HEALS (Healthy Eating And Lifestyle After Stroke)

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550822
• Other study ID #: 114
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: March 9, 2017
• Start date: April 2012
• Est. completion date: February 2016

Study information

• Verified date: March 2017
• Source: Los Amigos Research and Education Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• HEALS

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California

Sponsors (4)

Lead Sponsor	Collaborator
Los Amigos Research and Education Institute	American Heart Association, University of California, Los Angeles, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	90 minutes/week moderate activity; change in minutes of physical activity/week	6 months
Primary	Diet	=5 servings fruits/vegetables/day; change in # servings fruits/vegetables/day	6 months
Primary	BMI	BMI 18.5-24.9 kg/m2; change in BMI	6 months
Secondary	Abdominal obesity	achieve <88cm for F and <102cm for M; change in waist circumference	6 months