activity
level once discharged. One of the reasons for this is the limited availability
in professional guidance after discharge, which often leads to a decrease in
physical activity after discharge, resulting in increased risks to develop
obesity and secondary health problems. Additional guidance is clearly necessary
after inpatient discharge to facilitate an active lifestyle in wheelchair users
with SCI or LLA. Additional support to fill this gap can be achieved through
mobile health (mHealth).
mHealth provides the opportunity to support and monitor an active lifestyle on
individual and group level. Benefits of mHealth include easy access to
information and advice, feedback, self-monitoring, social support,
reinforcement and goal setting, and it is a promising tool in supporting
changes in lifestyle related behavior, such as diet and physical activity
behavior. The use of such techniques on lifestyle related determinants mediates
in the potential effectiveness of the mHealth platform. However, determinants
of physical activity can vary between populations and are different in
individuals with a disability or who are wheelchair dependent. So far, there is
no mHealth platform for this specific target group. An existing lifestyle
platform was therefore adapted based on the intervention mapping protocol.
Modifications were made to the wishes and needs of wheelchair users with SCI or
LLA together with professionals working with them. Due to different barriers
and facilitators for physical activity in daily life in wheelchair users,
different strategies are necessary. Behavioral change strategies were developed
and implemented in the lifestyle platform based on focus group outcomes.
It remains unclear which effect the platform has on the physical behavior and
lifestyle on wheelchair users. Therefore a double-baseline controlled trial is
proposed to investigate the effect of the platform on wheelchair users to gain
insight in possible changes in physical activity, nutritional habits, strength,
body composition and quality of life.

Primary objective:
Does the use of the application support a positive lifestyle development?

Secondary objectives:
Does the use of the application support an increase in physical activity levels?
Does the use of the application has a positive influence on body composition?
Does the use of the application has a positive influence in nutritional habits?
Does the use of the application has a positive influence on sleep quality?

A so called 'one group prestest posttest' design is suggested in which each
participant is measured before and after the intervention period.
All outcomes are measured with a pre-post test design, except data collected
with the Fitbit.
Participants will perform all measurements one week in advance before the
intervention period (questionnaires and self-reported body composition) and
will start wearing the Fitbit during this week.
After wearing the Fitbit for one week, participants will receive access to the
WHEELS application to support a positive lifestyle change. De registered Fitbit
data during the week before the intervention study on physical activity and
sleep will be used as pre intervention data. This data can then be used as
comparison of the physical and sleep behavior throughout the intervention
period.
after the 12 weeks have passed, participants will be asked to perform the same
questionnaires and when possible self-reported body composition measurements
with an additional questionnaire to gain insight about their experience and
satisfaction about the application.

During the first week participants will be asked to start wearing the supplied
Fitbit as much as possible (day and night) and perform all questionnaires that
will be presented digitally.
After the first week, participants will receive access to the WHEELS platform
in order to support them with a change towards a more healthy lifestyle. The
platform, a combination of an application and a website connected with a
Fitbit, could provide support in improving their lifestyle on physical
activity, nutritional habits and sleep & relaxation, which will act as the
intervention.This Fitbit will provide the user feedback on activity level and
sleep quality. During the 12 week intervention period, participants are asked
to wear the Fitbit as much as possible. Throughout the whole process the
research team will remain available for support and questions regarding the use
of the application and Fitbit.
After the 12 week intervention period, participants are asked to finish all
questionnaires again.

Considering that potential participants are screened with the ACSM risk profile
questionnaire before the start of the intervention study, limited risks are
present for participants to get involved in physical activity without
supervision.

Possible benefits of participating in this intervention study is an improved
lifestyle, possibly on multiple aspects. If the intervention is effective,
beneficial changes can occur on physical activity level, body composition,
nutritional habits, sleep quality, health and/or quality of life. Participants
will keep access to the application after completing the study.
Therefore the time needed and burden during this research are justified, since
it might possibly benefit the health of the participant eventually.

No direct in-person contact with any researcher is needed, in order to
minimalize possible risks of the COVID 19 virus. All measurements can be
administered and measured at home and are self-reported.