Clinical trial NCT01647438: Translating a Heart Disease Lifestyle Intervention Into the Community
Official title: Translating a Heart Disease Lifestyle Intervention Into the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hyperlipidemia
Hypertension
Pre-diabetes
Diabetes
Keywords: South Asians
Diabetes
Physical Activity
Coronary Heart Disease
Lifestyle
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 63
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Physical Activity (Minutes/Week)
timeFrame: baseline and 6-months
measure: Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake
timeFrame: baseline and 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University-Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Metropolitan Asian Family Services
state: Illinois
Study officials:
affiliation: Northwestern University
name: Namratha Kandula, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jayaprakash M, Puri-Taneja A, Kandula NR, Bharucha H, Kumar S, Dave SS. Qualitative Process Evaluation of a Community-Based Culturally Tailored Lifestyle Intervention for Underserved South Asians. Health Promot Pract. 2016 Nov;17(6):802-813. doi: 10.1177/1524839916650165. Epub 2016 May 24.
citation: Kandula NR, Dave S, De Chavez PJ, Bharucha H, Patel Y, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial. BMC Public Health. 2015 Oct 16;15:1064. doi: 10.1186/s12889-015-2401-2.
citation: Kandula NR, Patel Y, Dave S, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods. Contemp Clin Trials. 2013 Nov;36(2):479-87. doi: 10.1016/j.cct.2013.09.007. Epub 2013 Sep 21.