Cluster-randomized trial of infant nutrition training for caries prevention.
Ontology highlight
ABSTRACT:
SUBMITTER: Chaffee BW
PROVIDER: S-EPMC3706177 | biostudies-literature | 2013 Jul
REPOSITORIES: biostudies-literature
Publications
Cluster-randomized trial of infant nutrition training for caries prevention.
Chaffee B W BW Feldens C A CA Vítolo M R MR
Journal of dental research 20130520 7 Suppl
The objective of this study was to estimate the caries impact of providing training in infant feeding guidelines to workers at Brazilian public primary care clinics. In a cluster-randomized controlled trial (n = 20 clinics), health care workers either were trained in guidelines for infant nutrition, stressing healthful complementary feeding, or were assigned to a 'usual practices' control, which allowed for maternal counseling at practitioner discretion. Training occurred once; the amount of cou ...[more]
Similar Datasets
Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.
| S-EPMC4815216 | biostudies-other
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard nutritional approaches relying primarily on carbohydrates. We here hypothesize that a ketogenic diet improves sepsis treatment. We conducted a monocentric open-labeled randomized controlled trial enrolling 40 adult sepsis patients. Patients were randomly assigned to either ketogenic diet (KD) or standard high-carbohydrate nutrition for 14 days and followed up until day 30. The primary outcome measure was β-hydroxybutyrate (BHB) serum concentration on day 14. We assessed feasibility and safety of KD, as well as diet-associated clinical and immunological changes. The respective nutrition protocols were successfully applied, dropouts did not occur. Regression analysis revealed a greater increase in BHB concentrations from baseline to day 14 in KD patients compared to controls. Metabolic side effects were not observed under ketogenic diet. Ventilation-free, vasopressor-free, dialysis-free and ICU-free days significantly increased in patients under ketogenic diet. Transcriptome profiling of both CD4+ and CD8+ T cells at day 14 revealed substantial differential regulation of gene expression in the KD vs. the control group indicating a reduced T-cell activation and a shift towards a more regulated immunity.
2024-06-13 | GSE240861 | GEO
Project description:BackgroundLife skills are abilities for adaptive and positive behavior that enable individuals to deal effectively with the demands and challenges of everyday life. Life-skills training programs conducted within the school curriculum are effective in preventing the onset and escalation of substance use among adolescents. However, their dissemination is impeded due to their large resource requirements. Life-skills training provided via mobile phones may provide a more economic and scalable approach.ObjectiveThe goal of this study was to test the appropriateness (ie, acceptance, use, and evaluation) and short-term efficacy of a mobile phone-based life-skills training program to prevent substance use among adolescents within a controlled trial.MethodsThe study design was a two-arm, parallel-group, cluster-randomized controlled trial with assessments at baseline and follow-up assessments after 6 and 18 months. This report includes outcomes measured up to the 6-month follow-up. The efficacy of the intervention was tested in comparison to an assessment-only control group. The automated intervention program SmartCoach included online feedback and individually tailored text messages provided over 22 weeks. The contents were based on social cognitive theory and addressed self-management skills, social skills, and substance use resistance skills. Linear mixed models and generalized linear mixed models, as well as logistic or linear regressions, were used to investigate changes between baseline and 6-month follow-up in the following outcomes: 30-day prevalence rates of problem drinking, tobacco use, and cannabis use as well as quantity of alcohol use, quantity of cigarettes smoked, cannabis use days, perceived stress, well-being, and social skills.ResultsA total of 1759 students from 89 Swiss secondary and upper secondary school classes were invited to participate in the study. Of these, 1473 (83.7%) students participated in the study; the mean age was 15.4 years (SD 1.0) and 55.2% (813/1473) were female. Follow-up assessments at 6 months were completed by 1233 (83.7%) study participants. On average, program participants responded to half (23.6 out of 50) of the prompted activities. Program evaluations underlined its appropriateness for the target group of secondary school students, with the majority rating the program as helpful and individually tailored. The results concerning the initial effectiveness of this program based on 6-month follow-up data are promising, with three of nine outcomes of the intention-to-treat analyses showing beneficial developments of statistical significance (ie, quantity of alcohol use, quantity of tobacco use, and perceived stress; P<.05) and another three outcomes (ie, problem drinking prevalence, cannabis use days, and social skills) showing beneficial developments of borderline significance (P<.10).ConclusionsThe results showed good acceptance of this intervention program that could be easily and economically implemented in school classes. Initial results on program efficacy indicate that it might be effective in both preventing or reducing substance use and fostering life skills; however, data from the final 18-month follow-up assessments will be more conclusive.Trial registrationISRCTN Registry ISRCTN41347061; https://doi.org/10.1186/ISRCTN41347061.
| S-EPMC8317035 | biostudies-literature
Project description:PURPOSE: Targeted interventions to reduce the risk and increase the early detection of melanoma have the potential to save lives. We aimed to assess the effect of such an intervention on patient prevention behavior. METHODS: We conducted a pilot clustered randomized controlled trial, comparing a targeted screening and education intervention with a conventional information-based campaign in 20 private surgeries in western France. In the intervention group, 10 general practitioners identified patients at elevated risk for melanoma with a validated assessment tool, the Self-Assessment Melanoma Risk Score (SAMScore), examined their skin, and counseled them using information leaflets. In the control group, 10 general practitioners displayed a poster and the leaflets in their waiting room and examined patients' skin at their own discretion. The main outcome measures were sunbathing and skin self-examinations among patients at elevated risk, assessed 5 months later with a questionnaire. RESULTS: Analyses were based on 173 patients. Compared with control patients, intervention patients were more likely to remember the campaign (81.4% vs 50.0%, P = .0001) and to correctly identify their elevated risk of melanoma (71.1% vs 42.1%, P = .001). Furthermore, intervention patients had higher levels of prevention behaviors: they were less likely to sunbathe in the summer (24.7% vs 40.8%, P = .048) and more likely to have performed skin self-examinations in the past year (52.6% vs 36.8%, P = .029). The intervention was not associated with any clear adverse effects, although there were trends whereby intervention patients were more likely to worry about melanoma and to consult their general practitioner again about the disease. CONCLUSIONS: The combination of use of the SAMScore and general practitioner examination and counseling during consultations is an efficient way to promote patient behaviors that may reduce melanoma risk. Extending the duration of follow-up and demonstrating an impact on morbidity and mortality remain major issues for further research.
| S-EPMC3896535 | biostudies-literature
Project description:In rural Bangladesh, most births take place at home. There is little evidence regarding the influence of traditional birth attendants (TBAs) or community volunteers (CVs) on early infant feeding practices. We conducted a pragmatic cluster randomized controlled trial in Panchagarh District to examine the effects of training and post-training supervision of TBAs/CVs on early breastfeeding practices. Nine unions were randomized into three groups of three unions. We compared outcomes between mothers in a control group (CG), those living in unions where TBAs/CVs had received a 5-day training in early feeding practices (TG) and those living in unions where TBAs/CVs were both trained and supervised (SG). A total of 1182 mothers of infants aged 0-6 months were interviewed at baseline. After 6 months of intervention, an endline survey was conducted on a different sample of 1148 mothers of infants aged 0-6 months in the same areas. In both intervention areas, TBAs/CVs made regular home visits and attended births whenever possible. Rates of early initiation of breastfeeding, avoidance of prelacteal feeds and exclusive breastfeeding were compared between groups using cluster-controlled mixed model logistic regression. At endline, both intervention groups had significantly higher proportions of mothers who reported early initiation of breastfeeding (CG: 88%, TG: 96%, SG: 96%) and avoidance of prelacteal feeds (CG: 48%, TG: 80%, SG: 88%) compared with the control group; there were no significant differences between the two intervention groups. The endline rates of reported exclusive breastfeeding were not significantly different among groups (CG: 67%, TG: 76%, SG: 83%).
| S-EPMC6865915 | biostudies-literature
Project description:BACKGROUND:Intensified preventive regimen based on a 'high-risk' approach has been proposed instead the routine prevention that is generally given to the whole population. The effectiveness of these regimens may still be an issue. Therefore, the aim of this study was to compare two preventive programs carried out in a Public School for kindergarten children. METHODS:The data from clinical examinations were used to assess the caries risk for 121 children. Children with at least 2 carious lesions were considered as high risk for dental caries development. These children were randomized into two groups. Half (High risk basic-HRB group) were provided the basic prevention regimen (oral-hygiene instruction and hands-on brushing practice for teachers and caregivers, daytime tooth brushing supervised by teachers at least once a week, newly erupted first permanent molar sealant, provision of toothbrush, fluoride-containing dentifrice, and a guidebook), which was also given to low-risk children (Low risk basic-LRB group). The other half (High risk intensive-HRI group) were additionally given an intensified preventive regimen (F-varnish application, primary molar sealant, and silver diamine fluoride (SDF) application on carious lesions). Clinical examinations were performed semiannually to determine the dmfs caries increment of the three groups. RESULTS:The 89 children completed the 24-month examination were 3- to 5-year-old with 19, 35, and 35 children in the LRB, HRB, and HRI group, respectively. The new caries development at 24?months of the HRB group (75%) was higher than that of the HRI group (65.7%) and the LRB group (21.1%). One-way analysis of variance (ANOVA) indicated no significant differences of caries increment between the HRB and HRI groups at the end of our study (p?=?0.709). CONCLUSIONS:The negligible difference in caries increment between the HRI and HRB groups implies that intensified prevention produced minimal additional benefit. Offering all children only basic prevention could have obtained virtually the same preventive effect with substantially less effort and lower cost. TRIAL REGISTRATION:Thai Clinical Trials Registry (TCTR), TCTR20180124001. Registered 24 January 2018 - Retrospectively registered.
| S-EPMC7168866 | biostudies-literature
Project description:The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D(1-2)FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877).
| S-EPMC3261117 | biostudies-literature
Project description:Young women in Malawi face many challenges in accessing family planning (FP), including distance to the health facility and partner disapproval. Our primary objective was to assess if training HSAs in couples counseling would increase modern FP uptake among young women.In this cluster randomized controlled trial, 30 HSAs from Lilongwe, Malawi received training in FP. The HSAs were then randomized 1:1 to receive or not receive additional training in couples counseling. All HSAs were asked to provide FP counseling to women in their communities and record their contraceptive uptake over 6 months. Sexually-active women <30 years of age who had never used a modern FP method were included in this analysis. Generalized estimating equations with an exchangeable correlation matrix to account for clustering by HSA were used to estimate risk differences (RDs) and 95% confidence intervals (CIs).430 (53%) young women were counseled by the 15 HSAs who received couples counseling training, and 378 (47%) were counseled by the 15 HSAs who did not. 115 (26%) from the couples counseling group had male partners present during their first visit, compared to only 6 (2%) from the other group (RD: 0.21, 95% CI: 0.09 to 0.33, p<0.01). Nearly all (99.5%) initiated a modern FP method, with no difference between groups (p = 0.09). Women in the couples counseling group were 8% more likely to receive male condoms (RD: 0.08, 95% CI: -7% to 23%, p = 0.28) and 8% more likely to receive dual methods (RD: 0.08, 95% CI: -0.065, 0.232, p = 0.274).Training HSAs in FP led to high modern FP uptake among young women who had never used FP. Couples counseling training increased male involvement with a trend towards higher male condom uptake.
| S-EPMC5407810 | biostudies-other
Project description:Background:Weight regain after successful weight loss interventions is common. Objective:To establish the efficacy of a weight loss maintenance program compared with usual care in obese adults. Design:2-group, parallel, randomized trial stratified by initial weight loss (<10 kg vs. ?10 kg), conducted from 20 August 2012 to 18 December 2015. Outcome assessors were blinded to treatment assignment. (ClinicalTrials.gov: NCT01357551). Setting:3 primary care clinics at the Veterans Affairs Medical Center in Durham and Raleigh, North Carolina. Patients:Obese outpatients (body mass index ?30 kg/m2) who lost 4 kg or more of body weight during a 16-week, group-based weight loss program. Intervention:The maintenance intervention, delivered primarily by telephone, addressed satisfaction with outcomes, relapse-prevention planning, self-monitoring, and social support. Usual care involved no contact except for study measurements. Measurements:Primary outcome was mean weight regain at week 56. Secondary outcomes included self-reported caloric intake, walking, and moderate physical activity. Results:Of 504 patients in the initial program, 222 lost at least 4 kg of body weight and were randomly assigned to maintenance (n = 110) or usual care (n = 112). Retention was 85%. Most patients were middle-aged white men. Mean weight loss during initiation was 7.2 kg (SD, 3.1); mean weight at randomization was 103.6 kg (SD, 20.4). Estimated mean weight regain was statistically significantly lower in the intervention (0.75 kg) than the usual care (2.36 kg) group (estimated mean difference, 1.60 kg [95% CI, 0.07 to 3.13 kg]; P = 0.040). No statistically significant differences in secondary outcomes were seen at 56 weeks. No adverse events directly attributable to the intervention were observed. Limitations:Results may not generalize to other settings or populations. Dietary intake and physical activity were self-reported. Duration was limited to 56 weeks. Conclusion:An intervention focused on maintenance-specific strategies and delivered in a resource-conserving way modestly slowed the rate of weight regain in obese adults. Primary Funding Source:Veterans Affairs Health Services Research and Development Service.
| S-EPMC5483942 | biostudies-literature