The Effect of Lifestyle Intervention on Cardiovascular Disease Risk Among Women

NCT04601558 | Completed DMC

• 1 other identifier: No. IP-2019-04-4882
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor; Lifestyle Risk Reduction

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline 10-year risk of CVD at 6 months

Secondary Outcomes (5)

• Weight

  Change from baseline weight at 6 months

• Body Mass Index (BMI)

  Change from baseline BMI at 6 months

• Waist Circumference

  Change from baseline waist circumference at 6 months

• Hips Circumference

  Change from baseline hips circumference at 6 months

• Smoking Status

  Change from baseline smoking status at 6 months

Study Arms (3)

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.

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.

Behavioral: The letters with the Cochrane abstracts in the form of blog-shots

Interventions

The letters with the Cochrane abstracts in the form of blog-shots BEHAVIORAL

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.

Active-intervention group

The letters with remainder on cardiovascular risk factors BEHAVIORAL

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.

Passive-intervention group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 36261832 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: February 1, 2018
• Primary Completion: February 28, 2021
• Study Completion: March 1, 2021
• Last Updated: November 30, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)