Multiple SclerosisSLMMNCT03671499
A Study for Testing Text Messaging and Newsletter as a Strategy for Interrupting Sedentary Behavior
A study testing Social Cognitive Theory based text messages in people with Multiple Sclerosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Social Cognitive Theory based text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to 25 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- African American
- Definite diagnosis of MS
- Relapse free in the last 30 days
- Ambulatory with or without assistance
- Having a Patient-Determined Disease Steps score of 0-5
- Daily engagement in sedentary behavior ≥ 480 min/day
- Health contribution score of <14 calculated from the Godin Leisure-Time Exercise Questionnaire
- Absence of major musculoskeletal problems, and/or cardiovascular, cardiopulmonary, and/or metabolic diseases that can influence physical activity and sedentary behavior levels
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham
Birmingham, Alabama, 35209
About this study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Social Cognitive Theory based text messages
- Keywords
- sedentary behavior, physical activity
- Medical subject headings
- Multiple Sclerosis, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognitive Theory based text messagesBehavioural
Participants receive daily text messages and bi-weekly newsletters with information about reducing sitting behavior and increasing physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Social Cognitive Theory based text messages | Experimental | The study only contains 1 arm. All participants will receive the same experimental protocol. Participants will receive daily text messages and bi-weekly newsletters for reducing sedentary behavior based on Social Cognitive Theory. Receives: Behavioral: Social Cognitive Theory based text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sedentary behavior evaluated with activity monitors
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessments will be conducted at baseline and at the midpoint of the experiment (intervention week 6)
Change in sedentary behavior evaluated with activity monitors
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessments will be conducted at the midpoint of the intervention (intervention week 6) and at at the end of the intervention (immediately after intervention week 12).
Change in sedentary behavior evaluated with activity monitors
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessments will be conducted at baseline and at at the end of the intervention (immediately after intervention week 12).
Change in physical activity evaluated with activity monitors
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessments will be conducted at baseline and at the midpoint of the experiment (intervention week 6)
Change in physical activity evaluated with activity monitors
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessments will be conducted at the midpoint of the intervention (intervention week 6) and at at the end of the intervention (immediately after intervention week 12).
Change in physical activity evaluated with activity monitors
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Measured: Assessments will be conducted at baseline and at at the end of the intervention (immediately after intervention week 12).
Secondary outcomes (3)
Quality of Life will be evaluated with the 36-Item Short Form Health Survey (SF-36 questionnaire).
The SF-36 questionnaire is a 36 item self-report questionnaire designed to assess patient health status. The questionnaire is scored on 8 sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Scores are transformed into a 0-100 scale with 0 equivalent to maximum disability and 100 equivalent to no disability.
Measured: Assessments will be conducted at baseline and at the midpoint of the experiment (intervention week 6)
Quality of Life will be evaluated with the 36-Item Short Form Health Survey (SF-36 questionnaire).
The SF-36 questionnaire is a 36 item self-report questionnaire designed to assess patient health status. The questionnaire is scored on 8 sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Scores are transformed into a 0-100 scale with 0 equivalent to maximum disability and 100 equivalent to no disability.
Measured: Assessments will be conducted at the midpoint of the intervention (intervention week 6) and at at the end of the intervention (immediately after intervention week 12).
Quality of Life will be evaluated with the 36-Item Short Form Health Survey (SF-36 questionnaire).
The SF-36 questionnaire is a 36 item self-report questionnaire designed to assess patient health status. The questionnaire is scored on 8 sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Scores are transformed into a 0-100 scale with 0 equivalent to maximum disability and 100 equivalent to no disability.
Measured: Assessments will be conducted at baseline and at at the end of the intervention (immediately after intervention week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start27 Mar 2018
- Primary completion5 Jun 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers
- Responsible party
- Principal investigator, Robert W Motl, University of Alabama at Birmingham
- Investigators
- Robert W Motl, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671499
- Sponsor's protocol ID
- 0000518843
- Acronym
- SLMM
- Status last verified
- Nov 2019
- First submitted
- 10 Sep 2018
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baird JF, Sasaki JE, Sandroff BM, Cutter G, Motl RW. An Intervention for Changing Sedentary Behavior Among African Americans With Multiple Sclerosis: Protocol. JMIR Res Protoc. 2019 May 1;8(5):e12973. doi: 10.2196/12973.
PubMed 31042149
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03671499
- Acronym / sponsor ID
- SLMM / 0000518843
- Conditions
- Multiple Sclerosis
- Keywords
- sedentary behavior, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Cognitive Theory based text messages | Experimental | Behavioral: Social Cognitive Theory based text messagesThe study only contains 1 arm. All participants will receive the same experimental protocol. Participants will receive daily text messages and bi-weekly newsletters for reducing sedentary behavior based on Social Cognitive Theory. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- African American
- Definite diagnosis of MS
- Relapse free in the last 30 days
- Ambulatory with or without assistance
- Having a Patient-Determined Disease Steps score of 0-5
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Cognitive Theory based text messagesParticipants receive daily text messages and bi-weekly newsletters with information about reducing sitting behavior and increasing physical activity. | Behavioural | Social Cognitive Theory based text messages |
Primary outcome
Change in sedentary behavior evaluated with activity monitors
Time frame: Assessments will be conducted at baseline and at the midpoint of the experiment (intervention week 6)
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Change in sedentary behavior evaluated with activity monitors
Time frame: Assessments will be conducted at the midpoint of the intervention (intervention week 6) and at at the end of the intervention (immediately after intervention week 12).
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Change in sedentary behavior evaluated with activity monitors
Time frame: Assessments will be conducted at baseline and at at the end of the intervention (immediately after intervention week 12).
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Change in physical activity evaluated with activity monitors
Time frame: Assessments will be conducted at baseline and at the midpoint of the experiment (intervention week 6)
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Change in physical activity evaluated with activity monitors
Time frame: Assessments will be conducted at the midpoint of the intervention (intervention week 6) and at at the end of the intervention (immediately after intervention week 12).
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Change in physical activity evaluated with activity monitors
Time frame: Assessments will be conducted at baseline and at at the end of the intervention (immediately after intervention week 12).
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
3 secondary outcomes
Quality of Life will be evaluated with the 36-Item Short Form Health Survey (SF-36 questionnaire).
Time frame: Assessments will be conducted at baseline and at the midpoint of the experiment (intervention week 6)
Quality of Life will be evaluated with the 36-Item Short Form Health Survey (SF-36 questionnaire).
Time frame: Assessments will be conducted at the midpoint of the intervention (intervention week 6) and at at the end of the intervention (immediately after intervention week 12).
Quality of Life will be evaluated with the 36-Item Short Form Health Survey (SF-36 questionnaire).
Time frame: Assessments will be conducted at baseline and at at the end of the intervention (immediately after intervention week 12).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Derived from this study: PubMed 31042149Baird JF, Sasaki JE, Sandroff BM, Cutter G, Motl RW. An Intervention for Changing Sedentary Behavior Among African Americans With Multiple Sclerosis: Protocol. JMIR Res Protoc. 2019 May 1;8(5):e12973. doi: 10.2196/12973.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Motl, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognitive Theory based text messages in people with Multiple Sclerosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sedentary behavior evaluated with activity monitors (time frame: Assessments will be conducted at baseline and at the midpoint of the experiment (intervention week 6)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03671499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.