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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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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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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.
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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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Child Health Promotion in Underserved Communities: The FAMILIA Trial.
Fernandez-Jimenez, R, Jaslow, R, Bansilal, S, Santana, M, Diaz-Munoz, R, Latina, J, Soto, AV, Vedanthan, R, Al-Kazaz, M, Giannarelli, C, et al
Journal of the American College of Cardiology. 2019;(16):2011-2021
Abstract
BACKGROUND Preschool-based interventions offer promise to instill healthy behaviors in children, which can be a strategy to reduce the burden of cardiovascular disease later. However, their efficacy in underserved communities is not well established. OBJECTIVES The purpose of this study was to assess the impact of a preschool-based health promotion educational intervention in an underserved community. METHODS This cluster-randomized controlled study involved 15 Head Start preschools in Harlem, New York. Schools and their children were randomized 3:2 to receive either a 4-month (50 h) educational intervention to instill healthy behaviors in relation to diet, physical activity, body/heart awareness, and emotion management; or their standard curriculum (control). The primary outcome was the change from baseline in the overall knowledge, attitudes, and habits (KAH) score of the children at 5 months. As secondary outcomes, we evaluated the changes in KAH subcomponents and emotion comprehension. Linear mixed-effects models were used to test for intervention effects. RESULTS The authors enrolled 562 preschool children age 3 to 5 years, 51% female, 54% Hispanic/Latino, and 37% African-American. Compared with the control group, the mean relative change from baseline in the overall KAH score was ∼2.2 fold higher in the intervention group (average absolute difference of 2.86 points; 95% confidence interval: 0.58 to 5.14; p = 0.014). The maximal effect was observed in children who received >75% of the curriculum. Physical activity and body/heart awareness components, and knowledge and attitudes domains, were the main drivers of the effect (p values <0.05). Changes in emotion comprehension trended toward favoring intervened children. CONCLUSIONS This multidimensional school-based educational intervention may be an effective strategy for establishing healthy behaviors among preschoolers from a diverse and socioeconomically disadvantaged community. Early primordial prevention strategies may contribute to reducing the global burden of cardiovascular disease. (Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health [FAMILIA]; NCT02343341).
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Process Evaluation of Strong Hearts, Healthy Communities: A Rural Community-Based Cardiovascular Disease Prevention Program.
Sriram, U, Sandreuter, K, Graham, M, Folta, S, Pullyblank, K, Paul, L, Seguin, R
Journal of nutrition education and behavior. 2019;(2):138-149
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OBJECTIVE To evaluate the implementation of a community-based cardiovascular disease prevention program for rural women: Strong Hearts, Healthy Communities (SHHC). DESIGN Mixed-methods process evaluation. SETTING/PARTICIPANTS A total of 101 women from 8 rural towns were enrolled in the SHHC program; 93 were enrolled as controls. Eligible participants were aged ≥40 years, sedentary, and overweight or obese. Local health educators (n = 15) served as program leaders within each town. OUTCOME MEASURES Reach, fidelity, dose delivered, dose received, and program satisfaction were assessed using after-class surveys, participant satisfaction surveys, interviews with program leaders, and participant focus groups. ANALYSIS Descriptive statistics, chi-square tests of independence, and thematic analysis were employed. RESULTS Intervention sites reported high levels of fidelity (82%) and dose delivered (84%). Overall reach was 2.6% and program classes were rated as effective (3.9/5). Participants were satisfied with their experience and reported benefits such as camaraderie and awareness of healthy eating and exercise strategies. Common recommendations included increasing class time and enhancing group discussion. CONCLUSIONS AND IMPLICATIONS Implementation was good in terms of fidelity, dose delivered, and satisfaction, although low reach. Findings from this research have informed a second round of implementation and evaluation of the SHHC program in rural communities.
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Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial.
Fernandez-Jimenez, R, Santos-Beneit, G, Tresserra-Rimbau, A, Bodega, P, de Miguel, M, de Cos-Gandoy, A, Rodríguez, C, Carral, V, Orrit, X, Haro, D, et al
American heart journal. 2019;:27-40
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UNLABELLED Unhealthy habits in adolescents are increasing at an alarming rate. The school offers a promising environment in which to implement effective preventive strategies to improve adolescents' lifestyle behaviors. The SI! Program is a multilevel multicomponent school-based health-promotion intervention aimed at all stages of compulsory education in Spain. We present the study design of the SI! Program for Secondary Schools, targeting adolescents aged 12 to 16 years. AIM: The main goal of this study is to evaluate the impact of the SI! Program educational intervention on adolescent lifestyle behaviors and health parameters. METHODS The study was designed as a cluster-randomized controlled intervention trial and enrolled 1326 adolescents from 24 public secondary schools in Spain, together with their parents/caregivers. Schools and their students were randomly assigned to the intervention group (the SI! curriculum-based educational program over 2 or 4 academic years) or to the control group (usual curriculum). The primary endpoint will be the change from baseline at 2-year and 4-year follow-up in the composite Ideal Cardiovascular Health (ICH) score, consisting of four health behaviors (body mass index, dietary habits, physical activity, and smoking) and three health factors (blood pressure, total cholesterol, and glucose). Secondary endpoints will include 2-year and 4-year changes from baseline in ICH score subcomponents, the Fuster-BEWAT health scale, adiposity markers (waist circumference and body composition), polyphenol and carotenoid intake, and emotion management. DISCUSSION The overarching goal of the SI! Program is to instill healthy behaviors in children and adolescents that can be sustained into adulthood. The SI! Program for Secondary School is a comprehensive health-promotion intervention targeting 12-16-year-old adolescents and their immediate environment. The present study addresses the optimal timing and impact of the educational intervention on health in adolescence.
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Using facilitator-receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study.
Saez, L, Legrand, K, Alleyrat, C, Ramisasoa, S, Langlois, J, Muller, L, Omorou, AY, De Lavenne, R, Kivits, J, Lecomte, E, et al
BMJ open. 2018;(6):e019731
Abstract
OBJECTIVE To evaluate the feasibility of an innovative peer intervention promoting healthy eating and physical activity, which purposefully selected peer facilitators according to socioeconomic status to target less-advantaged overweight receivers. SETTING Nine high schools, two middle schools. PARTICIPANTS One hundred and fifty-six adolescents were approached to become facilitators, of whom 18 were trained. Thirty-two of 56 potential receivers agreed to participate. INTERVENTION The peer intervention was carried out in 2013-2014 and embedded in a larger trial: PRALIMAP-INÈS (Promotion de l'ALIMentation et l'Activité Physique-INEgalité de Santé). Facilitanoators were selected and trained to organise weight-control activities with specific peer receivers participating in the programme. PRIMARY AND SECONDARY OUTCOME MEASURES Different types of data were collected to assess demand, acceptability, implementation and practicality of the intervention. For the facilitators, this included 6 training sessions, 11 mid-programme interviews, 4 end-of-programme sessions, telephone notes and text message exchanges. All six potential receivers in one school were also interviewed. Sociodemographic and health characteristics were also analysed. RESULTS Agreeing to participate was more likely when asked by a peer compared with a professional (51.2% discordant pairs; p<0.02). Twelve activities, mostly based on physical activity and implemented during weekends or holidays, were carried out. The mean age of active receivers was 16 and their body mass index was higher than other participants. For both facilitators and active receivers, there were more participating girls. Qualitative analysis reveals key implementation challenges for facilitators. Interviews with the receivers highlight social difficulties, with most feeling bad about their appearance and wanting to lose weight. Those who participated in peer activities were very positive about the experience especially social support. CONCLUSIONS The present study suggests the peer intervention is feasible provided organisational difficulties are addressed. Good practice recommendations are formulated, including a longer training session, organising a joint meeting with the facilitators and receivers, matching dyads on place of residence and multiplying modes of contact. TRIAL REGISTRATION NUMBER NCT01688453.
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Strengthening integration of clinical and public health systems to prevent maternal-child obesity in the First 1,000Days: A Collective Impact approach.
Blake-Lamb, T, Boudreau, AA, Matathia, S, Tiburcio, E, Perkins, ME, Roche, B, Kotelchuck, M, Shtasel, D, Price, SN, Taveras, EM
Contemporary clinical trials. 2018;:46-52
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INTRODUCTION Obesity interventions may be most effective if they begin in the earliest stages of life, support changes across family, clinical, and public health systems, and address socio-contextual factors. METHODS The First 1000Days is a systematic program starting in early pregnancy lasting through the first 24months of infancy to prevent obesity among low-income mother-infant pairs in three community health centers in Massachusetts. The program uses a Collective Impact approach to create the infrastructure for sustained, system-wide changes for obesity prevention across early life clinical and public health services, including Obstetrics, Pediatrics, Adult Medicine, Behavioral Health, Nutrition, Community Health, the Women, Infants and Children (WIC) program, and the Maternal, Infant and Childhood Home Visiting program. Program components include 1) staff and provider training; 2) enhanced gestational weight gain and infant overweight tracking; 3) universal screening of adverse health behaviors and socio-contextual factors; 4) universal patient navigation to support individual behavior change and social needs, while strengthening integration of clinical and public health services; 5) individualized health coaching for mother-infant pairs at high risk of obesity; and 6) educational materials to support behavior change. RESULTS A quasi-experimental evaluation design will examine changes, between 2015 and 2019, in gestational weight gain and prevalence of infant overweight from 0 to 24months of age. CONCLUSIONS The First 1000Days program will examine the effectiveness of an early life obesity prevention program for mother-infant pairs. If successful, the program could provide a model for chronic disease prevention and health promotion among vulnerable families starting in early life.
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The Women's wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol.
Anderson, D, Seib, C, Tjondronegoro, D, Turner, J, Monterosso, L, McGuire, A, Porter-Steele, J, Song, W, Yates, P, King, N, et al
BMC cancer. 2017;(1):98
Abstract
BACKGROUND Despite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women's Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers. METHODS A single-blinded, multi-centre randomized controlled trial recruited a total of 351 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura's social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 weeks (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately. DISCUSSION Women treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP. TRIAL REGISTRATION The protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID: ACTRN12614000800628 , July 28, 2014.