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HEALS (Healthy Eating And Lifestyle After Stroke)

L

Los Amigos Research and Education Institute

Status

Completed

Conditions

Stroke

Treatments

Other: HEALS

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

HEALS
Active Comparator group
Description:
Intervention group which will receive group clinics addressing smoking cessation, healthy eating, physical activity, and the risk factors of stroke.
Treatment:
Other: HEALS
Usual Care
No Intervention group
Description:
This group will receive usual care for stroke survivors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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