HEALS (Healthy Eating And Lifestyle After Stroke)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: HEALS


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | 90 minutes/week moderate activity; change in minutes of physical activity/week | 6 months | 
| Diet | ≥5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day | 6 months | 
| BMI | BMI 18.5-24.9 kg/m2; change in BMI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal obesity | achieve <88cm for F and <102cm for M; change in waist circumference | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, lifestyle habits