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

NCT ID: NCT02531074

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mobile Application plus Usual Care

Group Type EXPERIMENTAL

Mobile Application

Intervention Type BEHAVIORAL

Usual Care

Intervention Type BEHAVIORAL

Food Journal plus Usual Care

Group Type ACTIVE_COMPARATOR

Food Journal

Intervention Type BEHAVIORAL

Usual Care

Intervention Type BEHAVIORAL

Interventions

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Mobile Application

Intervention Type BEHAVIORAL

Food Journal

Intervention Type BEHAVIORAL

Usual Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Nneka Lotea Ifejika

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Health Science Center at Houston Medical School

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26956032 (View on PubMed)

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.

Reference Type RESULT
PMID: 30442422 (View on PubMed)

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.

Reference Type RESULT
PMID: 32319963 (View on PubMed)

Other Identifiers

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HSC-MS-13-0608

Identifier Type: -

Identifier Source: org_study_id

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