Translating a Heart Disease Lifestyle Intervention Into the Community

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Translating a Heart Disease Lifestyle Intervention Into the Community

Conditions
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Obesity, Hyperlipidemia, Hypertension, Pre-diabetes, Diabetes

Intervention / Treatment
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* Behavioral: Lifestyle Intervention
* Other: Print Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Print Health Education<br>Participants receive print health education materials | Other: Print Health Education<br>* Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.<br>|
| Experimental: Lifestyle Intervention<br>Six weekly health education classes and phone counseling. | Behavioral: Lifestyle Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity (Minutes/Week) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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South Asians, Diabetes, Physical Activity, Coronary Heart Disease, Lifestyle