Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia

King Abdullah International Medical Research Center

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Lifestyle Modification

Study type: Interventional

Funder types: Other

Identifiers

NCT03532815

RJ13/039/J

Details and patient eligibility

About

Cardiovascular disease (CVD) remains the major cause of mortality globally. Applying a comprehensive interventional program based on the individual's risk may reduce the incidence and complications of CVD; thus, helping to decrease the burden on the healthcare system. This study compared the effects of a 3-month intervention involving lifestyle modification and physical activity with standard care in women ≥30 years having a moderate-to-high risk of CVD, with respect to improving physical activity and cardiovascular disease risk factors at the National Guard Residential City in Jeddah, Saudi Arabia, in 2015. The effects of this community-based lifestyle program were assessed through a randomized controlled trial. Women in the intervention group (n=31) received health education, exercise training, and diet counselling as individuals and in groups according to the participant's risk. Women in the control group (n=28) received one health education session at the screening site. The Framingham risk score (FRS) was calculated at baseline and at 3 months for both groups. The mean participant age was 42±8 years.

Enrollment: 85 patients

Sex: Female

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women aged ≥ 30 years.
2. The participants must be at moderate to high-risk of CVD according to FRS.

Exclusion criteria

1. Women aged < 30 years.
2. Women aged ≥ 30 years with low risk of CVD according to FRS.
3. Pregnant women.
4. Female patients diagnosed with CVD.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Lifestyle Modification group

Active Comparator group

Treatment:

Behavioral: Lifestyle Modification

Control group

No Intervention group