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HEALS (Healthy Eating And Lifestyle After Stroke)

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ClinicalTrials.gov Identifier: NCT01550822
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Stroke Other: HEALS

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:

  1. Physical Activity: Collected via survey using a version of the International Physical Activity Questionnaire
  2. Diet: Collected via survey using the Brief Dietary Assessment Tools for Hispanics
  3. Body Mass Index (BMI): Collected via physical exam following the Alaska State Department of Health and Social Services BMI Guidelines
  4. Abdominal Obesity: Collected via physical exam following the NIH Standard Circumference methods.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HEALS (Healthy Eating And Lifestyle After Stroke): A Pilot Trial of a Multidisciplinary Lifestyle Intervention Program
Study Start Date : April 2012
Primary Completion Date : February 2016
Study Completion Date : February 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: HEALS
Intervention group which will receive group clinics addressing smoking cessation, healthy eating, physical activity, and the risk factors of stroke.
Other: HEALS
No Intervention: Usual Care
This group will receive usual care for stroke survivors

Outcome Measures

Primary Outcome Measures :
  1. Physical activity [ Time Frame: 6 months ]
    90 minutes/week moderate activity; change in minutes of physical activity/week

  2. Diet [ Time Frame: 6 months ]
    ≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day

  3. BMI [ Time Frame: 6 months ]
    BMI 18.5-24.9 kg/m2; change in BMI

Secondary Outcome Measures :
  1. Abdominal obesity [ Time Frame: 6 months ]
    achieve <88cm for F and <102cm for M; change in waist circumference

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550822

United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
Sponsors and Collaborators
Los Amigos Research and Education Institute
American Heart Association
University of California, Los Angeles
University of Southern California
More Information

Responsible Party: Los Amigos Research and Education Institute
ClinicalTrials.gov Identifier: NCT01550822     History of Changes
Other Study ID Numbers: 114
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Los Amigos Research and Education Institute:
stroke, lifestyle habits

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases