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Completed

NCT Number: NCT02531074

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston Medical School

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic or hemorrhagic stroke.
  • Age 18-85 years.
  • African-American or Hispanic.
  • Modified Rankin Scale (mRS) of 0-3.
  • Body Mass Index greater than 30 kg/m2.
  • Currently taking prescription medication for diabetes mellitus, hypertension or hyperlipidemia.
  • Willing to follow a healthy eating pattern and NOT use weight loss medications for the duration of the study.
  • Personal ownership or caregiver ownership of a personal computer, SmartPhone or other SmartDevice (iPhone or Android platform) with Internet access.
  • If patient has alexia, agraphia, acalculia, dementia or blindness - caregiver must be willing to complete the intervention.

Exclusion criteria

  • Pre-existing disability with mRS > 4.
  • Contraindications to weight loss (planning to become pregnant, history of an eating disorder).
  • Steroid use for suspected vasculitis.
  • Current or recent (past 6 months) participation in a weight loss program or use of weight loss medication.

Treatment and study plan

Mobile application

Behavioral

Food Journal

Behavioral

Usual Care

Behavioral

Primary outcomes

  1. Number of participants with five percent or greater weight loss.

    Time frame: Six months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: SOS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2015
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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