Translating a Heart Disease Lifestyle Intervention Into the Community

Obesity Clinical Trial

Official title:

Translating a Heart Disease Lifestyle Intervention Into the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647438
• Other study ID #: R21HL113743-01
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: October 1, 2015
• Start date: August 2012
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

South Asian individuals were recruited from a community based organization in Chicago and randomly assigned to the print health education group or the SAHELI intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Heart Diseases
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Obesity
• Pre-diabetes

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.

Other:
• Print Health Education
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.

Locations

Country	Name	City	State
United States	Metropolitan Asian Family Services	Chicago	Illinois
United States	Northwestern University-Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity (Minutes/Week)	Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.	baseline and 6-months	No
Primary	Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake	Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months	baseline and 6-months	No