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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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Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial.
Hunt, M, Miguez, S, Dukas, B, Onwude, O, White, S
JMIR mHealth and uHealth. 2021;9(5):e26152
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Cognitive behavioural therapy (CBT) is a proven treatment method to tackle many psychiatric issues. Irritable bowel syndrome (IBS) is considered a chronic gastrointestinal disorder with psychiatric comorbidity. However, patients find it difficult to access CBT for IBS management. As per previous research findings, web-based and telephone-based CBT, self-help CBT books and CBT treatment manuals offer promising therapeutic effects in improving IBS. Therefore, this crossover randomised controlled trial aimed to look at the efficacy of Zemedy, a mobile digital therapeutic application that provides a comprehensive CBT programme to IBS patients. This study found that Zemedy is an effective modality that increases access to effective CBT treatment for IBS patients. Results showed significant improvement in gastrointestinal symptoms, irritable bowel syndrome quality of life, gastrointestinal cognition, visceral sensitivity, fear of food, depression, and improved health-related quality of life in 62 IBS patients enrolled in the immediate treatment group. Further robust studies are required to determine the efficacy of digital applications in IBS patients with significantly higher psychiatric comorbidity. Healthcare practitioners can use the results of the study to understand the importance of digital applications and make them part of intervention strategies.
Abstract
BACKGROUND Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks. OBJECTIVE The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework, and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life [IBS-QOL], Gastrointestinal Symptom Rating Scale [GSRS]) and secondary (Fear of Food Questionnaire [FFQ], Visceral Sensitivity Index [VSI], Gastrointestinal Cognition Questionnaire [GI-COG], Depression Anxiety Stress Scale [DASS], and Patient Health Questionnaire-9 [PHQ-9]) outcome measures. Waitlist controls were then offered the opportunity to crossover to treatment. All participants were assessed once more at 3 months posttreatment. RESULTS Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment. Scores on the GSRS, IBS-QoL, GI-COG, VSI, and FFQ all improved significantly more in the treatment group (F1,79=20.49, P<.001, Cohen d=1.01; F1,79=20.12, P<.001, d=1.25; F1,79=34.71, P<.001, d=1.47; F1,79=18.7, P<.001, d=1.07; and F1,79=12.13, P=.001, d=0.62, respectively). Depression improved significantly as measured by the PHQ-9 (F1,79=10.5, P=.002, d=1.07), and the DASS Depression (F1,79=6.03, P=.02, d=.83) and Stress (F1,79=4.47, P=.04, d=0.65) subscales in the completer analysis but not in the intention-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence-based treatment. TRIAL REGISTRATION ClinicalTrials.gov NCT04170686; https://www.clinicaltrials.gov/ct2/show/NCT04170686.
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Physical activity and nutrition interventions for older adults with cancer: a systematic review.
Forbes, CC, Swan, F, Greenley, SL, Lind, M, Johnson, MJ
Journal of cancer survivorship : research and practice. 2020;14(5):689-711
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Physical activity (PA) benefits people living with or beyond cancer by improving physical function and quality of life (QoL) during and after cancer treatment, and cancer-related outcomes. Furthermore, poor nutritional status is associated with worse overall survival and QoL in patients receiving chemotherapy than those with better nutritional status. The aim of this study was to summarize the current literature regarding activity and nutritional based interventions on health-related quality of life (HRQoL) in older adults with cancer delivered before, during or after active cancer treatments, or as part of best supportive care. This study is a systematic review and meta-analysis of 14 randomised-controlled studies. Results show that effects on QoL outcomes were mixed since most studies were not designed to test effectiveness; however, the evaluation phase trials showed positive trends in QoL related to lifestyle interventions. Authors conclude that activity/nutrition programmes targeting older adults should include candidate intervention components; the need to use a holistic and tailored approach with functional goals and some personal professional contact.
Abstract
PURPOSE The aim of this review was to summarize the current literature for the effectiveness of activity and nutritional based interventions on health-related quality of life (HRQoL) in older adults living with and beyond cancer (LWBC). METHODS We conducted systematic structured searches of CINAHL, Embase, Medline, Cochrane CENTRAL databases, and bibliographic review. Two independent researchers selected against inclusion criteria: (1) lifestyle nutrition and/or activity intervention for people with any cancer diagnosis, (2) measured HRQoL, (3) all participants over 60 years of age and (4) randomized controlled trials. RESULTS Searches identified 5179 titles; 114 articles had full text review, with 14 studies (participant n = 1660) included. Three had nutrition and activity components, one, nutrition only and ten, activity only. Duration ranged from 7 days to 1 year. Interventions varied from intensive daily prehabilitation to home-based gardening interventions. Studies investigated various HRQoL outcomes including fatigue, general and cancer-specific quality of life (QoL), distress, depression, global side-effect burden and physical functioning. Eight studies reported significant intervention improvements in one or more QoL measure. Seven studies reported using a psychosocial/theoretical framework. There is a gap in tailored nutrition advice. CONCLUSIONS Among the few studies that targeted older adults with cancer, most were activity-based programmes with half reporting improvements in QoL. Future research should focus on or include tailored nutrition components and consider appropriate behaviour change techniques to maximize potential QoL improvement. IMPLICATIONS FOR CANCER SURVIVORS More research is needed to address the research gap regarding older adults as current recommendations are derived from younger populations.
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Vitamin D supplementation for the prevention of type 2 diabetes in overweight adults: study protocol for a randomized controlled trial.
de Courten, B, Mousa, A, Naderpoor, N, Teede, H, de Courten, MP, Scragg, R
Trials. 2015;16:335
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With the rising rates of vitamin D deficiency, identifying cost-effective, preventative strategies are imperative. Vitamin D plays a well-known role in bone mineralisation, however its protective role against chronic diseases is not very well understood. The aim of this trial is to investigate whether vitamin D supplementation will increase insulin sensitivity and secretion, as well as to determine whether vitamin D deficiency underlies the inflammatory properties associated with obesity. 50 overweight adults between 18 and 60 years old were recruited and assigned to receive either 4,000 IU vitamin D daily or identical placebo capsules for 16 weeks. This study elucidates the potential role vitamin D supplementation could have on preventing diabetes and its associated co-morbidities. It also provides comprehensive insight into the potential mechanisms of action. The authors conclude that this trial can corroborate existing knowledge while expanding the understanding on the role of vitamin D in the inflammatory response and subsequent development of disease.
Abstract
BACKGROUND Despite Australia's sunny climate, low vitamin D levels are increasingly prevalent. Sun exposure is limited by long working hours, an increase in time spent indoors, and sun protection practices, and there is limited dietary vitamin D fortification. While the importance of vitamin D for bone mineralization is well known, its role as a protective agent against chronic diseases, such as type 2 diabetes and cardiovascular disease, is less understood. Observational and limited intervention studies suggest that vitamin D might improve insulin sensitivity and secretion, mainly via its anti-inflammatory properties, thereby decreasing the risk of development and progression of type 2 diabetes. The primary aim of this trial is to investigate whether improved plasma concentrations of 25-hydroxyvitamin D (25(OH)D), obtained through vitamin D supplementation, will increase insulin sensitivity and insulin secretion. A secondary aim is to determine whether these relationships are mediated by a reduction in underlying subclinical inflammation associated with obesity. METHODS/DESIGN Fifty overweight but otherwise healthy nondiabetic adults between 18 and 60 years old, with low vitamin D levels (25(OH)D < 50 nmol/l), will be randomly assigned to intervention or placebo. At baseline, participants will undergo a medical review and anthropometric measurements, including dual X-ray absorptiometry, an intravenous glucose tolerance test, muscle and fat biopsies, a hyperinsulinemic euglycemic clamp, and questionnaires assessing diet, physical activity, sun exposure, back and knee pain, and depression. The intervention group will receive a first dose of 100,000 IU followed by 4,000 IU vitamin D (cholecalciferol) daily, while the placebo group will receive apparently identical capsules, both for a period of 16 weeks. All measurements will be repeated at follow-up, with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion for the intervention group compared with the placebo group. Secondary outcome measures will compare changes in anthropometry, cardiovascular risk factors, and inflammatory markers. DISCUSSION The trial will provide much needed clinical evidence on the impact of vitamin D supplementation on insulin resistance and secretion and its underlying mechanisms, which are relevant for the prevention and management of type 2 diabetes. TRIAL REGISTRATION Clinicaltrials.gov ID: NCT02112721 .
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Modifying influence of dietary sugar in the relationship between cortisol and visceral adipose tissue in minority youth.
Gyllenhammer, LE, Weigensberg, MJ, Spruijt-Metz, D, Allayee, H, Goran, MI, Davis, JN
Obesity (Silver Spring, Md.). 2014;22(2):474-81
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Visceral adipose tissue (VAT) is one of the strongest risk factors associated with obesity and related co-morbidities. A potential mechanism for this association involves cortisol and cortisol receptors, however the specific interaction of cortisol and diet upon fat deposition has not yet been explored in humans. The purpose of this cross-sectional study was to assess the impact of a high-fat, high-sugar diet on the association between stress and visceral fat in 165 overweight minority youth. The results of this study showed that cortisol was significantly associated with elevated VAT under conditions of high sugar intake in this population. Based on these findings, the authors conclude that dietary sugar may play a crucial role in moderating the adverse effects of cortisol.
Abstract
OBJECTIVE Cortisol has been associated with preferential visceral adipose tissue (VAT) deposition; however, findings in humans are mixed, which may be clarified when diet is considered. DESIGN AND METHODS Participants included 165 African-American and Latino, overweight adolescents (BMI% 97.2±3.2%, ages 13-18, 67% Latino, 66% female). Body composition was determined by dual energy X-ray absorptiometry, abdominal fat depots [VAT, subcutaneous (SAT)] by multiple-slice MRI, time-controlled serum sample to measure cortisol, and 2-day multi-pass 24-hour dietary recall. Linear regression analysis examined the cross-sectional relationship between cortisol, and the interaction of diet and cortisol on adiposity measures. Sex, race, age, and total body fat were a priori covariates. RESULTS There was a significant interaction between cortisol and sugar (total and added) in the prediction of VAT (P(interaction) ≤ 0.05). Amongst participants with high total or added-sugar intake, cortisol was significantly associated with VAT (ß = 0.031 P < 0.001; ß = 0.026 P < 0.001), with no relationship in low consumers of total or added-sugar. CONCLUSION Dietary sugar may play an important role in modifying the relationship between cortisol and VAT, such that cortisol is significantly associated with elevated VAT under conditions of high sugar intake.