Multiple Sclerosis Clinical Trial
Official title:
A Pilot Study for Testing the Feasibility and Efficacy of Text Messaging and Newsletter as a Strategy for Interrupting Sedentary Behavior (Sit Less, Move More)
The study will examine the possibility of reducing sedentary behavior (SB) in African Americans with MS. SB consists of any waking activities that are done lying or sitting and do not demand significant physical effort (e.g., watching television, using the computer). SB is a major public health issue because it is associated with mortality and higher probabilities of presenting with health conditions and morbidity. There is indication that SB is related to physical disability, which is the inability of performing daily activities independently. This outcome is of high concern for persons with MS, especially those from underserved groups, such as African Americans. Thus, reducing the amount of time that people with MS spend in SB is important, but it is hard to find ways of doing so in large groups of people with MS. One possibility is to use text-messages to inform people about the necessity and benefits of interrupting SB by standing up, walking, or doing another activity. Text-messages are an ideal way to prompt behavior change because almost everyone owns a cellphone/smartphone in today's world. Considering this potential, the investigators will be studying whether or not it is possible to have a small group of African Americans with MS spend less time in SB by sending informative text-messages prompting individuals to stand-up and move around. This study will be used to inform the development of a much larger study that will aim to reduce SB in a very large sample of persons with MS.
The investigators are conducting a pilot study to examine the feasibility and efficacy of a
technology-based behavior change intervention for reducing SB in African Americans with MS
located in the United States. The intervention combines text message- and print-based
approaches for behavior change based on Social Cognitive Theory (SCT). SCT-based content will
be the active component for changing SB, while cellphone text messages and print newsletter
will be the delivery mechanism. The use of cellphone to deliver the intervention content is
based, in part, on the fact that cellphone is an ordinary form of communication in today's
world, providing an optimal medium for reaching large groups of people remotely. The study
will yield major advancement in identifying the feasibility and efficacy of interrupting and
reducing SB via a technology-based intervention in African Americans with MS, a segment of
the MS population that has been underrepresented in MS therapeutic management studies. If
successful, this research will lay the foundation for applying the current strategy in
large-scale interventions including African Americans and possibly other minority groups with
MS.
The intervention will be 12 weeks and divided into two parts. Part 1: Weeks 1-6 will focus on
interrupting long periods of SB. At the beginning of the first week, participants will
receive a packet containing print material providing lay information on what constitutes SB
and examples of such behavior, highlighting the importance of interrupting prolonged periods
of SB and the associated health benefits. The aim of the packet is to provide the basis to
introduce the key element (i.e., SCT-based instructional cellphone text-messages) of the
intervention. This will occur during the following six weeks, wherein participants will
receive two text-messages/day (i.e., morning and afternoon) on the importance and health
benefits of interrupting SB hourly. The text-messages will prompt individuals to interrupt SB
by standing still, standing while performing tasks, or walking around. The text-messages will
include further tips and strategies for interrupting SB. The investigators have previously
developed a computerized messaging system that will be used to send the text-messages twice a
day in the proposed intervention. The investigators will supplement the text messaging by
sending bi-weekly SCT-based newsletters to participants that highlight ways of overcoming
difficulties in effectively interrupting SB. The SCT content for the messages and newsletter
has been created in previous research and will be revised for the proposed intervention. Part
2: Weeks 7-12 will focus on replacing SB with light PA. On the first day of week 7,
participants will receive a second packet of print material explaining the concept of light
PA and emphasizing the importance of moving more daily. The print material will highlight the
benefits of replacing SB with light PA and will contain instructions for goal setting (i.e.,
target number of steps/day) and self-monitoring of daily PA, including receive a pedometer
and a log for recording total steps/day. Similar to part 1, the key element for intervention
delivery will be the SCT-based instructional cellphone text-messages, which participants will
receive during the second six-week intervention period. More specifically, they will receive
two text-messages/day on the importance and health benefits of replacing SB with light PA.
The text-messages will recommend participants to watch for prolonged periods of SB and try
and substitute these for light PA, such as light intensity walking and light-intensity focal
exercise (e.g., stationary walk, marching). The text-messages will also remind participants
to use the pedometer to set incremental personal goals for steps/day and to gauge the
replacement of SB with light PA by watching the pedometer readings. The investigators further
will include tips and strategies for replacing SB with light PA based on common daily
activities. Bi-weekly SCT-based newsletters will be used to supplement the stimulus from the
text-messages, by reinforcing the importance of sitting less and moving more.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |