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Effect of Nutrition Education in NAFLD Patients Undergoing Simultaneous Hyperlipidemia Pharmacotherapy: A Randomized Controlled Trial.
Lee, WM, Bae, JH, Chang, Y, Lee, SH, Moon, JE, Jeong, SW, Jang, JY, Kim, SG, Kim, HS, Yoo, JJ, et al
Nutrients. 2021;(12)
Abstract
BACKGROUND Patients with non-alcoholic fatty liver disease (NAFLD) have a high prevalence of combined hyperlipidemia. The importance of nutritional education is well-known in NAFLD, but the impact of medical nutrition therapy (MNT) is unclear in patients with NAFLD with hyperlipidemia. The purpose of this study is to investigate the effect of MNT on the improvement of steatohepatitis in patients with NAFLD taking antihyperlipidemic medications. METHODS Nondiabetic patients with dyslipidemia were prospectively randomized (1:1) either to the MNT group or the control group with standard advice for 48 weeks with simultaneous statin/ezetimibe combination pharmacotherapy at three tertiary centers in Korea. RESULTS Sixty-six patients were enrolled. Among them, 18 patients dropped out and, overall, 48 patients (MNT group 27, control group 21) were prospectively analyzed in the study. The serum ALT level at 48 weeks between the two groups was not significantly different (66.6 ± 37.7 IU/L vs. 57.4 ± 36.7 IU/L, p = 0.40). Serum liver enzymes, controlled attenuation parameter and fibrosis-4 index were significantly improved within the MNT group after 48 weeks compared to baseline. There was no significant difference between the two groups other than the NAFLD fibrosis score (p = 0.017). CONCLUSIONS Although there were no significant differences between the two groups in terms of steatosis, metabolic and fibrosis surrogate indicators after 48 weeks, MNT groups showed significant improvement within patient analysis over time. Future studies with a larger number of subjects and a longer study period regarding the effect of MNT are warranted.
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Group-based parenting interventions to promote child development in rural Kenya: a multi-arm, cluster-randomised community effectiveness trial.
Luoto, JE, Lopez Garcia, I, Aboud, FE, Singla, DR, Fernald, LCH, Pitchik, HO, Saya, UY, Otieno, R, Alu, E
The Lancet. Global health. 2021;(3):e309-e319
Abstract
BACKGROUND Early childhood development (ECD) programmes can help address early disadvantages for the 43% of children younger than 5 years in low-income and middle-income countries who have compromised development. We aimed to test the effectiveness of two group-based delivery models for an integrated ECD responsive stimulation and nutrition education intervention using Kenya's network of community health volunteers. METHODS We implemented a multi-arm, cluster-randomised community effectiveness trial in three rural subcounties across 60 villages (clusters) in western Kenya. Eligible participants were mothers or female primary caregivers aged 15 years or older with children aged 6-24 months at enrolment. If married or in established relationships, fathers or male caregivers aged 18 years or older were also eligible. Villages were randomly assigned (1:1:1) to one of three groups: group-only delivery with 16 fortnightly sessions; mixed delivery combining 12 group sessions with four home visits; and a comparison group. Villages in the intervention groups were randomly assigned (1:1) to invite or not invite fathers and male caregivers to participate. Households were surveyed at baseline and immediately post-intervention. Assessors were masked. Primary outcomes were child cognitive and language development (score on the Bayley Scales of Infant Development third edition), socioemotional development (score on the Wolke scale), and parental stimulation (Home Observation for Measurement of the Environment inventory). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03548558. FINDINGS Between Oct 1 and Nov 12, 2018, 1152 mother-child dyads were enrolled and randomly assigned (n=376 group-only intervention, n=400 mixed-delivery intervention, n=376 comparison group). At the 11-month endline survey (Aug 5-Oct 31, 2019), 1070 households were assessed for the primary outcomes (n=346 group only, n=373 mixed delivery, n=351 comparison). Children in group-only villages had higher cognitive (effect size 0·52 SD [95% CI 0·21-0·83]), receptive language (0·42 SD [0·08-0·77]), and socioemotional scores (0·23 SD [0·03-0·44]) than children in comparison villages at endline. Children in mixed-delivery villages had higher cognitive (0·34 SD [0·05-0·62]) and socioemotional scores (0·22 SD [0·05-0·38]) than children in comparison villages; there was no difference in language scores. Parental stimulation also improved for group-only (0·80 SD [0·49-1·11]) and mixed-delivery villages (0·77 SD [0·49-1·05]) compared with the villages in the comparison group. Including fathers in the intervention had no measurable effect on any of the primary outcomes. INTERPRETATION Parenting interventions delivered by trained community health volunteers in mother-child groups can effectively promote child development in low-resource settings and have great potential for scalability. FUNDING Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health.
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Influence of two different methods of nutrition education on the quality of life in children and adolescents with type 1 diabetes mellitus - a randomized study.
Dłużniak-Gołaska, K, Panczyk, M, Szypowska, A, Sińska, B, Szostak-Węgierek, D
Roczniki Panstwowego Zakladu Higieny. 2020;(2):197-206
Abstract
Background. Nutrition education is one of the most important factors determining the effectiveness of treatment and maintaining an adequate quality of life (QoL) in children and adolescents with type 1 diabetes. Material and Methods. A randomized single-blind study was conducted between October 2017 and April 2019 at the Children's Clinical Hospital in Warsaw. The study included 170 patients (aged 8-17) with at least 1-year history of type 1 diabetes, treated with insulin pumps. The participants were randomly divided into two groups: a control group (C) - traditional/ informative education methods, and an experimental group (E) - modern/interactive methods. PedsQL Diabetes Module 3.0 questionnaire was used in the assessment of the QoL. Total PedsQL score was the primary outcome. The secondary outcomes included the results obtained in five subscales of the questionnaire. The relationships between selected variables and changes in scores were also verified. Results. Data obtained from 136 patients were analyzed. In both groups no significant changes regarding total PedsQL were noted 6 months after the intervention. However, a significant reduction occurred as regards the scores of 'Communication' subscale in group C. Analyzing other determinants of the QoL, significant dependencies were observed between: the level of physical activity and a change in 'Diabetes symptoms' subscale, and the level of parents' education and a change in 'Treatment barriers' subscale. Conclusions. Both methods of nutrition education exerted a comparable influence on the total QoL. However, modern methods were more effective in terms of the improvement in the aspect of communication. Additionally, moderate physical activity and parents' tertiary education constituted valid determinants of various aspects of the QoL in children and adolescents with type 1 diabetes.
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Impact of a nutrition education programme on preschool children's willingness to consume fruits and vegetables.
Melnick, EM, Thomas, K, Farewell, C, Quinlan, J, LaFlamme, D, Brogden, D, Scarbro, S, Puma, JE
Public health nutrition. 2020;(10):1846-1853
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OBJECTIVE To evaluate the impact of a preschool-based nutrition education programme consisting of twelve 'hands on' nutrition education lessons delivered during the school year on young children's willingness to consume fruits and vegetables. DESIGN Quasi-experimental, pre-post design including the collection of plate waste evaluation data at the start and end of the 2015-2016 school year within two groups: (1) randomly selected classrooms receiving the intervention and (2) within conveniently sampled preschool classrooms not receiving the intervention serving as a comparison group. SETTING Centre-based preschool programmes serving low-income families in the Denver metro area. PARTICIPANTS Three- to five-year-old children in preschool classrooms participating in the intervention during the 2015-2016 school year (n 308) and children enrolled in comparison classrooms (n 215). RESULTS Repeated-measures logit models assessed whether increases in the odds of consuming small samples of fruits and vegetables between Time 1 (pre-intervention) and Time 2 (post-intervention) were different for children within the intervention group compared with the comparison group. Analyses showed that the change over time in consumption of the three vegetable samples varied by intervention status with greater change occurring among children within the intervention group (edamame: P = 0·001; cauliflower: P ≤ 0·0001 and red pepper: P ≤ 0·0001). Unlike vegetables, the change over time in consumption of the two fruit samples was not different between children within the intervention and comparison groups. CONCLUSIONS An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.
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Group Sessions or Home Visits for Early Childhood Development in India: A Cluster RCT.
Grantham-McGregor, S, Adya, A, Attanasio, O, Augsburg, B, Behrman, J, Caeyers, B, Day, M, Jervis, P, Kochar, R, Makkar, P, et al
Pediatrics. 2020;(6)
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OBJECTIVES Poor early childhood development in low- and middle-income countries is a major public health problem. Efficacy trials have shown the potential of early childhood development interventions but scaling up is costly and challenging. Guidance on effective interventions' delivery is needed. In an open-label cluster-randomized control trial, we compared the effectiveness of weekly home visits and weekly mother-child group sessions. Both included nutritional education, whose effectiveness was tested separately. METHODS In Odisha, India, 192 villages were randomly assigned to control, nutritional education, nutritional education and home visiting, or nutritional education and group sessions. Mothers with children aged 7 to 16 months were enrolled (n = 1449). Trained local women ran the two-year interventions, which comprised demonstrations and interactions and targeted improved play and nutrition. Primary outcomes, measured at baseline, midline (12 months), and endline (24 months), were child cognition, language, motor development, growth and morbidity. RESULTS Home visiting and group sessions had similar positive average (intention-to-treat) impacts on cognition (home visiting: 0.324 SD, 95% confidence interval [CI]: 0.152 to 0.496, P = .001; group sessions: 0.281 SD, 95% CI: 0.100 to 0.463, P = .007) and language (home visiting: 0.239 SD, 95% CI: 0.072 to 0.407, P = .009; group sessions: 0.302 SD, 95% CI: 0.136 to 0.468, P = .001). Most benefits occurred in the first year. Nutrition-education had no benefit. There were no consistent effects on any other primary outcomes. CONCLUSIONS Group sessions cost $38 per child per year and were as effective on average as home visiting, which cost $135, implying an increase by a factor of 3.5 in the returns to investment with group sessions, offering a more scalable model. Impacts materialize in the first year, having important design implications.
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Education Research: Online Alzheimer education for high school and college students: A randomized controlled trial.
Saif, N, Niotis, K, Dominguez, M, Hodes, JF, Woodbury, M, Amini, Y, Sadek, G, Scheyer, O, Caesar, E, Hristov, H, et al
Neurology. 2020;(16):e2305-e2313
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OBJECTIVE Alzheimer disease (AD) risk factors are present throughout the lifespan. This randomized controlled trial evaluated the effectiveness of various online education strategies concerning AD risk reduction and brain health in younger populations. METHOD High school and college students were recruited via social media (Facebook and Instagram) to join AlzU.org, an evidence-based education portal, and were randomized to 1 of 4 courses: highly interactive webinar lessons narrated by actor Seth Rogen (celebrity webinar) or a physician (doctor webinar), minimally interactive video lessons with Seth Rogen (celebrity video), or minimally interactive video lessons (control). Surveys were administered at baseline and postcourse. The primary outcome was change in knowledge of AD risk reduction assessed by pre vs post lesson quiz scores. Secondary outcomes included change in awareness of AD research, hopefulness about AD, interest in pursuing health care, willingness to volunteer, and likelihood of recommending AlzU.org. RESULT A total of 721 participants joined. A total of 281 (38.9%) completed the course. Among college students, quiz score improvements were greater in celebrity webinar and celebrity video vs doctor webinar and control. Among high school students, no differences were found in quiz scores. In both groups, celebrity webinar, celebrity video, and doctor webinar resulted in greater improvements in awareness that nutrition and exercise may reduce AD risk vs controls. Among college students, celebrity webinar and celebrity video group participants felt more hopeful about the future of AD and more likely to recommend AlzU.org vs doctor webinar and control participants. Among college students, celebrity webinar, celebrity video, and doctor webinar participants were more willing to volunteer for AD causes and pursue health care careers vs controls. CONCLUSION Online education involving a celebrity may be an effective strategy for educating college students about AD risk reduction strategies. Further studies are warranted in high school students.
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Health education improves referral compliance of persons with probable Diabetic Retinopathy: A randomized controlled trial.
Khair, Z, Rahman, MM, Kazawa, K, Jahan, Y, Faruque, ASG, Chisti, MJ, Moriyama, M
PloS one. 2020;(11):e0242047
Abstract
OBJECTIVE Lack of awareness about Diabetic Retinopathy (DR) is the most commonly cited reason why many persons with type 2 diabetes are non-compliant with referral instruction to undergo retinal screening. The purpose of this study was to evaluate the efficacy of a culturally, geographically and socially appropriate, locally adapted five-month-long health education on referral compliance of participants. METHOD A prospective randomized, open-label parallel group study was conducted on persons with type 2 diabetes who underwent basic eye screening at a diabetes hospital between September 2017 and August 2018. Participants who were noncompliant with referral instruction to visit a hospital for advanced DR management were randomly divided into health education intervention group (n = 143) and control group (n = 156). Both groups received information regarding DR and referral instruction at the diabetes hospital. The intervention group was provided personalized education followed by telephonic reminders. The primary endpoint was 'increase in referral compliance' and the secondary endpoint was 'increase in knowledge of DR'. Multivariate logistic regression model was used to identify significant predictors of compliance to referral. RESULTS A total of nine participants dropped and 290 completed the post intervention survey. The compliance rate in intervention group was found to be significantly higher than the control group (64.3% vs 28.2%; OR 4.73; 95% CI 2.87-7.79; p<0.001). Participants in the intervention group acquired better knowledge on DR (p<0.05). Apart from intervention, referral compliance rate was also found to be significantly associated with participants' self-perception of vision problem (OR 2.02; 95% CI 1.02-4.01; p = 0.045) and participants' income (OR 1.24; 95% CI 1.06-1.44; p = 0.008). DISCUSSION Our results suggest that intensive health education on DR should be integrated with diabetes education as it may result in significantly improved referral compliance. Outcomes may be sustainable if interventions are institutionalized at referral point. TRIAL REGISTRATION Clinical Trials.gov (Registration # NCT03658980); https://clinicaltrials.gov/ct2/show/NCT03658980.
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Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial.
Jacot, W, Arnaud, A, Jarlier, M, Lefeuvre-Plesse, C, Dalivoust, P, Senesse, P, Azzedine, A, Tredan, O, Sadot-Lebouvier, S, Mas, S, et al
Nutrients. 2020;(10)
Abstract
Supervised exercise dietary programs are recommended to relieve cancer-related fatigue and weight increase induced by adjuvant treatment of early breast cancer (EBC). As this recommendation lacks a high level of evidence, we designed a multicenter randomized trial to evaluate the impact of an Adapted Physical Activity Diet (APAD) education program on fatigue. We randomized 360 women with EBC who were receiving adjuvant chemotherapy and radiotherapy to APAD or usual care at eight French cancer institutions. Data were collected at baseline, end of chemotherapy, end of radiotherapy, and 6 months post-treatment. The primary endpoint was the general cancer-related fatigue score using the MFI-20 questionnaire. Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue (p = 0.274). The APAD arm has a smaller proportion of patients with confirmed depression at the end of follow-up (p = 0.052). A transient modification in physical activity levels and dietary intake was reported in the experimental arm. However, a mixed hospital- and home-based APAD education program is not enough to improve fatigue caused by adjuvant treatment of EBC. Cancer care centers should consider integrating more proactive diet-exercise supportive care in this population, focusing on precarious patients.
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Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.
Frith, P, Sladek, R, Woodman, R, Effing, T, Bradley, S, van Asten, S, Jones, T, Hnin, K, Luszcz, M, Cafarella, P, et al
Chronic respiratory disease. 2020;:1479973119897277
Abstract
We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention (n = 100) and control (n = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68; p = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all p values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14; p = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction (p = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).
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A town level comprehensive intervention study to reduce salt intake in China: protocol for a cluster randomised controlled trial.
Xu, J, Tang, B, Liu, M, Bai, Y, Yan, W, Zhou, X, Xu, Z, He, J, Jin, D, Sun, J, et al
BMJ open. 2020;(1):e032976
Abstract
INTRODUCTION Salt intake in China (≈12 g/day) is more than twice the upper limit recommended by the WHO (5 g/day). To reduce salt intake, Action on Salt China (ASC) was launched in 2017. As one of four randomised controlled trials (RCTs) in the ASC programme, a comprehensive intervention study was designed to test whether all the components of the interventions adopted by other RCTs are acceptable, scalable and effective when provided to a region in the real world. METHODS AND ANALYSIS Using a cluster RCT design, 2688 participants were selected from 48 towns (clusters) in 12 counties in 6 provinces and assigned to the intervention group or the control group. Randomisation was performed after the baseline survey was completed. Information on salt-related knowledge, attitude and practice (KAP), blood pressure and 24-hour urinary sodium were collected. The intervention includes government engagement, health education and other intervention components targeting restaurants, home cooks and primary school students and their families that have been used in other RCTs. The control group will not receive the intervention. The project will be followed up for 2 years, with the intervention being carried out for the first year only. The primary outcome is salt intake measured by 24-hour urinary sodium excretion after 1 year. The secondary outcomes are the long-lasting effectiveness on salt intake and blood pressure measured by the same method, as well as salt-related KAP and blood pressure at the 1-year and 2-year follow-ups. Process evaluation and health economics analysis will be conducted as well. ETHICS AND DISSEMINATION The study was reviewed and approved by the Institutional Review Board of the National Center for Chronic and Noncommunicable Disease Control and Prevention, the Chinese Center for Disease Control and Prevention, and Queen Mary Research Ethics Committee. Results will be disseminated through presentations, publications and social media. TRIAL REGISTRATION NUMBER ChiCTR1800018119.