Translating a Heart Disease Lifestyle Intervention Into the Community

Not Applicable

Completed

• Conditions: Obesity; Hyperlipidemia; Pre-diabetes; Diabetes; Hypertension

• Registration Number: NCT01647438
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-23
• Study Start: 2012-08
• Primary Completion: 2013-12
• Study Completion: 2015-02
• Results First Submitted: 2015-07-17
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-01
• Last Update Submitted: 2015-10-01
• Results First Posted: 2015-11-01
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Physical Activity (Minutes/Week)	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	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

Trial Locations

Locations (2)

Northwestern University-Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Metropolitan Asian Family Services; 🇺🇸 Chicago, Illinois, United States