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

NCT ID: NCT03532815

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2015-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle Modification group

Group Type: ACTIVE_COMPARATOR

Lifestyle Modification

Intervention Type: BEHAVIORAL

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle Modification

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Jumana Khouja

Assistant Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jumana Khouja, MD, SBCM

Role: PRINCIPAL_INVESTIGATOR

KAIMRC

References

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.

Reference Type: RESULT

PMID: 23796526 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

RJ13/039/J

Identifier Type: -

Identifier Source: org_study_id