Translating a Heart Disease Lifestyle Intervention Into the Community

This study has been completed.
Information provided by (Responsible Party):
Namratha Kandula, Northwestern University Identifier:
First received: July 19, 2012
Last updated: October 1, 2015
Last verified: October 2015
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.

Condition Intervention
Behavioral: Lifestyle Intervention
Other: Print Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Translating a Heart Disease Lifestyle Intervention Into the Community

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Physical Activity (Minutes/Week) [ Time Frame: baseline and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.

  • Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake [ Time Frame: baseline and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months

Enrollment: 63
Study Start Date: August 2012
Study Completion Date: February 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01647438

United States, Illinois
Metropolitan Asian Family Services
Chicago, Illinois, United States, 60645
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Namratha Kandula, MD, MPH Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Namratha Kandula, Dr. Namratha Kandula, MD, MPH, Northwestern University Identifier: NCT01647438     History of Changes
Other Study ID Numbers: R21 HL113743-01
Study First Received: July 19, 2012
Results First Received: July 17, 2015
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
South Asians
Physical Activity
Coronary Heart Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases processed this record on December 01, 2015