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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lifestyle Modification

Behavioral

Primary outcomes

Framingham Risk Scores Reduction

Time frame: 3 months

The proportion of individuals with moderate Framingham risk scores (FRS) reducing their risk by 10% and the proportion of individuals with high (FRS) reducing their risk by 25% using the Framingham risk score. It consists of six point scores including age, total cholesterol, smoking status, HDL level, diabetes status, systolic Blood Pressure and Treatment Status. The sum of these points will result in an estimate of the 10-Year risk of developing cardiovascular event and for risk categorization of low (< 10% FRS), moderate (10%-19% FRS), or high risk (≥ 20% FRS).

Secondary outcomes

Framingham Risk Category Changes

Time frame: 3 months

The proportion of individuals reducing their risk by ≥ 1 risk category using the Framingham risk score. It consists of six point scores including age, total cholesterol, smoking status, HDL level, diabetes status, systolic Blood Pressure and Treatment Status. The sum of these points will result in an estimate of the 10-Year risk of developing cardiovascular event and for risk categorization of low (< 10% FRS), moderate (10%-19% FRS), or high risk (≥ 20% FRS). .

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

A Randomized Controlled Trial of Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia, 2015

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: May 22, 2018
Registry last updated: Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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