NCT02531074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

August 20, 2015

Last Update Submit

August 16, 2020

Conditions

Stroke

Keywords

Mobile Applications

Outcome Measures

Primary Outcomes (1)

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

    Six months

Secondary Outcomes (2)

  • Percentage of patients with blood pressure reduction.

    Six months

  • Percentage of patients with decrease in serum cholesterol.

    Six months

Study Arms (2)

Mobile Application plus Usual Care

EXPERIMENTAL
Behavioral: Mobile ApplicationBehavioral: Usual Care

Food Journal plus Usual Care

ACTIVE COMPARATOR
Behavioral: Food JournalBehavioral: Usual Care

Interventions

Mobile ApplicationBEHAVIORAL
Mobile Application plus Usual Care
Food JournalBEHAVIORAL
Food Journal plus Usual Care
Usual CareBEHAVIORAL
Food Journal plus Usual CareMobile Application plus Usual Care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston Medical School

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

    PMID: 26956032RESULT

  • 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.

    PMID: 30442422RESULT

  • 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.

    PMID: 32319963RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 21, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

US(1)