Translating a Heart Disease Lifestyle Intervention Into the Community

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.

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Key information

Conditions

Obesity Behavior Body Weight Cardiovascular Diseases Coronary Disease Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Heart Diseases Hyperglycemia Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Motor Activity Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metropolitan Asian Family Services, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

Print Health Education

Other

Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.

Primary outcomes

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.
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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2015
First posted: Jul 23, 2012
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed