Neurological DisorderNCT04820153
Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders
A study testing Physical Activity Monitoring Device and Lifestyle Redesign Coaching in people with Neurological Disorder, run by University of Southern California at 1 site in United States.
Trial summary
The primary goal of this proposal is to demonstrate the feasibility of using a Fitbit charge to monitor and promote physical activity in a diverse population of Hispanic women with chronic neurological disorders. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Neurological Disorder
- What is being tested?
- Physical Activity Monitoring Device and Lifestyle Redesign Coaching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 30 Jun 2020
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Women of Hispanic origin;
- (2) established patient of the neurology clinic defined as clinic visits at the LAC/USC Neurology Clinic that have spanned greater than one year;
- (3) age > 30
- (4) willing and able to utilize a Fitbit activity Monitor;
- (5) own a smart phone device;
- (6) ambulatory without assistance;
Show all 10Show fewer
- (7) willing and able to provide informed consent;
- (8) within commuting distance to the wellness center and LAC/USC hospital;
- (9) reads or comprehends Spanish;
- (10) weekly internet access.
Who cannot join
- (1) Clinically significant neurological or psychiatric illness including mental retardation, dementia or severe depression/anxiety;
- (2) any physical condition that precludes engagement in exercise, including significant heart disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033-4606
About this study
The primary goal of this proposal is to demonstrate the feasibility of using a Fitbit charge to monitor and promote physical activity in a diverse population of Hispanic women with chronic neurological disorders. Hispanic women will also receive behavioral coaching using a Lifestyle Redesign approach to enhance physical activity in their daily lives. The secondary goal of this proposal is to investigate whether changes in physical activity are associated with (i) quality of life including perception of health and well- being and (ii) frequency of hospital and county clinic visits.
Read the detailed description
This pilot study will provide feasibility on use of wearable technology for tracking and self-monitoring physical activity (PA) as well as preliminary data to support our overall approach for promoting PA and improving disease status in a Hispanic women population. A larger application will be submitted to the NIH, DoD, or other federal agency focused on investigating the impact of PA on chronic neurological diseases in a diverse and inclusive Hispanic population in LA County.
2.1.1 Specific Aim 1 establishes feasibility of this approach by measuring adherence and change in PA using a Fitbit alta HR activity monitor in Hispanic women with chronic neurological diseases. Adherence will be determined through: (i) the average hours/day of use; and (ii) the length of time (percent of total study days) of usage throughout the 16-week study. Adherence defined as (i) 5 or more days/week of use and (ii) 10 or more hours of use during the day.
2.1.2 Specific Aim 2 tests the hypothesis that an increase in physical activity will be correlated with a decrease in LA County (LAC) Facilities health care use (hospital and clinic visits). Physical activity will be assessed by change in either: (i) the average number of steps/week; and (ii) average time spent in sedentary, light, or moderate to vigorous intensity based on MET (metabolic expenditure) of physical activity/week. Methods: Changes in PA outcome metrics over the 16-week period will be correlated with the total number of hospital/outpatient clinic visits. Total hospital use will be determined through the LAC/DHS (Department of Human Services) electronic medical records and will include outpatient provider visits, emergency room and urgent care visits, total hospitalizations, and days spent in hospital.
2.1.3 Specific Aim 3a tests the hypothesis that increase in physical activity is associated with an increase in the quality of life (QOL). Physical activity will be measured through: (i) the average number of steps/week; and (ii) average intensity of physical activity/week. QOL will be determined through measures of self-rated health and well-being. These Spanish validated surveys will include illness perception questionnaire and health and well-being questionnaire
- Conditions
- Neurological Disorder
- Being tested
- Physical Activity Monitoring Device, Lifestyle Redesign Coaching
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Monitoring DeviceDevice
Participants will be provided a Fitbit Alta HR and wall charger. Each participant will be assigned a unique ID# at baseline and used to set-up the data acquisition. The Fitbit app will be set up on their smartphone to allow self-monitoring of activity. The Fitbit device includes both an accelerometer and heart rate monitor, capable of continuous measuring and storing data up to 5 days. Fitbit data will be passively downloaded through smartphone connection to Fitabase, a research friendly application and data management program. The Fitbit will be worn on the wrist every day during the course of the 16-week study, with instructions on self- monitoring, usage and maintenance. Participants will be monitored for Fitbit compliance by weekly phone calls; and monitoring of passively downloaded Fitbit data through Fitabase. Follow-up phone call at 3-months post-study will assess continued use of the Fitbit activity monitor.
Lifestyle Redesign CoachingBehavioural
Participants will receive individualized goal setting and a guide to increase exercise at baseline and at week four visit. The Occupational therapist (OT) will administer a well published approach for promoting PA called Lifestyle Redesign which addresses physical, psychosocial and environmental barriers to health and incorporate self-care strategies and goal setting. Coaching will be administered by a bilingual OT and in Spanish. Based on studies examining PA and brain health, the OT will guide the participant through a goal setting process for moderate to vigorous intensity of physical activity including a specific guide plan to achieve these goals of 10,000 steps per day and/or 150 minutes/week of moderate to vigorous activity. Participants will also receive weekly calls from the study coordinator (overseen by OT) to review PA and goal setting for each week over the course of the 16-week study.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Other | Study participants will participate in both the Physical Activity Monitoring Device intervention and the Lifestyle Redesign Coaching intervention simultaneously. Both interventions are complementary to one another. Receives: Device: Physical Activity Monitoring Device; Behavioral: Lifestyle Redesign Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Demographic Data
Baseline demographic data will be obtained which will include age, recent healthcare visit frequency, medical history, medication, years of education, and tobacco use.
Measured: At Baseline Visit
Physical Activity Adherence Assessment- Step Count +
Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com). Step Count will be obtained during the course of the study.
Measured: 16 weeks
Physical Activity Adherence Assessment- Time spent in moderate to vigorous activity
Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com).Time spent in moderate to vigorous activity will be obtained during the course of the study.
Measured: 16 weeks
Physical Activity Adherence Assessment- length of wear.
Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com). Length of wear will be obtained during the course of the study.
Measured: 16 weeks
Determination of LA County Facilities Health Care Use- number of inpatient LA County Hospital visits
The investigators will utilize electronic medical record (EMR) system of LA County Department of Health Services (DHS) to determine the number of inpatient hospital visits The total number of visits to the LAC/USC medical center will be determined during the 16-week period prior to study initiation and during the period of the study intervention using electronic medical records. HIPPA guidelines will be followed.
Measured: 16 weeks
Determination of LA County Facilities Health Care Use- number of LA County Hospital Outpatient visits
The investigators will utilize electronic medical record (EMR) system of LA County Department of Health Services (DHS) to determine the number of outpatient hospital visits. The total number of visits to the LAC/USC medical center will be determined during the 16-week period prior to study initiation and during the period of the study intervention using electronic medical records. HIPPA guidelines will be followed.
Measured: 16 weeks
Secondary outcomes (5)
Quality of Life (QOL) Assessment
This measure assessed participants' views of their health, how well they feel, and how well they are able to complete their usual activities. The scale is comprised of 16 items with a 1-7 rating scale of points. A higher sum of points indicates feelings of better quality of life and a better outcome.
Measured: At Baseline Visit and Week 16
Spanish Acculturation
The purpose of this questionnaire is to assess the level to which participants acculturate or adopt the attitudes, values, customs, beliefs, and behaviors of another culture. The scale is comprised of 12 items measured on a scale of 1 to 5, which are averaged. Low acculturation is measured by an average score >2.99.
Measured: At Baseline
Brief Illness Perception Questionnaire (BIPQ)
The purpose of this questionnaire is to assess participants' perceptions of their health and well-being.
Each item of the Brief IPQ assesses one dimension of illness perceptions:
The consequences score is simply the response to item 1. The timeline score is the response to item 2 The personal control scores is the response to item 3 The treatment control score is the response to item 4 The identity score is the response to item 5 The coherence score is the response to item 7 The emotional representation is the response to item 8. Illness concern is measured by item 6. This reflects a combination of emotional and cognitive representations.
Item 9 is the causal item. Reponses can be grouped into categories such as stress, lifestyle, hereditary, etc. determined by the particular illness studied. Categorical analysis can then be performed, either on just the top listed cause or all three listed causes.
Measured: At Baseline and Week 16
Spanish Physical Activity Questionnaire
This self-administered questionnaire determines total physical activity (MET-h week-1 ) and total number of hours sitting down across a week to evaluate the levels of participants' physical activity and sedentary lifestyle. The number of METs (metabolic equivalents) corresponding to each activity are calculated using the Compendium of Physical Activities as the ratio of energy expended during a physical activity to the metabolic rate. Afterwards, the number of METs in each activity is multiplied by the weekly participation in that activity. The estimated number of MET-h week -1 is weighted according to the number of months dedicated to each activity. Recreational physical activity is quantified by summing the MET-h week -1 dedicated to all activities performed during leisure time. Total physical activity (MET-h week -1) is calculated by adding leisure-time physical activity to work physical activity.
Measured: At Baseline and Week 16
FitBit Wear Technology Questionnaire
The purpose of this questionnaire is to ascertain participants' opinions on the usability of the Fitbit phone application, Fitbit activity monitor, and combination of the Fitbit and Fitbit Application. Participants score questions pertaining to usability on a scale of 1 (strongly disagree) to 5 (strongly agree). These scores are averaged and expressed as a percentage of 100, with higher scores indicating greater usability.
Measured: At Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start26 Mar 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 Neurological DisorderStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Petzinger, MD, University of Southern California
- Investigators
- Giselle Petzinger, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820153
- Sponsor's protocol ID
- HS-18-00993
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Researchers interested in the study may contact PI to request information regarding study protocol and de-identified study data.
Publications
Garbin A, Diaz J, Bui V, Morrison J, Fisher BE, Palacios C, Estrada-Darley I, Haase D, Wing D, Amezcua L, Jakowec MW, Kaplan C, Petzinger G. Promoting Physical Activity in a Spanish-Speaking Latina Population of Low Socioeconomic Status With Chronic Neurological Disorders: Proof-of-Concept Study. JMIR Form Res. 2022 Apr 20;6(4):e34312. doi: 10.2196/34312.
PubMed 35442197
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders
- ClinicalTrials.gov ID
- NCT04820153
- Acronym / sponsor ID
- HS-18-00993
- Conditions
- Neurological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Mar 2021 (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 primary goal of this proposal is to demonstrate the feasibility of using a Fitbit charge to monitor and promote physical activity in a diverse population of Hispanic women with chronic neurological disorders. Hispanic women will also receive behavioral coaching using a Lifestyle Redesign approach to enhance physical activity in their daily lives. The secondary goal of this proposal is to investigate whether changes in physical activity are associated with (i) quality of life including perception of health and well- being and (ii) frequency of hospital and county clinic visits.
Detailed description
This pilot study will provide feasibility on use of wearable technology for tracking and self-monitoring physical activity (PA) as well as preliminary data to support our overall approach for promoting PA and improving disease status in a Hispanic women population. A larger application will be submitted to the NIH, DoD, or other federal agency focused on investigating the impact of PA on chronic neurological diseases in a diverse and inclusive Hispanic population in LA County.
2.1.1 Specific Aim 1 establishes feasibility of this approach by measuring adherence and change in PA using a Fitbit alta HR activity monitor in Hispanic women with chronic neurological diseases. Adherence will be determined through: (i) the average hours/day of use; and (ii) the length of time (percent of total study days) of usage throughout the 16-week study. Adherence defined as (i) 5 or more days/week of use and (ii) 10 or more hours of use during the day.
2.1.2 Specific Aim 2 tests the hypothesis that an increase in physical activity will be correlated with a decrease in LA County (LAC) Facilities health care use (hospital and clinic visits). Physical activity will be assessed by change in either: (i) the average number of steps/week; and (ii) average time spent in sedentary, light, or moderate to vigorous intensity based on MET (metabolic expenditure) of physical activity/week. Methods: Changes in PA outcome metrics over the 16-week period will be correlated with the total number of hospital/outpatient clinic visits. Total hospital use will be determined through the LAC/DHS (Department of Human Services) electronic medical records and will include outpatient provider visits, emergency room and urgent care visits, total hospitalizations, and days spent in hospital.
2.1.3 Specific Aim 3a tests the hypothesis that increase in physical activity is associated with an increase in the quality of life (QOL). Physical activity will be measured through: (i) the average number of steps/week; and (ii) average intensity of physical activity/week. QOL will be determined through measures of self-rated health and well-being. These Spanish validated surveys will include illness perception questionnaire and health and well-being questionnaire
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | Other | Device: Physical Activity Monitoring Device, Behavioral: Lifestyle Redesign CoachingStudy participants will participate in both the Physical Activity Monitoring Device intervention and the Lifestyle Redesign Coaching intervention simultaneously. Both interventions are complementary to one another. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- (1) Women of Hispanic origin;
- (2) established patient of the neurology clinic defined as clinic visits at the LAC/USC Neurology Clinic that have spanned greater than one year;
- (3) age > 30
- (4) willing and able to utilize a Fitbit activity Monitor;
- (5) own a smart phone device;
Key exclusion criteria (2 listed)
- (1) Clinically significant neurological or psychiatric illness including mental retardation, dementia or severe depression/anxiety;
- (2) any physical condition that precludes engagement in exercise, including significant heart disease.
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 |
|---|---|---|
| Physical Activity Monitoring DeviceParticipants will be provided a Fitbit Alta HR and wall charger. Each participant will be assigned a unique ID# at baseline and used to set-up the data acquisition. The Fitbit app will be set up on their smartphone to allow self-monitoring of activity. The Fitbit device includes both an accelerometer and heart rate monitor, capable of continuous measuring and storing data up to 5 days. Fitbit data will be passively downloaded through smartphone connection to Fitabase, a research friendly application and data management program. The Fitbit will be worn on the wrist every day during the course of the 16-week study, with instructions on self- monitoring, usage and maintenance. Participants will be monitored for Fitbit compliance by weekly phone calls; and monitoring of passively downloaded Fitbit data through Fitabase. Follow-up phone call at 3-months post-study will assess continued use of the Fitbit activity monitor. | Device | Study Participants |
| Lifestyle Redesign CoachingParticipants will receive individualized goal setting and a guide to increase exercise at baseline and at week four visit. The Occupational therapist (OT) will administer a well published approach for promoting PA called Lifestyle Redesign which addresses physical, psychosocial and environmental barriers to health and incorporate self-care strategies and goal setting. Coaching will be administered by a bilingual OT and in Spanish. Based on studies examining PA and brain health, the OT will guide the participant through a goal setting process for moderate to vigorous intensity of physical activity including a specific guide plan to achieve these goals of 10,000 steps per day and/or 150 minutes/week of moderate to vigorous activity. Participants will also receive weekly calls from the study coordinator (overseen by OT) to review PA and goal setting for each week over the course of the 16-week study. | Behavioural | Study Participants |
Primary outcome
Baseline Demographic Data
Time frame: At Baseline Visit
Baseline demographic data will be obtained which will include age, recent healthcare visit frequency, medical history, medication, years of education, and tobacco use.
Physical Activity Adherence Assessment- Step Count +
Time frame: 16 weeks
Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com). Step Count will be obtained during the course of the study.
Physical Activity Adherence Assessment- Time spent in moderate to vigorous activity
Time frame: 16 weeks
Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com).Time spent in moderate to vigorous activity will be obtained during the course of the study.
Physical Activity Adherence Assessment- length of wear.
Time frame: 16 weeks
Data gathered from Fitbit based device will be stored, visualized and aggregated through a commercially available service (Fitabase Inc, Https:/www.Fitabase.com). Length of wear will be obtained during the course of the study.
Determination of LA County Facilities Health Care Use- number of inpatient LA County Hospital visits
Time frame: 16 weeks
The investigators will utilize electronic medical record (EMR) system of LA County Department of Health Services (DHS) to determine the number of inpatient hospital visits The total number of visits to the LAC/USC medical center will be determined during the 16-week period prior to study initiation and during the period of the study intervention using electronic medical records. HIPPA guidelines will be followed.
Determination of LA County Facilities Health Care Use- number of LA County Hospital Outpatient visits
Time frame: 16 weeks
The investigators will utilize electronic medical record (EMR) system of LA County Department of Health Services (DHS) to determine the number of outpatient hospital visits. The total number of visits to the LAC/USC medical center will be determined during the 16-week period prior to study initiation and during the period of the study intervention using electronic medical records. HIPPA guidelines will be followed.
5 secondary outcomes
Quality of Life (QOL) Assessment
Time frame: At Baseline Visit and Week 16
Spanish Acculturation
Time frame: At Baseline
Brief Illness Perception Questionnaire (BIPQ)
Time frame: At Baseline and Week 16
Spanish Physical Activity Questionnaire
Time frame: At Baseline and Week 16
FitBit Wear Technology Questionnaire
Time frame: At Week 16
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 1 Apr 2021.
- Derived from this study: PubMed 35442197Garbin A, Diaz J, Bui V, Morrison J, Fisher BE, Palacios C, Estrada-Darley I, Haase D, Wing D, Amezcua L, Jakowec MW, Kaplan C, Petzinger G. Promoting Physical Activity in a Spanish-Speaking Latina Population of Low Socioeconomic Status With Chronic Neurological Disorders: Proof-of-Concept Study. JMIR Form Res. 2022 Apr 20;6(4):e34312. doi: 10.2196/34312.
- Individual participant dataSharing planned: Yes. Researchers interested in the study may contact PI to request information regarding study protocol and de-identified study data.
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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.
Giselle Petzinger, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Monitoring Device and Lifestyle Redesign Coaching in people with Neurological Disorder, run by University of Southern California 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 10 inclusion and 2 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 1 Apr 2021. 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?
Baseline Demographic Data (time frame: At Baseline Visit). 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 NCT04820153, 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 1 Apr 2021.