Clinical trial NCT04601558: The Effect of Lifestyle Intervention on Cardiovascular Disease Risk Among Women
Official title: The Lifestyle Intervention on 10-year Year Risk of Cardiovascular Disease Among Women in the Form of Cochrane Abstracts: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lifestyle Risk Reduction
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 210
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Ten-year Risk of Cardiovascular Disease (CVD)
timeFrame: Change from baseline 10-year risk of CVD at 6 months
Secondary outcomes:
measure: Weight
timeFrame: Change from baseline weight at 6 months
measure: Body Mass Index (BMI)
timeFrame: Change from baseline BMI at 6 months
measure: Waist Circumference
timeFrame: Change from baseline waist circumference at 6 months
measure: Hips Circumference
timeFrame: Change from baseline hips circumference at 6 months
measure: Smoking Status
timeFrame: Change from baseline smoking status at 6 months
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
References:
citation: 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.