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Translating a Heart Disease Lifestyle Intervention Into the Community

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Namratha Kandula, Northwestern University
ClinicalTrials.gov Identifier:
NCT01647438
First received: July 19, 2012
Last updated: July 17, 2014
Last verified: July 2014

July 19, 2012
July 17, 2014
August 2012
December 2013   (final data collection date for primary outcome measure)
  • Change in Physical Activity (minutes/week) [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]

    Change from baseline in minutes per week of physical activity measured by accelerometer at 3 and 6-months.

    Change from baseline in minutes per week of physical activity measured by the total weekly physical activity survey at 3 and 6-months.

  • Change in Saturated Fat (% of daily kilo-calories from fat) Intake [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 3 and 6-months
Same as current
Complete list of historical versions of study NCT01647438 on ClinicalTrials.gov Archive Site
  • Change in Blood Pressure (mmHg) [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in blood pressure measured in mmHg at 3 and 6-months
  • Change in Lipids [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in lipids (fasting plasma glucose, total cholesterol, triglycerides, HDL-C and LDL-C) assayed following antecubital venipuncture at 3 and 6-months
  • Change in Weight (kg) [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in body weight in kg measured using calibrated scale at 3 and 6-months
  • Change in Fruit/Vegetable Serving Intake [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in standard fruit/vegetable serving intake measured at 3 and 6-months
  • Change in Self-Efficacy [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in self-efficacy measured by the Exercise Confidence Survey and Eating Habits Confidence Survey self reported questionnaire at 3 and 6-months
  • Change in Social Support [ Time Frame: 3 and 6-months ] [ Designated as safety issue: No ]
    Change from baseline in social support measured by the Social Support and eating Habits Survey and Social Support Exercise Survey self-report questionnaire at 3 and 6-months
Same as current
Not Provided
Not Provided
 
Translating a Heart Disease Lifestyle Intervention Into the Community
Translating a Heart Disease Lifestyle Intervention Into the Community

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Obesity
  • Hyperlipidemia
  • Hypertension
  • Pre-diabetes
  • Diabetes
  • 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.
  • Other: 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.
  • Primary Care Referral and Print Health Education
    Intervention: Other: Primary Care Referral and Print Health Education
  • Experimental: Lifestyle Intervention
    Intervention: Behavioral: Lifestyle Intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01647438
R21 HL113743-01
No
Namratha Kandula, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Namratha Kandula, MD, MPH Northwestern University
Northwestern University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP