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

Cardiovascular Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532815
• Other study ID #: RJ13/039/J
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: September 1, 2015

Study information

• Verified date: November 2019
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: September 1, 2015
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Lifestyle Modification

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

References & Publications (1)

Cox JL, Vallis TM, Pfammatter A, Szpilfogel C, Carr B, O'Neill BJ. A novel approach to cardiovascular health by optimizing risk management (ANCHOR): behavioural modification in primary care effectively reduces global risk. Can J Cardiol. 2013 Nov;29(11):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Framingham Risk Scores Reduction	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).	3 months
Secondary	Framingham Risk Category Changes	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). .	3 months