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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Lifestyle Modification

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Active Comparator: Lifestyle Modification group	Behavioral: Lifestyle Modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Jumana Khouja, MD, SBCM, KAIMRC

Publications and helpful links

General Publications

• 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):1400-7. doi: 10.1016/j.cjca.2013.03.007. Epub 2013 Jun 21.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases, Framingham risk score, Life style modification, Randomized Controlled Trial
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: RJ13/039/J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No