Monitoring Physical Activity in Hispanic Women With Chronic Neurological Disorders

NCT04820153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-04-01

No results posted yet for this study

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

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Giselle Petzinger, MD · University of Southern California

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04820153 on ClinicalTrials.gov