HEALS (Healthy Eating And Lifestyle After Stroke)

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: HEALS

• Registration Number: NCT01550822
• Lead Sponsor: Los Amigos Research and Education Institute

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.

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-12
• Study Start: 2012-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEALS	HEALS	Intervention group which will receive group clinics addressing smoking cessation, healthy eating, physical activity, and the risk factors of stroke.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Abdominal obesity	6 months	achieve \<88cm for F and \<102cm for M; change in waist circumference

Trial Locations

Locations (1)

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States