Translating a Heart Disease Lifestyle Intervention Into the Community

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Namratha Kandula, Northwestern University
ClinicalTrials.gov Identifier:
NCT01647438
First received: July 19, 2012
Last updated: October 1, 2015
Last verified: October 2015
Results First Received: July 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Obesity
Hyperlipidemia
Hypertension
Pre-diabetes
Diabetes
Interventions: Behavioral: Lifestyle Intervention
Other: Print Health Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Community outreach

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Primary Care Referral and Print Health Education Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Lifestyle Intervention 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.

Participant Flow:   Overall Study
    Primary Care Referral and Print Health Education     Lifestyle Intervention  
STARTED     32     31  
COMPLETED     32     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Primary Care Referral and Print Health Education Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Lifestyle Intervention 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.
Total Total of all reporting groups

Baseline Measures
    Primary Care Referral and Print Health Education     Lifestyle Intervention     Total  
Number of Participants  
[units: participants]
  32     31     63  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     32     31     63  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  50  (7)     50  (8)     50  (8)  
Gender  
[units: participants]
     
Female     20     20     40  
Male     12     11     23  
Region of Enrollment  
[units: participants]
     
United States     32     31     63  



  Outcome Measures
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1.  Primary:   Change in Physical Activity (Minutes/Week)   [ Time Frame: baseline and 6-months ]

2.  Primary:   Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake   [ Time Frame: baseline and 6-months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Namratha Kandula, Principal Investigator
Organization: Northwestern University
phone: 312-503-6470
e-mail: nkandula@nm.org


No publications provided by Northwestern University

Publications automatically indexed to this study:

Responsible Party: Namratha Kandula, Northwestern University
ClinicalTrials.gov Identifier: NCT01647438     History of Changes
Other Study ID Numbers: R21HL113743-01 ( US NIH Grant/Contract Award Number )
Study First Received: July 19, 2012
Results First Received: July 17, 2015
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board