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Translating a Heart Disease Lifestyle Intervention Into the Community

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ClinicalTrials.gov Identifier: NCT01647438
Recruitment Status : Completed
First Posted : July 23, 2012
Results First Posted : November 2, 2015
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Namratha Kandula, Northwestern University

Brief Summary:
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 or disease Intervention/treatment
Obesity Hyperlipidemia Hypertension Pre-diabetes Diabetes Behavioral: Lifestyle Intervention Other: Print Health Education

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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Translating a Heart Disease Lifestyle Intervention Into the Community
Study Start Date : August 2012
Primary Completion Date : December 2013
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647438

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Namratha Kandula, Dr. Namratha Kandula, MD, MPH, Northwestern University
ClinicalTrials.gov Identifier: NCT01647438     History of Changes
Other Study ID Numbers: R21HL113743-01 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2012    Key Record Dates
Results First Posted: November 2, 2015
Last Update Posted: November 2, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders