HEALS (Healthy Eating And Lifestyle After Stroke)

This study is enrolling participants by invitation only.
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: April 1, 2015
Last verified: April 2015
  Purpose

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 Intervention
Stroke
Other: HEALS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HEALS (Healthy Eating And Lifestyle After Stroke): A Pilot Trial of a Multidisciplinary Lifestyle Intervention Program

Further study details as provided by Los Amigos Research and Education Institute:

Primary Outcome Measures:
  • Physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    90 minutes/week moderate activity; change in minutes of physical activity/week

  • Diet [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    ≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day

  • BMI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    BMI 18.5-24.9 kg/m2; change in BMI


Secondary Outcome Measures:
  • Abdominal obesity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    achieve <88cm for F and <102cm for M; change in waist circumference


Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550822

Locations
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

No publications provided

Responsible Party: Los Amigos Research and Education Institute
ClinicalTrials.gov Identifier: NCT01550822     History of Changes
Other Study ID Numbers: 114
Study First Received: March 8, 2012
Last Updated: April 1, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 25, 2015