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OpenTrials
Completed

NCT Number: NCT01550822

HEALS (Healthy Eating And Lifestyle After Stroke)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

HEALS

Other

Primary outcomes

  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 outcomes

  1. Abdominal obesity

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Los Amigos Research and Education Institute

Other

Collaborators

  • American Heart Association
  • University of California, Los Angeles
  • University of Southern California

Registry information

Official study title

HEALS (Healthy Eating And Lifestyle After Stroke): A Pilot Trial of a Multidisciplinary Lifestyle Intervention Program

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2012
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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