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Nutritional counseling frequency and baseline food pattern predict implementation of a high-protein and high-polyunsaturated fatty acid dietary pattern: 1-year results of the randomized NutriAct trial.
Pletsch-Borba, L, Wernicke, C, Apostolopoulou, K, Spira, D, Pohrt, A, Hornemann, S, Gerbracht, C, Pfeiffer, AFH, Spranger, J, Mai, K
Clinical nutrition (Edinburgh, Scotland). 2021;(11):5457-5466
Abstract
BACKGROUND & AIMS NutriAct is a 36-month randomized controlled multi-center trial designed to analyze the effects of a food pattern focusing on a high-protein and high-unsaturated fatty acids (UFA) intake on healthy aging. We aimed to determine factors associated with a successful modulation of dietary pattern after 12 months in elderly participants. METHODS 502 participants were randomized into either usual care control group including dietary recommendations of the German Nutrition Society (DGE) or an intervention group, which used supplementation of rapeseed oil and specifically designed foods as well as repetitive advices to implement a food pattern based on high intake of predominantly plant proteins, UFA and fiber (NutriAct pattern). Food intake was repeatedly assessed by 3-day food records at months 0, 3, 6 and 12. Linear regression models were used to investigate determinants of basal food intake and modulation of dietary pattern during the intervention. RESULTS Food records of 242 intervention and 246 control participants (median age 66 y, 37% males) were available at baseline and were included. At baseline, high BMI was related to higher protein and saturated fatty acids and lower fiber intake. The intervention resulted in higher intake of protein, mono- and polyunsaturated fatty acids (MUFA and PUFA) and fiber, and lower carbohydrate and saturated fatty acid consumption (all p < 0.001). While individuals who were already at baseline closer to the NutriAct pattern also achieved a diet closer to the proposed pattern at month 12, the strongest absolute changes (%E) of dietary behavior were seen in those with dietary patterns further away from the proposed pattern at baseline. Attendance to nutritional sessions was crucial to change MUFA, PUFA, fiber and carbohydrate intake. CONCLUSIONS A successful modification of dietary pattern was achieved by the performed intervention within 12 months. Baseline dietary habits and attendance to nutritional sessions were substantial determinants predicting changes in dietary pattern. CLINICAL TRIAL REGISTRATION The trial was registered at German Clinical Trials Register (drks.de) as DRKS00010049.
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A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial.
Munk, T, Svendsen, JA, Knudsen, AW, Østergaard, TB, Thomsen, T, Olesen, SS, Rasmussen, HH, Beck, AM
Clinical nutrition (Edinburgh, Scotland). 2021;(11):5500-5510
Abstract
BACKGROUND Many older hospitalized patients are at nutritional risk or malnourished and the nutritional condition is often further impaired during hospitalization. When discharged to own home, a "Nutrition Gap" often occurs, causing inadequate dietary intake, and potentially impeded recovery. Previously, cross-sectorial studies of single component nutritional intervention have shown a limited effect on clinically relevant outcomes. We hypothesized that a multimodal nutritional intervention is necessary to elicit a beneficial effect on clinically relevant outcomes. METHODS A randomized controlled trial was performed for a period of 16 weeks. At discharge, the intervention group (IG) received dietetic counselling including a recommendation of daily training, an individual nutrition plan and a package containing foods and drinks covering dietary requirements for the next 24 h. Further, a goodie-bag containing samples of protein-rich milk-based drinks were provided. Information regarding recommendations of nutritional therapy after discharge was systematically and electronically communicated to the municipality. The dietician performed telephone follow-ups on day 4 and 30 and a home visit at 16 weeks. The control group (CG) received standard treatment. The primary outcome was readmissions within 6 month, secondary outcomes were Length of Stay (LOS), Health Related Quality of Life (EQ-5D-3L), nutritional status, physical function (30s-CST) and mortality. This trial was registered under ClinicalTrials.gov Identifier no. NCT03488329. RESULTS We included 191 patients (IG: n = 93). No significant difference was seen in readmissions within 6 month (IG: 45% vs. CG: 45%, Risk Ratio (RR): 0.96 0.71-1.31, p = 0.885). At the 16-weeks follow-up more patients in the IG reached at least 75% of energy and protein requirements (82% vs. CG: 61%, p = 0,007). The energy (kcal) and protein intake (g) per kg was significantly higher in the IG (26.4 kcal/kg (±7.4) vs. 22.6 (±7.4), p = 0.0248) (1.1 g/kg (±0.3) vs. 0.9 g/kg (±0.3). Furthermore, significant lower weight loss was seen in IG (0.7 (±4.3) vs. -1.4 (±3.6), p = 0.002). A significant and clinically relevant difference was found in the EQ-5D-3L VAS-score (IG: mean 61.6 ± 16.2 vs. CG: 53.3 ± 19.3, p = 0.011) (Δ14.3 (±15.5) vs. Δ5.6 (±17.2), p = 0.002). A significant difference in mean 30s-CST in IG was also found (7.2 (±4.3) vs. 5.3 (±4.1), p = 0.010). The improvements in physical function were of clinical relevance in both groups, but significantly higher in the IG (Δ4.2 (±4.4) vs. Δ2.2 (±2.5), p = 0.008). In fact, 86% in IG experienced improvements in the 30s-CST compared with 68% in the CG (p = 0.022). LOS was found to be lower at all time points, however not significant (30 days: -3 (-8.5 to 2.5), p = 0.276, 16 weeks: -4 (-10.2 to 2.2, p = 0.204), 6 months: -3 (-9.3 to 3.3, p = 0346)). All-cause mortality was not different between groups, however RR showed a non-significantly 47% reduction at day 30 (0.53 (0.14-2.05, p = 0.499)) and a 17% reduction at 16 weeks (0.83 (0.40-1.73, p = 1.000)) in IG. Per protocol (PP) analysis revealed a non-significant decrease of 32% in readmission at 6 months (RR: 0.68 (0.42-1.08), p = 0.105). CONCLUSION The present study, using a multimodal nutritional approach, revealed no significant effect on readmissions however a significant positive effect on nutritional status, quality of life and physical function was found. The improvements in quality of life and physical function were of clinical relevance. No significant effect was found on LOS and mortality.
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QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.
Pinto, E, Nardi, MT, Marchi, R, Cavallin, F, Alfieri, R, Saadeh, L, Cagol, M, Baldan, I, Saraceni, E, Parotto, M, et al
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(2):1025-1033
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BACKGROUND Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life. METHODS At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores. RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD - 3.1, 95% CI - 10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI - 5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI - 5.9 to 7.2). CONCLUSIONS Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.
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Moderate-Intensity Aerobic vs Resistance Exercise and Dietary Modification in Patients With Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial.
Charatcharoenwitthaya, P, Kuljiratitikal, K, Aksornchanya, O, Chaiyasoot, K, Bandidniyamanon, W, Charatcharoenwitthaya, N
Clinical and translational gastroenterology. 2021;(3):e00316
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INTRODUCTION This randomized trial aimed to compare the effects of moderate-intensity aerobic vs resistance exercise with dietary modification in patients with nonalcoholic fatty liver disease (NAFLD). METHODS Patients with NAFLD were randomly assigned (1:1) to a 12-week supervised training program of moderate-intensity aerobic or resistance exercise with dietary intervention consisting of monthly individual nutritional counseling by a dietician. Transient elastography, anthropometry, body composition, cardiorespiratory fitness, biochemistries, and glucose tolerance were measured at baseline and 12 weeks. RESULTS Eighteen subjects exercised for an average of 3.35 ± 0.30 sessions a week in the aerobic group, and 17 subjects exercised an average of 3.39 ± 0.28 sessions a week in the resistance group. After completion of the training program, hepatic fat content was similarly reduced in both groups (P < 0.001). The mean relative reduction from baseline in the aerobic group was -10.3% (95% confidence interval -18.2 to -2.40) and the resistance group was -12.6% (-20.5 to -4.69). Liver steatosis (defined as controlled attenuation parameter >248 dB/m) disappeared in 9 (50%) of the aerobic group and in 9 (53%) of the resistance group. Whole-body and muscle insulin sensitivity indexes were improved, and waist circumference was reduced comparably in both exercise groups. The number of exercise sessions per week was correlated with the absolute reduction in hepatic fat content (r = 0.52; P = 0.001). Weekly exercise training ≥3 sessions substantially attenuates liver fat accumulation independent of weight loss. DISCUSSION Moderate-intensity aerobic training and resistance training with dietary modification are equally effective for reducing intrahepatic fat and improving underlying insulin resistance among patients with NAFLD.
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Food Insecurity and Weight Loss in an Underserved Primary Care Population: A Post Hoc Analysis of a Cluster Randomized Trial.
Myers, CA, Martin, CK, Apolzan, JW, Arnold, CL, Davis, TC, Johnson, WD, Katzmarzyk, PT, ,
Annals of internal medicine. 2021;(7):1032-1034
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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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Lifestyle counselling by persuasive information and communications technology reduces prevalence of metabolic syndrome in a dose-response manner: a randomized clinical trial (PrevMetSyn).
Seo, YG, Salonurmi, T, Jokelainen, T, Karppinen, P, Teeriniemi, AM, Han, J, Park, KH, Oinas-Kukkonen, H, Savolainen, MJ
Annals of medicine. 2020;(6):321-330
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OBJECTIVES The aim was to investigate whether lifestyle changes produced by persuasive Information and Communication Technology (ICT) counselling can lower the prevalence of metabolic syndrome (MetS). METHODS A total of 532 participants (20-60 years, body mass index 27-35 kg/m2) were randomly assigned to six arms according to counselling type (no, short-term, or intensive) with or without ICT intervention. In this report the prevalence of MetS and its components were compared between no-ICT group and ICT group. Moreover, the frequency of the web information system usage was analysed for the number of logins, responses to weekly messages, and other record variables. RESULTS The ICT group had significantly lower proportion of MetS (33.7% vs. 45.3%, p = .022) than the no-ICT group at 2-year follow-up. In mixed model, the ICT group had lower prevalence of MetS than no-ICT group (OR 0.50, 95%CI 0.27-0.90) after intervention. The tertile with the highest utilization had 71% lower prevalence of MetS compared with the lowest utilization tertile or the no-ICT group. CONCLUSIONS Web-based ICT is able to reduce the prevalence of MetS. In addition, higher utilization of the web information system is associated with a greater decrease in the prevalence of MetS. Key messages Our internet health behaviour change support system based on persuasive design and cognitive behaviour therapy markedly reduces metabolic syndrome in overweight/obese subjects. As a stand-alone tool it may save healthcare personnel resources as it is suitable at a low cost for both obese/overweight patients and the public at large.
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Japan Trial in High-Risk Individuals to Enhance Their Referral to Physicians (J-HARP)-A Nurse-Led, Community-Based Prevention Program of Lifestyle-Related Disease.
Noguchi, M, Kojima, S, Sairenchi, T, Kinuta, M, Yamakawa, M, Nishizawa, H, Takahara, M, Imano, H, Kitamura, A, Yoshida, T, et al
Journal of epidemiology. 2020;(4):194-199
Abstract
BACKGROUND It is uncertain whether health counselling after community-based health checkups for high-risk individuals of lifestyle-related disease enhances their referral to physicians. METHODS We performed a clustered randomized controlled trial of untreated high-risk individuals aged 40 to 74 years who were screened from the annual health checkup in 2014 and 2015 under the national health insurance in 43 municipalities around Japan, assigning 21 intervention and 22 usual care municipalities. The high-risk conditions were severe forms of hypertension, diabetes, dyslipidemia (for men), and proteinuria. For the intervention group, the theory-based health counselling was performed to enhance referrals to physicians, while each municipality performed its own standard counselling for the usual care group. Data on clinical visits and risk factors were collected systematically and anonymously from the databases of health insurance qualification, health insurance claims, and annual health checkups. Hypotheses are that the cumulative proportion of seeing physicians (clinical visits) is higher in the intervention than the usual care groups, and that those in the intervention group have lower cumulative incidence of composite outcomes associated with lifestyle-related diseases. RESULTS The numbers of subjects for the analyses were 8,977 in the intervention group and 6,733 in the usual care group. Among them, 6,758 had hypertension, 2,147 had diabetes, 2,861 had dyslipidemia, and 1,221 had proteinuria in the intervention group, with corresponding numbers of 4,833, 1,517, 2,262, and 845, respectively, in the usual care group. There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups. CONCLUSIONS We expect to provide scientific evidence on the effectiveness of health counselling.
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Effects of 20-year infancy-onset dietary counselling on cardiometabolic risk factors in the Special Turku Coronary Risk Factor Intervention Project (STRIP): 6-year post-intervention follow-up.
Pahkala, K, Laitinen, TT, Niinikoski, H, Kartiosuo, N, Rovio, SP, Lagström, H, Loo, BM, Salo, P, Jokinen, E, Magnussen, CG, et al
The Lancet. Child & adolescent health. 2020;(5):359-369
Abstract
BACKGROUND Primordial and primary prevention is the cornerstone for cardiometabolic health. In the randomised, controlled Special Turku Coronary Risk Factor Intervention Project (STRIP; n=1116), a 20-year dietary counselling intervention was given to children biannually from infancy, and cardiometabolic health benefits had been observed among the participants in the intervention group. Here, we report on the key results of the first follow-up done 6 years after the end of the intervention, at age 26 years. METHODS The randomised controlled STRIP study recruited children at age 5 months from well-baby clinics in Turku, Finland, and randomly assigned them to either an intervention or control group; group allocation was unmasked. The intervention introduced participants to a heart-healthy diet, characterised by low proportional intake of saturated fat and cholesterol, by dietary counselling and nutrition education sessions to parents and children from the age of 7 months to 20 years. Children in the control group received only the basic health education given at Finnish well-baby clinics and school health care. We assessed diet, lifestyle, and cardiometabolic risk factor data, including blood pressure, anthropometry, serum biochemistry (lipids, apolipoproteins, glucose, and insulin), and homoeostatic model assessment of insulin resistance (HOMA-IR) in the participants at age 26 years. FINDINGS 1116 children were included in the original STRIP study, of whom 551 provided data at the age 26 years follow-up, and data for 507 participants were analysed (243 in the intervention group and 264 in the control group). At follow-up, those who had been in the intervention group had slightly lower mean intake of saturated fat as a proportion of total energy intake than the control group (13·0% [SD 3·3] vs 13·7% [3·6], p=0·049). A higher proportion of participants in the intervention group achieved the targeted monounsaturated and polyunsaturated fat to saturated fat ratio of more than 2:1 than the control group (78 [39%] of 200 vs 70 [30%] of 235; risk ratio [RR] 1·16 [95% CI 1·01-1·33]; p=0·035). A higher proportion of intervention group participants met the ideal total cholesterol concentration of less than 5·17 mmol/L (194 [81%] of 240 vs 187 [72%] of 261; RR 1·45 [1·05-2·01], p=0·024) and optimal LDL cholesterol concentration of less than 3·0 mmol/L (166 [69%] of 240 vs 158 [61%] of 251; RR 1·30 [1·03-1·66], p=0·031). Those who received the intervention had lower glucose (5·00 mmol/L [SD 0·43] vs 5·07 mmol/L [0·46], p=0·040) and HOMA-IR (median 1·44 [IQR 1·09-1·91] vs 1·62 [1·22-2·09], p=0·037) than the participants in the control group. INTERPRETATION Previously observed intervention effects during the 20-year counselling were largely maintained into adulthood 6 years after the withdrawal of the intervention. Dietary counselling introduced in infancy thus provided a sustained benefit to diet quality and cardiometabolic risk factor levels. FUNDING Academy of Finland, Juho Vainio Foundation, Finnish Foundation for Cardiovascular Research, Finnish Ministry of Education and Culture, Finnish Cultural Foundation, Sigrid Jusélius Foundation, Special Governmental grants for Health Sciences Research (Turku University Hospital), Yrjö Jahnsson Foundation, Finnish Medical Foundation, and Turku University Foundation.
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"[Repeat] testing and counseling is one of the key [services] that the government should continue providing": participants' perceptions on extended repeat HIV testing and enhanced counseling (ERHTEC) for primary HIV prevention in pregnant and lactating women in the PRIMAL study, Uganda.
Bannink Mbazzi, F, Namukwaya, Z, Amone, A, Ojok, F, Etima, J, Byamugisha, J, Katabira, E, Fowler, MG, Homsy, J, King, R, et al
BMC public health. 2020;(1):694
Abstract
BACKGROUND The 'Primary HIV Prevention among Pregnant and Lactating Ugandan Women' (PRIMAL) randomized controlled trial aimed to assess an enhanced counseling strategy linked to extended postpartum repeat HIV testing and enhanced counseling among 820 HIV-negative pregnant and lactating women aged 18-49 years and 410 of their male partners to address the first pillar of the WHO Global Strategy for the Prevention of Mother-to-Child HIV transmission (PMTCT). This paper presents findings of qualitative studies aimed at evaluating participants' and service providers' perceptions on the acceptability and feasibility of the intervention and at understanding the effects of the intervention on risk reduction, couple communication, and emotional support from women's partners. METHODS PRIMAL Study participants were enrolled from two antenatal care clinics and randomized 1:1 to an intervention or control arm. Both arms received repeat sexually transmitted infections (STI) and HIV testing at enrolment, labor and delivery, and at 3, 6, 12, 18 and 24 months postpartum. The intervention consisted of enhanced quarterly counseling on HIV risk reduction, couple communication, family planning and nutrition delivered by study counselors through up to 24 months post-partum. Control participants received repeat standard post-test counseling. Qualitative data were collected from intervention women participants, counsellors and midwives at baseline, midline and end of the study through 18 focus group discussions and 44 key informant interviews. Data analysis followed a thematic approach using framework analysis and a matrix-based system for organizing, reducing, and synthesizing data. RESULTS At baseline, FGD participants mentioned multiple sexual partners and lack of condom use as the main risks for pregnant and lactating women to acquire HIV. The main reasons for having multiple sexual partners were 1) the cultural practice not to have sex in the late pre-natal and early post-natal period; 2) increased sexual desire during pregnancy; 3) alcohol abuse; 4) poverty; and 5) conflict in couples. Consistent condom use at baseline was limited due to lack of knowledge and low acceptance of condom use in couples. The majority of intervention participants enrolled as couples felt enhanced counselling improved understanding, faithfulness, mutual support and appreciation within their couple. Another benefit mentioned by participants was improvement of couple communication and negotiation, as well as daily decision-making around sexual needs, family planning and condom use. Participants stressed the importance of providing counselling services to all couples. CONCLUSION This study shows that enhanced individual and couple counselling linked to extended repeat HIV and STI testing and focusing on HIV prevention, couple communication, family planning and nutrition is a feasible and acceptable intervention that could enhance risk reduction programs among pregnant and lactating women. TRIAL REGISTRATION ClinicalTrials.gov registration number NCT01882998, date of registration 21st June 2013.