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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT02531074
Collaborator
(none)
56
1
2
29
1.9

Study Details

Study Description

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
  • Behavioral: Mobile Application
  • Behavioral: Food Journal
  • Behavioral: Usual Care
N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2015
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with five percent or greater weight loss. [Six months]

Secondary Outcome Measures

  1. Percentage of patients with blood pressure reduction. [Six months]

  2. Percentage of patients with decrease in serum cholesterol. [Six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nneka Lotea Ifejika, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02531074
Other Study ID Numbers:
  • HSC-MS-13-0608
First Posted:
Aug 21, 2015
Last Update Posted:
Aug 18, 2020
Last Verified:
Aug 1, 2020
Keywords provided by Nneka Lotea Ifejika, Associate Professor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2020