StrokeSOSNCT02531074
Swipe Out Stroke (SOS): Feasibility of Using a Consumer Based Electronic Application to Improve Compliance With Weight Loss in Obese Minority Stroke Patients
A study testing Mobile Application and Food Journal in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mobile Application and Food Journal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030
About this study
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.
- Conditions
- Stroke
- Being tested
- Mobile Application, Food Journal, Usual Care
- Keywords
- Mobile Applications
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationBehavioural
Food JournalBehavioural
Usual CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application plus Usual Care | Experimental | Not described Receives: Behavioral: Mobile Application; Behavioral: Usual Care |
| Food Journal plus Usual Care | Active comparator | Not described Receives: Behavioral: Food Journal; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with five percent or greater weight loss.
Measured: Six months
Secondary outcomes (2)
Percentage of patients with blood pressure reduction.
Measured: Six months
Percentage of patients with decrease in serum cholesterol.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nneka Lotea Ifejika, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531074
- Sponsor's protocol ID
- HSC-MS-13-0608
- Acronym
- SOS
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2015
- Last updated
- 18 Aug 2020
- Results posted
- No
Publications
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.
PubMed 26956032Ifejika 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.
PubMed 30442422Ifejika 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.
PubMed 32319963
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02531074
- Acronym / sponsor ID
- SOS / HSC-MS-13-0608
- Conditions
- Stroke
- Keywords
- Mobile Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application plus Usual Care | Experimental | Behavioral: Mobile Application, Behavioral: Usual Care |
| Food Journal plus Usual Care | Active comparator | Behavioral: Food Journal, Behavioral: Usual Care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Application | Behavioural | Mobile Application plus Usual Care |
| Food Journal | Behavioural | Food Journal plus Usual Care |
| Usual Care | Behavioural | Food Journal plus Usual Care, Mobile Application plus Usual Care |
Primary outcome
Number of participants with five percent or greater weight loss.
Time frame: Six months
2 secondary outcomes
Percentage of patients with blood pressure reduction.
Time frame: Six months
Percentage of patients with decrease in serum cholesterol.
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Results publication: PubMed 26956032Ifejika 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.
- Results publication: PubMed 30442422Ifejika 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.
- Results publication: PubMed 32319963Ifejika 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application and Food Journal in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with five percent or greater weight loss. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531074, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.