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

NCT03532815 | Completed DMC

• 1 other identifier: RJ13/039/J
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular Diseases, Framingham risk score, Life style modification, Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Framingham Risk Category Changes

  3 months

Study Arms (2)

Lifestyle Modification group

ACTIVE COMPARATOR

Behavioral: Lifestyle Modification

Control group

NO INTERVENTION

Interventions

Lifestyle Modification BEHAVIORAL

Lifestyle Modification group

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

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

  PMID: 23796526 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Jumana Khouja, MD, SBCM

  KAIMRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Consultant

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: May 22, 2018
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 6, 2019

Record last verified: 2019-11