The Effect of Lifestyle Intervention on Cardiovascular Disease Risk Among Women
Condition: Cardiovascular Risk Factor; Lifestyle Risk Reduction
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

Intervention name(s): The letters with the Cochrane abstracts in the form of blog-shots; The letters with remainder on cardiovascular risk factors
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention