Back to resultsHEALS (Healthy Eating And Lifestyle After Stroke)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HEALS
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring stroke, lifestyle habits
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Rancho Los Amigos National Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
HEALS
Usual Care
Arm Description
Intervention group which will receive group clinics addressing smoking cessation, healthy eating, physical activity, and the risk factors of stroke.
This group will receive usual care for stroke survivors
Outcomes
Primary Outcome Measures
Physical activity
90 minutes/week moderate activity; change in minutes of physical activity/week
Diet
≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day
BMI
BMI 18.5-24.9 kg/m2; change in BMI
Secondary Outcome Measures
Abdominal obesity
achieve <88cm for F and <102cm for M; change in waist circumference
Full Information
NCT ID
NCT01550822
First Posted
March 8, 2012
Last Updated
March 9, 2017
Sponsor
Los Amigos Research and Education Institute
Collaborators
American Heart Association, University of California, Los Angeles, University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT01550822
Brief Title
HEALS (Healthy Eating And Lifestyle After Stroke)
Official Title
HEALS (Healthy Eating And Lifestyle After Stroke): A Pilot Trial of a Multidisciplinary Lifestyle Intervention Program
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Los Amigos Research and Education Institute
Collaborators
American Heart Association, University of California, Los Angeles, University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Study data collection will consist of a baseline and outcome study visit. Each visit will consist of a survey and physical exam to collect height, weight and body measurements.
Outcome measures include:
Physical Activity: Collected via survey using a version of the International Physical Activity Questionnaire
Diet: Collected via survey using the Brief Dietary Assessment Tools for Hispanics
Body Mass Index (BMI): Collected via physical exam following the Alaska State Department of Health and Social Services BMI Guidelines
Abdominal Obesity: Collected via physical exam following the NIH Standard Circumference methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, lifestyle habits
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEALS
Arm Type
Active Comparator
Arm Description
Intervention group which will receive group clinics addressing smoking cessation, healthy eating, physical activity, and the risk factors of stroke.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
This group will receive usual care for stroke survivors
Intervention Type
Other
Intervention Name(s)
HEALS
Primary Outcome Measure Information:
Title
Physical activity
Description
90 minutes/week moderate activity; change in minutes of physical activity/week
Time Frame
6 months
Title
Diet
Description
≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day
Time Frame
6 months
Title
BMI
Description
BMI 18.5-24.9 kg/m2; change in BMI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Abdominal obesity
Description
achieve <88cm for F and <102cm for M; change in waist circumference
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33002791
Citation
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.
Results Reference
derived
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HEALS (Healthy Eating And Lifestyle After Stroke)
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