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Artigo em Inglês | MEDLINE | ID: mdl-33143369


This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca+VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.

Trials ; 21(1): 244, 2020 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-32138765


BACKGROUND: There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy and also to describe the patient-, study protocol- and setting-related factors related to women's ineligibility and refusal to participate in the study. METHODS: A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2 × 2 factorial feasibility clinical trial were used. Eighteen women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions, and the data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies. RESULTS: Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (> 20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Non-participation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, patients being unresponsive to phone calls and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthful and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation costs) could hinder participation in the study. CONCLUSION: Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related sociodemographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings. TRIAL REGISTRATION:, NCT03148483. Registered on 11 May 2017.

Artigo em Inglês | MEDLINE | ID: mdl-30873290


Background: Periodontitis is a common oral inflammation, which is a risk factor for adverse pregnancy outcomes. Intakes of vitamin D and calcium are inversely associated with occurrence and progression of periodontitis. This study aims to assess the feasibility of a multi-component intervention, including provision of milk powder supplemented with calcium and vitamin D and periodontal therapy (PT), for improving maternal periodontal health and metabolic and inflammatory profiles of low-income Brazilian pregnant women with periodontitis. Methods: The IMPROVE trial is a feasibility randomised controlled trial (RCT) with a 2 × 2 factorial design with a parallel process evaluation. Pregnant women with periodontitis, aged 18-40 years and with < 20 gestational weeks (n = 120) were recruited and randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus PT during pregnancy, (2) placebo sachet and powdered milk plus PT during pregnancy, (3) fortified sachet (vitamin D and calcium) and powdered milk plus PT after delivery and (4) placebo sachet and powdered milk plus PT after delivery. Dentists and participants are blinded to fortification. Acceptability of study design, recruitment strategy, random allocation, data collection procedures, recruitment rate, adherence and attrition rate will be evaluated. Data on serum levels of vitamin D, calcium and inflammatory biomarkers; clinical periodontal measurements; anthropometric measurements; and socio-demographic questionnaires are collected at baseline, third trimester and 6-8 weeks postpartum. Qualitative data are collected using focus group, for analysis of favourable factors and barriers related to study adherence. Discussion: Oral health and mineral/vitamin supplementation are much overlooked in the public prenatal assistance in Brazil and of scarcity of clinical trials addressing these issues in low and middle-income countries,. To fill this gap the present study was designed to assess the feasibility of a RCT on acceptability of a multi-component intervention combining conventional periodontal treatment and consumption of milk fortified with calcium-vitamin D for improving periodontal conditions and maternal metabolic and inflammation status, among Brazilian low-income pregnant women with periodontitis. Thus, we hope that this relatively low-cost and safe multicomponent intervention can help reduce inflammation, improve maternal periodontal health and metabolic profile and consequently prevent negative gestational outcomes. Trial registration: NCT, NCT03148483. Registered on May 11, 2017.

Cien Saude Colet ; 16(1): 107-19, 2011 Jan.
Artigo em Português | MEDLINE | ID: mdl-21180820


Based on Bourdieu's thoughts about the scientific fields, we visited the Research Groups Directory of the National Council for Scientific and Technological Development (CNPq), seeking to invest in critical and reflective approach on the segment of Brazilian research work concerned with "food". We identified a stable and growing set of research groups whose visibility is compromised, once its name is not included in the institutional taxonomies within the agencies that support research and researchers' formation. Its epistemological foundations, its theoretical and methodological bases are located in the sphere of Humanities and include a wide range of interacting disciplines, forming a significant complexity around its central object: food. The study of feeding phenomena calls for interdisciplinarity and makes the challenge of facing the tensions inherent to democratic life in which we have a glimpse in which the growing and collaborative coexistence among different epistemic references must take institutional place.

Alimentos , Ciências da Nutrição , Pesquisa , Brasil
Cien Saude Colet ; 16(1): 147-54, 2011 Jan.
Artigo em Português | MEDLINE | ID: mdl-21180823


The incorporated senses represent a set of possibilities for future life able to build individual and collective identities. This work deepens the habitus, in Bourdieu's terms, associated with "natural" and fast-food styles, making an interpretative analysis of symbolic exchanges of elements reproduced in feeding practices. We believe that this bricolage arrangement of elements enables bartering and hybridism, marked by a tension that reflects the insecurity of technological innovations. The "natural" style represents an ideal of self-sustainability, non-polluting production, which faces the sanitary and ecologic crisis of the planet, against the large-scale industrialization and fast urbanization, defined as depredation factors of basic living conditions. The exchanges happen in a symbolic game connected with the global economic game, in which social actors make bets, illusio, according to particular intentions in concrete action. There is a chance to reformulate the rules of the game in the "game", although with a precarious balance of forces, in which the weaker side loses, an agent may have the possibility of not reproducing the pressures of globalized feeding, which is far from what might seem supernatural.

Alimentos Orgânicos , Simbolismo , Fast Foods , Humanos
Cien Saude Colet ; 16(1): 155-63, 2011 Jan.
Artigo em Português | MEDLINE | ID: mdl-21180824


Eating, nourishment or nutrition circulate in our culture as synonyms and thus do not account for the changes that occur in nourishment, which intended or unintended, have a hybridization pattern that represents a change of rules and food preferences. This paper aims to take these common sense conceptions as analytic categories for analyzing and interpreting research for the Humanities and Health Sciences in a theoretical perspective, through conceptualization. The food is associated with a natural function (biological), a concept in which nature is opposed to culture, and nourishment takes cultural meanings (symbolic), expressing the division of labor, wealth, and a historical and cultural creation through which one can study a society. One attributes to Nutrition a sense of rational action, derived from the constitution of this science in modernity, inserted in a historical process of scientific rationalization of eating and nourishing. We believe that through the practice of conceptualization in interdisciplinary research, which involves a shared space of knowledge, we can be less constrained by a unified theoretical model of learning and be freer to think about life issues.

Ingestão de Alimentos , Alimentos , Fenômenos Fisiológicos da Nutrição , Ciências da Nutrição , Pesquisa Biomédica , Humanos