Cardiovascular Risk FactorNCT04601558
The Effect of Lifestyle Intervention on Cardiovascular Disease Risk Among Women
A study testing The letters with the Cochrane abstracts in the form of blog-shots and The letters with remainder on cardiovascular risk factors in people with Cardiovascular Risk Factor and Lifestyle Risk Reduction, run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
Patient education in lifestyle changes has a positive effect on health in individuals with cardiovascular (CV) risk. Despite current positive evidence about lifestyle and dietary change in the prevention of CVD, the recommendations are still not consistently and optimally applied to women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Lifestyle Risk Reduction
- What is being tested?
- The letters with the Cochrane abstracts in the form of blog-shots and The letters with remainder on cardiovascular risk factors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Feb 2018to 1 Mar 2021
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female sex;
- age 45 to 65 years, with one or more CV risk factors [overweight or obesity, i. e. body mass index (BMI) ≥25 kg/m2, and/or central obesity - waist circumference ≥88 cm, high blood pressure (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg), high blood cholesterol (≥5.2 mmol/L) and active smoking];
- the participants on antihypertensive therapy were also included in the study.
Who cannot join
- current cardiovascular disease (ischemic heart disease, peripheral artery disease, and stroke) were excluded;
- the participants with malignant diseases;
- the participants with serious systemic disease;
- the participants with mental disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Lifestyle Intervention on 10-year Year Risk of Cardiovascular Disease Among Women in the Form of Cochrane Abstracts: Randomized Controlled Trial
Patient education in lifestyle changes has a positive effect on health in individuals with cardiovascular (CV) risk. Despite current positive evidence about lifestyle and dietary change in the prevention of CVD, the recommendations are still not consistently and optimally applied to women.
The aim of the study was to analyze the effect of an intervention in the form of Cochrane abstract letters on women between 45 to 65 years.
Read the detailed description
The study took place in family medicine (FM) offices from 1 February 2018 to 1 June 2020. Two FM offices were in the city of Split, the capital of the Split-Dalmatian County, two offices were in Osijek, the capital of the Osijek-Baranja County, one in Kutina, and one in Rijeka.
The participants were all women between 45 to 65 years. The investigators enrolled 210 participants, and the participants were divided in three groups. The first group was control group, and participants were not exposed to the intervention. The second group was passive-intervention group, which means the participants received letters in the same time period as active-intervention group but only with a reminder at their own cardiovascular disease risk. The third group was active-intervention group, where the participants received letters every three months, with their own cardiovascular disease risk and Cochrane abstracts in the form of blog-shots.
The study participants first completed the Pre-study questionnaire (Questionnaire 1), which included: a) demographic data, b) attitudes and knowledge questionnaire about CV risk factors, c) decisional conflict scale (DCS), and d) integrative hope scale (IHS).
Attitudes and knowledge questionnaire about CV risk factors was created according to the model of "Ottawa Decision Support Tutorial".
The DCS consist of 16 items rated in a 5-point Likert-type response format, and measures individual's uncertainty toward a course of action. There are five subscales: uncertainty, informed, values clarity, support and effective decision. The scores on the total scale and subscales are calculated as a sum of items, divided by the number of items and multiplied by 25, allowing for a score range from zero (no decisional conflict) to 100 points (extreme decisional conflict). The Croatian version of the scale was previously validated.
The IHS is 23-items scale, a self-rating instrument with items being rated on a six-point Likert scale from 1, strongly disagree, to 6, strongly agree. It provides an overall score and four dimension scores, obtained by summing up the individual item scores, with negative items being rated inversely. This produces possible overall hope scores ranging from 23 to 138 with higher scores representing higher hopefulness. The scores for the sub-dimensions vary according to the number of items. The Croatian version of the scale was previously validated. Hope to be healthy at 70 and hope to reduce CV risk was assessed by a visual analogue scale from 0 to 100.
Ten-year risk of fatal CVD was estimated using the ACC/AHA (American College of Cardiology/American Heart Association) guidelines, based on the following data collected from the study participants: age, gender, race, total and HDL (high-density lipoprotein) cholesterol, systolic blood pressure, data about antihypertensive therapy, diabetes mellitus and smoking status. Also, BMI, waist and hip circumference, systolic and diastolic blood pressure, blood cholesterol, triglycerides, and smoking status were measured.
In the first months after recruitment, all participants received letter on home address with the count of their 10-year risk of cardiovascular disease.
After that, every two months, passive-intervention group and active-intervention group were receiving letters. The passive-intervention group of women were receiving the letters only with remainder on their own CV risk, and the active-intervention group were receiving Cochrane abstracts in the form of blog-shots.
There were three Cochrane blog-shots. The first was about calcium in prevention of high blood pressure, the second was about the effect of reducing saturated fat acids in eating habits and the third consisted informations of green and black tea for the prevention of cardiovascular diseases.
- Being tested
- The letters with the Cochrane abstracts in the form of blog-shots, The letters with remainder on cardiovascular risk factors
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The letters with the Cochrane abstracts in the form of blog-shotsBehavioural
The active intervention were letters with the remainder on participant's own cardiovascular risk factors, a participant's own count of 10-year risk of cardiovascular disease, and Cochrane abstract in the form of blog-shots and personal advice in reducing cardiovascular disease risk.
There were three Cochrane blog-shots. The first was about calcium in prevention of high blood pressure, the second was about the effect of reducing saturated fat acids in eating habits and the third consisted evidence of green and black tea for the prevention of cardiovascular diseases.
The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk.
The letters with remainder on cardiovascular risk factorsBehavioural
The passive intervention were letters with the remainder on participant's own cardiovascular risk factors and participant's own count of 10-year risk of cardiovascular disease.
The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The first group of participants was control group. The number of participant was 70, and the participants in this group after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. |
| Passive-intervention group | Sham comparator | The second group of participant was passive-intervention group. There were 70 participants. This group of women after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. After this letter, every two months, they were receiving remainder on their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. Receives: Behavioral: The letters with remainder on cardiovascular risk factors |
| Active-intervention group | Active comparator | The third group of participant was active-intervention group. There were also 70 participants. This group of women after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. After this letter, every two months, active-intervention group were receiving Cochrane abstracts in the form of blog-shots. Receives: Behavioral: The letters with the Cochrane abstracts in the form of blog-shots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ten-year Risk of Cardiovascular Disease (CVD)
Ten-year risk of fatal CVD was estimated using the ACC/AHA (American College of Cardiology/American Heart Association) guidelines, based on the following data collected from the study participants: age, gender, race, total and HDL (high-density lipoprotein) cholesterol, systolic blood pressure, data about antihypertensive therapy, diabetes mellitus and smoking status.
Measured: Change from baseline 10-year risk of CVD at 6 months
Secondary outcomes (5)
Weight
Weight in kilograms (kg).
Measured: Change from baseline weight at 6 months
Body Mass Index (BMI)
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. BMI can be used to screen for weight categories that may lead to health problems but it is not diagnostic of the body fatness or health of an individual.
Measured: Change from baseline BMI at 6 months
Waist Circumference
Waist circumference in centimeters (cm).
Measured: Change from baseline waist circumference at 6 months
Hips Circumference
Hips circumference in centimeters (cm).
Measured: Change from baseline hips circumference at 6 months
Smoking Status
Smoking status related to continued or excessive smoking.
Measured: Change from baseline smoking status at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Feb 2018
- Primary completion28 Feb 2021
- Study completion1 Mar 2021
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 Risk FactorStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601558
- Sponsor's protocol ID
- No. IP-2019-04-4882
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juric Petricevic S, Buljan I, Bjelanovic D, Mrduljas-Dujic N, Pekez T, Curkovic M, Vojvodic Z, Pavlicevic I, Marusic M, Marusic A. Effectiveness of letters to patients with or without Cochrane blogshots on 10-year cardiovascular risk change among women in menopausal transition: 6-month three-arm randomized controlled trial. BMC Med. 2022 Oct 20;20(1):381. doi: 10.1186/s12916-022-02555-2.
PubMed 36261832
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lifestyle Intervention on 10-year Year Risk of Cardiovascular Disease Among Women in the Form of Cochrane Abstracts: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04601558
- Acronym / sponsor ID
- No. IP-2019-04-4882
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 23 Oct 2020 (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.
Patient education in lifestyle changes has a positive effect on health in individuals with cardiovascular (CV) risk. Despite current positive evidence about lifestyle and dietary change in the prevention of CVD, the recommendations are still not consistently and optimally applied to women.
The aim of the study was to analyze the effect of an intervention in the form of Cochrane abstract letters on women between 45 to 65 years.
Detailed description
The study took place in family medicine (FM) offices from 1 February 2018 to 1 June 2020. Two FM offices were in the city of Split, the capital of the Split-Dalmatian County, two offices were in Osijek, the capital of the Osijek-Baranja County, one in Kutina, and one in Rijeka.
The participants were all women between 45 to 65 years. The investigators enrolled 210 participants, and the participants were divided in three groups. The first group was control group, and participants were not exposed to the intervention. The second group was passive-intervention group, which means the participants received letters in the same time period as active-intervention group but only with a reminder at their own cardiovascular disease risk. The third group was active-intervention group, where the participants received letters every three months, with their own cardiovascular disease risk and Cochrane abstracts in the form of blog-shots.
The study participants first completed the Pre-study questionnaire (Questionnaire 1), which included: a) demographic data, b) attitudes and knowledge questionnaire about CV risk factors, c) decisional conflict scale (DCS), and d) integrative hope scale (IHS).
Attitudes and knowledge questionnaire about CV risk factors was created according to the model of "Ottawa Decision Support Tutorial".
The DCS consist of 16 items rated in a 5-point Likert-type response format, and measures individual's uncertainty toward a course of action. There are five subscales: uncertainty, informed, values clarity, support and effective decision. The scores on the total scale and subscales are calculated as a sum of items, divided by the number of items and multiplied by 25, allowing for a score range from zero (no decisional conflict) to 100 points (extreme decisional conflict). The Croatian version of the scale was previously validated.
The IHS is 23-items scale, a self-rating instrument with items being rated on a six-point Likert scale from 1, strongly disagree, to 6, strongly agree. It provides an overall score and four dimension scores, obtained by summing up the individual item scores, with negative items being rated inversely. This produces possible overall hope scores ranging from 23 to 138 with higher scores representing higher hopefulness. The scores for the sub-dimensions vary according to the number of items. The Croatian version of the scale was previously validated. Hope to be healthy at 70 and hope to reduce CV risk was assessed by a visual analogue scale from 0 to 100.
Ten-year risk of fatal CVD was estimated using the ACC/AHA (American College of Cardiology/American Heart Association) guidelines, based on the following data collected from the study participants: age, gender, race, total and HDL (high-density lipoprotein) cholesterol, systolic blood pressure, data about antihypertensive therapy, diabetes mellitus and smoking status. Also, BMI, waist and hip circumference, systolic and diastolic blood pressure, blood cholesterol, triglycerides, and smoking status were measured.
In the first months after recruitment, all participants received letter on home address with the count of their 10-year risk of cardiovascular disease.
After that, every two months, passive-intervention group and active-intervention group were receiving letters. The passive-intervention group of women were receiving the letters only with remainder on their own CV risk, and the active-intervention group were receiving Cochrane abstracts in the form of blog-shots.
There were three Cochrane blog-shots. The first was about calcium in prevention of high blood pressure, the second was about the effect of reducing saturated fat acids in eating habits and the third consisted informations of green and black tea for the prevention of cardiovascular diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The first group of participants was control group. The number of participant was 70, and the participants in this group after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. |
| Passive-intervention group | Sham comparator | Behavioral: The letters with remainder on cardiovascular risk factorsThe second group of participant was passive-intervention group. There were 70 participants. This group of women after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. After this letter, every two months, they were receiving remainder on their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. |
| Active-intervention group | Active comparator | Behavioral: The letters with the Cochrane abstracts in the form of blog-shotsThe third group of participant was active-intervention group. There were also 70 participants. This group of women after recruitment received letter with their own cardiovascular risk factors and count of their 10-year risk of cardiovascular disease. After this letter, every two months, active-intervention group were receiving Cochrane abstracts in the form of blog-shots. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female sex;
- age 45 to 65 years, with one or more CV risk factors [overweight or obesity, i. e. body mass index (BMI) ≥25 kg/m2, and/or central obesity - waist circumference ≥88 cm, high blood pressure (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg), high blood cholesterol (≥5.2 mmol/L) and active smoking];
- the participants on antihypertensive therapy were also included in the study.
Key exclusion criteria (4 listed)
- current cardiovascular disease (ischemic heart disease, peripheral artery disease, and stroke) were excluded;
- the participants with malignant diseases;
- the participants with serious systemic disease;
- the participants with mental disease.
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 |
|---|---|---|
| The letters with the Cochrane abstracts in the form of blog-shotsThe active intervention were letters with the remainder on participant's own cardiovascular risk factors, a participant's own count of 10-year risk of cardiovascular disease, and Cochrane abstract in the form of blog-shots and personal advice in reducing cardiovascular disease risk. There were three Cochrane blog-shots. The first was about calcium in prevention of high blood pressure, the second was about the effect of reducing saturated fat acids in eating habits and the third consisted evidence of green and black tea for the prevention of cardiovascular diseases. The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk. | Behavioural | Active-intervention group |
| The letters with remainder on cardiovascular risk factorsThe passive intervention were letters with the remainder on participant's own cardiovascular risk factors and participant's own count of 10-year risk of cardiovascular disease. The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk. | Behavioural | Passive-intervention group |
Primary outcome
Ten-year Risk of Cardiovascular Disease (CVD)
Time frame: Change from baseline 10-year risk of CVD at 6 months
Ten-year risk of fatal CVD was estimated using the ACC/AHA (American College of Cardiology/American Heart Association) guidelines, based on the following data collected from the study participants: age, gender, race, total and HDL (high-density lipoprotein) cholesterol, systolic blood pressure, data about antihypertensive therapy, diabetes mellitus and smoking status.
5 secondary outcomes
Weight
Time frame: Change from baseline weight at 6 months
Body Mass Index (BMI)
Time frame: Change from baseline BMI at 6 months
Waist Circumference
Time frame: Change from baseline waist circumference at 6 months
Hips Circumference
Time frame: Change from baseline hips circumference at 6 months
Smoking Status
Time frame: Change from baseline smoking status at 6 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 30 Nov 2021.
- Derived from this study: PubMed 36261832Juric Petricevic S, Buljan I, Bjelanovic D, Mrduljas-Dujic N, Pekez T, Curkovic M, Vojvodic Z, Pavlicevic I, Marusic M, Marusic A. Effectiveness of letters to patients with or without Cochrane blogshots on 10-year cardiovascular risk change among women in menopausal transition: 6-month three-arm randomized controlled trial. BMC Med. 2022 Oct 20;20(1):381. doi: 10.1186/s12916-022-02555-2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The letters with the Cochrane abstracts in the form of blog-shots and The letters with remainder on cardiovascular risk factors in people with Cardiovascular Risk Factor and Lifestyle Risk Reduction, run by University of Split, School of Medicine at 1 site in Croatia.
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 3 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 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Ten-year Risk of Cardiovascular Disease (CVD) (time frame: Change from baseline 10-year risk of CVD at 6 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 NCT04601558, 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 30 Nov 2021.