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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Mobile Application; Behavioral: Food Journal; Behavioral: Usual Care

• Registration Number: NCT02531074
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-16
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Application plus Usual Care	Mobile Application	-
Food Journal plus Usual Care	Food Journal	-
Mobile Application plus Usual Care	Usual Care	-
Food Journal plus Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Number of participants with five percent or greater weight loss.	Six months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with blood pressure reduction.	Six months
Percentage of patients with decrease in serum cholesterol.	Six months

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston Medical School; 🇺🇸 Houston, Texas, United States