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CompletedNCT01550822Updated Mar 13, 2017

HEALS (Healthy Eating And Lifestyle After Stroke)

An interventional study of HEALS in Stroke, sponsored by Los Amigos Research and Education Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-13.

Sponsored by Los Amigos Research and Education Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Stroke

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Keywords

  • stroke, lifestyle habits
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Los Amigos Research and Education Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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).
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • OtherHEALS
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What researchers measure

Primary outcomes

  1. Physical activity

    90 minutes/week moderate activity; change in minutes of physical activity/week

    Time frame: 6 months

  2. Diet

    ≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day

    Time frame: 6 months

  3. BMI

    BMI 18.5-24.9 kg/m2; change in BMI

    Time frame: 6 months

Secondary outcomes

  1. Abdominal obesity

    achieve \<88cm for F and \<102cm for M; change in waist circumference

    Time frame: 6 months

07

Study locations

1 site
  • Rancho Los Amigos National Rehabilitation Center
    Downey, California 90242, United States
08

References and documents

Publications

  • 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. PubMed 33002791 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01550822
Lead sponsor
Los Amigos Research and Education Institute
Collaborators
American Heart Association, University of California, Los Angeles, University of Southern California
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Apr 2012
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Mar 13, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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