N/A N=63 Randomized Single-blind Prevention

Translating a Heart Disease Lifestyle Intervention Into the Community

Obesity · Hyperlipidemia · Hypertension · Pre-diabetes · Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01647438 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Change in Physical Activity (Minutes/Week) — 4; 10 min/week

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lifestyle Intervention (Behavioral); Print Health Education (Other)
Age: Adult · 30+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Physical Activity (Minutes/Week)	4; 10	—
PRIMARY Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake	0.58; 0.37	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01647438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.