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NCT ID: NCT05309044 Not yet recruiting - Obesity Clinical Trials

Evaluation of the Planetary Health Diet Included in a Lifestyle Program in Overweight or Obese Mexican Adults.

Start date: April 2022
Phase: N/A
Study type: Interventional

The EAT-Lancet Commission proposed the planetary health diet as a strategy to achieve health and sustainability goals. Currently, its effect in the treatment of obesity has not been evaluated. The main aim is to evaluate the efficacy of the planetary health diet included in an intensive lifestyle change program compared to a waiting list group, on weight and body fat at 4 months, in Mexican adults with overweight or obesity, in an online modality. This study is a 4-month randomized controlled trial, in an online modality in individuals with overweight or obesity randomly assigned 1:1:1 to one of three groups: 1) planetary health diet, 2) waiting list and 3) low fat-diet. The primary outcome is the difference in change in weight (kg) and body fat (kg) at 4 months between the planetary health diet group and the waiting list group. Comparison with the low-fat diet group will be an exploratory analysis. Secondary variables include changes in waist circumference, BMI, blood pressure, and health-related quality of life. Between group comparisons will be analyzed by intention-to-treat. The protocol was approved by a Research Bioethics Committee.

NCT ID: NCT05282537 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Health Parameters of University Students After Pandemic Isolation

Start date: March 14, 2022
Phase:
Study type: Observational

The COVID-19 pandemic caused by the SARS-CoV-2 coronavirus represents threats to global health and economy. The high pathogenesis of SARS-CoV-2 extent that the Mexican government declared a national health emergency, agreeing to take extraordinary measures such as the suspension of non-essential work, including the suspension of academic activities at all levels, in order to minimize the dispersion and transmission of the virus and its consequences. Several previously reported quarantine evaluations have shown that psychological stress reactions can arise from the experience of physical and social isolation, so the current global threat of isolation has shaken the usual practices of the general population, including young people, and resulting in the modification of their academic, labor and social dynamics. The usual behavior in this phenomenon establishes that greater social isolation is associated with less satisfaction with life, higher levels of depression and lower levels of psychological well-being or performance as well as changes in diet. Understanding the factors related to coping with COVID-19 is essential to issue guidance on health in the student population, for that, the present proposal intends to evaluate changes in health parameters derived from the resumption of academic activities in person for a year in university students of health sciences area.

NCT ID: NCT05225701 Not yet recruiting - Depression Clinical Trials

Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders.

Start date: September 2022
Phase: N/A
Study type: Interventional

Emotional, trauma and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression care. However, these treatments are not often used. The reasons for this are: limited access and low availability to effective interventions; a minority of people actively seek psychological care because of their own distress condition, fearing social stigma, because of geographical reasons that separate them from health centers, because of time, preference for other treatment or self-help, for the high cost of treatment, which makes it inaccessible and unaffordable to both, the user, and the public health system. It has also been stated that the comorbidity between mental disorders, as well as the gap between research findings and clinical practice could influence the poor dissemination of effective treatments, resulting in a lack of up-to-date professionals providing relevant interventions. This has motivated the practice of some studies aimed at knowing the moderating, mediating variables and psychological mechanisms that improve the process of clinical change. Emotional deregulation of negative affection has been found to be a moderating factor and/or mediation in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In this way, transdiagnostic treatments could help overcome the drawbacks related to comorbidity between disorders. However, technological advancement has created alternatives for psychological assistance, highlighting the possibilities offered by technologies since Internet-supported interventions have been empirically tested for effectiveness, efficiency and this efficiency can be key to ensuring access to those who are inaccessible. Thus, the study aims to identify the indicators of efficacy, acceptability, and moderation of clinical change of a transdiagnostic intervention through a telepsychology platform for the treatment of emotional disorders and derived from stress and trauma.

NCT ID: NCT05158673 Not yet recruiting - Metabolic Syndrome Clinical Trials

Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Postmenopausal Women

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

Several epidemiological studies have shown that premenopausal women are protected from cardiovascular diseases compared to men of the same age; however, after menopause (postmenopause), the cardiovascular risk increases progressively to equal the cardiovascular risk of men of the same age group. In addition, in Mexico, the incidence of women entering the postmenopausal stage with overweight or obesity increases each year. Therefore, it is essential to generate public initiatives to reduce the metabolic and physiological alterations caused by overweight/obesity and improve postmenopausal women's health and quality of life. Flavonoids are bioactive compounds that have been shown to reduce the cardiovascular risk associated with obesity since they participate in the regulation of lipid metabolism, improve body composition, reduce oxidative stress and inflammation; Therefore, our objective is to reduce the cardiovascular risk of postmenopausal women and improve the oxidative and inflammatory state, through oral supplementation with cocoa flavonoids. To do this, an innovative method will be used to assess cardiovascular risk based on knowledge of the type, number, and size of lipoprotein particles and knowing the oxidative and inflammatory state before and after supplementation with cocoa flavonoids.

NCT ID: NCT05081830 Not yet recruiting - Depression Clinical Trials

Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The general objective of this study is to determine the indicators of suitability, clinical utility and satisfaction of the transdiagnostic online intervention for the treatment of emotional disorders and those derived from stress and trauma in a Mexican community sample. The specific aims are: - To Carry out a screening evaluation from the transdiagnostic model by evaluating clinical indicators (depression, anxiety, acute / post-traumatic stress, emotional regulation strategies, intolerance to uncertainty) and that allow determining the frequency, intensity and severity of cases identified by type of emotional problem. - Measure the fidelity of the use of the intervention manual in each treatment condition. - Evaluate the degree of satisfaction, acceptance, complexity and modality of the transdiagnostic intervention. - To know the degree of suitability of the transdiagnostic intervention from the point of view of therapists and supervisors in relation to the problems of the studied sample and the recommendations for its improvement. - To compare the clinical utility of the transdiagnostic intervention via the internet for the treatment of emotional disorders and those derived from stress and trauma against the efficacy of the CBT intervention and the waiting list group.

NCT ID: NCT04947111 Not yet recruiting - Dengue Clinical Trials

Serological Study of Dengue and Characterization of Immune Response in Ten Endemic and Non-Endemic Cities in Mexico

Start date: April 30, 2022
Phase: N/A
Study type: Interventional

Background: Dengue continues to be a high priority disease for public health in tropical and subtropical countries, where vector control measures have not had the expected impact on transmission. The development of new vaccines opens the possibility of having an additional measure capable of preventing the development of the disease and avoiding its complications. Currently, in two of the Dengue virus (DENV) vaccines a differential behaviour of the immune response has been observed between seropositive and seronegative individuals, which makes the generation of evidence from prevalence studies in places of high and low endemicity more relevant. Objective: To determine the predominant type of humoral immune response in high areas and to estimate the serotype-specific prevalence for DENV in people groups aged 5 to 35 years living in Mexican cities with low and high dengue endemicity. Methodology: Descriptive cross-sectional study with subgroup analysis (by endemic and non-endemic areas, by age groups and by sex). Expected results: In areas of low dengue endemicity the humoral immune response against dengue is predominantly monotypic (against one serotype) while in areas of high dengue endemicity it is predominantly multitype (against two or more serotypes).

NCT ID: NCT04658875 Not yet recruiting - Clinical trials for Overweight and Obesity

Effect of Spirulina Maxima and Exercise on General Fitness and Blood Lipids in Older Adults

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

The global older adult population has grown more than any other age group, which could be explained by the decrease of birth rate and increase of life expectancy. The healthy life expectancy of older adult in Mexico is 65.8 years, and the population's life expectancy in general is 74.4 years, this means that the population meeting that age is at increased risk of developing some disease or dependence during approximately nine years of their life. For the population over 60 years, the three most frequent health conditions reported were hypertension (40%), diabetes (24.3%), and hypercholesterolemia (20.4%). In this sense, the search for a healthy lifestyle is necessary, which includes a healthy diet that includes supplementation with nutraceuticals and the daily practice of physical activity. Regarding nutraceutical supplementation, the cyanobacterium Spirulina maxima (S. maxima) is an important source of proteins, carotenoids, phenolic compounds and polyunsaturated fatty acids which have been tested for diverse biological activities such as lipid lowering effects, however, existing studies of effects of S. maxima on body composition, physical function and blood lipid profile in humans, mainly in older adults, have a low level of evidence and absence of adequate experimental designs, so its value as a nutraceutical cannot be assured. The effects of performing systematic physical exercise in older adults have been shown to have positive effects on body composition and blood lipid profile, so in the present study it is proposed to evaluate the synergy presented by a supplement such as S. maxima in a systematic physical exercise program on the body composition, physical function and blood lipid profile of sedentary older adults with excess weight in a randomized, double-blind, crossover, placebo controlled trial.

NCT ID: NCT04540926 Not yet recruiting - COVID 19 Pneumonia Clinical Trials

Cyclosporine A Plus Low-steroid Treatment in COVID-19 Pneumonia

Start date: September 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Methods: Single-center pilot study included PCR+ SARS-CoV2-patients, hospitalized from April to May 2020 in Puebla, Mexico. Comparative treatment with steroids plus CsA or steroids. Mild, moderate or severe pneumonia was measured by clinical, laboratory tests, lung damage score by computed tomography, and score for clinical improvement. Death rate was evaluated at 28 days.

NCT ID: NCT04520464 Not yet recruiting - HPV DNA Clinical Trials

Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Samples From Service Provider (Xyto-Ro)

Xyto-Ro
Start date: October 2020
Phase: N/A
Study type: Interventional

Problem Description When cervical cancer screening is needed, the Pap test (or Pap smears) is still the most common, although there are challenges that continue to prevent effective screening services in many countries, poor quality testing, long delays until screening is available, they give the results to women, poor population coverage and insufficient follow-up treatment. HPV testing can remove barriers related to access to screening services, since the woman can obtain the sample herself. Women's self-sampling for HPV testing has been used in a programmatic context in some countries. For a good impact, screening coverage must reach at least 70% of the target population. In the Region of the Americas, only seven countries have reported this level of coverage, so there is a great need for improvement. Several factors make it difficult to improve coverage: most screening programs are unorganized, available mainly in urban areas, and based on the Pap test, which has been shown to have low sensitivity, limited and requires multiple consultations. However, screening alone is not enough to prevent cervical cancer. Follow-up treatment of women with abnormal screening test results is necessary and remains a challenge. Main objective To evaluate the effectiveness of cervicovaginal self-test in comparison with direct sampling by the service provider, for the identification of HR-HPV DNA via real-time PCTR and triage with dual staining biomarker p16 & ki67. Methodology Under inclusion and exclusion criteria and signed informed consent, cervical sample will be taken with the corresponding method according to the randomization (self-test or service provider) and certify that the device did not cause damage or lacerations in the vaginal canal. In addition, an acceptability survey will be completed. All women with positive p16 & ki67 will be referred for colposcopy and biopsy. Patients will be informed her results with a specialist physician for guidance and indications. Clinical study design is crossover, monocentric, randomized, open, and non-inferiority. Statistical differences between self-test and service rpovider will be assesed.

NCT ID: NCT04512508 Not yet recruiting - Anal Cancer Clinical Trials

Anal Injury Screening for High Risk HPV

AnalTest
Start date: August 30, 2020
Phase: N/A
Study type: Interventional

The diagnosis of anal cancer is superior with the Anal Test system compared to liquid cytology and anoscopy.