Back to resultsTranslating a Heart Disease Lifestyle Intervention Into the Community
Primary Purpose
Obesity, Hyperlipidemia, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Print Health Education
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring South Asians, Diabetes, Physical Activity, Coronary Heart Disease, Lifestyle
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
Sites / Locations
- Northwestern University-Feinberg School of Medicine
- Metropolitan Asian Family Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Print Health Education
Lifestyle Intervention
Arm Description
Participants receive print health education materials
Six weekly health education classes and phone counseling.
Outcomes
Primary Outcome Measures
Change in Physical Activity (Minutes/Week)
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
Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01647438
Brief Title
Translating a Heart Disease Lifestyle Intervention Into the Community
Official Title
Translating a Heart Disease Lifestyle Intervention Into the Community
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hyperlipidemia, Hypertension, Pre-diabetes, Diabetes
Keywords
South Asians, Diabetes, Physical Activity, Coronary Heart Disease, Lifestyle
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Print Health Education
Arm Type
Other
Arm Description
Participants receive print health education materials
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
Six weekly health education classes and phone counseling.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Print Health Education
Intervention Description
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Primary Outcome Measure Information:
Title
Change in Physical Activity (Minutes/Week)
Description
Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.
Time Frame
baseline and 6-months
Title
Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake
Description
Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months
Time Frame
baseline and 6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namratha Kandula, MD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University-Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Metropolitan Asian Family Services
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60645
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27225217
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.
Results Reference
derived
PubMed Identifier
26475629
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.
Results Reference
derived
PubMed Identifier
24060673
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.
Results Reference
derived
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Translating a Heart Disease Lifestyle Intervention Into the Community
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