NCT03671499

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

September 10, 2018

Last Update Submit

November 26, 2019

Conditions

Keywords

sedentary behaviorphysical activity

Outcome Measures

Primary Outcomes (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.

    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.

    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.

    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.

    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.

    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.

    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).

    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).

    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).

    Assessments will be conducted at baseline and at at the end of the intervention (immediately after intervention week 12).

Study Arms (1)

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.

Behavioral: Social Cognitive Theory based text messages

Interventions

Participants receive daily text messages and bi-weekly newsletters with information about reducing sitting behavior and increasing physical activity.

Social Cognitive Theory based text messages

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35209, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple SclerosisSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Robert W Motl, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 14, 2018

Study Start

March 27, 2018

Primary Completion

June 5, 2019

Study Completion

October 25, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Locations