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In this 2 × 2 factorial, outcome-assessor blinded, feasibility randomised trial we explored the effect of a non-pharmaceutical multi-component intervention on periodontal health and metabolic and inflammatory profiles among pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre. 69 pregnant women (gestational age ≤20 weeks, T0) were randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT) (n = 17); (2) placebo sachet and powdered milk plus early PT (n = 15); (3) fortified sachet and powdered milk plus late PT (after delivery) (n = 19); (4) placebo sachet and powdered milk plus late PT (n = 18). Third trimester (T1) and 6-8 weeks postpartum (T2) exploratory outcomes included periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D. The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups. No significant effect of fortification on BOP was observed. Changes in glucose levels and variation on birthweight did not differ among groups This feasibility trial provides preliminary evidence for estimating the minimum clinically important differences for selected maternal outcomes. A large-scale trial to evaluate the interventions' clinical benefits and cost-effectiveness is warranted.

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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.

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BACKGROUND: Eating disorders (ED) and disordered eating behaviours (DEB) have been found to be common in people with diabetes mellitus (DM). However, findings have been inconsistent. OBJECTIVE: This study investigated the association between self-reported diabetes (Type 1 or 2) with ED/DEB (binge eating, subjective binge eating or loss of control overeating, severe dieting and purging) weight/shape overvaluation, and health-related quality of life (HRQoL) in a household survey in South Australia. METHOD: In 2017 2977 people aged ≥15 years, who were representative of the general population, were interviewed. Participants reported their gender, age, household income, highest educational attainment, area of residence, presence of DM, ED/DEB, level of overvaluation, current HRQoL and height and weight. For the analyses between ED/DEB, self-reported DM and HRQoL, a grouping variable was created: 1) people without ED/DEB or self-reported DM; 2) people without ED/DEB and with self-reported DM; 3) people with ED/DEB and without self-reported DM; and 4) people with ED/DEB and self-reported DM. Analyses were stratified by sex and age group. RESULTS: Subjective binge eating prevalence was higher in people with self-reported DM (6.6% vs 2.8%, p = 0.016), and overvaluation was lower in those with DM (36% vs 43.8%, p = 0.007). In analyses stratified by sex and age group, subjective binge eating was higher in women and in people over 45 years with self-reported DM and overvaluation was lower in men and in people over 45 years with self-reported DM. However, these differences were not significant on tests of gender and age interaction. People in both DM groups scored significantly lower than people without DM groups on physical HRQoL. In contrast, people in both ED/DEB groups scored lower than people without ED/BEB on mental HRQoL. CONCLUSION: People with self-reported DM had a higher prevalence of subjective binge eating, a lower prevalence of overvaluation and there were no significant effects of age or gender. Furthermore, participants with self-reported DM and comorbid ED or DEB had impairments of both mental and physical HRQoL. Assessing an individual's sense of control over eating along with other DEB is likely important for identification of these mental health problems.