Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02531074
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Nneka Lotea Ifejika, 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Mobile Application Behavioral: Food Journal Behavioral: Usual Care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : January 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile Application plus Usual Care Behavioral: Mobile Application
Behavioral: Usual Care
Active Comparator: Food Journal plus Usual Care Behavioral: Food Journal
Behavioral: Usual Care



Primary Outcome Measures :
  1. Number of participants with five percent or greater weight loss. [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Percentage of patients with blood pressure reduction. [ Time Frame: Six months ]
  2. Percentage of patients with decrease in serum cholesterol. [ Time Frame: Six months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531074


Locations
Layout table for location information
United States, Texas
University of Texas Health Science Center at Houston Medical School
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston

Layout table for additonal information
Responsible Party: Nneka Lotea Ifejika, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02531074     History of Changes
Other Study ID Numbers: HSC-MS-13-0608
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Keywords provided by Nneka Lotea Ifejika, The University of Texas Health Science Center, Houston:
Mobile Applications

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Weight Loss
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Body Weight Changes
Body Weight
Signs and Symptoms