Translating a Heart Disease Lifestyle Intervention Into the Community

Not Applicable

Completed

• Conditions: Obesity; Hyperlipidemia; Pre-diabetes; Diabetes; Hypertension
• Interventions: Behavioral: Lifestyle Intervention; Other: Print Health Education

• 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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Intervention	Six weekly health education classes and phone counseling.
Print Health Education	Print Health Education	Participants receive print health education materials

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