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

Los Amigos Research and Education Institute1 site in 1 country100 target enrollmentApril 2012

ConditionsStroke

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stroke
Sponsor: Los Amigos Research and Education Institute
Enrollment: 100
Locations: 1
Primary Endpoint: Physical activity
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Los Amigos Research and Education Institute

Responsible Party

Sponsor

Eligibility Criteria

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).