Expired Study
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Houston, Texas 77030


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

HSC-MS-13-0608


NCT ID:

NCT02531074


Secondary ID:


Study Acronym:

SOS


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The University of Texas Health Science Center, Houston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Actual


Study Dates

Start Date:January 2015
Completion Date:June 2017
Completion Type:Actual
Primary Completion Date:June 2017
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 28, 2018
First Received Date:August 20, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Percentage of patients with decrease in serum cholesterol.
Time Frame:Six months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients with blood pressure reduction.
Time Frame:Six months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of participants with five percent or greater weight loss.
Time Frame:Six months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Mobile Application
Arm Name:Mobile Application plus Usual Care
Intervention Type:Behavioral
Name:Food Journal
Arm Name:Food Journal plus Usual Care
Intervention Type:Behavioral
Name:Usual Care
Arm Name:Mobile Application plus Usual Care

Study Arms

Study Arm Type:Experimental
Arm Name:Mobile Application plus Usual Care
Study Arm Type:Active Comparator
Arm Name:Food Journal plus Usual Care

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas Health Science Center, Houston

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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