Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders

NCT04820153 | Completed FDA Device

• 1 other identifier: HS-18-00993
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Disorder

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  16 weeks

Secondary Outcomes (5)

• Quality of Life (QOL) Assessment

  At Baseline Visit and Week 16

• Spanish Acculturation

  At Baseline

• Brief Illness Perception Questionnaire (BIPQ)

  At Baseline and Week 16

• Spanish Physical Activity Questionnaire

  At Baseline and Week 16

• FitBit Wear Technology Questionnaire

  At Week 16

Study Arms (1)

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.

Device: Physical Activity Monitoring Device; Behavioral: Lifestyle Redesign Coaching

Interventions

Physical Activity Monitoring Device 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.

Study Participants

Lifestyle Redesign Coaching 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.

Study Participants

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033-4606, United States

Location

Related Publications (1)

• 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.

  PMID: 35442197 DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Giselle Petzinger, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scholar

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: March 29, 2021
• Study Start: March 26, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: upon completion of study.
• Access Criteria: Researchers interested in the study may contact PI to request information regarding study protocol and de-identified study data.

Locations

US (1)