scholarly journals Black tea is not significantly different from water in the maintenance of normal hydration in human subjects: results from a randomised controlled trial

2011 ◽  
Vol 106 (4) ◽  
pp. 588-595 ◽  
Author(s):  
Carrie H. Ruxton ◽  
Valerie A. Hart
Keyword(s):  
Randomised Controlled Trial ◽  
Human Subjects ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Black Tea ◽  
Blood Cell Count ◽  
Factorial Anova ◽  
The Mean ◽  
Randomised Controlled ◽  
Boiled Water

There is a belief that caffeinated drinks, such as tea, may adversely affect hydration. This was investigated in a randomised controlled trial. Healthy resting males (n21) were recruited from the general population. Following 24 h of abstention from caffeine, alcohol and vigorous physical activity, including a 10 h overnight fast, all men underwent four separate test days in a counter-balanced order with a 5 d washout in between. The test beverages, provided at regular intervals, were 4 × 240 ml black (i.e. regular) tea and 6 × 240 ml black tea, providing 168 or 252 mg of caffeine. The controls were identical amounts of boiled water. The tea was prepared in a standardised way from tea bags and included 20 ml of semi-skimmed milk. All food taken during the 12 h intervention period was controlled, and subjects remained at rest. No other beverages were offered. Blood was sampled at 0, 1, 2, 4, 8 and 12 h, and a 24 h urine sample was collected. Outcome variables were whole blood cell count, Na, K, bicarbonate, total protein, urea, creatinine and osmolality for blood; and total volume, colour, Na, K, creatinine and osmolality for urine. Although data for all twenty-one participants were included in the analysis (mean age 36 years and mean BMI 25·8 kg/m2), nineteen men completed all conditions. Statistical analysis, using a factorial ANOVA approach within PROC MIXED, revealed no significant differences between tea and water for any of the mean blood or urine measurements. It was concluded that black tea, in the amounts studied, offered similar hydrating properties to water.

scholarly journals Effectiveness of SMS messaging for diarrhoea measurement: a factorial cross-over randomised controlled trial

2020 ◽  
Author(s):  
Ryan Trevor Titus Rego ◽  
Samuel Watson ◽  
Philbert Ishengoma ◽  
Philemon Langat ◽  
Hezekiah Pireh Otieno ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Text Messaging ◽  
Response Rate ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Response Rates ◽  
Lower Response ◽  
Lower Response Rate ◽  
The Mean ◽  
Randomised Controlled

Abstract Background Text messaging systems are used to collect data on symptom prevalence. Using a text messaging system, we evaluated the effects of question load, question frequency, and financial incentive on response rates and reported infant diarrhoea rates in an infant diarrhoea survey. Methods We performed a factorial cross-over randomised controlled trial of an SMS surveying system for infant diarrhoea surveillance with treatments: financial incentive (yes/no), question load (1-question/3-question), and questioning frequency (daily/fortnightly). Participants progressed through all treatment combinations over eight two-week rounds. Data were analysed using multivariable logistic regressions to determine the impacts of the treatments on the response rates and reported diarrhoea rates. Attitudes were explored through qualitative interviews. Results For the 141 participants, the mean response rate was 47%. In terms of percentage point differences (ppd), daily questioning was associated with a lower response rate than fortnightly (-1·2[95%CI:-4·9,2·5]); high (3-question) question loads were associated with a lower response rate than low (1-question) question loads (-7·0[95%CI:-10·8,-3·1]); and financial incentivisation was associated with a higher response rate than no financial incentivisation (6·4[95%CI:2·6,10·2]). The mean two-week diarrhoea rate was 36·4%. Daily questioning was associated with a higher reported diarrhoea rate than fortnightly (29·9[95%CI:22·8,36·9]); with little evidence for impact by incentivisation or question load. Conclusions Close to half of all participants responded to the SMS survey. Daily questioning evoked a statistically higher rate of reported diarrhoea, while financial incentivisation and low (1-question) question loads evoked higher response rates than no incentive and high (3-question) question loads respectively. Trial Registration The protocol was registered on ISRCTN on the 20 th of March 2019 under number ISRCTN11410773 .

scholarly journals Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e017511 ◽  
Author(s):  
Nishma Patel ◽  
Rebecca J Beeken ◽  
Baptiste Leurent ◽  
Rumana Z Omar ◽  
Irwin Nazareth ◽  
...  
Keyword(s):  
General Practice ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Usual Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
The Mean ◽  
Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

scholarly journals Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037303
Author(s):  
Fumiya Tanji ◽  
Yasutake Tomata ◽  
Saho Abe ◽  
Sanae Matsuyama ◽  
Yumika Kotaki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Intervention Period ◽  
The Mean ◽  
Randomised Controlled

ObjectiveThe aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.Study designTwo-arm, parallel-group randomised controlled trial.Setting/participantsWe recruited physically inactive community-dwelling adults from Sendai city, Japan. Eligible participants were randomly allocated to an intervention or a wait list control group. Pedometers were used to assess the mean number of daily steps in three periods: baseline (weeks 1–3), intervention (weeks 4–6) and follow-up (weeks 7–9).InterventionThe intervention group was offered a financial incentive (shopping points) to meet the target number of increased daily steps in the intervention period.Main outcome measuresThe primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.ResultsSeventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804) were randomised to the intervention (n=36) and control groups (n=36). During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311). In addition, compared with controls, a significantly higher proportion of participants in the intervention group showed an increase in mean daily steps of ≥1000 (69.4% vs 30.6%, respectively; OR=5.17, 95% CI=1.89 to 14.08). There were no adverse effects from the intervention.ConclusionsThe present results suggest that financial incentives are effective in promoting short-term increases in physical activity.Trial registration numberUMIN000033276.

scholarly journals Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be)

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e053711
Author(s):  
Lili L Kókai ◽  
Diarmaid T Ó Ceallaigh ◽  
Anne I Wijtzes ◽  
Jeanine E Roeters van Lennep ◽  
Martin S Hagger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Well Being ◽  
Behaviour Change Techniques ◽  
Automatic Processes ◽  
Post Intervention ◽  
Randomised Controlled

IntroductionEfficacy tests of physical activity interventions indicate that many have limited or short-term efficacy, principally because they do not sufficiently build on theory-based processes that determine behaviour. The current study aims to address this limitation.Methods and analysisThe efficacy of the 8-week intervention will be tested using a three-condition randomised controlled trial delivered through an app, in women with a prior hypertensive pregnancy disorder. The intervention is based on the integrated behaviour change model, which outlines the motivational, volitional and automatic processes that lead to physical activity. The mechanisms by which the behaviour change techniques lead to physical activity will be tested.Following stratification on baseline factors, participants will be randomly allocated in-app to one of three conditions (1:1:1). The information condition will receive information, replicating usual care. Additionally to what the information condition receives, the motivation condition will receive content targeting motivational processes. Additionally to what the motivation condition receives, the action condition will receive content targeting volitional and automatic processes.The primary outcome is weekly minutes of moderate-to-vigorous physical activity, as measured by an activity tracker (Fitbit Inspire 2). Secondary outcomes include weekly average of Fitbit-measured daily resting heart rate, and self-reported body mass index, waist-hip ratio, cardiorespiratory fitness and subjective well-being. Tertiary outcomes include self-reported variables representing motivational, volitional, and automatic processes. Outcome measures will be assessed at baseline, immediately post-intervention, and at 3 and 12 months post-intervention. Physical activity will also be investigated at intervention midpoint. Efficacy will be determined by available case analysis. A process evaluation will be performed based on programme fidelity and acceptability measures.Ethics and disseminationThe Medical Ethics Committee of the Erasmus MC has approved this study (MEC-2020-0981). Results will be published in peer reviewed scientific journals and presented at scientific conferences.Trial registration numberNetherlands trial register, NL9329.

scholarly journals An effective app for self-management of urgency and mixed urinary incontinence in women: results from a randomised controlled trial (Preprint)

2020 ◽  
Author(s):  
Towe Wadensten ◽  
Emma Nyström ◽  
Karin Franzén ◽  
Anna Lindam ◽  
Elisabet Wasteson ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Mixed Urinary Incontinence ◽  
Self Management ◽  
Information Group ◽  
The Mean ◽  
Randomised Controlled

BACKGROUND Many women experience urgency and mixed urinary incontinence, but commonly hesitate to seek care. Treatment access and self-management can be supported through eHealth methods. OBJECTIVE This study investigated the efficacy of a mobile app for self-management of urgency and mixed urinary incontinence. METHODS This randomised controlled trial was conducted in Sweden. We included women of ≥18 year old, with urgency or mixed urinary incontinence and ≥2 leakages/week, excluding those with alarm symptoms. The women were recruited via information on TV, radio, and newspapers, and via Facebook advertisements. Initial selection was performed using a web-based screening questionnaire at our webpage. Data was then collected using an inclusion questionnaire and a two-day bladder diary. Symptom diagnosis was confirmed through a telephone interview. Participants were randomised to a treatment app (pelvic floor muscle training, bladder training, psychology, lifestyle advice, individual advice, statistics, reinforcement messages, and reminders) or brief information app (control). No guidance on the treatment was provided outside of the apps. The primary outcome was incontinence symptoms at follow-up (15 weeks), measured by ICIQ-UI SF score. Urgency symptoms were assessed via ICIQ-OAB score, and quality of life via ICIQ-LUTSqol score. Improvement was measured using Patient’s Global Impression of Improvement (PGI-I). These outcomes were patient reported. Cure was defined as no leakages (based on bladder diary). Intention-to-treat analysis was performed. RESULTS Between April 2017 and March 2018, 123 women were randomised to treatment (n=60, two lost to follow-up) or information (n=63). Of the included women, 28% had symptoms of urgency urinary incontinence, and 72% had mixed urinary incontinence. The mean age was 58.3 (SD 9.6) years and the majority had a university education. Half of the women were overweight or obese. Baseline characteristics did not differ between the two groups. The mean follow-up ICIQ-UI SF score was lower in the treatment group than the information group (estimated difference 3.1; 95% CI −4.8 to −1.3). For the follow-up ICIQ-OAB score, the estimated between-groups difference was −1∙8 (95% CI −2∙8 to −0∙99) and for the ICIQ-LUTSqol, the estimated between-groups difference was -6.3 (95% CI -10.5 to -2.1). Of women in the treatment group 90% reported an improvement, compared to 30% in the information group. Cure was reported by 19 women in the treatment group, and 4 in the control group (OR 5.38, 95% CI 1.86 to 15.57, p=0.002). During the 15-week treatment period, 69% of women in the treatment group used the app daily, and 10% used it at least three times per day. CONCLUSIONS The tested treatment app was effective for improvement and cure of urgency and mixed incontinence in women. It may be a good alternative to pharmacological treatment or other conservative management, increasing access to care. CLINICALTRIAL ClinicalTrials.gov NCT03097549

scholarly journals Prophylactic Administration of Per Rectal Misoprostol vs Intramuscular Injection of Oxytocin in Third-stage of Labour for Prevention of Postpartum Haemorrhage: A Randomised Controlled Trial

2021 ◽  
Author(s):  
Sougata Kumar Burman ◽  
Ritwik Samanta ◽  
Kumari Kanak Lata ◽  
Jayeeta Mukherjee ◽  
Tapan Kumar Dey
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Blood Loss ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Effective Control ◽  
Control Group ◽  
Third Stage ◽  
The Mean ◽  
Randomised Controlled

Introduction: In India, the routine Active Management of Third- Stage of Labour (AMTSL) with conventional intramuscular oxytocin, at the rural, resource-constrained areas, is often compromised due to lack of trained healthcare personnel and proper maintenance of cold chain system, causing maternal mortality and morbidity from Postpartum Haemorrhage (PPH). In these scenarios, tablet misoprostol, can be efficacious and convenient alternative. Aim: To evaluate efficacy and safety of misoprostol administered per rectum with respect to intramuscular oxytocin for effective control of PPH in a Randomised Controlled Trial (RCT). Materials and Methods: In this RCT, conducted in Sambhunath Pandit Hospital, kolkata, West Bengal, India from September 2015 to August 2016, total 80 eligible pregnant mothers in normal labour with prior consent and fulfilled criteria, were allocated to two separated groups (n=40) by computer generated randomisation table. Control group received 10 IU injection oxytocin and case group received 600 μg misoprostol tablet per rectally within one minute of cord clamping and cutting. The primary outcome measures were mean third- stage and mean postpartum blood loss up to eight hours after delivery. Secondary outcome variables were Mean Arterial Pressure (MAP) after eight hours postdelivery, haemoglobin and haematocrit after 24 hours of delivery and reported side effects. Data was entered into a Microsoft excel spreadsheet and statistical analysis was done by Statistical Package for the Social Sciences (SPSS) version 20.0.1 and Graph Pad Prism version 5.0. Results: Total sample size was 80 equally divided into two groups, with a mean age of 23.20±3.1558 years and 23.7750±3.8927 years in case and control group respectively. The mean third-stage blood loss (332.4105±72.6632 mL versus {vs} 329.0088±59.4503 mL, p=0.8193) and mean total blood loss (426.5575±80.0215 mL vs 424.8783±61.5808 mL, p=0.9165) were statistically indifferent between misoprostol and oxytocin groups by two-sample t-tests. The mean for eight hours postpartum MAP (p=0.0894), 24 hours postpartum haemoglobin (p=0.4534) and haematocrit (p=0.1325) were statistically insignificant between the two groups by two- sample t-tests. Incidence of adverse effects like shivering, diarrhoea, compared by Pearson’s Chi-square test, were found to be more but non significant in misoprostol group. Conclusion: This study concludes that per-rectal misoprostol is equally effective as intramuscular oxytocin to control PPH without significant adverse effects.

scholarly journals Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e033844
Author(s):  
Kamilya Jamel Baljon ◽  
Muhammad Hibatullah Romli ◽  
Adibah Hanim Ismail ◽  
Lee Khuan ◽  
Boon How Chew
Keyword(s):  
Saudi Arabia ◽  
Randomised Controlled Trial ◽  
Sample Size ◽  
Study Protocol ◽  
Human Subjects ◽  
Controlled Trial ◽  
Labour Pain ◽  
Control Group ◽  
Breathing Exercises ◽  
Randomised Controlled

IntroductionLabour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae.Methods and analysisThis randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26–34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.Ethics and disseminationEthical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019–169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.Trial registration numberISRCTN87414969, registered 3 May 2019.

Physiological stability in an indigenous sleep device: a randomised controlled trial

2017 ◽  
Vol 103 (4) ◽  
pp. 377-382 ◽  
Author(s):  
Sally A Baddock ◽  
David Tipene-Leach ◽  
Sheila M Williams ◽  
Angeline Tangiora ◽  
Raymond Jones ◽  
...  
Keyword(s):  
Heart Rate ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Oxygen Saturation ◽  
Outcome Measures ◽  
Thermal Environment ◽  
Controlled Trial ◽  
Intention To Treat ◽  
The Mean ◽  
Randomised Controlled

ObjectiveTo compare overnight oxygen saturation, heart rate and the thermal environment of infants sleeping in an indigenous sleep device (wahakura) or bassinet to identify potential risks and benefits.DesignRandomised controlled trial.SettingFamily homes in low socio-economic areas in New Zealand.Patients200 mainly Māori mothers and their infants.InterventionsParticipants received a wahakura or bassinet from birth.Main outcome measuresOvernight oximetry, heart rate and temperature at 1 month.ResultsIntention-to-treat analysis for 83 bassinet and 84 wahakura infants showed no significant differences between groups for the mean time oxygen saturation (SpO2) was less than 94% (0.54 min, 95% CI -1.36 to 2.45) or less than 90% (0.22 min, 95% CI -0.56 to 1.00), the mean number of SpO2 dips per hour >5% (-0.19, 95% CI -3.07 to 2.69) or >10% (-0.41, 95% CI -1.63 to 0.81), mean heart rate (1.99 beats/min, 95% CI -1.02 to 4.99), or time shin temperature >36°C (risk ratio (RR): 0.63, 95% CI 0.13 to 2.99) or <34°C (RR: 0.89, 95% CI 0.61 to 1.30). A per-protocol analysis of 45 bassinet and 26 wahakura infants and an as-used analysis of 104 infants in a bassinet and 48 in a wahakura found no significant differences between groups for all outcome measures.ConclusionsThis indigenous sleep device is at least as safe as the currently recommended bassinet, which supports its use as a sleep environment that offers an alternative way of bed-sharing.Trial registration numberAustralian New Zealand Clinical Trials Registry: ACTRN12610000993099.

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