scholarly journals Effect of 12-month intervention with lipid-based nutrient supplement on the physical activity of Malawian toddlers: a randomised, controlled trial

2017 ◽  
Vol 117 (4) ◽  
pp. 511-518 ◽  
Author(s):  
A. Pulakka ◽  
Y. B. Cheung ◽  
K. Maleta ◽  
K. G. Dewey ◽  
C. Kumwenda ◽  
...  
Keyword(s):  
Physical Activity ◽  
Essential Fatty Acids ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Nutrient Supplement ◽  
Randomised Controlled ◽  
Objectively Measured ◽  
Blinded Trial ◽  
Vector Magnitude

AbstractPhysical activity is beneficial for children’s well-being. The effect of dietary supplementation on children’s physical activity in food-insecure areas remains little studied. We examined the effects of a lipid-based nutrient supplement (LNS) on children’s objectively measured physical activity in a randomised, controlled, outcome-assessor-blinded trial. Mothers of the children received one capsule daily of Fe-folic acid (IFA), one capsule containing eighteen micronutrients (MMN) or one 20 g sachet of LNS (containing twenty-two MMN, protein, carbohydrates, essential fatty acids and 494 kJ (118 kcal)) during pregnancy and for 6 months thereafter. Children in the IFA and MMN groups received no supplementation, and these groups were collapsed into a single control group; children in the LNS group received 20 g LNS from 6 to 18 months. We measured physical activity with accelerometers over 1 week at 18 months. The main outcome was mean vector magnitude counts/15 s. Of the 728 children at the beginning of child intervention at 6 months, 570 (78 %) provided sufficient data for analysis. The mean accelerometer counts for the 190 children in the LNS group and for the 380 children in the control group were 303 (sd 59) and 301 (sd 56), respectively (Pfor difference=0·65). LNS, given to mothers during pregnancy and 6 months postpartum and to their infants from 6 to 18 months of age, did not increase physical activity among 18-month-old children.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016966 ◽  
Author(s):  
Sarah Thomas ◽  
Louise Fazakarley ◽  
Peter W Thomas ◽  
Sarah Collyer ◽  
Sarah Brenton ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Well Being ◽  
Recruitment Rate ◽  
Controlled Study ◽  
Activity Levels ◽  
Nintendo Wii ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectivesWhile the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention.DesignA single-centre wait-list randomised controlled study.SettingMS service in secondary care.ParticipantsAmbulatory, relatively inactive people with clinically confirmed MS.InterventionThirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources.OutcomesIncluded self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants’ experiences and, at study end, the two Mii-vitaliSe facilitators’ experiences of intervention delivery (main qualitative findings reported separately).ResultsMean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person.DiscussionMii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design.Trial registrationISRCTN49286846

scholarly journals Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

2021 ◽  
Author(s):  
Waqar M. Naqvi
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Well Being ◽  
Likert Scale ◽  
Control Group ◽  
Group A ◽  
Measuring Scale ◽  
Group B ◽  
Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

scholarly journals Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018409 ◽  
Author(s):  
Sarah G Dean ◽  
Leon Poltawski ◽  
Anne Forster ◽  
Rod S Taylor ◽  
Anne Spencer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cognitive Capacity ◽  
Economic Evaluations ◽  
Control Group ◽  
Rehabilitation Training ◽  
One To One ◽  
Randomised Controlled

ObjectivesTo assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.DesignA two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.SettingCommunity settings across two sites in Devon.ParticipantsEligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.InterventionsReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.Outcome measuresCandidate primary outcomes included functional mobility and physical activity.ResultsForty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.ConclusionsAll objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.Trial registration numberNCT02429180; Results.

scholarly journals Development and evaluation of a WeChat-based life review programme for patients with cancer: protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e020239 ◽  
Author(s):  
Xiaoling Zhang ◽  
Huimin Xiao
Keyword(s):  
Meaning In Life ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Life Review ◽  
Development Theory ◽  
Control Group ◽  
Patients With Cancer ◽  
Self Transcendence ◽  
Randomised Controlled

IntroductionPatients with cancer often suffer from considerable distress. Life review is a process of recalling, evaluating and integrating life experiences to alleviate a sense of despair and achieve self-integrity. Empirical data have supported the fact that life review is an effective psychological intervention, but it is not always accessible to patients with cancer. There is little evidence of internet-based life review programmes tailored to patients with cancer. This study aims to develop a WeChat-based life review programme and evaluate its effectiveness on the psycho-spiritual well-being of patients with cancer undergoing chemotherapy.Methods and analysisA single-centre randomised parallel group superiority design will be used. Patients with cancer will be randomised, to either a control group, or to an experimental group receiving a 6-week WeChat-based life review programme. The programme, which was mainly developed based on Erikson’s psycho-social development theory and Reed’s self-transcendence theory, provides synchronous and asynchronous communication modes for patients to review their life. The former is real-time communication, providing an e-life review interview guided by a facilitator online. The latter is not simultaneously dialogic and is used to interact with patients before and after a life review interview through Memory Prompts, Review Extraction, Mind Space and E-legacy products. The primary outcomes include anxiety, depression and self-transcendence, and the secondary outcomes are meaning in life and hope. These will be measured at baseline, and immediately, at 3 months, and at 6 months after the programme’s conclusion.Ethics and disseminationEthics approval has been obtained from the Biological and Medical Research Ethics Committee of the corresponding author’s university (IRB Ref No: 2016/00020). The trial results will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration numberChiCTR-IOR-17011998.

scholarly journals Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640)

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031290
Author(s):  
Erica Schytt ◽  
Anna Wahlberg ◽  
Amani Eltayb ◽  
Rhonda Small ◽  
Nataliia Tsekhmestruk ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
Ethical Review ◽  
Control Group ◽  
Migrant Women ◽  
Intrapartum Care ◽  
Community Based ◽  
Randomised Controlled

IntroductionMigrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden.Methods and analysisA randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women’s ratings of the intrapartum care experiences and postnatal well-being are assessed at 6–8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2).Trial registration numberNCT03461640; Pre-results.

scholarly journals A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vladimir Carli ◽  
Danuta Wasserman ◽  
Gergö Hadlaczky ◽  
Nuhamin Gebrewold Petros ◽  
Sara Carletto ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Physiological Data ◽  
Control Group ◽  
Evidence Based ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017.

scholarly journals Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes—the Sophia Step Study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Jenny Rossen ◽  
Kristina Larsson ◽  
Maria Hagströmer ◽  
Agneta Yngve ◽  
Kerstin Brismar ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Single Component ◽  
Control Group ◽  
Self Monitoring ◽  
Randomised Controlled ◽  
Step Study

Abstract Background This aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes. Methods The Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model. Results In total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group. Conclusion This 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015—Retrospectively registered.

scholarly journals Virtual reality for relatives of ICU patients to improve psychological sequelae: study protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049704
Author(s):  
Johan H Vlake ◽  
Jasper van Bommel ◽  
Evert-Jan Wils ◽  
Tim Korevaar ◽  
Merel E Hellemons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Virtual Reality ◽  
Intensive Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Icu Patients ◽  
Randomised Controlled

IntroductionIntensive care unit (ICU) admission of a relative might lead to psychological distress and complicated grief (post-intensive care syndrome–family; PICS-F). Evidence suggests that increased distress during ICU stay increases risk of PICS-F, resulting in difficulty returning to their normal lives after the ICU experience. Effective interventions to improve PICS-F are currently lacking. In the present trial, we hypothesised that information provision using ICU-specific Virtual Reality for Family members/relatives (ICU-VR-F) may improve understanding of the ICU and subsequently improve psychological well-being and quality of life in relatives of patients admitted to the ICU.Methods and analysisThis multicentre, clustered randomised controlled trial will be conducted from January to December 2021 in the mixed medical-surgical ICUs of four hospitals in Rotterdam, the Netherlands. We aim to include adult relatives of 160 ICU patients with an expected ICU length of stay over 72 hours. Participants will be randomised clustered per patient in a 1:1 ratio to either the intervention or control group. Participants allocated to the intervention group will receive ICU-VR-F, an information video that can be watched in VR, while the control group will receive usual care. Initiation of ICU-VR-F will be during their hospital visit unless participants cannot visit the hospital due to COVID-19 regulations, then VR can be watched digitally at home. The primary objective is to study the effect of ICU-VR-F on psychological well-being and quality of life up to 6 months after the patients’ ICU discharge. The secondary outcome is the degree of understanding of ICU treatment and ICU modalities.Ethics and disseminationThe Medical Ethics Committee of the Erasmus Medical Centre, Rotterdam, the Netherlands, approved the study and local approval was obtained from each participating centre (NL73670.078.20). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals.Trial registration numberNetherlands Trial Register (TrialRegister.nl, NL9220).

Sign in / Sign up

Export Citation Format

Share Document