Translating a Heart Disease Lifestyle Intervention Into the Community

October 1, 2015 updated by: Namratha Kandula, Northwestern University
Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be randomly assigned to either a group to receive heart disease prevention classes or to another group where they will receive written materials about heart disease prevention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

South Asian individuals were recruited from a community based organization in Chicago and randomly assigned to the print health education group or the SAHELI intervention.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University-Feinberg School of Medicine
      • Chicago, Illinois, United States, 60645
        • Metropolitan Asian Family Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • South Asians between 30 and 60 years
  • Have at least one CHD risk factor: obesity (body mass index > 25 kg/m2- cutoff for obesity in South Asians), hyperlipidemia, hypertension, pre-diabetes, or diabetes.

Exclusion Criteria:

  • Inability to speak English, Hindi, or Urdu
  • History of clinically evident CVD (e.g. heart attack, stroke)
  • Pregnant, lactating, or planning to become pregnant during the study period
  • Conditions that inhibit moderate intensity physical activity
  • Systolic blood pressure ≥190 or diastolic blood pressure ≥105; Triglycerides ≥ 400
  • Using insulin for diabetes
  • Significant medical or psychiatric co-morbidities
  • Plans to move out of the area within 2 years
  • Family/household member enrolled in study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Print Health Education
Participants receive print health education materials
Other: Print Health Education
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Experimental: Lifestyle Intervention
Six weekly health education classes and phone counseling.
Behavioral: Lifestyle Intervention
Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity (Minutes/Week)
Time Frame: baseline and 6-months
Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.
baseline and 6-months
Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake
Time Frame: baseline and 6-months
Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months
baseline and 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Namratha Kandula, MD, MPH, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21HL113743-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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