Translating a Heart Disease Lifestyle Intervention Into the Community
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Change in Physical Activity (Minutes/Week)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- 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
Arms & Interventions
Print Health Education
Participants receive print health education materials
Intervention: Print Health Education (Other)
Lifestyle Intervention
Six weekly health education classes and phone counseling.
Intervention: Lifestyle Intervention (Behavioral)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Namratha Kandula
Dr. Namratha Kandula, MD, MPH
Northwestern University