Overview

This trial is active, not recruiting.

Conditions obesity, hyperlipidemia, hypertension, pre-diabetes, diabetes
Treatments lifestyle intervention, primary care referral and print health education
Sponsor Northwestern University
Start date August 2012
End date December 2013
Trial size 60 participants
Trial identifier NCT01647438, R21 HL113743-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(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
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.

Primary Outcomes

Measure
Change in Physical Activity (minutes/week)
time frame: 3 and 6-months
Change in Saturated Fat (% of daily kilo-calories from fat) Intake
time frame: 3 and 6-months

Secondary Outcomes

Measure
Change in Blood Pressure (mmHg)
time frame: 3 and 6-months
Change in Lipids
time frame: 3 and 6-months
Change in Weight (kg)
time frame: 3 and 6-months
Change in Fruit/Vegetable Serving Intake
time frame: 3 and 6-months
Change in Self-Efficacy
time frame: 3 and 6-months
Change in Social Support
time frame: 3 and 6-months

Eligibility Criteria

Male or female participants from 30 years up to 60 years old.

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

Additional Information

Official title Translating a Heart Disease Lifestyle Intervention Into the Community
Principal investigator Namratha Kandula, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Northwestern University.