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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Application
Food Journal
Usual Care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Mobile Applications

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas Health Science Center at Houston Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Application plus Usual Care

Food Journal plus Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with five percent or greater weight loss.

Secondary Outcome Measures

Percentage of patients with blood pressure reduction.
Percentage of patients with decrease in serum cholesterol.

Full Information

First Posted
August 20, 2015
Last Updated
August 16, 2020
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02531074
Brief Title
Swipe Out Stroke (SOS): Feasibility of Using a Consumer Based Electronic Application to Improve Compliance With Weight Loss in Obese Minority Stroke Patients
Acronym
SOS
Official Title
Swipe Out Stroke (SOS): Feasibility of Using a Consumer Based Electronic Application to Improve Compliance With Weight Loss in Obese Minority Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Mobile Applications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Application plus Usual Care
Arm Type
Experimental
Arm Title
Food Journal plus Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mobile Application
Intervention Type
Behavioral
Intervention Name(s)
Food Journal
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Number of participants with five percent or greater weight loss.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Percentage of patients with blood pressure reduction.
Time Frame
Six months
Title
Percentage of patients with decrease in serum cholesterol.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic or hemorrhagic stroke. Age 18-85 years. African-American or Hispanic. Modified Rankin Scale (mRS) of 0-3. Body Mass Index greater than 30 kg/m2. Currently taking prescription medication for diabetes mellitus, hypertension or hyperlipidemia. Willing to follow a healthy eating pattern and NOT use weight loss medications for the duration of the study. Personal ownership or caregiver ownership of a personal computer, SmartPhone or other SmartDevice (iPhone or Android platform) with Internet access. If patient has alexia, agraphia, acalculia, dementia or blindness - caregiver must be willing to complete the intervention. Exclusion Criteria: Pre-existing disability with mRS > 4. Contraindications to weight loss (planning to become pregnant, history of an eating disorder). Steroid use for suspected vasculitis. Current or recent (past 6 months) participation in a weight loss program or use of weight loss medication.
Facility Information:
Facility Name
University of Texas Health Science Center at Houston Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26956032
Citation
Ifejika NL, Noser EA, Grotta JC, Savitz SI. Swipe out Stroke: Feasibility and efficacy of using a smart-phone based mobile application to improve compliance with weight loss in obese minority stroke patients and their carers. Int J Stroke. 2016 Jul;11(5):593-603. doi: 10.1177/1747493016631557. Epub 2016 Mar 8.
Results Reference
result
PubMed Identifier
30442422
Citation
Ifejika NL, Bhadane M, Cai C, Noser EA, Savitz SI. Cluster Enrollment: A Screening Tool for Stroke Risk Factors in Minority Women Caregivers. J Natl Med Assoc. 2019 Jun;111(3):281-284. doi: 10.1016/j.jnma.2018.10.013. Epub 2018 Nov 12.
Results Reference
result
PubMed Identifier
32319963
Citation
Ifejika NL, Bhadane M, Cai CC, Noser EA, Grotta JC, Savitz SI. Use of a Smartphone-Based Mobile App for Weight Management in Obese Minority Stroke Survivors: Pilot Randomized Controlled Trial With Open Blinded End Point. JMIR Mhealth Uhealth. 2020 Apr 22;8(4):e17816. doi: 10.2196/17816.
Results Reference
result

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

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