HEALS (Healthy Eating And Lifestyle After Stroke)

Los Amigos Research and Education Institute100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Stroke

Interventions

HEALSOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Outcomes

Primary Outcomes

Physical activity

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

Time frame: 6 months

Diet

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

Time frame: 6 months

BMI

BMI 18.5-24.9 kg/m2; change in BMI

Time frame: 6 months

Secondary Outcomes

Abdominal obesity

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

Time frame: 6 months

Data from ClinicalTrials.gov

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