Translating a Heart Disease Lifestyle Intervention Into the Community
1 other identifier
interventional
63
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2012
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 23, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
November 2, 2015
CompletedNovember 2, 2015
October 1, 2015
1.3 years
July 19, 2012
July 17, 2015
October 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Physical Activity (Minutes/Week)
Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.
baseline and 6-months
Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake
Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months
baseline and 6-months
Study Arms (2)
Print Health Education
OTHERParticipants receive print health education materials
Lifestyle Intervention
EXPERIMENTALSix weekly health education classes and phone counseling.
Interventions
Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Metropolitan Asian Family Services
Chicago, Illinois, 60645, United States
Related Publications (3)
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.
PMID: 27225217DERIVEDKandula 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.
PMID: 26475629DERIVEDKandula 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.
PMID: 24060673DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Namratha Kandula, Principal Investigator
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Namratha Kandula, MD, MPH
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Namratha Kandula, MD, MPH
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 23, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
February 1, 2015
Last Updated
November 2, 2015
Results First Posted
November 2, 2015
Record last verified: 2015-10