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: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Obesity
Hyperlipidemia
Hypertension
Pre-diabetes
Diabetes
Behavioral: Lifestyle Intervention
Other: Primary Care Referral and Print Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Translating a Heart Disease Lifestyle Intervention Into the Community

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Primary Care Referral and Print Health Education 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.
Experimental: Lifestyle Intervention 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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647438

Locations
United States, Illinois
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Metropolitan Asian Family Services
Chicago, Illinois, United States, 60645
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Namratha Kandula, MD, MPH Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Namratha Kandula, Dr. Namratha Kandula, MD, MPH, Northwestern University
ClinicalTrials.gov Identifier: NCT01647438     History of Changes
Other Study ID Numbers: R21 HL113743-01
Study First Received: July 19, 2012
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
South Asians
Diabetes
Physical Activity
Coronary Heart Disease
Lifestyle

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Hyperlipidemias
Hypertension
Obesity
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia

ClinicalTrials.gov processed this record on July 10, 2014