Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period

NCT05387174 | Completed DMC

• 1 other identifier: CEBB 649-2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Abdominal; Hypertension; Quality of Life; Menopause

Keywords

Metabolic syndrome, Menopause, Quality of life

Outcome Measures

Primary Outcomes (3)

• Change in abdominal obesity

  Anthropometric measurements (abdominal circumference)

  Until the end of the study (3 months duration)

• Reduce systolic and diastolic blood pressure

  Vital sign (systolic and diastolic blood pressure)

  Until the end of the study (3 months duration)

• Improve health-related quality of life

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

  Until the end of the study (3 months duration)

Secondary Outcomes (1)

• Increase the level of physical activity

  Until the end of the study (3 months duration)

Study Arms (2)

Experimental group nursing intervention with technological support

EXPERIMENTAL

Experimental group composed of 40 with the same characteristics as above and attending the San Antonio de Pichincha Health Center, this group will additionally receive a nursing intervention of 3 months, to reduce the risk factors of MS and improve the quality of life related to health. The nursing intervention with web application support will consist of three elements: Individual face-to-face individual Nursing Counseling, Group Education and Physical Activity sessions through virtual platform.

Behavioral: : Nursing intervention in two risk factors of the Metabolic Syndrome, abdominal obesity and arterial hypertension and quality of life in the climacteric period.

Group compared regular care at the MSP Health Center

NO INTERVENTION

Comparison group composed of 40 women in the climacteric stage between 40 and 59 years old who have two risk factors of MS (abdominal obesity and arterial hypertension), who go to the Health Center of the People's Committee, to the group of the Hypertensive Program that receive the usual attention of the Institution on group talks, health fairs based on general topics of the disease.

Interventions

: Nursing intervention in two risk factors of the Metabolic Syndrome, abdominal obesity and arterial hypertension and quality of life in the climacteric period. BEHAVIORAL

Nursing intervention with technological support (Metamorphosis) in two risk factors of Metabolic Syndrome, abdominal obesity and hypertension and quality of life in the climacteric period, developed in 3 months, in the experimental group that includes individual nursing counseling, group education virtually and physical activity sessions for 12 weeks virtually.

Experimental group nursing intervention with technological support

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Concepcion: lead
• Universidad Central del Ecuador: collaborator

Study Sites (1)

Centro de Salud de San Antonio de Pichincha

Quito, Pichincha, 593, Ecuador

Location

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MeSH Terms

Conditions

Obesity, Abdominal; Hypertension; Metabolic Syndrome

Interventions

Methods; Quality of Life

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Sandra C Riofrío Terrazas, Dra (c)

  Universidad Central del Ecuador

  PRINCIPAL INVESTIGATOR

• Sandra C Riofrío Terrazas, Dra (c)

  Centro de Salud San Antonio de Pichincha

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 24, 2022
• Study Start: September 4, 2021
• Primary Completion: September 11, 2021
• Study Completion: December 22, 2021
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)