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NCT05387174
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
NA trial testing : Nursing intervention in two risk factors of the Metabolic Syndrome, abdominal obesity and arterial hypertension and quality of life in the climacteric period. in Obesity, Abdominal in 80 participants. Completed in 22 December 2021.
11 September 2021
Quick facts
| Lead sponsor | Universidad de Concepcion |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 4 September 2021 |
| Primary completion | 11 September 2021 |
| Estimated completion | 22 December 2021 |
| Sites | 1 location across Ecuador |
Drugs / interventions tested
- : Nursing intervention in two risk factors of the Metabolic Syndrome, abdominal obesity and arterial hypertension and quality of life in the climacteric period.
Conditions studied
- Obesity, Abdominal — all drugs for Obesity, Abdominal →
- Hypertension — all drugs for Hypertension →
- Quality of Life — all drugs for Quality of Life →
- Menopause — all drugs for Menopause →
Sponsor
Universidad de Concepcion — full company profile →
Who can join
Adults 40 to 59, female only, with Obesity, Abdominal or Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Design and development of the content of a mobile application to reduce risk factors of the metabolic syndrome in the climacteric.
Riofrío Terrazas S, Salazar Molina A, Vílchez Barboza V, Cuadra Montoya L, et al · · 2024 · PMID 39669169 · DOI 10.1016/j.heliyon.2024.e40169
Verify or expand the search:
- PubMed search for NCT05387174
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05387174 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de Concepcion
- Last refreshed: 27 May 2022
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