HEALS (Healthy Eating And Lifestyle After Stroke)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01550822

Enrollment

100

Registered

2012-03-12

Start date

2012-04-30

Completion date

2016-02-29

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, lifestyle habits

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.

Interventions

OTHERHEALS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026