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HEALS (Healthy Eating And Lifestyle After Stroke)

This study has been completed.
Sponsor:
Collaborators:
American Heart Association
University of California, Los Angeles
University of Southern California
Information provided by (Responsible Party):
Los Amigos Research and Education Institute
ClinicalTrials.gov Identifier:
NCT01550822
First received: March 8, 2012
Last updated: March 9, 2017
Last verified: March 2017

March 8, 2012
March 9, 2017
April 2012
February 2016   (Final data collection date for primary outcome measure)
  • Physical activity [ Time Frame: 6 months ]
    90 minutes/week moderate activity; change in minutes of physical activity/week
  • Diet [ Time Frame: 6 months ]
    ≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day
  • BMI [ Time Frame: 6 months ]
    BMI 18.5-24.9 kg/m2; change in BMI
Not Provided
Complete list of historical versions of study NCT01550822 on ClinicalTrials.gov Archive Site
Abdominal obesity [ Time Frame: 6 months ]
achieve <88cm for F and <102cm for M; change in waist circumference
Not Provided
Not Provided
Not Provided
 
HEALS (Healthy Eating And Lifestyle After Stroke)
HEALS (Healthy Eating And Lifestyle After Stroke): A Pilot Trial of a Multidisciplinary Lifestyle Intervention Program
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Stroke
Other: HEALS
  • Active Comparator: HEALS
    Intervention group which will receive group clinics addressing smoking cessation, healthy eating, physical activity, and the risk factors of stroke.
    Intervention: Other: HEALS
  • No Intervention: Usual Care
    This group will receive usual care for stroke survivors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2016
February 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01550822
114
No
Not Provided
Not Provided
Not Provided
Los Amigos Research and Education Institute
Los Amigos Research and Education Institute
  • American Heart Association
  • University of California, Los Angeles
  • University of Southern California
Not Provided
Los Amigos Research and Education Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP