HEALS (Healthy Eating And Lifestyle After Stroke)
1 other identifier
interventional
100
1 country
1
Brief Summary
This lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise, and smoking cessation) among stroke survivors and result in a reduction in measures of general and abdominal obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Apr 2012
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 13, 2017
March 1, 2017
3.8 years
March 8, 2012
March 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Physical activity
90 minutes/week moderate activity; change in minutes of physical activity/week
6 months
Diet
≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day
6 months
BMI
BMI 18.5-24.9 kg/m2; change in BMI
6 months
Secondary Outcomes (1)
Abdominal obesity
6 months
Study Arms (2)
HEALS
ACTIVE COMPARATORIntervention group which will receive group clinics addressing smoking cessation, healthy eating, physical activity, and the risk factors of stroke.
Usual Care
NO INTERVENTIONThis group will receive usual care for stroke survivors
Interventions
Eligibility Criteria
You may qualify if:
- Phase I: Completed 12 month SUSTAIN trial (SUSTAIN criteria: age ≥ 40 years, acute TIA or ischemic stroke within the prior one month and systolic blood pressure (SBP) \>120 mm Hg).
- Phase II: Stroke or TIA \> 3 months prior to screening date, age \> 20 years, blood pressure (SBP) \> 120 mm Hg.
You may not qualify if:
- Phase I and Phase II: Same as SUSTAIN criteria: medical condition limiting participation in follow up assessments, severe cognitive impairment (MMSE ≤24), and severe global disability (modified Rankin ≥3).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Los Amigos Research and Education Institutelead
- American Heart Associationcollaborator
- University of California, Los Angelescollaborator
- University of Southern Californiacollaborator
Study Sites (1)
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Related Publications (1)
Towfighi A, Cheng EM, Hill VA, Barry F, Lee M, Valle NP, Mittman B, Ayala-Rivera M, Moreno L, Espinosa A, Dombish H, Wang D, Ochoa D, Chu A, Atkins M, Vickrey BG. Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke. J Stroke Cerebrovasc Dis. 2020 Dec;29(12):105323. doi: 10.1016/j.jstrokecerebrovasdis.2020.105323. Epub 2020 Sep 28.
PMID: 33002791DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 12, 2012
Study Start
April 1, 2012
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 13, 2017
Record last verified: 2017-03