Clinical trial NCT02531074: Swipe Out Stroke (SOS): Feasibility of Using a Consumer Based Electronic Application to Improve Compliance With Weight Loss in Obese Minority Stroke Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Mobile Applications
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Number of participants with five percent or greater weight loss.
timeFrame: Six months
Secondary outcomes:
measure: Percentage of patients with blood pressure reduction.
timeFrame: Six months
measure: Percentage of patients with decrease in serum cholesterol.
timeFrame: Six months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston Medical School
state: Texas
Study officials:
References:
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.
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.
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.