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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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The Influence of Prenatal DHA Supplementation on Individual Domains of Behavioral Functioning in School-Aged Children: Follow-Up of a Randomized Controlled Trial.
Gould, JF, Anderson, PJ, Yelland, LN, Gibson, RA, Makrides, M
Nutrients. 2021;13(9)
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Omega-3 fatty acids such as docosahexaenoic acid (DHA) are thought to be beneficial for the development of the fetal brain. Women with a singleton pregnancy at <21 weeks’ gestation enrolled in this multicentre, double-blind, randomised controlled trial to assess the fetal neurodevelopment effects of 800 mg/day, which they took until the birth of their children. A follow-up assessment was arranged when the children reached age seven to evaluate their neurodevelopment. Children of women who took DHA supplements showed increased risk scores on hyperactivity, behavioural problems that may impact daily activities, ADHD, peer relationships, Metacognition Indexes, Shift, Inhibit, Monitor, Working Memory, and Organization of Materials scales. Supplementing with high doses of DHA during pregnancy might not have any protective effects on neurodevelopment in women with high baseline DHA levels. However, further robust studies are required to confirm the results to determine the clinical applicability of DHA supplementation in pregnant women. Healthcare professionals can use the results of this study to understand the dose-dependent therapeutic application of DHA and its impact on fetal neurodevelopment.
Abstract
Docosahexaenoic acid (DHA) accumulates in the fetal brain during pregnancy and is thought to have a role in supporting neurodevelopment. We conducted a multicenter, double-blind, randomized controlled trial in women with a singleton pregnancy who were <21 weeks' gestation at trial entry. Women were provided with 800 mg DHA/day or a placebo supplement from trial entry until birth. When children reached seven years of age, we invited parents to complete the Strengths and Difficulties Questionnaire (SDQ), the Behavior Rating Inventory of Executive Function (BRIEF), and the Conners 3rd Edition Attention-Deficit Hyperactivity Disorder (ADHD) Index to assess child behavior and behavioral manifestations of executive dysfunction. There were 543 parent-child pairs (85% of those eligible) that participated in the follow-up. Scores were worse in the DHA group than the placebo group for the BRIEF Global Executive, Behavioral Regulation and Metacognition Indexes, and the Shift, Inhibit, Monitor, Working Memory, and Organization of Materials scales, as well as for the Conners 3 ADHD index, and the SDQ Total Difficulties score, Hyperactivity/Inattention score, and Peer Relationship Problems score. In this healthy, largely term-born sample of children, prenatal DHA supplementation conferred no advantage to childhood behavior, and instead appeared to have an adverse effect on behavioral functioning, as assessed by standardized parental report scales.
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Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease.
Broers, ER, Gavidia, G, Wetzels, M, Ribas, V, Ayoola, I, Piera-Jimenez, J, Widdershoven, JWMG, Habibović, M
The American journal of cardiology. 2020;125(3):370-375
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Modifiable (behavioural) risk factors such as sedentary lifestyle and low sleep efficiency, are associated with increased mortality risk and disease progression in individuals with cardiovascular disease. The main aim of this study was to evaluate changes in objectively measured lifestyle and health data derived from wearable devices. This study was part of an international, multicenter randomized controlled trial, the Do Cardiac Health Advanced New Generation Ecosystem 2 study. Only the participants (n=70) randomised to the intervention group were analysed. The participants received the devices to monitor their lifestyle and health parameters. Results indicate significant changes over time in the number of steps and activity level. No significant improvement over time was observed in other outcome measures (i.e., blood pressure, weight, and sleep efficiency). Secondary analysis showed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. Authors conclude that a personalised approach might be the way forward in order to improve health outcomes in the future.
Abstract
The importance of modifying lifestyle factors in order to improve prognosis in cardiac patients is well-known. Current study aims to evaluate the effects of a lifestyle intervention on changes in lifestyle- and health data derived from wearable devices. Cardiac patients from Spain (n = 34) and The Netherlands (n = 36) were included in the current analysis. Data were collected for 210 days, using the Fitbit activity tracker, Beddit sleep tracker, Moves app (GPS tracker), and the Careportal home monitoring system. Locally Weighted Error Sum of Squares regression assessed trajectories of outcome variables. Linear Mixed Effects regression analysis was used to find relevant predictors of improvement deterioration of outcome measures. Analysis showed that Number of Steps and Activity Level significantly changed over time (F = 58.21, p < 0.001; F = 6.33, p = 0.01). No significant changes were observed on blood pressure, weight, and sleep efficiency. Secondary analysis revealed that being male was associated with higher activity levels (F = 12.53, p < 0.001) and higher number of steps (F = 8.44, p < 0.01). Secondary analysis revealed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. In conclusion results showed that physical activity increased over time and that certain subgroups of patients were more likely to have a better lifestyle behaviors based on their demographic, clinical, and psychological profile. This advocates a personalized approach in future studies in order to change lifestyle in cardiac patients.
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Behaviour change, weight loss and remission of Type 2 diabetes: a community-based prospective cohort study.
Dambha-Miller, H, Day, AJ, Strelitz, J, Irving, G, Griffin, SJ
Diabetic medicine : a journal of the British Diabetic Association. 2020;37(4):681-688
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Type 2 Diabetes is considered a lifelong condition, but calorie restriction or weight loss can lead to complete remission. Patients newly diagnosed with Type 2 Diabetic may benefit from behavioural change over the long run. When Type 2 Diabetes is diagnosed early in the disease trajectory, it may increase the patient's motivation and make them more receptive to weight-loss interventions. This prospective cohort study included 865 newly diagnosed Type 2 diabetic patients from the ADDICTION Cambridge Trial, a pragmatic, parallel-group cluster randomised controlled trial. The study assessed the relationship between behaviour change and weight loss and the prospect of type 2 diabetes remission in the first year, following four years and after five years without intense dietary or lifestyle intervention in patients. 30% of the patients achieved diabetes remission at 5-year follow-up, with a significant likelihood of remission among those who achieved ≥ 10% weight loss in the first year of diagnosis. A self-reported change in intake of alcohol units was found to be the only consistent association between behaviour change and remission in this study. The role of behaviour change in the remission of diabetes requires further robust research. This study will help healthcare professionals understand the association between weight loss and remission in diabetic patients.
Abstract
AIM: To quantify the association between behaviour change and weight loss after diagnosis of Type 2 diabetes, and the likelihood of remission of diabetes at 5-year follow-up. METHOD We conducted a prospective cohort study in 867 people with newly diagnosed diabetes aged 40-69 years from the ADDITION-Cambridge trial. Participants were identified via stepwise screening between 2002 and 2006, and underwent assessment of weight change, physical activity (EPAQ2 questionnaire), diet (plasma vitamin C and self-report), and alcohol consumption (self-report) at baseline and 1 year after diagnosis. Remission was examined at 5 years after diabetes diagnosis via HbA1c level. We constructed log binomial regression models to quantify the association between change in behaviour and weight over both the first year after diagnosis and the subsequent 1-5 years, as well as remission at 5-year follow-up. RESULTS Diabetes remission was achieved in 257 participants (30%) at 5-year follow-up. Compared with people who maintained the same weight, those who achieved ≥ 10% weight loss in the first year after diagnosis had a significantly higher likelihood of remission [risk ratio 1.77 (95% CI 1.32 to 2.38; p<0.01)]. In the subsequent 1-5 years, achieving ≥10% weight loss was also associated with remission [risk ratio 2.43 (95% CI 1.78 to 3.31); p<0.01]. CONCLUSION In a population-based sample of adults with screen-detected Type 2 diabetes, weight loss of ≥10% early in the disease trajectory was associated with a doubling of the likelihood of remission at 5 years. This was achieved without intensive lifestyle interventions or extreme calorie restrictions. Greater attention should be paid to enabling people to achieve weight loss following diagnosis of Type 2 diabetes.
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Mediators of Lifestyle Behaviour Changes in Obese Pregnant Women. Secondary Analyses from the DALI Lifestyle Randomised Controlled Trial.
van Poppel, MN, Jelsma, JGM, Simmons, D, Devlieger, R, Jans, G, Galjaard, S, Corcoy, R, Adelantado, JM, Dunne, F, Harreiter, J, et al
Nutrients. 2019;11(2)
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Obesity in pregnancy is rising and is associated with increased risks for both mother and baby. In particular, obese women and women with excess weight gain during pregnancy are at an increased risk for developing gestational diabetes (GDM). A better understanding of what drives behaviour change in obese pregnant women is needed to improve the effectiveness of lifestyle interventions such as dietary changes. In this randomised controlled trial, researchers set out to assess what factors might support behaviour change in pregnant women at risk of GDM. A total of 436 women, with pre-pregnancy body mass index of ≥29 kg/m², without GDM, were split into four groups: three of them received counselling based on motivational interviewing (MI) on 1) healthy eating and physical activity, 2) healthy eating alone or 3) physical activity alone, whilst the fourth group received their usual care. Physical activity and food intake were measured at the start of the study, and at 24-28 and 35-37 weeks of pregnancy. Social and psychological factors such as outcome expectancy, risk perception, task self-efficacy (peoples’ confidence to succeed in a specific situation) and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three groups that received MI demonstrated an increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. Women with higher self-efficacy tended to be more physically active and consumed less sugary drinks and smaller portion sizes. The authors concluded that motivational interviewing was successful in increasing outcome expectancy and task self-efficacy, both of which were related to improvements in diet and physical activity.
Abstract
A better understanding of what drives behaviour change in obese pregnant overweight women is needed to improve the effectiveness of lifestyle interventions in this group at risk for gestational diabetes (GDM). Therefore, we assessed which factors mediated behaviour change in the Vitamin D and Lifestyle Intervention for GDM Prevention (DALI) Lifestyle Study. A total of 436 women, with pre-pregnancy body mass index ≥29 kg/m², ≤19 + 6 weeks of gestation and without GDM, were randomised for counselling based on motivational interviewing (MI) on healthy eating and physical activity, healthy eating alone, physical activity alone, or to a usual care group. Lifestyle was measured at baseline, and at 24⁻28 and 35⁻37 weeks of gestation. Outcome expectancy, risk perception, task self-efficacy and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three interventions resulted in increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. The latter mediated intervention effects on physical activity and reduced sugared drink consumption. In conclusion, our MI intervention was successful in increasing task self-efficacy, which was related to improved health behaviours.
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Healthy ageing at work- Efficacy of group interventions on the mental health of nurses aged 45 and older: Results of a randomised, controlled trial.
Maatouk, I, Müller, A, Angerer, P, Schmook, R, Nikendei, C, Herbst, K, Gantner, M, Herzog, W, Gündel, H
PloS one. 2018;13(1):e0191000
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According to the German statistics office, nurses frequently suffer from emotional distress or mental disorders, due to the physical and social demands of the nursing profession in comparison to other professions. The high psychological burden was one of the main factors that was associated with an intention to leave the nursing profession by nurses. The aim of this study was to implement an intervention programme for nursing staff aged 45 and older, with the primary purpose of reducing work-related distress in order to maintain mental health and wellbeing until retirement age. The intervention included several strategies for stress prevention including group dynamic principles and cognitive behavioural techniques. Nurses attended seven weekly session of 120 min with a booster session after six weeks as part of a randomised control trial carried out in four hospital sites in Germany. The outcomes were measured via self –reported questionnaire. Significant positive effects were noted in relation to mental health, but with regards to psychological health only small significant effect was noted in the intervention group. The authors concluded that the ageing workforce should be reached via a specifically designed intervention adapted to their profession.
Abstract
OBJECTIVE This multicentre, randomised controlled trial (RCT) aimed to evaluate the efficacy of a small-group intervention promoting successful ageing at work in older nurses (aged ≥45). METHOD A sample of 115 nurses aged ≥45 from 4 trial sites in Germany were randomly assigned to either the intervention group (IG), that received a small-group intervention of seven weekly sessions of 120 min with a booster session after six weeks or to a wait-list control condition (WLC). Outcomes were measured via validated self-report questionnaires at baseline (T1) and at post-treatment (T2). Primary outcomes were mental health-related well-being and mental health-related quality of life (QOL). The secondary outcomes included mental health-related and work-related measures. RESULTS The intention to treat (ITT) analysis showed significant positive effects of the intervention on mental health. A significant small effect (d = 0.3) in favour of the IG was found for psychological health-related quality of life. Positive small effects (d = 0.24 to d = 0.31) were also found for work related mental strain. CONCLUSIONS Our small-group intervention based on a theory of successful ageing for nurses aged ≥45 was found to be effective with regard to improvements of psychological health related quality of life and other mental health-related outcomes. Thus, our study shows that the ageing workforce can be reached through specifically designed preventive interventions. The components of our intervention could be easily adapted to the belongings of other professions. Our results suggest that these components should be evaluated in various settings outside the healthcare sector.
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Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.
Svanevik, M, Risstad, H, Karlsen, TI, Kristinsson, JA, Småstuen, MC, Kolotkin, RL, Søvik, TT, Sandbu, R, Mala, T, Hjelmesæth, J
Obesity surgery. 2018;28(3):606-614
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Bariatric surgery may induce weight loss, improvement of weight-associated comorbidities, and improved health and well-being. The aim of the study is to compare the effects of standard and distal Rou-en-Y gastric bypass on obesity-specific health related quality of life, weight-related symptoms, eating behaviour, anxiety and depression. The study is a double-blind, parallel-group randomised controlled trial. The participants’ age ranged from 18 to 60 years of age with a BMI of 50 to 60 kg/m2. Results indicated improvements in most patient-reported outcome measures after both surgeries, but no significant difference between groups after surgery in relation to obesity-specific health related quality of life, weight-related symptoms, anxiety and depression, or eating behaviour. Authors conclude that both surgeries lead to sustained weight loss and improved health related quality of life 2 years after surgery in patients with a BMI 50-60kg/m2.
Abstract
BACKGROUND The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. METHODS A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard (n = 57) or distal (n = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. RESULTS Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (- 0.4 (95% CI = - 8.4, 7.2) points, p = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (- 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2-26.7) vs. 28.9 (23.3-34.5) points), cognitive restraint (57.4 (52.0-62.7) vs. 62.1 (57.9-66.2) points), and emotional eating (26.8 (20.5-33.1) vs. 32.6 (25.5-39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB (p = 0.53), and for depression 12 and 9%, respectively (p = 0.76). CONCLUSIONS There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. TRIAL REGISTRATION Clinical Trials.gov number NCT00821197.
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Patterns of Eating Disorder Pathology are Associated with Weight Change in Family-Based Behavioral Obesity Treatment.
Balantekin, KN, Hayes, JF, Sheinbein, DH, Kolko, RP, Stein, RI, Saelens, BE, Hurst, KT, Welch, RR, Perri, MG, Schechtman, KB, et al
Obesity (Silver Spring, Md.). 2017;25(12):2115-2122
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Children who are overweight or obese have higher rates of eating disorder pathology (extreme dietary restraint, loss of control eating and emotional eating) than their peers who are not overweight or obese, thus having an increased risk of developing a clinical eating disorder. The aim of the study is to classify overweight or obese children entering family-based treatment into groups with distinct patterns of eating disorder pathology and then examine eating disorder pattern differences in 3 categories. The study includes data from a multi-site randomised controlled trial. The analysis focused on data from the initial weight loss phase which included 241 obese or overweight children aged between 7 to 11 years. Results showed that eating disorders are more common among females than males, yet males also experience high levels of eating disorder pathology. Levels of eating disorder pathology decreased after family-based behavioural weight-loss treatment and so decreased the risk of the development of a clinical eating disorder. Authors conclude that eating disorder pathology is prevalent among children with overweight or obesity but has varying presentations.
Abstract
OBJECTIVE Children with overweight or obesity have elevated eating disorder (ED) pathology, which may increase their risk for clinical EDs. The current study identified patterns of ED pathology in children with overweight or obesity entering family-based behavioral weight loss treatment (FBT) and examined whether children with distinct patterns differed in their ED pathology and BMI z score (zBMI) change across FBT. METHODS Before participating in a 16-session FBT, children (N = 241) completed surveys or interviews assessing ED pathology (emotional eating, shape/weight/eating concerns, restraint, and loss of control [LOC]). Shape and weight concerns (SWC) and LOC were also assessed post treatment. Child height and weight were measured at baseline and post treatment. Latent class analysis identified patterns of ED pathology. Repeated-measures ANOVA examined changes in zBMI and ED pathology. RESULTS Four patterns of ED pathology were identified: low ED pathology, SWC, only loss of control, and high ED pathology. SWC decreased across treatment, with the highest decreases in patterns characterized by high SWC. All groups experienced significant decreases in zBMI; however, children with the highest ED pathology did not achieve clinically significant weight loss. CONCLUSIONS ED pathology decreased after FBT, decreasing ED risk. While all children achieved zBMI reductions, further research is needed to enhance outcomes for children with high ED pathology.