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An Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides Modifies the Fecal Microbiome and Metabolome in Infants with Cow's Milk Protein Allergy.
Boulangé, CL, Pedersen, HK, Martin, FP, Siegwald, L, Pallejà Caro, A, Eklund, AC, Jia, W, Zhang, H, Berger, B, Sprenger, N, et al
International journal of molecular sciences. 2023;24(14)
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Human milk oligosaccharides (HMO) are important for the establishment and maturation of the early microbiome in infants and as such play a role in modulating immunity. The aim of this double-blind, randomised, controlled study was to evaluate the effect of HMO supplementation of extensively hydrolysed formula (EHF) on the faecal microbiome in infants with cow’s milk protein allergy (CMPA). 194 non-breastfed infants with CMPA were randomised to receive either an HMO supplemented EHF or control EHF until 12 months of age. The HMO supplemented infants displayed a higher abundance of bifidobacteria and slower microbiome maturation compared to controls as well as changes in faecal amino acid degradation and bile acid conjugation. These effects were more pronounced in infants who were started on the intervention before the age of 3 months. The authors concluded that HMO supplementation reversed, in part, the dysbiosis commonly observed in infants with CMPA.
Abstract
Cow's milk protein allergy (CMPA) is a prevalent food allergy among infants and young children. We conducted a randomized, multicenter intervention study involving 194 non-breastfed infants with CMPA until 12 months of age (clinical trial registration: NCT03085134). One exploratory objective was to assess the effects of a whey-based extensively hydrolyzed formula (EHF) supplemented with 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose (LNnT) on the fecal microbiome and metabolome in this population. Thus, fecal samples were collected at baseline, 1 and 3 months from enrollment, as well as at 12 months of age. Human milk oligosaccharides (HMO) supplementation led to the enrichment of bifidobacteria in the gut microbiome and delayed the shift of the microbiome composition toward an adult-like pattern. We identified specific HMO-mediated changes in fecal amino acid degradation and bile acid conjugation, particularly in infants commencing the HMO-supplemented formula before the age of three months. Thus, HMO supplementation partially corrected the dysbiosis commonly observed in infants with CMPA. Further investigation is necessary to determine the clinical significance of these findings in terms of a reduced incidence of respiratory infections and other potential health benefits.
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Association between prealbumin, all-cause mortality, and response to nutrition treatment in patients at nutrition risk: Secondary analysis of a randomized controlled trial.
Bretscher, C, Buergin, M, Gurzeler, G, Kägi-Braun, N, Gressies, C, Tribolet, P, Lobo, DN, Evans, DC, Stanga, Z, Mueller, B, et al
JPEN. Journal of parenteral and enteral nutrition. 2023;47(3):408-419
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Malnutrition amongst the elderly and those who are hospitalised due to multiple illnesses is frequent and increases risk of death. There have however been studies to show that there may be a way of identifying individuals at risk of malnutrition through measurements of biological markers. Prealbumin is a protein made in the liver that has been shown in smaller trials to be a possible biomarker for individuals at risk of malnutrition. This large cohort study of 517 individuals aimed to determine if prealbumin was associated with death and if nutritional support would improve survival. The results showed that individuals who were at risk of malnutrition with low prealbumin levels had almost double the mortality rate after 6 months. However individualised nutritional support did not improve mortality. It was concluded that prealbumin is a prognostic marker for death in nutritionally at-risk patients but does not identify individuals who may respond to nutritional support. This study could be used by healthcare professionals to understand that prealbumin may be helpful in identifying mortality risk amongst individuals at risk of malnutrition but not those who may benefit from personalised nutrition recommendations.
Abstract
BACKGROUND Because of the shorter half-life as compared with albumin, serum prealbumin concentrations have been proposed to be useful nutrition biomarkers for the assessment of patients at nutrition risk. In a post hoc analysis of patients at nutrition risk from a randomized controlled nutrition trial, we tested the hypothesis that (1) prealbumin is associated with higher all-cause 180-day mortality rates and that (2) individualized nutrition support compared with usual-care nutrition more effectively improves survival at 30 days in patients with low prealbumin levels compared with patients with normal prealbumin levels. METHODS We performed a prespecified cohort study in patients included in the pragmatic, Swiss, multicenter randomized controlled EFFORT trial comparing the effects of individualized nutrition support with usual care. We studied low prealbumin concentrations (<0.17 g/L) in a subgroup of 517 patients from one participating center. RESULTS A total of 306 (59.2%) patients (mean age 71.9 years, 53.6% men) had low admission prealbumin levels (<0.17 g/L). There was a significant association between low prealbumin levels and mortality at 180 days (115/306 [37.6%] vs 47/211 [22.3%], fully adjusted hazard ratio [HR]=1.59, 95% CI 1.11-2.28; P = 0.011). Prealbumin levels significantly improved the prognostic value of the Nutritional Risk Screening total score regarding mortality prediction at short- and long-term. The difference in mortality between patients receiving individualized nutrition support and usual-care nutrition was similar for patients with low prealbumin levels compared with patients with normal prealbumin levels (HR=0.90 [95% CI=0.51-1.59] vs HR=0.88 [95% CI=0.35-2.23]) with no evidence for interaction (P = 0.823). CONCLUSION Among medical inpatients at nutrition risk, low admission prealbumin levels correlated with different nutrition markers and higher mortality risk, but patients with low or high prealbumin levels had a similar benefit from nutrition support. Further studies should identify nutrition markers that help further personalize nutrition interventions.
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Improving health-related quality of life in women with breast, blood, and gynaecological Cancer with an eHealth-enabled 12-week lifestyle intervention: the women's wellness after Cancer program randomised controlled trial.
Seib, C, Anderson, D, McGuire, A, Porter-Steele, J, McDonald, N, Balaam, S, Sapkota, D, McCarthy, AL
BMC cancer. 2022;22(1):747
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Aging populations and the increased prevalence of other cancer risk factors have led to an increased incidence of cancer in women globally. Cancer treatments often leave women with a range of residual physical and psychological side effects. Comprehensive cancer rehabilitation can reduce symptom burden and health service utilisation, whilst generally improving health-related quality of life (HRQOL). The primary aim of this study was to test the efficacy of a multimodal, digitised lifestyle intervention on HRQOL of women treated for cancer. This study is a multi-centre, single-blinded, randomised controlled 12-week trial. Fifty-one women previously treated for breast, blood or gynaecological cancer were randomly assigned to either an intervention or usual care arm. Results indicate improvements in many HRQoL domains and in component summary scores. Particularly notable were the improvements in general health and bodily pain, vitality, mental health, and global physical and mental health summary scores among women in the intervention group. Authors conclude that the complex and synergistic effects of many modifiable health behaviours emphasise the need for bundled health behaviour interventions to optimise women’s health and wellbeing after completion of active cancer treatment.
Abstract
BACKGROUND The residual effects of cancer and its treatment can profoundly affect women's quality of life. This paper presents results from a multisite randomized controlled trial that evaluated the clinical benefits of an e-health enabled health promotion intervention (the Women's Wellness after Cancer Program or WWACP) on the health-related quality of life of women recovering from cancer treatment. METHODS Overall, 351 women previously treated for breast, blood or gynaecological cancers were randomly allocated to the intervention (WWACP) or usual care arms. The WWACP comprised a structured 12-week program that included online coaching and an interactive iBook that targeted physical activity, healthy diet, stress and menopause management, sexual wellbeing, smoking cessation, alcohol intake and sleep hygiene. Data were collected via a self-completed electronic survey at baseline (t0), 12 weeks (post-intervention, t1) and 24 weeks (to assess sustained behaviour change, t2). The primary outcome, health-related quality of life (HRQoL), was measured using the Short Form Health Survey (SF-36). RESULTS Following the 12-week lifestyle program, intervention group participants reported statistically significant improvements in general health, bodily pain, vitality, and global physical and mental health scores. Improvements were also noted in the control group across several HRQoL domains, though the magnitude of change was less. CONCLUSIONS The WWACP was associated with improved HRQoL in women previously treated for blood, breast, and gynaecological cancers. Given how the synergy of different lifestyle factors influence health behaviour, interventions accounting for the reciprocity of multiple health behaviours like the WWACP, have real potential for immediate and sustainable change. TRIAL REGISTRATION The protocol for this randomised controlled trial was submitted to the Australian and New Zealand Clinical Trials Registry on 15/07/2014 and approved on 28/07/2014 ( ACTRN12614000800628 ).
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Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study.
Montemayor, S, Mascaró, CM, Ugarriza, L, Casares, M, Llompart, I, Abete, I, Zulet, MÁ, Martínez, JA, Tur, JA, Bouzas, C
Nutrients. 2022;14(15)
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Non-alcoholic fatty liver disease (NAFLD) is characterised by fat deposition that is not linked to excessive alcohol intake. This condition is often linked to other health issues such as obesity, metabolic syndrome, type 2 diabetes and cardiovascular disease, and they share common diagnostic biomarkers. An unhealthy diet and lifestyle are also linked to the progression of NAFLD. Mediterranean diet is a predominantly plant-based diet that may have an association with lower risk and reduced severity of NAFLD. This multicentre, prospective, randomised controlled trial included one hundred and thirty-six NAFLD patients to analyse the effect of Mediterranean diet adherence on NAFLD in patients with metabolic syndrome. The NAFLD patients followed a personalised Mediterranean diet and physical activity interventions for six months. Individuals with greater adherence to the Mediterranean diet and physical activity interventions showed improvements in body mass index, body weight, waist circumference, blood pressure and intrahepatic fat content after six months of intervention. Healthcare professionals can use the results of this study to understand the benefits of adherence to the Mediterranean diet and physical activity interventions in reducing NAFLD severity and metabolic irregularities. However, due to the small sample size of this study, further robust studies are required to evaluate the benefits of different dietary strategies, the therapeutic value of different food items and the intervention duration required to achieve improvements in NAFLD and metabolic syndrome.
Abstract
Unhealthy diet is an important factor in the progression of non-alcoholic fatty liver disease (NAFLD). Previous studies showed the benefits of a Mediterranean diet (MedDiet) on Metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), and cardiovascular diseases, which usually have a pathophysiological relationship with NAFLD. To assess the effect of adherence to a MedDiet on NAFLD in MetS patients after lifestyle intervention, this multicentre (Mallorca and Navarra, Spain) prospective randomized trial, with personalized nutritional intervention based on a customized MedDiet, coupled with physical activity promotion was performed to prevent, and reverse NAFLD among patients with MetS. The current analysis included 138 patients aged 40 to 60 years old, Body Mass Index (BMI) 27-40 kg/m2, diagnosed with NAFLD using MRI, and MetS according to the International Diabetes Federation (IDF). A validated food frequency questionnaire was used to assess dietary intake. Adherence to Mediterranean diet by means of a 17-item validated questionnaire, anthropometrics, physical activity, blood pressure, blood biochemical parameters, and intrahepatic fat contents (IFC) were measured. The independent variable used was changes in MedDiet adherence, categorized in tertiles after 6 months follow-up. Subjects with high adherence to the MedDiet showed higher decreases in BMI, body weight, WC, SBP, DBP, and IFC. An association between improvement in adherence to the MedDiet and amelioration of IFC after 6-month follow-up was observed. High adherence to the MedDiet is associated with better status of MetS features, and better values of IFC.
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Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized Placebo-Controlled Multicenter Trial.
Pietrzak, A, Banasiuk, M, Szczepanik, M, Borys-Iwanicka, A, Pytrus, T, Walkowiak, J, Banaszkiewicz, A
Nutrients. 2022;14(16)
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Inflammatory bowel diseases (IBD), such as Crohn’s Disease and ulcerative colitis, are chronic gastrointestinal disorders with periods of exacerbation and remission. The disease develops as a result of an abnormal immune response in the gastrointestinal mucosa in genetically predisposed individuals exposed to certain environmental conditions. The primary aim of this study was to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD. This study is a prospective, randomised, and placebo-controlled trial. Patients (n = 80) were randomised and assigned to one of two groups: group A received butyric acid at a dose of 150 mg, and group B received 150 mg placebo. Results show that supplementation with sodium butyrate to be ineffective in the add-on treatment of newly diagnosed children and adolescents with IBD. Furthermore, during the study, none of the participants reported adverse events. Authors conclude that the results of their study will contribute to further studies that will determine which patients with IBD may benefit from sodium butyrate supplementation. Further clinical trials on large groups of patients are needed to establish if IBD patients may benefit from sodium butyrate.
Abstract
BACKGROUND Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD. METHODS This was a prospective, randomized, placebo-controlled multicenter study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study. RESULTS In total, 72 patients with initially active disease completed the study, 29 patients in group A and 43 in group B. At week 12 of the study, the majority of patients achieved remission. No difference in remission rate or median disease activity was found between the two groups (p = 0.37 and 0.31, respectively). None of the patients reported adverse events. CONCLUSIONS A 12-week supplementation with sodium butyrate, as adjunctive therapy, did not show efficacy in newly diagnosed children and adolescents with IBD.
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High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial.
Annweiler, C, Beaudenon, M, Gautier, J, Gonsard, J, Boucher, S, Chapelet, G, Darsonval, A, Fougère, B, Guérin, O, Houvet, M, et al
PLoS medicine. 2022;19(5):e1003999
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The Coronavirus Disease 2019 (COVID-19) caused hundreds of thousands of deaths, mostly in older adults. The aim of this study was to test whether a single oral high-dose of cholecalciferol (vitamin D3) administered within 72 hours after the diagnosis of COVID-19 improves, compared to standard-dose cholecalciferol, the 14-day overall survival among at-risk older adults who are positive to COVID-19. This study is an investigator-initiated, multicentre, open-label, parallel group, intent-to-treat, randomised controlled superiority clinical trial which involves the collaboration of 9 medical centres. Eligible participants (n=260) were randomly assigned to receive a single oral dose of either 400,000 IU (n=130) or 50,000 IU (n=130) cholecalciferol on the day of inclusion. Results show: - reduced overall mortality at day 14. - that high-dose cholecalciferol was safe and did not result in more frequent adverse effects compared to the standard dose. - that some benefits were also found on the 14-day mortality due to COVID-19 as well as on the overall mortality between day 6 and day 14. - that there was no evidence that the single high-dose vitamin D3 administered early in COVID-19 provided any benefit on overall mortality for up to 28 days. Authors conclude that high-dose oral cholecalciferol supplementation is a simple, safe, and inexpensive treatment which may be of interest as an adjuvant to provide a bridge to recovery for at-risk older adults facing the emergence of immune escape variants.
Abstract
BACKGROUND Vitamin D supplementation has been proposed as a treatment for Coronavirus Disease 2019 (COVID-19) based on experimental data and data from small and uncontrolled observational studies. The COvid19 and VITamin d TRIAL (COVIT-TRIAL) study was conducted to test whether a single oral high dose of cholecalciferol (vitamin D3) administered within 72 hours after the diagnosis of COVID-19 improves, compared to standard-dose cholecalciferol, the 14-day overall survival among at-risk older adults infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). METHODS AND FINDINGS This multicenter, randomized, controlled, open-label, superiority trial involved collaboration of 9 medical centers in France. Patients admitted to the hospital units or living in nursing homes adjacent to the investigator centers were eligible if they were ≥65 years, had SARS-CoV-2 infection of less than 3 days, and at least 1 COVID-19 worsening risk factor (among age ≥75 years, SpO2 ≤94%, or PaO2/FiO2 ≤300 mm Hg). Main noninclusion criteria were organ failure requiring ICU, SpO2 ≤92% despite 5 L/min oxygen, life expectancy <3 months, vitamin D supplementation >800 IU/day during the preceding month, and contraindications to vitamin D supplements. Eligible and consenting patients were randomly allocated to either a single oral high-dose (400,000 IU) or standard-dose (50,000 IU) cholecalciferol administered under medical supervision within 72 hours after the diagnosis of COVID-19. Participants and local study staff were not masked to the allocated treatment, but the Steering Committee and the Data and Safety Monitoring Board were masked to the randomization group and outcome data during the trial. The primary outcome was 14-day overall mortality. Between April 15 and December 17, 2020, of 1,207 patients who were assessed for eligibility in the COVIT-TRIAL study, 254 met eligibility criteria and formed the intention-to-treat population. The median age was 88 (IQR, 82 to 92) years, and 148 patients (58%) were women. Overall, 8 (6%) of 127 patients allocated to high-dose cholecalciferol, and 14 (11%) of 127 patients allocated to standard-dose cholecalciferol died within 14 days (adjusted hazard ratio = 0.39 [95% confidence interval [CI], 0.16 to 0.99], P = 0.049, after controlling for randomization strata [i.e., age, oxygen requirement, hospitalization, use of antibiotics, anti-infective drugs, and/or corticosteroids] and baseline imbalances in important prognostic factors [i.e., sex, ongoing cancers, profuse diarrhea, and delirium at baseline]). The number needed to treat for one person to benefit (NNTB) was 21 [NNTB 9 to ∞ to number needed to treat for one person to harm (NNTH) 46]. Apparent benefits were also found on 14-day mortality due to COVID-19 (7 (6%) deaths in high-dose group and 14 (11%) deaths in standard-dose group; adjusted hazard ratio = 0.33 [95% CI, 0.12 to 0.86], P = 0.02). The protective effect of the single oral high-dose administration was not sustained at 28 days (19 (15%) deaths in high-dose group and 21 (17%) deaths in standard-dose group; adjusted hazard ratio = 0.70 [95% CI, 0.36 to 1.36], P = 0.29). High-dose cholecalciferol did not result in more frequent adverse effects compared to the standard dose. The open-label design and limited study power are the main limitations of the study. CONCLUSIONS In this randomized controlled trial (RCT), we observed that the early administration of high-dose versus standard-dose vitamin D3 to at-risk older patients with COVID-19 improved overall mortality at day 14. The effect was no longer observed after 28 days. TRIAL REGISTRATION ClinicalTrials.gov NCT04344041.
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Association of Major Dietary Protein Sources With All-Cause and Cause-Specific Mortality: Prospective Cohort Study.
Sun, Y, Liu, B, Snetselaar, LG, Wallace, RB, Shadyab, AH, Kroenke, CH, Haring, B, Howard, BV, Shikany, JM, Valdiviezo, C, et al
Journal of the American Heart Association. 2021;10(5):e015553
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Dietary recommendations for human health focusing on total protein intake without considering specific protein sources may be simplistic and insufficient. The aim of this study was to investigate whether different dietary protein sources would be differentially associated with mortality risk. The study is based on data from a large prospective cohort study with up to 18-years of follow-up to investigate the risks of all-cause and cause-specific mortality in relation to animal and plant protein intake, and major sources of dietary protein. Results indicate that intake of plant protein and substitution of animal protein with plant protein, were associated with lower risk of all-cause, cardiovascular disease, and dementia mortality. Furthermore, substitution of red meat, eggs, dairy products, or legumes with nuts was associated with lower risk of all-cause mortality. Authors conclude that their findings support the need for consideration of protein sources, in addition to the amount of protein intake, in future dietary guidelines.
Abstract
Background Dietary recommendations regarding protein intake have been focused on the amount of protein. However, such recommendations without considering specific protein sources may be simplistic and insufficient. Methods and Results We included 102 521 postmenopausal women enrolled in the Women's Health Initiative between 1993 and 1998, and followed them through February 2017. During 1 876 205 person-years of follow-up, 25 976 deaths occurred. Comparing the highest with the lowest quintile, plant protein intake was inversely associated with all-cause mortality (hazard ratio [HR], 0.91 [0.86, 0.96]), cardiovascular disease mortality (HR, 0.88 [0.79, 0.97]), and dementia mortality (HR, 0.79 [0.67, 0.94]). Among major protein sources, comparing the highest with the lowest quintile of consumption, processed red meat (HR, 1.06 [1.01, 1.10]) or eggs (HR, 1.14 [1.10, 1.19]) was associated with higher risk of all-cause mortality. Unprocessed red meat (HR, 1.12 [1.02, 1.23]), eggs (HR, 1.24 [1.14, 1.34]), or dairy products (HR, 1.11 [1.02, 1.22]) was associated with higher risk of cardiovascular disease mortality. Egg consumption was associated with higher risk of cancer mortality (HR, 1.10 [1.02, 1.19]). Processed red meat consumption was associated with higher risk of dementia mortality (HR, 1.20 [1.05, 1.32]), while consumption of poultry (HR, 0.85 [0.75, 0.97]) or eggs (HR, 0.86 [0.75, 0.98]) was associated with lower risk of dementia mortality. In substitution analysis, substituting of animal protein with plant protein was associated with a lower risk of all-cause mortality, cardiovascular disease mortality, and dementia mortality, and substitution of total red meat, eggs, or dairy products with nuts was associated with a lower risk of all-cause mortality. Conclusions Different dietary protein sources have varying associations with all-cause mortality, cardiovascular disease mortality, and dementia mortality. Our findings support the need for consideration of protein sources in future dietary guidelines.
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Health behavior patterns of sugar-sweetened beverage consumption among Brazilian adolescents in a nationally representative school-based study.
Rocha, LL, Pessoa, MC, Gratão, LHA, Carmo, ASD, Cunha, CF, Oliveira, TRPR, Mendes, LL
PloS one. 2021;16(1):e0245203
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Sugar sweetened beverages (SSB) are ultra-processed foods containing several man-made chemicals, which heavily feature in the diets of adolescents in many developing countries. This cross-sectional study of 74,589 adolescents aimed to determine health behaviour patterns that affect SSB consumption to focus education and policy efforts to reduce consumption. The results showed that most adolescents who consumed SSB’s had higher consumption of processed foods, more screen time, more days of alcoholic beverage consumption, were more likely to purchase food from the school canteen, and a smoking habit. Those who had a higher consumption of water, minimally processed foods and frequent physical activity were less likely to consume SSB’s. It was concluded that healthy habits can aid implementation of other beneficial health behaviours. This study could be used by healthcare professionals to understand the importance of adopting healthy habits to decrease SSB and ultra-processed food consumption.
Abstract
Studies on sugar-sweetened beverage consumption patterns can help in the individual and population level management of chronic non-communicable diseases and other conditions. This study aimed to identify the association between health behavior patterns and the consumption of sugar-sweetened beverages among Brazilian adolescents from a nationally representative school-based study. A cross-sectional study analyzed data from 71,553 adolescents aged 12-17 years who attended public and private schools in Brazilian cities, from the Study of Cardiovascular Risk in Adolescents. Principal component analysis was performed to identify health behavior patterns, and ordered logistic regression was performed to identify the association between health behavior patterns and sugar-sweetened beverage consumption. Sugar-sweetened beverage consumption (mL/day) was used as the dependent variable. The analyses were performed using Stata software version 14.0 with a significance level of 0.05. Patterns 2 (alcoholic beverage and smoking habit) and 3 (ultra-processed food and screen time) of health behaviors and regularly purchasing snacks in the school cafeteria increased the odds of sugar-sweetened beverage consumption, while pattern 1 (water, unprocessed and minimally processed food and physical activity) decreased these odds. The adoption of healthy habits can indirectly stimulate the adoption of other habits beneficial to health. These results indicate the importance of adopting a set of regulatory measures to reduce sugar-sweetened beverage consumption.
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Digital messaging to support control for type 2 diabetes (StAR2D): a multicentre randomised controlled trial.
Farmer, A, Bobrow, K, Leon, N, Williams, N, Phiri, E, Namadingo, H, Cooper, S, Prince, J, Crampin, A, Besada, D, et al
BMC public health. 2021;21(1):1907
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Many individuals with type 2 diabetes find it challenging to adhere to treatments possibly due to lack of support. Text messaging has been shown to be effective for treatment adherence in various parts of the world, yet it is unclear on its effect in Malawi and sub-Saharan Africa. The aim of this randomised control trial of 1186 individuals was to determine the effect of motivational and educational text messages three to four times per week for 12 months on treatment success. The results showed that SMS text messages resulted in improved blood pressure and achievement of treatment goals, yet no effect on blood sugar control. It was concluded that text messaging without other support from health care professionals may be inadequate for the self-management of type 2 diabetes. This study could be used by health care professionals to understand that there are additional support strategies for individuals with type 2 diabetes, yet these should be secondary to the input from professionals.
Abstract
BACKGROUND Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes. METHODS StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals. RESULTS The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (- 0.08% (- 0.31 to 0.16) (IFCC - 0.82 mmol/mol (- 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was - 0.71% (- 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful. CONCLUSIONS Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes. TRIAL REGISTRATION Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.
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The PREVIEW intervention study: Results from a 3-year randomized 2 x 2 factorial multinational trial investigating the role of protein, glycaemic index and physical activity for prevention of type 2 diabetes.
Raben, A, Vestentoft, PS, Brand-Miller, J, Jalo, E, Drummen, M, Simpson, L, Martinez, JA, Handjieva-Darlenska, T, Stratton, G, Huttunen-Lenz, M, et al
Diabetes, obesity & metabolism. 2021;23(2):324-337
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The main risk for the development of type 2 diabetes is being overweight or obese. Strategies to decrease weight are important to prevent its development or reverse disease. This long-term, randomised control trial of 2326 adults with prediabetes, aimed to compare the effectiveness of different maintenance diets, after initial weight loss; one which was high protein and low glycaemic index, and the other which was moderate protein and moderate glycaemic index. These diets were then combined with either moderate intensity or high intensity exercise. The results showed that after 3 years, the incidence of type 2 diabetes was low and did not differ between the diet and exercise groups. However, more individuals achieved normal blood sugar levels when on a moderate protein diet combined with moderate exercise and when on a high protein diet combined with moderate exercise. The high protein diet with high intensity exercise was the least effective at maintaining normal blood sugar levels. The amount of weight lost was the same no matter what combination of diet and exercise. It was concluded that the incidence of type 2 diabetes was lower than expected with the diet and exercise regimes and did not differ between the diets. This study could be used by healthcare professionals to introduce a long-term protocol combining weight loss, healthy eating, and physical activity to pre diabetic individuals who want to reduce their chance of developing type 2 diabetes.
Abstract
AIM: To compare the impact of two long-term weight-maintenance diets, a high protein (HP) and low glycaemic index (GI) diet versus a moderate protein (MP) and moderate GI diet, combined with either high intensity (HI) or moderate intensity physical activity (PA), on the incidence of type 2 diabetes (T2D) after rapid weight loss. MATERIALS AND METHODS A 3-year multicentre randomized trial in eight countries using a 2 x 2 diet-by-PA factorial design was conducted. Eight-week weight reduction was followed by a 3-year randomized weight-maintenance phase. In total, 2326 adults (age 25-70 years, body mass index ≥ 25 kg/m2 ) with prediabetes were enrolled. The primary endpoint was 3-year incidence of T2D analysed by diet treatment. Secondary outcomes included glucose, insulin, HbA1c and body weight. RESULTS The total number of T2D cases was 62 and the cumulative incidence rate was 3.1%, with no significant differences between the two diets, PA or their combination. T2D incidence was similar across intervention centres, irrespective of attrition. Significantly fewer participants achieved normoglycaemia in the HP compared with the MP group (P < .0001). At 3 years, normoglycaemia was lowest in HP-HI (11.9%) compared with the other three groups (20.0%-21.0%, P < .05). There were no group differences in body weight change (-11% after 8-week weight reduction; -5% after 3-year weight maintenance) or in other secondary outcomes. CONCLUSIONS Three-year incidence of T2D was much lower than predicted and did not differ between diets, PA or their combination. Maintaining the target intakes of protein and GI over 3 years was difficult, but the overall protocol combining weight loss, healthy eating and PA was successful in markedly reducing the risk of T2D. This is an important clinically relevant outcome.