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How do previously inactive individuals restructure their time to 'fit in' morning or evening exercise: a randomized controlled trial.
Brooker, PG, Gomersall, SR, King, NA, McMahon, NF, Leveritt, MD
Journal of behavioral medicine. 2023;46(3):429-439
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The number of hours in a day is fixed and finite, distributed between obligatory time (such as time spent working, sleeping, domestic activities, commuting or eating) and discretionary time (the remaining ‘free’ time). The way individuals restructure the timing of their behaviours can influence the effectiveness of exercise, and have important health consequences, depending on what activities are displaced. The aim of this study was to investigate how previously inactive adults restructure their time when they undertake morning or evening exercise. This study was conducted within a larger randomised controlled trial which used a three-armed, randomised controlled trial design, with a 12-week lifestyle intervention. Participants (n = 100) were randomized into one of two intervention groups, or a waitlist control group at a 2:2:1 ratio. Results showed that time spent engaging in physical activity was significantly increased from baseline at both mid- and post-intervention for both intervention groups. Furthermore, participants in both intervention groups reported more time spent sleeping, and less time watching television/playing videogames. Authors conclude that the time for exercise was largely drawn from a discretionary time (watching TV), and the patterns of change in time use was similar when exercise was performed in the morning compared with the evening.
Abstract
The objective of this study was to investigate changes in sedentary and active behaviors when previously inactive adults start exercising in the morning or evening. One-hundred adults with overweight or obesity (BMI ≥ 25 kg/m2) were recruited for a 12-week intervention and randomized to one of three groups: (i) morning exercise (AMEx; 0600-0900); (ii) evening exercise (PMEx; 1600-1900); or (iii) waitlist control. AMEx and PMEx were prescribed self-paced aerobic exercise to achieve a weekly total of 250 min via a combination of supervised and unsupervised training. Sedentary and active behavior times were measured at baseline, mid- and post-intervention using the multimedia activity recall for children and adults. Time spent engaging in physical activity was significantly increased from baseline at both mid- (+ 14-22 min·day-1) and post-intervention (+ 12-19 min·day-1), for AMEx and PMEx. At 12-weeks, participants in both morning and evening exercise groups reported increased time spent Sleeping (+ 36 and + 20 min·day-1, respecitively), and reduced time spent watching TV/playing videogames (- 32 and - 25 min·day-1, respectively). In response to an exercise stimulus, previously inactive adults make encouraging modifications in how they use their time, and the patterns of change are similar with morning and evening exercise.
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Causal relationship between nonalcoholic fatty liver disease and different sleep traits: a bidirectional Mendelian randomized study.
Sun, Z, Ji, J, Zuo, L, Hu, Y, Wang, K, Xu, T, Wang, Q, Cheng, F
Frontiers in endocrinology. 2023;14:1159258
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Non-alcoholic fatty liver disease (NAFLD) is caused by a build up of fat in the liver. NAFLD is becoming more common, with the rise in rates of obesity. There are no specific medications available for NAFLD and patients are advised to manage their diets and lifestyle following diagnosis. The aim of this study was to assess and evaluate the causal relationship between sleep and NAFLD. The study was a two-way Mendelian randomised clinical trial. Results showed that different sleep traits can be the cause of the onset and exacerbation of NAFLD. NAFLD does not change sleep traits and the causal relationship between them is unidirectional. Authors conclude that sleep characteristics are associated with an elevated risk of NAFLD. Thus, enhancing sleep should be considered by healthcare practitioners as part of prevention and management NAFLD.
Abstract
BACKGROUND AND AIMS Non-alcoholic fatty liver disease(NAFLD) is common worldwide and has previously been reported to be associated with sleep traits. However, it is not clear whether NAFLD changes sleep traits or whether the changes in sleep traits lead to the onset of NAFLD. The purpose of this study was to investigate the causal relationship between NAFLD and changes in sleep traits using Mendelian randomization. METHODS We proposed a bidirectional Mendelian randomization (MR) analysis and performed validation analyses to dissect the association between NAFLD and sleep traits. Genetic instruments were used as proxies for NAFLD and sleep. Data of genome-wide association study(GWAS) were obtained from the center for neurogenomics and cognitive research database, Open GWAS database and GWAS catalog. Three MR methods were performed, including inverse variance weighted method(IVW), MR-Egger, weighted median. RESULTS In total,7 traits associated with sleep and 4 traits associated with NAFLD are used in this study. A total of six results showed significant differences. Insomnia was associated with NAFLD (OR(95% CI)= 2.25(1.18,4.27), P = 0.01), Alanine transaminase levels (OR(95% CI)= 2.79(1.70, 4.56), P =4.71×10-5) and percent liver fat(OR(95% CI)= 1.31(1.03,1.69), P = 0.03). Snoring was associated with percent liver fat (1.15(1.05,1.26), P =2×10-3), alanine transaminase levels (OR(95% CI)= 1.27(1.08,1.50), P =0.04).And dozing was associated with percent liver fat(1.14(1.02,1.26), P =0.02).For the remaining 50 outcomes, no significant or definitive association was yielded in MR analysis. CONCLUSION Genetic evidence suggests putative causal relationships between NAFLD and a set of sleep traits, indicating that sleep traits deserves high priority in clinical practice. Not only the confirmed sleep apnea syndrome, but also the sleep duration and sleep state (such as insomnia) deserve clinical attention. Our study proves that the causal relationship between sleep characteristics and NAFLD is the cause of the change of sleep characteristics, while the onset of non-NAFLD is the cause of the change of sleep characteristics, and the causal relationship is one-way.
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Effects of sleep fragmentation and partial sleep restriction on heart rate variability during night.
Schlagintweit, J, Laharnar, N, Glos, M, Zemann, M, Demin, AV, Lederer, K, Penzel, T, Fietze, I
Scientific reports. 2023;13(1):6202
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Adequate sleep is essential for physical and mental health and wellbeing. This randomised cross-over study of 20 healthy men compared the effects of sleep restriction (sleeping 5 instead of 8 hours) and sleep fragmentation (being woken hourly during the 8-hour sleeping time) on heart rate (HR) and heart rate variability (HRV), both markers of the sympathetic (“fight or flight”) and parasympathetic (“rest and digest”) arms of the autonomic nervous system. Sleep restriction increased HR and decreased HRV, suggesting increased sympathetic and decreased parasympathetic activation. This affected the lighter sleep phases in particular. Sleep fragmentation, on the other hand, did not affect HR or HRV compared to baseline. The authors conclude that sleep restriction may cause more stress than sleep fragmentation.
Abstract
We developed a cross-over study design with two interventions in randomized order to compare the effects of sleep fragmentation and partial sleep restriction on cardiac autonomic tone. Twenty male subjects (40.6 ± 7.5 years old) underwent overnight polysomnography during 2 weeks, each week containing one undisturbed baseline night, one intervention night (either sleep restriction with 5 h of sleep or sleep fragmentation with awakening every hour) and two undisturbed recovery nights. Parameters of heart rate variability (HRV) were used to assess cardiac autonomic modulation during the nights. Sleep restriction showed significant higher heart rate (p = 0.018) and lower HRV-pNN50 (p = 0.012) during sleep stage N1 and lower HRV-SDNN (p = 0.009) during wakefulness compared to the respective baseline. For HR and SDNN there were recovery effects. There was no significant difference comparing fragmentation night and its baseline. Comparing both intervention nights, sleep restriction had lower HRV high frequency (HF) components in stage N1 (p = 0.018) and stage N2 (p = 0.012), lower HRV low frequency (LF) (p = 0.007) regarding the entire night and lower SDNN (p = 0.033) during WASO during sleep. Sleep restriction increases sympathetic tone and decreases vagal tone during night causing increased autonomic stress, while fragmented sleep does not affect cardiac autonomic parameters in our sample.
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Effect of Sleep Changes on Health-Related Quality of Life in Healthy Children: A Secondary Analysis of the DREAM Crossover Trial.
Taylor, RW, Haszard, JJ, Jackson, R, Morrison, S, Beebe, DW, Meredith-Jones, KA, Elder, DE, Galland, BC
JAMA network open. 2023;6(3):e233005
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While inadequate or poor-quality sleep has been associated with a wide range of adverse physical and psychological health outcomes in infants, children and adolescents, interest is growing regarding the association of sleep with more global indices of health, such as health-related quality of life (HRQOL). The aim of this study was to determine the effect of mild sleep deprivation on HRQOL in children without major sleep issues. This study was a secondary analysis based on the DREAM randomised crossover trial. Children were randomised to one of two groups (sleep restriction or sleep extension) with a 1-week washout in between. Bedtimes were manipulated to be 1 hour later (sleep restriction) and 1 hour earlier (sleep extension) than usual for 1 week each. Wake times were unchanged. Results showed that after only 1 week of receiving 39 minutes less sleep per night between sleep conditions, children reported significantly lower HRQOL in terms of their physical and overall well-being and ability to cope well at school. Authors conclude that ensuring children receive sufficient good-quality sleep is an important child health issue.
Abstract
IMPORTANCE Little is known regarding the effect of poor sleep on health-related quality of life (HRQOL) in healthy children. OBJECTIVE To determine the effect of induced mild sleep deprivation on HRQOL in children without major sleep issues. DESIGN, SETTING, AND PARTICIPANTS This prespecified secondary analysis focused on HRQOL, a secondary outcome of the Daily Rest, Eating, and Activity Monitoring (DREAM) randomized crossover trial of children who underwent alternating weeks of sleep restriction and sleep extension and a 1-week washout in between. The DREAM trial intervention was administered at participants' homes between October 2018 and March 2020. Participants were 100 children aged 8 to 12 years who lived in Dunedin, New Zealand; had no underlying medical conditions; and had parent- or guardian-reported normal sleep (8-11 hours/night). Data were analyzed between July 4 and September 1, 2022. INTERVENTIONS Bedtimes were manipulated to be 1 hour later (sleep restriction) and 1 hour earlier (sleep extension) than usual for 1 week each. Wake times were unchanged. MAIN OUTCOMES AND MEASURES All outcome measures were assessed during both intervention weeks. Sleep timing and duration were assessed using 7-night actigraphy. Children and parents rated the child's sleep disturbances (night) and impairment (day) using the 8-item Pediatric Sleep Disturbance and 8-item Sleep-Related Impairment scales of the Patient-Reported Outcomes Measurement Information System questionnaire. Child-reported HRQOL was assessed using the 27-item KIDSCREEN questionnaire with 5 subscale scores and a total score. Both questionnaires assessed the past 7 days at the end of each intervention week. Data were presented as mean differences and 95% CIs between the sleep restriction and extension weeks and were analyzed using intention to treat and an a priori difference in sleep of at least 30 minutes per night. RESULTS The final sample comprised 100 children (52 girls [52%]; mean [SD] age, 10.3 [1.4] years). During the sleep restriction week, children went to sleep 64 (95% CI, 58-70) minutes later, and sleep offset (wake time) was 18 (95% CI, 13-24) minutes later, meaning that children received 39 (95% CI, 32-46) minutes less of total sleep per night compared with the sleep extension week in which the total sleep time was 71 (95% CI, 64-78) minutes less in the per-protocol sample analysis. Both parents and children reported significantly less sleep disturbance at night but greater sleep impairment during the day with sleep restriction. Significant standardized reductions in physical well-being (standardized mean difference [SMD], -0.28; 95% CI, -0.49 to -0.08), coping in a school environment (SMD, -0.26; 95% CI, -0.42 to -0.09), and total HRQOL score (SMD, -0.21; 95% CI, -0.34 to -0.08) were reported by children during sleep restriction, with an additional reduction in social and peer support (SMD, -0.24; 95% CI, -0.47 to -0.01) in the per-protocol sample analysis. CONCLUSIONS AND RELEVANCE Results of this secondary analysis of the DREAM trial indicated that even 39 minutes less of sleep per night for 1 week significantly reduced several facets of HRQOL in children. This finding shows that ensuring children receive sufficient good-quality sleep is an important child health issue. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12618001671257.
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Improving perinatal sleep via a scalable cognitive behavioural intervention: findings from a randomised controlled trial from pregnancy to 2 years postpartum.
Bei, B, Pinnington, DM, Quin, N, Shen, L, Blumfield, M, Wiley, JF, Drummond, SPA, Newman, LK, Manber, R
Psychological medicine. 2023;53(2):513-523
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Sleep disturbance is a universal experience during the pregnancy and postpartum periods. Sleep disturbance is linked to a range of negative consequences. Literature shows that cognitive behavioural Therapy for Insomnia (CBT-I) is an effective treatment, with comparable short-term and superior long-term effects to sleep medication alone. The aim of this study was to evaluate the short-, medium-, and long-term efficacy of a non-pharmacological sleep intervention in the perinatal periods. The study was a longitudinal randomised controlled trial based on the SEED (Sleep Eat Emotions and Development) project which was a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Participants were pregnant women enrolled in Childbirth Education and were randomised 1:1 to the intervention or a comparison condition. Results showed that compared to receiving an attention- and time-matched control, receiving a cognitive behavioural sleep intervention was associated with lower symptoms of insomnia, sleep disturbance, and sleep-related impairment during late pregnancy. Moreover, the intervention had long-term benefits to gestational parents’ sleep at 2-year postpartum. Authors conclude that a scalable cognitive behavioural sleep intervention, tailored for the perinatal periods, is feasible, acceptable, and efficacious in buffering against the natural increase in sleep complaints during the 3rd trimester.
Abstract
BACKGROUND Sleep disturbance is common in gestational parents during pregnancy and postpartum periods. This study evaluated the feasibility and efficacy of a scalable cognitive behavioural therapy (CBT) sleep intervention tailored for these periods. METHODS This is a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Nulliparous females without severe medical/psychiatric conditions were randomised 1:1 to CBT or attention- and time-matched control. All participants received a 1 h telephone session and automated multimedia emails from the third trimester until 6 months postpartum. Outcomes were assessed with validated instruments at gestation weeks 30 (baseline) and 35 (pregnancy endpoint), and postpartum months 1.5, 3, 6 (postpartum endpoint), 12 and 24. RESULTS In total, 163 eligible participants (age M ± s.d. = 33.35 ± 3.42) were randomised. The CBT intervention was well accepted, with no reported adverse effect. Intention-to-treat analyses showed that compared to control, receiving CBT was associated with lower insomnia severity and sleep disturbance (two primary outcomes), and lower sleep-related impairment at the pregnancy endpoint (p values ⩽ 0.001), as well as at 24 months postpartum (p ranges 0.012-0.052). Group differences across the first postpartum year were non-significant. Participants with elevated insomnia symptoms at baseline benefitted substantially more from CBT (v. control), including having significantly lower insomnia symptoms throughout the first postpartum year. Group differences in symptoms of depression or anxiety were non-significant. CONCLUSIONS A scalable CBT sleep intervention is efficacious in buffering against sleep disturbance during pregnancy and benefitted sleep at 2-year postpartum, especially for individuals with insomnia symptoms during pregnancy. The intervention holds promise for implementation into routine perinatal care.
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Physical activity, inactivity and sleep during the Diabetes Remission Clinical Trial (DiRECT).
Cassidy, S, Trenell, M, Stefanetti, RJ, Charman, SJ, Barnes, AC, Brosnahan, N, McCombie, L, Thom, G, Peters, C, Zhyzhneuskaya, S, et al
Diabetic medicine : a journal of the British Diabetic Association. 2023;40(3):e15010
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Increasing physical activity is difficult for many individuals living with obesity and diabetes. Sustained, moderate activity is likely to be valuable for weight loss maintenance. The aim of this study was to explore whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep. DiRECT was a 2-year, open-label, cluster-randomised controlled trial conducted at 49 primary care (PC) practices. PC practices were randomised (1:1) to either an evidence-based weight management programme (Counterweight Plus; intervention) or best-practice care in accordance with guidelines (control). Results showed that: - repeated low-intensity advice to increase physical activity in the DiRECT intervention group did not produce change. - those people who had long-term weight loss success with the low-energy diet had positive changes in physical activity and inactivity. - wakefulness after sleep onset decreased in the intervention group. - weight loss ≥10% was associated with both increased physical activity and sleep quality. Authors conclude that it is important to optimise long-term weight loss maintenance by developing interventions encompassing restrained food intake, together with effective but affordable physical activity/inactivity strategies.
Abstract
AIMS: As sustained weight loss is vital for achieving remission of type 2 diabetes, we explored whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep. METHODS Participants were randomised to either a dietary weight management programme or best-practice care. The weight management group were encouraged to increase daily physical activity to their sustainable maximum. Objective measurement was achieved using a wrist-worn GENEActiv accelerometer for 7 days at baseline, 12 and 24 months in both groups. RESULTS Despite average weight loss of 10 kg at 12 months in the intervention (n = 66) group, there were no differences in total physical activity or inactivity compared with the control (n = 104) at any time point. However, in our exploratory analysis, those who lost more than 10% of their baseline body weight performed on average 11 mins/day more light activity than the <10% group at 24 months (p = 0.033) and had significantly lower bouts of Inactivity30min (interaction, p = 0.005) across 12 and 24 months. At 24 months, the ≥10% group had higher daily acceleration (38.5 ± 12.1 vs. 33.2 ± 11.1 mg, p = 0.020), and higher accelerations in the most active 5-hour period (59.4 ± 21.8 vs. 50.6 ± 18.3 mg, p = 0.023). Wakefulness after sleep onset decreased in the intervention group compared with the control group and also in the ≥10% weight loss group at 12 and 24 months. CONCLUSIONS Randomisation to a successful intensive weight loss intervention, including regular physical activity encouragement, was not associated with increased physical activity although sleep parameters improved. Physical activity was greater, and night-time waking reduced in those who maintained >10% weight loss at 12 and 24 months. TRIAL REGISTRATION ISRCTN03267836.
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Does providing feedback and guidance on sleep perceptions using sleep wearables improve insomnia? Findings from "Novel Insomnia Treatment Experiment": a randomized controlled trial.
Spina, MA, Andrillon, T, Quin, N, Wiley, JF, Rajaratnam, SMW, Bei, B
Sleep. 2023;46(9)
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Insomnia involves difficulties with initiating sleep, maintaining sleep and early morning awakenings. Sleep–wake state discrepancy is a common phenomenon observed in 9%–50% of individuals with insomnia. In fact, sleep–wake state discrepancy is important to explore as it is linked to daytime functioning, self-reported happiness, social support and self-reported sleep. The primary aim of this study was to examine whether providing individuals with insomnia feedback about sleep using wearable devices, along with support for appropriate interpretation of sleep–wake state discrepancy, improves symptoms of insomnia as the primary outcome. This study was a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Eligible participants were randomised 1:1 to intervention or control groups. Results showed that the intervention group had lower insomnia symptom severity and sleep disturbance and lower rates of insomnia disorder. However, the two groups did not meaningfully differ on all other secondary and exploratory outcomes at post-intervention. Authors conclude that addressing sleep–wake state discrepancy by providing education and guidance on wearable measured sleep data could reduce symptoms of insomnia. Additionally, future studies need to examine how sleep–wake state discrepancy guidance using wearable devices could supplement cognitive behavioural therapy for insomnia (CBT-I), and whether this addition could enhance the benefits of CBT-I.
Abstract
STUDY OBJECTIVES Insomnia is a disorder diagnosed based on self-reported sleep complaints. Differences between self-reported and sensor-based sleep parameters (sleep-wake state discrepancy) are common but not well-understood in individuals with insomnia. This two-arm, parallel-group, single-blind, superiority randomized-controlled trial examined whether monitoring sleep using wearable devices and providing support for interpretation of sensor-based sleep data improved insomnia symptoms or impacted sleep-wake state discrepancy. METHODS A total of 113 (age M = 47.53; SD = 14.37, 64.9% female) individuals with significant insomnia symptoms (Insomnia Severity Index(ISI) ≥10) from the community were randomized 1:1 (permuted block randomization) to receive 5 weeks (1) Intervention (n = 57): feedback about sensor-based sleep (Fitbit and EEG headband) with guidance for data interpretation and ongoing monitoring, and (2) Control (n = 56): sleep education and hygiene. Both groups received one individual session and two check-in calls. The ISI (primary outcome), sleep disturbance (SDis), sleep-related impairment (SRI), depression, and anxiety were assessed at baseline and post-intervention. RESULTS In total, 103 (91.2%) participants completed the study. Intention-to-treat multiple regression with multiple imputations showed that after controlling for baseline values, compared to the Control group (n = 51), the Intervention group (n = 52) had lower ISI (p = .011, d = 0.51) and SDis (p = .036, d = 0.42) post-intervention, but differences in SRI, depression, anxiety, and sleep-wake state discrepancy parameters (total sleep time, sleep onset latency, and wake after sleep onset) were not meaningful (P-values >.40). CONCLUSIONS Providing feedback and guidance about sensor-based sleep parameters reduced insomnia severity and sleep disturbance but did not alter sleep-wake state discrepancy in individuals with insomnia more than sleep hygiene and education. The role of sleep wearable devices among individuals with insomnia requires further research. CLINICAL TRIAL REGISTRATION The Novel Insomnia Treatment Experiment (NITE): the effectiveness of incorporating appropriate guidance for sleep wearables in users with insomnia. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378452, Australia New Zealand Clinical Trials Registry: ACTRN12619001636145.
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Attitudes and adherence to changes in nutrition and physical activity following surgery for prostate cancer: a qualitative study.
Robles, LA, Shingler, E, McGeagh, L, Rowe, E, Koupparis, A, Bahl, A, Shiridzinomwa, C, Persad, R, Martin, RM, Lane, JA
BMJ open. 2022;12(6):e055566
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Prostate cancer is a leading cancer in men from the United Kingdom. Diet and exercise are recommended for men with prostate cancer however, few achieve the recommendations. Psychological and behavioural factors are often responsible for the lack of change and this qualitative study aimed to determine the most common, with a view to helping individuals to affect change. The results showed that several men believed that diet and physical activity had no association with cancer and those who did, maintained a healthy diet and took regular exercise. Most men thought they had a good diet before diagnosis, however evidence for this was mixed. Barriers to change were plentiful and included physical inability, taste of food, and side effects of supplements. It was concluded that behaviour change models could help with adherence to a better diet and exercise regime. This study could be used by healthcare professionals to understand that it may not be enough to simply recommend diet and exercise to men with prostate cancer. Support and guidance may also be needed.
Abstract
OBJECTIVES Interventions designed to improve men's diet and physical activity (PA) have been recommended as methods of cancer prevention. However, little is known about specific factors that support men's adherence to these health behaviour changes, which could inform theory-led diet and PA interventions. We aimed to explore these factors in men following prostatectomy for prostate cancer (PCa). DESIGN, SETTING AND PARTICIPANTS A qualitative study using semistructured interviews with men, who made changes to their diet and/or PA as part of a factorial randomised controlled trial conducted at a single hospital in South West England. Participants were 17 men aged 66 years, diagnosed with localised PCa and underwent prostatectomy. Interview transcripts underwent thematic analysis. RESULTS Men were ambivalent about the relationship of nutrition and PA with PCa risk. They believed their diet and level of PA were reasonable before being randomised to their interventions. Men identified several barriers and facilitators to performing these new behaviours. Barriers included tolerance to dietary changes, PA limitations and external obstacles. Facilitators included partner involvement in diet, habit formation and brisk walking as an individual activity. Men discussed positive effects associated with brisk walking, such as feeling healthier, but not with nutrition interventions. CONCLUSIONS The facilitators to behaviour change suggest that adherence to trial interventions can be supported using well-established behaviour change models. Future studies may benefit from theory-based interventions to support adherence to diet and PA behaviour changes in men diagnosed with PCa.
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Dose-response relationship between weight loss and improvements in obstructive sleep apnea severity after a diet/lifestyle interventions: secondary analyses of the "MIMOSA" randomized clinical trial.
Georgoulis, M, Yiannakouris, N, Kechribari, I, Lamprou, K, Perraki, E, Vagiakis, E, Kontogianni, MD
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 2022;18(5):1251-1261
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Obstructive sleep apnoea (OSA) represents one of the most common and serious sleep-related breathing disorders. Excess body weight has emerged as the strongest modifiable predictor of the onset and severity of OSA. The aim of this study was to explore the dose-response relationship between the degree of weight loss and improvements in OSA severity. This study is a secondary analysis of the Mediterranean diet/lifestyle Intervention for the Management of Obstructive Sleep Apnea (MIMOSA) study, which was designed as a single-centre, single-blind, parallel, randomised, controlled clinical trial. Results show that respiratory events and oximetry indices improved only in patients who lost weight and improvements were proportional to the degree of weight loss. Authors conclude that their findings indicate a dose-response relationship between the degree of weight loss and improvement in OSA severity and symptoms. However, further research is needed to gather more data on the optimal degree of weight loss and appropriate weight-loss interventions for managing the wide spectrum of OSA severity to guide clinical practice.
Expert Review
Conflicts of interest:
None
Take Home Message:
Important from a public health perspective:
- This study has confirmed that even a small degree of weight loss can have a beneficial effect on respiratory events and oxygen desaturation in moderate-to-severe OSA, but clinicians should preferably aim at a ≥ 5% weight loss, and ideally a ≥ 10% weight loss, to achieve clinically meaningful reductions in OSA severity.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
OSA represents one of the most common and serious sleep-related breathing disorders, with a high worldwide prevalence of almost 1 billion people. OSA has numerous well-established cardiometabolic consequences.
The authors highlight that weight loss is essential for obstructive sleep apnea (OSA) management. However, the optimal degree of weight loss for improving OSA severity or eliminating sleep-disordered breathing has not been extensively studied. The aim of this study was to explore the dose-response relationship between the degree of weight loss and improvements in OSA severity.
Methods
This is a secondary analysis of the Mediterranean diet/lifestyle Intervention for the Management of Obstructive Sleep Apnea (MIMOSA) study. This study was designed as a single-center, single-blind, parallel, randomised, controlled clinical trial to evaluate the effectiveness of a weight-loss Mediterranean dietary/lifestyle intervention on managing OSA.
This 6-month long clinical trial included 180 adult, overweight/obese moderate-to-severe OSA patients (45 patients per study group plus a 29% dropout rate). All patients were prescribed the standard of care continuous positive airway pressure (CPAP) therapy and were randomised to 3 arms: standard care; Mediterranean diet; Mediterranean lifestyle
Based on percent change in weight at 6 months, participants were categorised into a weight-stable/gain (WS/GG) group or one of 3 weight-loss groups (WLG): < 5%WLG; 5%–10%WLG; ≥ 10%WLG. Polysomnographic data and OSA symptoms were also evaluated preintervention and postintervention.
Results
Results confirm a dose-response relationship between the degree of weight loss achieved through a dietary/lifestyle intervention and improvements in OSA severity.
- Respiratory events and oximetry indices improved only in patients who lost weight. Improvements were proportional to the degree of weight loss.
- Median percent change in apnea-hypopnea index (AHI) was −11.7%, − 37.9%, and − 49.3% in the < 5%WLG, 5%–10%WLG, and ≥ 10%WLG, respectively (P < .001).
- Compared to the WS/GG, the age-, sex-, baseline-, and CPAP use–adjusted relative risk (95% confidence interval) of severe OSA (AHI ≥ 30 events/h) was 0.45 (0.23–0.87) in the 5%–10%WLG and 0.32 (0.17–0.64) in the ≥ 10%WLG; the risk was also lower in the ≥ 10%WLG vs the < 5%WLG (0.42 [0.22–0.82]).
- Insomnia and daytime sleepiness also improved more in participants exhibiting ≥ 5% weight loss.
- The dose-response relationship between weight loss and improvement in OSA severity was evident regardless of self-reported CPAP use.
Conclusions
The authors conclude that even a < 5% weight loss was sufficient for improvements in respiratory events and oximetry indices, but the prevalence of severe OSA reduced only after a ≥ 5% weight loss, and patients achieving a ≥ 10% weight loss exhibited the greatest benefits compared to weight-stable/gain patients.
Clinical practice applications:
These findings might be useful for Nutritional Therapists and Clinical Practitioners:
- Clinicians should aim for a ≥ 5% weight loss, and ideally a ≥ 10% weight loss, to achieve clinically meaningful reductions in OSA severity.
- Improvements after weight loss were significant even though a healthy body weight was not achieved.
Considerations for future research:
- The study sample consisted of predominantly male, overweight, otherwise healthy patients with moderate-to-severe OSA. Therefore, findings cannot be generalised to the whole OSA population and further research is required with broader, diverse, study samples.
- 6 months is a short duration period, therefore longer trials are required.
- Self-reported CPAP use by participants is a limitation of this study. Further robust analysis methods should be considered for future trials.
- Participants were advised to abstain from CPAP therapy for 2 days prior to the follow-up PSG but this was not evaluated or confirmed in this study and should be in future research.
Abstract
STUDY OBJECTIVES Lifestyle-induced weight loss is a complementary therapeutic approach for obstructive sleep apnea (OSA). We aimed at identifying the dose-response relationship between weight loss and OSA severity improvement. METHODS This is a secondary analysis of a 6-month clinical trial in 180 adult, overweight/obese moderate-to-severe OSA patients. Participants were randomized to a standard care, a Mediterranean diet, or a Mediterranean lifestyle arm. All patients were prescribed with continuous positive airway pressure (CPAP), while intervention arms additionally participated in a weight-loss dietary/lifestyle intervention. Based on percent change in weight at 6 months, participants were categorized into a weight-stable/gain (WS/GG) group or 3 weight-loss groups (WLG): < 5%WLG, 5%-10%WLG, and ≥ 10%WLG. Polysomnographic data and OSA symptoms were evaluated preintervention and postintervention. RESULTS Respiratory events and oximetry indices improved only in patients who lost weight and improvements were proportional to the degree of weight loss. Median percent change in apnea-hypopnea index (AHI) was -11.7%, - 37.9%, and - 49.3% in the < 5%WLG, 5%-10%WLG, and ≥ 10%WLG, respectively (P < .001). Compared to the WS/GG, the age-, sex-, baseline-, and CPAP use-adjusted relative risk (95% confidence interval) of severe OSA (AHI ≥ 30 events/h) was 0.45 (0.23-0.87) in the 5%-10%WLG and 0.32 (0.17-0.64) in the ≥ 10%WLG; the risk was also lower in the ≥ 10%WLG vs the < 5%WLG (0.42 [0.22-0.82]). Insomnia and daytime sleepiness also improved more in participants exhibiting ≥ 5% weight loss. CONCLUSIONS Even a < 5% weight loss can reduce respiratory events, but a ≥ 5% and ideally ≥ 10% weight loss is necessary for reducing the prevalence of severe OSA. CLINICAL TRIAL REGISTRATION Registry: ClinicalTrials.gov; Name: Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT02515357; Identifier: NCT02515357. CITATION Georgoulis M, Yiannakouris N, Kechribari I, et al. Dose-response relationship between weight loss and improvements in obstructive sleep apnea severity after a diet/lifestyle intervention: secondary analyses of the "MIMOSA" randomized clinical trial. J Clin Sleep Med. 2022;18(5):1251-1261.
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Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux: A Double-Blind, Randomized, Sham-Controlled Trial.
Schuitenmaker, JM, Kuipers, T, Oude Nijhuis, RAB, Schijven, MP, Smout, AJPM, Fockens, P, Bredenoord, AJ
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2022;20(12):2753-2762.e2
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Plain language summary
Up to 80% of gastroesophageal reflux disease (GORD) patients experience symptoms during the night, such as heartburn and regurgitation, which can have a profound negative impact on sleep quality and daytime functioning. The aim of this study was to evaluate the effect of sleep positional therapy, using a novel electronic sleep positional therapy wearable device, on sleep position and on nocturnal gastroesophageal reflux symptoms. This study was a single-centre, double-blind, randomised, sham-controlled trial in 100 patients with nocturnal gastroesophageal reflux symptoms. Patients were randomised to one of the two groups (intervention or sham group), and analysed according to the intention-to-treat approach. Results showed that treatment with an electronic sleep positional–wearable device led to an increase in time spent sleeping in the left lateral decubitus position and effectively alleviated nocturnal reflux symptoms compared with sham treatment. Authors conclude that positional therapy can be a valuable addition to other therapeutic strategies in GORD.
Abstract
BACKGROUND & AIMS Experimental studies have suggested that sleep position plays a role in the occurrence of nocturnal gastroesophageal reflux and the left lateral decubitus position is most favorable. The aim of this study was to evaluate the effect of a novel electronic sleep positional therapy wearable device on sleep position and nocturnal reflux symptoms. METHODS We performed a double-blind, randomized, sham-controlled trial in patients with nocturnal symptoms of gastroesophageal reflux. Patients were advised to sleep in the left lateral decubitus position and were assigned randomly (1:1) to an electronic sleep positional therapy wearable device, programmed to either produce a vibration when in the right lateral position (intervention) or only during the first 20 minutes (sham). The primary outcome was treatment success, defined as a 50% or more reduction in the nocturnal reflux score. Secondary outcomes included change in sleep position and reflux symptoms. RESULTS One hundred patients were randomized. In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group (22 of 50) vs 24% in the sham group (12 of 50) (risk difference, 20%; 95% CI, 1.8%-38.2%; P = .03). Treatment led to a significant avoidance of sleeping in the right lateral decubitus position (intervention 2.2% vs sham 23.5%; P = .000) and increased time sleeping in the left lateral decubitus position (intervention 60.9% vs sham 38.5%; P = .000). More reflux-free nights were observed in the intervention group (intervention 9 nights [interquartile range, 6-11 nights] vs sham 6 nights [interquartile range, 3-9 nights]; P = .01). CONCLUSIONS Sleep positional therapy using an electronic wearable device promotes sleeping in the left lateral decubitus position and effectively alleviates nocturnal reflux symptoms compared with sham treatment (https://www.trialregister.nl, NL8655).