Swipe Out Stroke (SOS): Feasibility of Using a Consumer Based Electronic Application to Improve Compliance With Weight Loss in Obese Minority Stroke Patients (SOS)

August 16, 2020 updated by: Nneka Lotea Ifejika, The University of Texas Health Science Center, Houston
This pilot study evaluates the use of a mobile application to improve weight loss in obese stroke patients. The investigators hypothesize that acute stroke patients who use the mobile application are more likely to achieve a minimum 5% weight reduction during the critical six months post-stroke, yielding considerable improvement in stroke risk factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ischemic or hemorrhagic stroke.
  2. Age 18-85 years.
  3. African-American or Hispanic.
  4. Modified Rankin Scale (mRS) of 0-3.
  5. Body Mass Index greater than 30 kg/m2.
  6. Currently taking prescription medication for diabetes mellitus, hypertension or hyperlipidemia.
  7. Willing to follow a healthy eating pattern and NOT use weight loss medications for the duration of the study.
  8. Personal ownership or caregiver ownership of a personal computer, SmartPhone or other SmartDevice (iPhone or Android platform) with Internet access.
  9. If patient has alexia, agraphia, acalculia, dementia or blindness - caregiver must be willing to complete the intervention.

Exclusion Criteria:

  1. Pre-existing disability with mRS > 4.
  2. Contraindications to weight loss (planning to become pregnant, history of an eating disorder).
  3. Steroid use for suspected vasculitis.
  4. Current or recent (past 6 months) participation in a weight loss program or use of weight loss medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Application plus Usual Care
Behavioral: Usual Care
Behavioral: Mobile Application
Active Comparator: Food Journal plus Usual Care
Behavioral: Usual Care
Behavioral: Food Journal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with five percent or greater weight loss.
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with blood pressure reduction.
Time Frame: Six months
Six months
Percentage of patients with decrease in serum cholesterol.
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 16, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-13-0608

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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