Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders

NCT ID: NCT04820153

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-26
• Study Completion Date: 2020-06-30

Brief 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. 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

Conditions

Neurological Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Participants

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.

Group Type: OTHER

Physical Activity Monitoring Device

Intervention Type: DEVICE

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 Coaching

Intervention Type: BEHAVIORAL

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.

Interventions

Physical Activity Monitoring Device

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.

Intervention Type: DEVICE

Lifestyle Redesign Coaching

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• (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;
• (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.

Exclusion Criteria

• (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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Giselle Petzinger, MD

Clinical Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giselle Petzinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35442197 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HS-18-00993

Identifier Type: -

Identifier Source: org_study_id