Translating a Heart Disease Lifestyle Intervention Into the Community

NCT ID: NCT01647438

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-02-28

Brief 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.

Detailed 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.

Conditions

Obesity; Hyperlipidemia; Hypertension; Pre-diabetes; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Print Health Education

Participants receive print health education materials

Group Type: OTHER

Print Health Education

Intervention Type: OTHER

Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.

Lifestyle Intervention

Six weekly health education classes and phone counseling.

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Print Health Education

Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Namratha Kandula

Dr. Namratha Kandula, MD, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Namratha Kandula, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, United States

Metropolitan Asian Family Services

Chicago, Illinois, United States

Countries

United States

References

Jayaprakash M, Puri-Taneja A, Kandula NR, Bharucha H, Kumar S, Dave SS. Qualitative Process Evaluation of a Community-Based Culturally Tailored Lifestyle Intervention for Underserved South Asians. Health Promot Pract. 2016 Nov;17(6):802-813. doi: 10.1177/1524839916650165. Epub 2016 May 24.

Reference Type: DERIVED

PMID: 27225217 (View on PubMed)

Kandula NR, Dave S, De Chavez PJ, Bharucha H, Patel Y, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial. BMC Public Health. 2015 Oct 16;15:1064. doi: 10.1186/s12889-015-2401-2.

Reference Type: DERIVED

PMID: 26475629 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24060673 (View on PubMed)

Other Identifiers

R21HL113743-01

Identifier Type: NIH

Identifier Source: org_study_id

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