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临床试验/NCT05387174
NCT05387174已完成不适用

Nursing Intervention in Two Risk Factors of the Metabolic Syndrome, Abdominal Obesity and Arterial Hypertension, and Quality of Life in the Climacteric Period

Universidad de Concepcion2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Change in abdominal obesity

研究概览

简要总结

The estrogenic deficit characteristic of the climacteric stage is accompanied by a high incidence of health problems, such as the presence of Metabolic Syndrome risk factors that contribute to the increase of cardiovascular diseases.

Objective: To determine the effect of a nursing intervention based on self-care aimed at improving the control of two metabolic syndrome risk factors (abdominal obesity and arterial hypertension) and health-related quality of life in climacteric women.

Material and methods: Quasi-experimental study, non-equivalent control group design with women between 40 and 59 years old who present two risk factors of the Metabolic Syndrome (abdominal obesity and arterial hypertension) from two type C Health Centers of District 17D03 of Quito, Ecuador. Among one of the conceptual hypotheses, the researchers have Conceptual hypothesis 1: Climacteric women of the experimental group after the intervention of Nursing based on self-care improve two risk factors of MS with respect to those of the comparison group. A sample of 40 women was selected for experimental group and 40 for comparison group. Instruments and measurements: Abdominal Circumference, Blood Pressure, Menopause Rating Scale, International Physical Activity Questionnaire (IPAQ). Women in both groups received the usual care and those in the experimental group received a Nursing Intervention with technological support that included individual face-to-face nursing counseling, group education and physical activity sessions through a virtual platform for 12 weeks. Ethical requirements were considered.

Expected results: It is expected that after the Nursing Intervention based on self-care the women of the experimental group will decrease the parameters of abdominal circumference, blood pressure and improve health-related quality of life.

详细描述

  1. INTRODUCTION 1.1 Presentation and rationale of the problem During the last decade, health needs have been changing, with a significant increase in the life expectancy of the population in general and with it the increase of non- communicable diseases, which threaten the health and development of people, especially in developing countries, being predicted for the year 2050.

The World Health Organization (WHO) considers noncommunicable diseases (NCDs) to be the leading cause of morbidity and mortality worldwide, killing 41 million people each year, which is equivalent to 71% of deaths worldwide. Specifically, among individuals aged 30-69 years, 15 million die each year from this type of disease and more than 85% of these premature deaths occur in low- and middle-income countries. According to WHO projections, annual deaths from noncommunicable diseases will increase to 55 million by the year 2030, which at an economic level will bring consequently a high cost to the countries of the world, constituting one of the greatest challenges facing health systems.

Because of the context presented and the projected data, the 2030 Agenda for Sustainable Development recognizes NCDs as a major obstacle to development, WHO has developed the Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020 to address them. This is expected to reduce premature deaths by 33% by 2030 through prevention and treatment of these conditions (target 3.4 of the Sustainable Development Goals).

Regarding cardiovascular diseases, it is mentioned that the risk factors that are closely related to them are: causal (hypercholesterolemia, hypertension, diabetes mellitus, smoking and age), predisposing (obesity, sedentary lifestyle, family history, sex and psychosocial factors) and conditional (hypertriglyceridemia, high LDL-oxidized, high prothrombotic factor and microalbuminuria), increasing their suffering.

About predisposing factors, it is necessary to consider that the female population is the most affected by cardiovascular diseases because they have a significantly higher risk of mortality, due to their biological difference as well as the complex interactions of cultural and socioeconomic conditions. In this regard, the researchers must consider that female sex, gender, ethnicity, hormonal changes, onset of menarche, pregnancy, premature birth, presence of pathologies such as gestational hypertension, polycystic ovary and menopause, combined with the epidemiological and demographic transition, which have changed habits and lifestyles, further condition the presence of cardiovascular diseases. In addition, the life expectancy of women worldwide has risen considerably and they spend a third or more of their lives after the climacteric period with some risk factor.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

盲法说明

As blinding is an unavoidable condition in this type of study, the surveyors in the data collection will not have knowledge about the experimental group and comparison group, so they will be given as group A and B, both at the beginning and at the end of the study in the pre- and post-tests, with the aim of preventing certain biases in some of the stages of the trial and thus protect the sequence after the allocation for convenience.

入排标准

年龄范围
40 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Be between 40 and 59 years of age.
  • Abdominal circumference equal to or greater than 80 cm.
  • Blood pressure equal to or greater than 130/85mmHg or on antihypertensive treatment
  • Being able to ambulate without assistance.
  • Population residing in the sector in which you are registered.
  • Access to mobile or fixed internet service.

排除标准

  • Women on hormone replacement therapy.
  • Women with hysterectomy and/or oophorectomy
  • Pregnant women.
  • Women with cardiovascular disease such as dyslipidemia, type II diabetes; cancer; hypothyroidism; respiratory disease; neuromuscular or terminal illness.
  • People who cannot read or write.

结局指标

主要结局

Change in abdominal obesity

时间窗: Until the end of the study (3 months duration)

Anthropometric measurements (abdominal circumference)

Improve health-related quality of life

时间窗: Until the end of the study (3 months duration)

Instrument Menopause Rating Scale: (Minimum total value "0 points" and maximum "44 points", if the score is higher the result is negative)

Reduce systolic and diastolic blood pressure

时间窗: Until the end of the study (3 months duration)

Vital sign (systolic and diastolic blood pressure)

次要结局

  • Increase the level of physical activity(Until the end of the study (3 months duration))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alide Salazar Molina

Research Director

Universidad de Concepcion

研究点 (2)

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