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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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Effect of a multi-domain lifestyle intervention on cardiovascular risk in older people: the FINGER trial.
Lehtisalo, J, Rusanen, M, Solomon, A, Antikainen, R, Laatikainen, T, Peltonen, M, Strandberg, T, Tuomilehto, J, Soininen, H, Kivipelto, M, et al
European heart journal. 2022;43(21):2054-2061
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Older people are at high risk of cardiovascular disease, and 90% of the risk factors can be modified, including an unhealthy diet, poor physical activity, obesity, smoking, and obesity-related comorbidities. This randomised controlled trial examined a multifactorial approach combining several lifestyle modifications in 1259 older adults between 60 and 77 years of age to reduce the risk of cardiovascular disease. Participants were randomly assigned to intensive multi-domain lifestyle intervention or regular health advice control groups. The multifactorial lifestyle intervention incorporated dietary counselling, exercise training, cognitive training, and managing CVD and metabolic risk factors. Dietary interventions included tailored strategies that considered increased consumption of fruits, berries, vegetables, whole grains, margarine, oil, and fish. Physical exercise interventions included strength training, balance exercises, and aerobic exercises. Cognitive interventions and intensive strategies to manage metabolic factors were also implemented. In the multifactorial lifestyle intervention group, cerebrovascular events were lower after two years than in the control group. In addition, cardiovascular disease and stroke incidence were lower in the elderly with a history of cardiovascular disease. Healthcare professionals can use the results from this study to understand the benefits of multifactorial lifestyle interventions on cardiovascular disease. However, there is a need for longer-term robust studies since the evidence is sparse.
Abstract
AIMS: Joint prevention of cardiovascular disease (CVD) and dementia could reduce the burden of both conditions. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) demonstrated a beneficial effect on cognition (primary outcome) and we assessed the effect of this lifestyle intervention on incident CVD (pre-specified secondary outcome). METHODS AND RESULTS FINGER enrolled 1259 individuals aged 60-77 years (ClinicalTrials.gov NCT01041989). They were randomized (1:1) to a 2-year multi-domain intervention with diet, physical and cognitive activity, and vascular monitoring (n = 631), or general health advice (n = 628). National registries provided data on CVD including stroke, transient ischaemic attack (TIA), or coronary heart event. During an average of 7.4 years, 229 participants (18%) had at least one CVD diagnosis: 107 in the intervention group and 122 in the control group. The incidence of cerebrovascular events was lower in the intervention than the control group: hazard ratio (HR) for combined stroke/TIA was 0.71 [95% confidence interval (CI): 0.51-0.99] after adjusting for background characteristics. Hazard ratio for coronary events was 0.84 (CI: 0.56-1.26) and total CVD events 0.80 (95% CI: 0.61-1.04). Among those with history of CVD (n = 145), the incidence of both total CVD events (HR: 0.50, 95% CI: 0.28-0.90) and stroke/TIA (HR: 0.40, 95% CI: 0.20-0.81) was lower in the intervention than the control group. CONCLUSION A 2-year multi-domain lifestyle intervention among older adults was effective in preventing cerebrovascular events and also total CVD events among those who had history of CVD.
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Quantifying dementia prevention potential in the FINGER randomized controlled trial using the LIBRA prevention index.
Deckers, K, Köhler, S, Ngandu, T, Antikainen, R, Laatikainen, T, Soininen, H, Strandberg, T, Verhey, F, Kivipelto, M, Solomon, A
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2021;17(7):1205-1212
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Lifestyle interventions are being increasingly recognised to delay or prevent the onset of dementia. Scientific research targeting one lifestyle factor has continually failed to show any benefits and therefore interventions targeting several lifestyle factors, before disease onset may be more beneficial. The Lifestyle for BRAin Health (LIBRA) score is a tool which assesses peoples risk of dementia based on several lifestyle factors and this trial used this tool to determine the dementia risk of individuals who entered The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). This study was the first randomised control trial showing benefits to cognition following multi-domain lifestyle interventions. The results showed that higher LIBRA score at the start of the trial was associated with poorer brain function over time and that the multi-domain lifestyle intervention was effective at decreasing LIBRA score, regardless of the risk at the start of the trial. It was concluded that LIBRA may be a useful tool to determine risk of dementia and that the FINGER intervention was of benefit to individuals regardless of their risk of dementia.
Abstract
INTRODUCTION Individuals in early dementia prevention trials may differ in how much they benefit from interventions depending on their initial risk level. Additionally, modifiable dementia risk scores might be used as surrogate/intermediate outcomes. METHODS In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), we investigated in post hoc analyses (N = 1207) whether the cognitive benefits of the 2-year multi-domain lifestyle intervention differed by baseline dementia risk measured with the "LIfestyle for BRAin Health" (LIBRA) score. We also investigated intervention effects on change in LIBRA score over time. RESULTS Overall, higher baseline LIBRA was related to less cognitive improvement over time. This association did not differ between the intervention and control groups. The intervention was effective in decreasing LIBRA scores over time, regardless of baseline demographics or cognition. DISCUSSION The cognitive benefit of the FINGER intervention was similar across individuals with different LIBRA scores at baseline. Furthermore, LIBRA may be useful as a surrogate/intermediate endpoint and surveillance tool to monitor intervention success during trial execution.
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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
Abstract
Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
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Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial.
Vargas-Ortiz, K, Lira-Mendiola, G, Gómez-Navarro, CM, Padilla-Estrada, K, Angulo-Romero, F, Hernández-Márquez, JM, Villa-Martínez, AK, González-Mena, JN, Macías-Cervantes, MH, Reyes-Escogido, ML, et al
BMC public health. 2020;20(1):97
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In individuals at high risk of type 2 diabetes, lifestyle interventions rather than medication have been more successful in preventing development of the disease, however the benefits of lifestyle strategies diminishes over time due to possible adherence issues. Prolonged lifestyle changes may be affected by lack of family support, but research on family support during lifestyle changes in individuals prior to diabetes is lacking. This parallel randomised control trial of 122 patients with prediabetes and 101 of their family members aimed to assess the impact of family supported diet and exercise changes compared to self-motivation on individuals with prediabetes. At 6 months, body measurements and markers of prediabetes improved in both groups. Lipids were significantly improved in the group with family support compared to having no support. At 12 months there were a high number of dropouts due to lack of patient interest. Benefits shown at 6 months in both groups were only maintained or improved upon with family support and the lipid profile of the individual intervention group actually worsened in comparison to when participants entered the trial. After 12 months the incidence rate of type 2 diabetes was similar in both groups. Individuals with prediabetes who had family support whilst undergoing a diet and exercise regime were more successful at maintaining improvements of factors contributing to diabetes, compared to individuals without support. However this did not affect the occurrence of type 2 diabetes. Clinicians could use this paper to communicate the importance of family support during lifestyle changes in patients at high risk of developing type 2 diabetes, although close monitoring may be required to ensure compliance.
Abstract
BACKGROUND Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. METHODS Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015-2016 and analyzed in 2017-2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. RESULTS FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%). CONCLUSIONS FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. TRIAL REGISTRATION This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).
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Ethnic Differences in the Prevalence of Type 2 Diabetes Diagnoses in the UK: Cross-Sectional Analysis of the Health Improvement Network Primary Care Database.
Pham, TM, Carpenter, JR, Morris, TP, Sharma, M, Petersen, I
Clinical epidemiology. 2019;11:1081-1088
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Type 2 diabetes mellitus is associated with substantial disease burden, including increased mortality risk and significant long-term morbidity. The aim of this study was to examine the prevalence of type 2 diabetes diagnoses based on primary care electronic health records. This study is a cross-sectional analysis of health records data from The Health Improvement Network primary care database. The sample comprised 51% women; most of the individuals in the sample (approximately 80%) were below 60 years of age. Results show that compared with those of White ethnicity, the likelihood of having a type 2 diabetes diagnosis was more than double among Asian people, 65% more likely among Black people, and 17% more likely among people of Mixed/Other ethnicity. Authors conclude that accurate estimates of ethnic prevalence of type 2 diabetes are important for ensuring that public health resources are allocated appropriately for diabetes screening and lifestyle interventions.
Abstract
AIMS/HYPOTHESIS Type 2 diabetes mellitus is associated with high levels of disease burden, including increased mortality risk and significant long-term morbidity. The prevalence of diabetes differs substantially among ethnic groups. We examined the prevalence of type 2 diabetes diagnoses in the UK primary care setting. METHODS We analysed data from 404,318 individuals in The Health Improvement Network database, aged 0-99 years and permanently registered with general practices in London. The association between ethnicity and the prevalence of type 2 diabetes diagnoses in 2013 was estimated using a logistic regression model, adjusting for effect of age group, sex, and social deprivation. A multiple imputation approach utilising population-level information about ethnicity from the UK census was used for imputing missing data. RESULTS Compared with those of White ethnicity (5.04%, 95% CI 4.95 to 5.13), the crude percentage prevalence of type 2 diabetes was higher in the Asian (7.69%, 95% CI 7.46 to 7.92) and Black (5.58%, 95% CI 5.35 to 5.81) ethnic groups, while lower in the Mixed/Other group (3.42%, 95% CI 3.19 to 3.66). After adjusting for differences in age group, sex, and social deprivation, all minority ethnic groups were more likely to have a diagnosis of type 2 diabetes compared with the White group (OR Asian versus White 2.36, 95% CI 2.26 to 2.47; OR Black versus White 1.65, 95% CI 1.56 to 1.73; OR Mixed/Other versus White 1.17, 95% CI 1.08 to 1.27). CONCLUSION The prevalence of type 2 diabetes was higher in the Asian and Black ethnic groups, compared with the White group. Accurate estimates of ethnic prevalence of type 2 diabetes based on large datasets are important for facilitating appropriate allocation of public health resources, and for allowing population-level research to be undertaken examining disease trajectories among minority ethnic groups, that might help reduce inequalities.
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Comparison of the Effectiveness of Lifestyle Modification with Other Treatments on the Incidence of Type 2 Diabetes in People at High Risk: A Network Meta-Analysis.
Yamaoka, K, Nemoto, A, Tango, T
Nutrients. 2019;11(6)
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The prevalence of diabetes has been increasing worldwide. The accompanying increase in the prevalence of diabetes-related complications and the occurrence of diabetes are likely to have a substantial impact on healthcare costs. The aim of the study was to compare the effectiveness of lifestyle modifications to other treatments for patients at high risk of type 2 diabetes. The study design is a systemic review of published literature and a network meta-analysis of data from each selected study. Forty-seven interventions were used for the analyses. The results of the meta-analysis highlight the efficacy of lifestyle modification in preventing the onset of type 2 diabetes in high-risk patients in comparison with standard treatment or placebo as well as other treatments. The proportion of patients with onset of type 2 diabetes in the intervention (lifestyle modification) group was approximately twice as low as compared to the control (standard intervention) group. Authors conclude that lifestyle modification is the superior treatment intervention among 12 treatments for the prevention of type 2 diabetes in high-risk individuals.
Abstract
BACKGROUND Many clinical trials have been conducted to verify the effects of interventions for prevention of type 2 diabetes (T2D) using different treatments and outcomes. The aim of this study was to compare the effectiveness of lifestyle modifications (LM) with other treatments in persons at high risk of T2D by a network meta-analysis (NMA). METHODS Searches were performed of PUBMED up to January 2018 to identify randomized controlled trials. The odds ratio (OR) with onset of T2D at 1 year in the intervention group (LM, dietary, exercise, or medication) versus a control group (standard treatments or placebo) were the effect sizes. Frequentist and Bayesian NMAs were conducted. RESULTS Forty-seven interventions and 12 treatments (20,113 participants) were used for the analyses. The OR in the LM was approximately 0.46 (95% CI: 0.33 to 0.61) times lower compared to the standard intervention by the Bayesian approach. The effects of LM compared to other treatments by indirect comparisons were not significant. CONCLUSIONS This meta-analysis further strengthened the evidence that LM reduces the onset of T2D compared to standard and placebo interventions and appears to be at least as effective as nine other treatments in preventing T2D.
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Evaluation of a 12-week lifestyle education intervention with or without partial meal replacement in Thai adults with obesity and metabolic syndrome: a randomised trial.
Chaiyasoot, K, Sarasak, R, Pheungruang, B, Dawilai, S, Pramyothin, P, Boonyasiri, A, Supapueng, O, Jassil, FC, Yamwong, P, Batterham, RL
Nutrition & diabetes. 2018;8(1):23
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Obesity and metabolic syndrome (MetS) have markedly increased in many low- and middle-income countries, such as Thailand, as a consequence of economic growth, increased urbanisation and adoption of a ‘western’ lifestyle. Weight-loss interventions by reducing energy intake and increasing physical activity through behavioural modification are the mainstay of the treatment of obesity and MetS, but poor compliance is a problem. The aim of this randomised study was to evaluate the effect of a low-cost lifestyle education intervention (LEI) alone or a LEI with meal replacements (LEI + MR) in Thai adults with obesity and MetS for 12 weeks. The lifestyle education was delivered by a dietitian and comprised a group session at baseline with advice on diet and physical activity, followed by four individual sessions at weeks 2, 4, 8 and 12. In addition, the LEI + MR group also received two meal replacement formula meals per day. The LEI+MR group lost more weight than the LEI group, 2.86% versus 1.53%. Weight loss was maintained at 26 weeks after the end of the intervention, but had gone back to baseline after another 26 weeks. Overall, the LEI+MR group had better outcomes in blood sugar control and metabolic syndrome scores. The authors conclude that both LEI and LEI + MR are acceptable for Thai patients with obesity and MetS and lead to modest weight loss and improvement in MetS and blood sugar control, with the LEI + MR group showing greater benefits at 12 weeks
Abstract
BACKGROUND/OBJECTIVES There have been no studies examining the efficacy of meal replacement (MR) on weight loss and metabolic syndrome (MS) improvement in Southeast Asians. Thus, we undertook a 12-week randomised trial to evaluate the effect of a lifestyle education intervention alone (LEI) or with partial MR (LEI + MR) in obese Thai adults with MS. SUBJECTS/METHODS A total of 110 patients were randomised to receive either LEI or LEI + MR. Both groups received LEI to achieve weight loss. LEI + MR group additionally received two MR daily to replace either breakfast, lunch or dinner. Mean ± SE body mass index of all participants was 34.6 ± 0.6 kg/m2, mean ± SE age was 42.5 ± 1.1 years and 83% of patients were female. Both groups were compared for anthropometric and cardiometabolic indices at 12-week. Body weight was also compared at weeks 38 and 64. RESULTS At 12 weeks, both groups exhibited statistically significant percentage weight loss (%WL) compared to initial weight but greater %WL was observed in LEI + MR compared to LEI, 2.9% vs. 1.5%, respectively (p < 0.05). MS criteria such as waist circumference and blood pressure improved significantly in both groups compared to baseline. However, improvement in fasting plasma glucose (FPG) was only significant in LEI + MR, and more participants with impaired FPG at baseline in LEI + MR (42.9%) than LEI (19%) returned to normal FPG at 12 weeks (p < 0.05). HbA1c, fasting insulin and HOMA-IR in LEI + MR were significantly lower than with LEI. At the end of the 12-week intervention period, 16% of participants no longer fulfilled MS criteria. A statistically significant weight loss from baseline persisted until 38 weeks but no longer reached statistically significant difference between groups CONCLUSIONS LEI and LEI + MR were acceptable and led to improvement in weight and MS. LEI + MR group exhibited additional weight reduction and glycemic benefits at 12 weeks.
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Physical activity, diet and other behavioural interventions for improving cognition and school achievement in children and adolescents with obesity or overweight.
Martin, A, Booth, JN, Laird, Y, Sproule, J, Reilly, JJ, Saunders, DH
The Cochrane database of systematic reviews. 2018;3:CD009728
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Obesity in children and teenagers is markedly high worldwide and this has been linked to poor performance in school. While physical activity and diet are known to impact cognitive function, studies have not considered to what extent healthy lifestyle interventions can improve school performance in this cohort. The aim of this systematic review was to explore whether these interventions can improve school performance in children and teenagers with obesity. Based on the current literature, increased nutrition education and improved food offered within schools can lead to moderate improvements in school achievement when compared with standard school practice in children with obesity. The authors conclude that more high quality, school subject-specific research is needed to shed light on the extent of these benefits.
Abstract
BACKGROUND The global prevalence of childhood and adolescent obesity is high. Lifestyle changes towards a healthy diet, increased physical activity and reduced sedentary activities are recommended to prevent and treat obesity. Evidence suggests that changing these health behaviours can benefit cognitive function and school achievement in children and adolescents in general. There are various theoretical mechanisms that suggest that children and adolescents with excessive body fat may benefit particularly from these interventions. OBJECTIVES To assess whether lifestyle interventions (in the areas of diet, physical activity, sedentary behaviour and behavioural therapy) improve school achievement, cognitive function (e.g. executive functions) and/or future success in children and adolescents with obesity or overweight, compared with standard care, waiting-list control, no treatment, or an attention placebo control group. SEARCH METHODS In February 2017, we searched CENTRAL, MEDLINE and 15 other databases. We also searched two trials registries, reference lists, and handsearched one journal from inception. We also contacted researchers in the field to obtain unpublished data. SELECTION CRITERIA We included randomised and quasi-randomised controlled trials (RCTs) of behavioural interventions for weight management in children and adolescents with obesity or overweight. We excluded studies in children and adolescents with medical conditions known to affect weight status, school achievement and cognitive function. We also excluded self- and parent-reported outcomes. DATA COLLECTION AND ANALYSIS Four review authors independently selected studies for inclusion. Two review authors extracted data, assessed quality and risks of bias, and evaluated the quality of the evidence using the GRADE approach. We contacted study authors to obtain additional information. We used standard methodological procedures expected by Cochrane. Where the same outcome was assessed across different intervention types, we reported standardised effect sizes for findings from single-study and multiple-study analyses to allow comparison of intervention effects across intervention types. To ease interpretation of the effect size, we also reported the mean difference of effect sizes for single-study outcomes. MAIN RESULTS We included 18 studies (59 records) of 2384 children and adolescents with obesity or overweight. Eight studies delivered physical activity interventions, seven studies combined physical activity programmes with healthy lifestyle education, and three studies delivered dietary interventions. We included five RCTs and 13 cluster-RCTs. The studies took place in 10 different countries. Two were carried out in children attending preschool, 11 were conducted in primary/elementary school-aged children, four studies were aimed at adolescents attending secondary/high school and one study included primary/elementary and secondary/high school-aged children. The number of studies included for each outcome was low, with up to only three studies per outcome. The quality of evidence ranged from high to very low and 17 studies had a high risk of bias for at least one item. None of the studies reported data on additional educational support needs and adverse events.Compared to standard practice, analyses of physical activity-only interventions suggested high-quality evidence for improved mean cognitive executive function scores. The mean difference (MD) was 5.00 scale points higher in an after-school exercise group compared to standard practice (95% confidence interval (CI) 0.68 to 9.32; scale mean 100, standard deviation 15; 116 children, 1 study). There was no statistically significant beneficial effect in favour of the intervention for mathematics, reading, or inhibition control. The standardised mean difference (SMD) for mathematics was 0.49 (95% CI -0.04 to 1.01; 2 studies, 255 children, moderate-quality evidence) and for reading was 0.10 (95% CI -0.30 to 0.49; 2 studies, 308 children, moderate-quality evidence). The MD for inhibition control was -1.55 scale points (95% CI -5.85 to 2.75; scale range 0 to 100; SMD -0.15, 95% CI -0.58 to 0.28; 1 study, 84 children, very low-quality evidence). No data were available for average achievement across subjects taught at school.There was no evidence of a beneficial effect of physical activity interventions combined with healthy lifestyle education on average achievement across subjects taught at school, mathematics achievement, reading achievement or inhibition control. The MD for average achievement across subjects taught at school was 6.37 points lower in the intervention group compared to standard practice (95% CI -36.83 to 24.09; scale mean 500, scale SD 70; SMD -0.18, 95% CI -0.93 to 0.58; 1 study, 31 children, low-quality evidence). The effect estimate for mathematics achievement was SMD 0.02 (95% CI -0.19 to 0.22; 3 studies, 384 children, very low-quality evidence), for reading achievement SMD 0.00 (95% CI -0.24 to 0.24; 2 studies, 284 children, low-quality evidence), and for inhibition control SMD -0.67 (95% CI -1.50 to 0.16; 2 studies, 110 children, very low-quality evidence). No data were available for the effect of combined physical activity and healthy lifestyle education on cognitive executive functions.There was a moderate difference in the average achievement across subjects taught at school favouring interventions targeting the improvement of the school food environment compared to standard practice in adolescents with obesity (SMD 0.46, 95% CI 0.25 to 0.66; 2 studies, 382 adolescents, low-quality evidence), but not with overweight. Replacing packed school lunch with a nutrient-rich diet in addition to nutrition education did not improve mathematics (MD -2.18, 95% CI -5.83 to 1.47; scale range 0 to 69; SMD -0.26, 95% CI -0.72 to 0.20; 1 study, 76 children, low-quality evidence) and reading achievement (MD 1.17, 95% CI -4.40 to 6.73; scale range 0 to 108; SMD 0.13, 95% CI -0.35 to 0.61; 1 study, 67 children, low-quality evidence). AUTHORS' CONCLUSIONS Despite the large number of childhood and adolescent obesity treatment trials, we were only able to partially assess the impact of obesity treatment interventions on school achievement and cognitive abilities. School and community-based physical activity interventions as part of an obesity prevention or treatment programme can benefit executive functions of children with obesity or overweight specifically. Similarly, school-based dietary interventions may benefit general school achievement in children with obesity. These findings might assist health and education practitioners to make decisions related to promoting physical activity and healthy eating in schools. Future obesity treatment and prevention studies in clinical, school and community settings should consider assessing academic and cognitive as well as physical outcomes.
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Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Johansen, MY, MacDonald, CS, Hansen, KB, Karstoft, K, Christensen, R, Pedersen, M, Hansen, LS, Zacho, M, Wedell-Neergaard, AS, Nielsen, ST, et al
JAMA. 2017;318(7):637-646
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First-line treatment of Type 2 diabetes includes diet, physical activity, and weight loss prior to or in parallel with initiation of medication. The aim of this study was to examine whether an intensive lifestyle intervention results in equivalent blood sugar control compared with standard care. A secondary aim was to test whether an intensive lifestyle intervention leads to a reduction in glucose-lowering medication in participants with Type 2 diabetes. The study was a randomized, assessor-blind clinical study of 98 adults with Type 2 diabetes diagnosed for less than 10 years. The participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Results show that an intensive lifestyle intervention did not achieve comparable blood sugar control in comparison with standard care, however, the former led to a substantial and parallel reduction in glucose-lowering medication. The authors conclude that even though a lifestyle intervention compared to standard care did not result in the expected glycaemic control, it was still in a direction consistent with benefit.
Abstract
Importance: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. Objective: To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Design, Setting, and Participants: Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Interventions: All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Main Outcomes and Measures: Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Results: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group. Conclusions and Relevance: Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings. Trial Registration: clinicaltrials.gov Identifier: NCT02417012.