Cardiovascular DiseasesNCT03532815
Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia
A study testing Lifestyle Modification in people with Cardiovascular Diseases, run by King Abdullah International Medical Research Center.
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Lifestyle Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged ≥ 30 years.
- The participants must be at moderate to high-risk of CVD according to FRS.
Who cannot join
- Women aged < 30 years.
- Women aged ≥ 30 years with low risk of CVD according to FRS.
- Pregnant women.
- Female patients diagnosed with CVD.
About this study
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
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
- Being tested
- Lifestyle Modification
- Keywords
- Cardiovascular Diseases, Framingham risk score, Life style modification, Randomized Controlled Trial
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification group | Active comparator | Not described Receives: Behavioral: Lifestyle Modification |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (1)
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). .
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Jan 2015
- Primary completion1 Aug 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jumana Khouja, King Abdullah International Medical Research Center
- Investigators
- Jumana Khouja, MD, SBCM, Principal investigator, KAIMRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532815
- Sponsor's protocol ID
- RJ13/039/J
- Status last verified
- Nov 2019
- First submitted
- 6 Dec 2017
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23796526
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03532815
- Acronym / sponsor ID
- RJ13/039/J
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Framingham risk score, Life style modification, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification group | Active comparator | Behavioral: Lifestyle Modification |
| Control group | No intervention | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged ≥ 30 years.
- The participants must be at moderate to high-risk of CVD according to FRS.
Key exclusion criteria (4 listed)
- Women aged < 30 years.
- Women aged ≥ 30 years with low risk of CVD according to FRS.
- Pregnant women.
- Female patients diagnosed with CVD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Modification | Behavioural | Lifestyle Modification group |
Primary outcome
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).
1 secondary outcome
Framingham Risk Category Changes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Results publication: PubMed 23796526Cox 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jumana Khouja, MD, SBCM principal investigator
KAIMRC
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification in people with Cardiovascular Diseases, run by King Abdullah International Medical Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Framingham Risk Scores Reduction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03532815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.