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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531074
• Other study ID #: HSC-MS-13-0608
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Weight Loss

Intervention

Behavioral:
• Mobile Application

• Food Journal

• Usual Care

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston Medical School	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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; — View 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with five percent or greater weight loss.		Six months
Secondary	Percentage of patients with blood pressure reduction.		Six months
Secondary	Percentage of patients with decrease in serum cholesterol.		Six months