Translating a Heart Disease Lifestyle Intervention Into the Community
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01647438|
Recruitment Status : Completed
First Posted : July 23, 2012
Results First Posted : November 2, 2015
Last Update Posted : November 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hyperlipidemia Hypertension Pre-diabetes Diabetes||Behavioral: Lifestyle Intervention Other: Print Health Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Translating a Heart Disease Lifestyle Intervention Into the Community|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||February 2015|
Print Health Education
Participants receive print health education materials
Other: Print Health Education
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Experimental: Lifestyle Intervention
Six weekly health education classes and phone counseling.
Behavioral: Lifestyle Intervention
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.
- Change in Physical Activity (Minutes/Week) [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647438
|United States, Illinois|
|Northwestern University-Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Metropolitan Asian Family Services|
|Chicago, Illinois, United States, 60645|
|Principal Investigator:||Namratha Kandula, MD, MPH||Northwestern University|