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Background: Tobacco use represents a significant public health burden, being especially harmful for smokers with Type 2 Diabetes Mellitus (T2DM). Effective smoking cessation interventions are required for this vulnerable population. The goal is to describe a study protocol of a randomized controlled trial (RCT) aimed at analyzing the effectiveness and efficiency of a multicomponent smoking cessation intervention for T2DM smokers, including a training protocol on healthy lifestyle habits and self-management of T2DM (DiMe-SALUD2 project). Methods: This RCT will assign participants to: (1) Control Group (n = 30), including a brief psychoeducation advice about smoking cessation; (2) Cognitive-behavioral treatment (CBT) for smoking cessation (n = 30), based on a multicomponent program implemented in group-based sessions over an eight-week period; and (3) CBT plus DiMeSALUD2 protocol (n = 30), which will develop an additional psychoeducational protocol specifically designed to improve healthy lifestyle habits. Participants will be assessed at baseline, post-treatment and several follow-ups (1-, 6- and 12-months). Primary outcomes will include smoking abstinence (24-h point prevalence abstinence at post-treatment and 7-day point prevalence at follow-ups) and smoking continuous abstinence. Secondary outcomes will include treatment retention, changes in smoking patterns and nicotine dependence, as well as the impact on T2DM clinical variables, mental health, and quality of life. Discussion: The DiMeSALUD2 program could assist T2DM smokers in quitting tobacco use and improving their overall quality of life. This project will help incorporating improvements in routine clinical practice with T2DM patients, offering a smoking cessation program adapted to their specific needs. Trial registration: ClinicalTrials.gov. Identifier: NCT05885659. Date of registration: June 2nd, 2023.

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Medical residents constitute a vulnerable population susceptible to mental health disorders. In Italy, this was evident during the COVID-19 pandemic, when medical residents served on the front line and provided significant support to healthcare services. Therefore, the working group on "Public Mental Health" of the Medical Residents' Council of the Italian Society of Hygiene, Preventive Medicine, and Public Health (S.It.I.) designed the "Residents' mental health investigation, a dynamic longitudinal study in Italy" (ReMInDIt). This longitudinal study aims to assess the mental status of medical residents and to explore potential cause-effect relationships between risk/protective factors (identified among sociodemographic, residency program, and lifestyle characteristics) and mental health outcomes (anxiety and depressive symptoms). Data will be collected from a study population of 3615 residents enrolled in Italian residency programs in public health, occupational medicine, and forensic medicine through an online questionnaire that includes validated tools, requires 10 min for completion, and is disseminated by the residents' Councils. It will be followed by a follow-up administration after 12 months. The ReMInDIt study will play a significant role in generating evidence crucial for enhancing mental health services and promoting protective factors for the mental well-being of this important segment of healthcare professionals.

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BACKGROUND: Having competence in initiating sexual interactions is one of the challenges of sexual health in any society. Given that the social, cultural, and religious background of some societies can prevent the acquisition of sexual competence in young women, this study will be done to design, implement, and determine the effectiveness of an intervention program to improve the sexual competence of young women on the eve of marriage. METHODS: The current research is a mixed-method study in a qualitative-quantitative sequence. In the first phase, a qualitative study will be conducted to explore the needs of sexual competence in young adult women about to get married and ways to improve it. Then, after the literature review and combining it with the results of the qualitative study, a draft of the intervention program will be developed. After reviewing the content of the program and validating it in the panel of experts, the final program will be developed. In the second phase, the effect of the program to promote the sexual competence of adult women about to get married will be determined in a quantitative study with a two-group quasi-experimental method. DISCUSSION: Providing a comprehensive and practical intervention program to promote sexual competence based on cultural, social, and religious background can help to improve the quality of sexual interactions of young women about to get married, reduce harm caused by lack of sexual competence, and ensure women's sexual health.

Preparing young people to start safe and satisfactory sexual behaviors and as a result to acquire sexual competence can play an important role in ensuring their sexual health. But in some countries, talking about sexual issues is a cultural and religious taboo. Given that Lack of sexual competence is associated with negative consequences, the present study aims to design, implement, and determine the effectiveness of a program to promote sexual competence in young adult women who are about to get married. In the first phase, to identify the needs of acquiring sexual competence and to explore the strategies for improving sexual competence, a qualitative study will be conducted with a content analysis approach. Individual interviews will be conducted with women aged 18 to 25 about to get married, the teachers of pre-marriage classes, midwives, gynecologists, reproductive health specialists, psychiatrists, and psychologists who work in the field of sexual health. Based on the findings of this phase and after reviewing the literature, an intervention program to improve sexual competence in young adult women will be designed and prepared. After the experts approve the intervention program, in the second phase, a quantitative study will be conducted to determine the effect of the intervention program on improving the sexual competence of young adult women about to get married.

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BACKGROUND: Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: advanced practice nurses (APN). They have many broad-based skills, at the interface of nursing and medical exercises. The purpose of this study is to assess the impact of an APN intervention versus usual care on hypertension control. METHODS: The study will take place at the Hôtel-Dieu University Hospital, Paris, France, as prospective, open-label, controlled, randomized 1-to-1, monocentric, and superiority trial. The participants will be recruited during day hospitalization for cardiovascular assessment in the context of their hypertension management. Patients will be divided into two groups: a "usual care" group which will continue traditional follow-up (day hospitalization followed by consultation with a medical doctor (MD) within approximately 2-12 months) and an "intervention" group which will meet an APN between the day hospitalization and the MD consultation. Participants will be monitored until 12 months after the day hospitalization, depending on their last follow-up study appointment (MD consultation). The primary outcome is the rate of controlled BP (BP < 140/90 mmHg in office BP measurement) in each group. The hypothesis formulated is that an individual APN intervention, included in usual hypertension management, improves hypertension control. DISCUSSION: This innovative study will be the first in France where APNs are beginning to be established in the healthcare system. It will provide an objective look at this new profession and the impact it can have in the framework of global management of hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT0448249. Registered on June 24, 2020.

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Background: Chronic kidney disease (CKD) is a prevalent and progressive disease that is impacted by hyperglycemia, hypertension (HTN), and oxidative stress (OS). Propolis, a natural resinous mixture produced by honeybees from plant materials, has been shown to possess antioxidant, anti-inflammatory, antihyperglycemic, and antihypertensive properties, along with hepato-renal protective effects. This study aims to evaluate the efficacy of propolis supplementation on patients with CKD. Methods: This multi-centered, randomized, double-blind, placebo-controlled clinical trial will evaluate the effectiveness of propolis supplementation in 44 eligible patients with CKD. Participants will be randomly allocated to receive either propolis capsule (500 mg, containing 125 mg Iranian alcoholic propolis extract) or placebo, twice daily for three months. The primary outcome is improvement in kidney function parameters of CKD patients, while secondary outcomes include changes in prooxidant-antioxidant balance (PAB), glycemic status, quality of life, and blood pressure (BP). The study will be conducted at Tabriz University of Medical Sciences in Tabriz, Iran. Discussion: If the results of this study reveal remarkable effectiveness of propolis in improving quality of life and clinical outcomes in patients with CKD, this compound may reach a new milestone as an adjunctive therapy for CKD and it opens a new window for further studies. Trial registration: Iranian Registry of Clinical Trials, IRCT20191218045798N1. Prospectively registered on 07 June 2020. Updated on 30 August 2021. https://en.irct.ir/trial/48603.

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The COVID-19 pandemic has evolved into a severe psychosocial crisis affecting patients, their relatives, friends, and healthcare professionals. In Italy, public health residents (PHRs) remain essential to the national response to the pandemic. To assess their mental sphere, the "Public Mental Health" working group of the medical residents' Assembly of the Italian Society of Hygiene and Preventive Medicine has designed the Public Health Residents' Anonymous Survey in Italy (PHRASI). This is a nation-wide cross-sectional study based on an 88-item self-administered voluntary survey that evaluates how sociodemographic variables are associated with mental issues, including wellness, eating disorders, sleeplessness, alcohol misuse, depression, and anxiety. Data will be gathered by disseminating a Google Forms link across the Assembly network of medical residents. All PHRs enrolled in a four-year program in one of the Italian postgraduate schools of public health will be qualified as participants. PHRASI aims to draw a comprehensive and detailed picture of the mental health state of Italian PHRs. PHRs are a significant group of healthcare professionals that may serve as a future benchmark for developing and enacting regulations intended to support the mental health of healthcare professionals.

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PURPOSE: The Pivot Shift (PS) test is a complex clinical sign that assesses the internal rotation and anterior tibial translation, which occurs abnormally in ACL deficient-knees. Because of the high inter-observer variability, different devices have been designed to characterize this complex movement in quantitative variables. The objective of this pilot study is to validate the reproducibility of intraoperative quantitative assessment of the PS with a smartphone accelerometer. METHODS: Twelve ACL-injured knees were included and compared with the contralateral uninjured side. The PS was measured by two independent observers utilizing a smartphone accelerometer and graded according to the IKDC classification. Measurements were taken preoperatively, intraoperatively and postoperatively. Intraoperative readings were taken during each stage of reconstruction or repair of meniscoligamentous lesions including meniscal lesions, ramp lesions, ACL reconstruction and lateral tenodesis. Reproducibility of the measurements were evaluated according to an intraclass correlation coefficient (ICC). RESULTS: The intra-observer reliability was good for the first examiner and excellent for the second examiner, with the ICC 0.89 [0.67, 0.98] p < 0,001 and ICC 0.97 [0.91, 1.0] p < 0,001 respectively. The inter-observer reliability was excellent between the two observers with the ICC 0.99 [0.97, 1.0] p < 0,001. The mean tibial acceleration measured 3.45 m.s2 (SD = 1.71) preoperatively on the injured knees and 1.03 m.s2 (SD = 0.36) on the healthy knees, demonstrating a significant difference following univariate analysis p < 0.001. Postoperatively, no significant difference was observed between healthy and reconstructed knees The magnitudes of tibial acceleration values were correlated with the PS IKDC grade. CONCLUSION: The smartphone accelerometer is a reproducible device to quantitatively assess the internal rotation and anterior tibial translation during ACL reconstruction surgery. The measurements are influenced by the different surgical steps. Other larger cohort studies are needed to evaluate the specific impact of each step of the ACL reconstruction and meniscal repair on this measurement. An external validation using other technologies are needed to validate the reliability of this device to assess the PS test. LEVEL OF EVIDENCE: Level IV, case series, pilot study.

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BACKGROUND: Osteoporosis, the fourth most common disease in the world, affects the elderly and postmenopausal women and imposes a great financial and social burden on individuals and society. Furthermore, it has a significant impact on the quality of patients' life. This study tries to take an effective step toward improving the quality of patients' life by developing and evaluating the self-care program of women with osteoporosis. MATERIALS AND METHODS: In this research, a hybrid sequential design of quantitative and qualitative type consisting of three phases is used. This mixed-method study aimed to develop and evaluate a self-care program for women with osteoporosis. CONCLUSION: Familiarity with the needs of these patients and the use of self-care programs and considering social, cultural, and psychological factors could be effective steps to improve the health of women with osteoporosis. These steps can improve the quality of life and reduce the costs of treatment for this group of women.

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Introduction: The effective translation of evidence-based interventions has contributed to implementing actions that impact public policies and the population's health. However, there is a gap in the literature regarding the factors associated with the successful implementation of these interventions. The Active Life Improving Health Behavior Change Program (BCP-VAMOS) uses behavioral strategies to promote an active and healthy lifestyle in the community. Characterized as a health innovation, it also provides health professionals with online training to implement the program in Primary Health Care (PHC). Our study describes a pragmatic trial that aims to evaluate the implementation of BCP-VAMOS, version 3.0, in PHC in southern Brazil. Methods and analysis: A pragmatic randomized controlled trial (PRCT) of two arms comparing a group of PHC professionals who will participate in a traditional didactic approach (control group) vs. a group that will receive ongoing support (intervention group) for the implementation of BCP-VAMOS. The intervention will be available to adults (≥18 years old) registered at PHC. Program recipient's will be assessed at baseline and post-intervention (9 months after) to measure markers of physical activity and eating behavior (primary outcomes). Program's implementation process will be monitored for 12 months and will be evaluated using the RE-AIM and Consolidated Framework for Implementation Research (CFIR) frameworks. Discussions: The survey findings can be used widely throughout Brazil, guiding the work of health professionals, service planners and policy-makers. Also, the results may help to inform the national health promotion policy to plan interventions and improve the implementation of programs in PHC. This research results will provide practical guidance for researchers to develop similar protocols to implement and adapt public health interventions. Ethics and dissemination: Ethics approval has been granted by the Human Research Ethics Committee of the Federal University of Santa Catarina (UFSC), Brazil, under no. 1394492. Results will be published in full as open access in the UFSC library and main trial results and associated papers in high-impact peer-reviewed journals. Trial registration number: RBR-2vw77q-Brazilian Registry of Clinical Trials - ReBEC (http://www.ensaiosclinicos.gov.br).

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Diabetic foot ulcer (DFU) is the leading cause of lower-limb amputations, with a significant impact on patients, families, and society. Since DFU medical treatments represent a major socioeconomic burden, cost-effective interventions are needed. This trial aims to assess the effectiveness of a muscle relaxation intervention compared to a hypnosis intervention versus active and passive control groups on DFU healing, physiological indicators of healing prognosis, and quality of life (QoL) in clinically distressed patients with a chronic DFU. A multicenter, randomized controlled trial with three assessment moments (baseline, two months post-intervention, and four months follow-up) will be conducted. Approximately 170 patients will be randomized and allocated to either treatment or control groups. Primary outcomes will be DFU healing, physiological indicators of healing prognosis, and QoL. Secondary outcomes will include perceived stress, psychological morbidity, and DFU representations. The efficacy of sessions on DFU healing will be qualitatively assessed in 12 patients allocated to the treatment and active control groups, as well as their family caregivers. This study will provide evidence regarding the effectiveness of two psychological interventions for the DFU healing process and the QoL of patients, with direct clinical relevance regarding DFU treatment and recurrence.

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INTRODUCTION: Colorectal cancer(CRC) patients are among the incurable groups who need comprehensive palliative care covering all aspects including physical, mental, social, and spiritual. The purpose of this study is to develop, implement, and evaluate a holistic palliative care program for CRC patients in order to improve quality of life of CRC patients. METHODS: This study is an exploratory mixed methods study which will be conducted using a sequential qualitative-quantitative design (QUAL quan) consists of four sequential steps using the approach proposed by Ewles & Sminett to develop the program. In the first phase, a qualitative study (semi-structured interview) will be conducted to discover the needs of CRC patients from the perspective of patients, family members and care providers. In the second phase, the literature review will be performed with the aim of confirming and completing the discovering new needs. In the third phase, in order to prioritize the identified needs and prepare a initial draft of the palliative care program will be done a panel of experts. In the fourth phase, the part of the developed program according to the opinions of the panel of experts, will be implemented as quasi-experimental intervention and the effect of intervention on quality of life will be evaluated. DISCUSSION: This results of this study are expected to meet the needs of CRC patients and their families through providing a holistic care and improve their quality of life in the socio-cultural context of Iran. This program can be useful in providing care, education, policy making and for future research.

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BACKGROUND: Prior studies have shown that meal composition may affect the metabolic responses and arterial stiffness indices, and these responses may be different in lean and obese adults. The primary objective of this study is to determine the feasibility of conducting a trial to compare the effect of three test meals in lean and obese men. Due to the lack of a comprehensive study that concurrently compares metabolic responses and vascular stiffness indices after receiving three different meals in lean and obese men, this pilot study will be conducted with a three-phase parallel design, aiming to investigate the effects of meal composition on the metabolic parameters and arterial stiffness indices of lean and obese adults. METHODS: This pilot, a parallel clinical trial will be performed on 24 male adults aged 18-35 years since January 2021 and will continue until March 2021 who are disease-free and selected based on the inclusion and exclusion criteria at Mashhad University of Medical Sciences, Iran. The subjects will complete three interventions at a 1-week interval, including high carbohydrate (70% carbohydrates, 10% protein, 20% fat), high protein (30% protein, 50% carbohydrates, 20% fat), and high-fat meal (50% fat, 40% carbohydrates, 10% protein). Postprandial effects will be assessed within 360 min after each meal, including the energy expenditure component (resting energy expenditure, thermic effects of feeding, respiratory quotient, and substrate oxidation) and arterial stiffness indices (augmentation index and pulse wave velocity). In addition, blood sampling will be performed to measure glucose, insulin, free fatty acids, and lipid profile. DISCUSSION: The differences in the postprandial responses can affect the metabolic and vascular parameters due to different meal compositions, thereby providing beneficial data for the establishment of new strategies in terms of nutritional education and metabolic/vascular improvement. Also, the results from this pilot study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial. TRIAL REGISTRATION: Iranian Registry of Clinical Trials; code: IRCT20190818044552N1 ; registered on August 26, 2019.

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BACKGROUND: Psychological interventions may reduce fertility problems. Positive emotion, engagement, meaning, positive relationship and accomplishment (PERMA) is a cognitive intervention and integrative-behavioral couple therapy (IBCT) is a behavioral intervention. Appropriate mental interventions are important in infertility treatment. OBJECTIVE: To investigate the effect of the PERMA model vs. IBCT in reducing the fertility problems of couples. MATERIALS AND METHODS: The content of the interventions was developed and adjusted based on a literature review and the opinions of experts. In this three-arm parallel randomized clinical trial, 42 couples undergoing infertility treatment will be allocated randomly into three groups (n = 14 couples/each). Group 1 will receive the PERMA intervention, group 2 will receive the IBCT intervention, and group 3 as the control group will receive an infertility treatment training program intervention. The primary outcome will be the fertility problems, which will be measured by completing a fertility problem inventory at baseline, as well as in the 5 th and 9 th wk as a follow-up. Another primary outcome, satisfaction with the intervention, will also be assessed in the 5 th and 9 th wk. The secondry outcome will be a positive pregnancy test at wk 12. The interventions will be conducted through a combination of face-to-face and online via WhatsApp. CONCLUSION: This study will assess social, sexual, and parenthood concerns. A combination of online and face-to-face interventions will be appropriate given the COVID-19 pandemic. Couple's counseling may provide better counseling outcomes for fertility problems in comparison with group counseling. This study will try to optimize resilience during infertility treatment through learning better relationship and problem-solving skills, and may have an indirect impact on pregnancy rate, burden of infertility, and costs of treatment due to increased effectiveness.

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Study design: Multi-centre mixed-method study design organised into several phases. Background: The Veneto region has recently defined a set of policies on nursing care by determining the needed amount of daily care in minutes and by initiating a systematic measurement of nursing outcomes; also, with a more recent policy, missed nursing care (MNC) has been established as a process measure of interest. To measure the effect of these policies, a research protocol - aimed at evaluating several end points - has been designed, involving a large target population and hospital units. The aim of this manuscript is to briefly present the research protocol and to discuss the public health implications of its expected end-points. Methods: The endpoints of the protocol are: (a) to describe the frequency of MNC as perceived by nurses; (b) to identify contributing factors; (c) to identify practices adopted in low-occurrence MNC units and to assess the effectiveness of implementing them in units with higher levels of MNC; (d) to explore the relationship between the amount of nursing care provided, MNC, and patient outcomes; and (e) to validate a tool that measures MNC as perceived by patients/caregivers. A total of 3,460 nurses, 5,000 patient/day and 160 nursing coordinators of the medical and surgical units of public hospitals in the Veneto Region will be included. Conclusions: Measuring the association between the amount of nursing care and patient outcomes, as well as evaluating the role of MNC as perceived by nurses and patients in hindering or increasing the risk of some patient outcomes can provide a body of evidence capable of further informing policies in the field, both at the national and at the international level. Moreover, emerging good practices capable of preventing or minimising MNC, sharing and implementing them in other units where high levels of missed care are reported and evaluating their effectiveness, can also inform public health policies.

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OBJECTIVES: This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). TRIAL DESIGN: This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. PARTICIPANTS: Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. INTERVENTION AND COMPARATOR: Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. MAIN OUTCOMES: The main outcomes are changes in the coronavirus disease's clinical symptoms including duration and severity from baseline to the end of 2 weeks. RANDOMIZATION: Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial's pharmacist with the use of random-number tables. BLINDING (MASKING): The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The calculated total sample size is 80 patients, with 40 patients in each group. TRIAL STATUS: The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021. TRIAL REGISTRATION: The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1 . Date of trial registration: 20 October 2020, retrospectively registered. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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Clinical cancer research in Canada entered a new phase in 1971. In that year, the National Cancer Institute of Canada agreed to initiate and support a multidisciplinary cooperative clinical trials program. The first collaborative randomized controlled trial (RCT) for the treatment of advanced Hodgkin's disease was launched in medical centres across the country in December 1971. Simultaneously, in the United States, the National Cancer Act came into effect. To what extent were these Canadian and American developments coincidental? I argue that the cooperative clinical trials program in Canada was timed to coincide with the US declaration of war on cancer, but it was not its corollary. Against the background of this American anti-cancer campaign, the cooperative clinical trials program emerged as a link between the strong radiotherapy tradition in Canada and the new trial infrastructure of chemotherapeutic regimes in the United States. The evolution of the Hodgkin's disease trial serves as a good example to demonstrate how growing collaboration among Canadian and American physician-investigators brought about a large-scale national study. The latter became a prototype of further cooperative oncological RCTs in Canada during the 1970s.

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BACKGROUND: The psychological consequences of infertility in couples undergoing oocyte donation differ culturally, racially, religiously, and legally from other infertile couples undergoing assisted reproductive treatments. Therefore, the inclusion of a mental health program in assisted reproductive services is essential for these couples. As such, the aim of this study is to develop a program for improving the mental health of these couples. METHODS: This study is designed using an exploratory mixed method and the program based on Talbot and Verrinder model. Different steps of this research include determination of a specific topic for planning (needs assessment), initial design of the program, finalization of the program (using the views of experts in this area), implementation of the program, monitoring of the implementation of the program and evaluation of the program. To perform the first step of Talbot's program, the first phase of the study will be conducted. At first, through a qualitative study, the items of the questionnaire are designed and then its psychometric steps will be performed by a cross-sectional study. In the second and third steps, the classic Delphi technique will be used in four-round for initiation and finalization of the program, and the second phase will be completed. The fourth, fifth and sixth steps of the program including implementation, monitoring of the implementation and evaluation of the program in the future will be performed. DISCUSSION: Designing an appropriate program based on the documentations of the qualitative study and evidence can improve the mental health and quality of life of the couples undergoing oocyte donation. The program, based on the measurement of needs, will be implemented using a tool designed specifically for the target population and can be useful in the processes of treatment, education, policymaking and legislation as well as research.

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BACKGROUND: Sexual satisfaction is considered as one of the key factors in assessing a person's quality of life and the quality and continuity of marital relationships. According to the results of reports in Iran, many couples are dissatisfied with their sexual lives. Sexuality education is one of the important strategies to prevent early sexual problems and improve sexual satisfaction. The aim of this randomized controlled trial is to compare the efficacy of sexual and marital enrichment package using information, motivation and behavioral skills model on sexual satisfaction of new couples in Iran to routine sexual care program that provided at governmental health centers. METHODS: This is a randomized, controlled, superiority trial with two parallel groups. One hundred new couples (n = 200) will be recruited and randomized with simple randomization method and a 1:1 allocation. Recruitment will be from governmental health centers and calling on social networks. Couples will be randomized to intervention which will receive Sexual and Marital Enrichment package and control group (routine care at health centers). Couples will be followed up for 4 months. Then primary outcomes (mean score of couples' sexual information, motivation and behavior skills) and secondary outcome (mean score of couples' sexual satisfaction) of study will be measured through the online questionnaire. DISCUSSION: This trial will be examined the impact of the sexual and marital skills training package tailored to the values and norms governing the sexual life of Iranian couples on their sexual satisfaction. If the trial is effective, its results will be presented to policy makers for implementation at national level. TRIAL REGISTRATION: (Iranian Registry of Clinical Trials (IRCT) number): IRCT20181211041926N1. Date of registration: March 2, 2019.

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BACKGROUND: The European school-based drug addiction prevention program Unplugged was adapted to the Brazilian context by the Ministry of Health and renamed #Tamojunto. Its first implementations, in the form of a public policy in Brazil, showed contradictory and different effects from those observed in Europe. Adaptations were made to #Tamojunto in 2018 to reintroduce the essential content of the original program. METHODS: A parallel, two-arm, randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the new version of the school-based government program #Tamojunto2.0 for the prevention of drug use among 8th grade middle school students from 70 public schools in three Brazilian cities, totaling approximately 6.300 participating students distributed in 210 classes. For intervention, the experimental group will receive the 12 lessons of the #Tamojunto2.0 program under the supervision of a Brazilian Ministry of Health team. The control group will not receive any intervention. Information will be collected from the students at three time points: preintervention and 9 and 18 months postintervention. Multilevel analyses will be performed using the Gllamm Stata program to assess simultaneous differences in prevalence, in time and among groups for the outcomes of interest. Structural equation modeling will be used to evaluate the effectiveness of the intervention in changing the behavioral patterns of the adolescents through latent transition analysis. The effect of the mediators involved in the program effectiveness outcomes will also be analyzed. The program doses applied in all classes of the intervention group will be collected using a form completed by the teacher at the end of each lesson, indicating the activities taught and not taught in each lesson. DISCUSSION: This study will show whether the #Tamojunto2.0 program can be expanded as a public policy for all schools with the aim of preventing drug use among Brazilian students. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (RBR-8cnkwq) under the name "Avaliação do Efeito do Programa de Prevenção Escolar ao Uso de Drogas #Tamojunto2.0, Versão 2018", on August 30th, 2018 ( http://www.ensaiosclinicos.gov.br/rg/RBR-8cnkwq/ ).

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INTRODUCTION: Many studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits-healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted. METHOD AND ANALYSIS: MEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression. PROSPERO REGISTRATION NUMBER: CRD42018100253; Pre-results.

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