Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial

Abstract Background We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions. Methods We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the ‘Join Dementia Research’ register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary. Results Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention. Conclusion We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial. Trial registration ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

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101 A Posture and Mobility Training Package for Care Home Staff: Results of A Cluster Randomised Controlled Feasibility Trial

Age and Ageing ◽

10.1093/ageing/afz196.03 ◽

2020 ◽

Vol 49 (Supplement_1) ◽

pp. i34-i36

Author(s):

L Graham ◽

B Cundill ◽

A Ellwood ◽

J Fisher ◽

M Goodwin ◽

...

Keyword(s):

Care Home ◽

Direct Care ◽

Care Staff ◽

Feasibility Trial ◽

Direct Care Staff ◽

Intervention Delivery ◽

Care Home Staff ◽

Mobility Training ◽

Randomised Controlled

Abstract Introduction Provision of care for care home residents with complex needs is challenging. Physiotherapy and activity interventions can improve physical well-being but are often time-limited and resource intensive. A sustainable approach is to enhance the confidence, skills and abilities of care home staff. This trial assessed the feasibility of undertaking a definitive evaluation of the Skilful Care Training Package (SCTP) - a posture and mobility training programme developed by physiotherapists for care home staff. Methods A parallel-group, cluster randomised controlled feasibility trial was undertaken in ten care homes in Yorkshire. Five were randomised to receive SCTP, five to usual care. SCTP was delivered by specialist physiotherapists, with the intention of training all direct care staff. Following consent, data were collected from and about residents with restricted mobility (those fulfilling the eligibility criteria) at baseline, three and six months post-randomisation by blinded researchers. Outcome measurement included resident mobility, posture, pain and quality of life. The feasibility of recruitment, retention, data collection and intervention delivery was assessed. Results All residents (348) at participating homes were screened for eligibility. 250 were eligible and 146 took part. Follow-up was balanced between arms, with an overall loss-to-follow-up rate of 28.8% at six months. Where residents were available for six-month follow-up, proxy data provision was excellent (97.1% - 100% of expected data). Difficulty collecting data directly from residents was experienced (43.3% of expected data) due to high levels of cognitive impairment. Staff attendance at training met or was close to pre-specified criteria for acceptability in three homes, with 63.0%, 63.6% and 65.8% direct care staff attending all sessions, and >85% attending at least one session across all three homes. However attendance fell short of acceptability in two homes, with only 21.4% and 12.5% staff attending all sessions. Conclusions It is feasible to recruit and follow-up residents in a randomised trial comparing SCTP and usual care. Proxy data collection is a successful method, but collection of data from residents is difficult. Intervention delivery success was variable, illustrating heterogeneity between care homes. Future research will be informed by learning from those homes with greater intervention compliance. Work should be undertaken to investigate how best to collect meaningful data from residents.

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71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

Emergency Medicine Journal ◽

10.1136/emj-2020-rcemabstracts.21 ◽

2020 ◽

Vol 37 (12) ◽

pp. 835.3-836

Author(s):

Hamza Malik ◽

Andrew Appelboam ◽

Gordon Taylor ◽

Daryl Wood ◽

Karen Knapp

Keyword(s):

Data Collection ◽

Controlled Trial ◽

Wrist Fracture ◽

Recruitment Rate ◽

Feasibility Trial ◽

Point Of Care Ultrasound ◽

Distal Radial Fractures ◽

Definitive Trial ◽

Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

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Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00788-1 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Laura Williams ◽

Charlotte L. Hall ◽

Sue Brown ◽

Boliang Guo ◽

Marilyn James ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Controlled Trial ◽

Medication Management ◽

Control Group ◽

Global Functioning ◽

Children And Young People ◽

Link Type ◽

Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

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Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): results from a randomised controlled feasibility trial

BMJ Open ◽

10.1136/bmjopen-2019-029233 ◽

2019 ◽

Vol 9 (11) ◽

pp. e029233 ◽

Cited By ~ 3

Author(s):

David Bosanquet ◽

Graeme Ambler ◽

Cherry-Ann Waldron ◽

Emma Thomas-Jones ◽

Lucy Brookes-Howell ◽

...

Keyword(s):

Postoperative Pain ◽

Local Anaesthetic ◽

Lower Limb ◽

Rating Scale ◽

Lower Limb Amputation ◽

Feasibility Trial ◽

Limb Amputation ◽

Effectiveness Trial ◽

Randomised Controlled

ObjectivesTo determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.DesignRandomised controlled feasibility trial.SettingTwo vascular Centres in South Wales, UK.Participants50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.InterventionsThe treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.Primary and secondary outcome measuresThe primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.ResultsSeventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.ConclusionsRecruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.Trial registration numberISRCTN: 85 710 690. EudraCT: 2016-003544-37.

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Imatinib Long Term Effects (ILTE) Study: An Independent, International Study in CML Patients.

Blood ◽

10.1182/blood.v112.11.1099.1099 ◽

2008 ◽

Vol 112 (11) ◽

pp. 1099-1099

Author(s):

Carlo Gambacorti-Passerini ◽

Dong-Wook Kim ◽

François-Xavier Mahon ◽

Giuseppe Saglio ◽

Fabrizio Pane ◽

...

Keyword(s):

Adverse Events ◽

International Study ◽

Imatinib Treatment ◽

Long Term Effects ◽

First Line ◽

Eligibility Criteria ◽

Serious Adverse Events ◽

Second Cancers

Abstract Imatinib is an effective first line therapy for chronic myeloid leukemia (CML) and has substantially changed its biological and clinical behavior. Durable complete cytogenetic responses (CCyR) were reported in the majority of patients, with a rather benign side effect profile, despite the ‘off target’ inhibition of several other kinases, including Kit, PDGFR and Lck. Since available information is largely based on industry-sponsored trials and long-term field studies are lacking, the ILTE study was conceived as an industryindependent, academic, multicenter trial supported by the Italian Drug Safety Agency (AIFA). ILTE is an international study on a retrospective cohort and includes 31 centers in Europe, North/South America, Africa and Asia; therefore it is uniquely positioned to present a global picture of imatinib long-term effects. Consecutive patients with Ph+ CML who started imatinib between 01 September 1999 and 31 December 2004 were eligible if they were in Complete Cytogenetic Response (CCyR) after two years of imatinib treatment. Study endpoints were survival, serious adverse events (SAE, including second cancers), toxicities not qualifying as SAE (NSAE) but judged by the referring physician as substantially impacting quality of life, loss of CCyR, and development of PCR negativity. A total of 957 patients were enrolled, 92% of which met eligibility criteria. The median age of eligible patients was 50 (range 15–92) years; 59% of patients were males and the median follow-up was 3.1 years (excluding the first 2 years of treatment). As of Dec. 31 2007, 2564 person years were available for analysis. Eleven deaths were observed (only 3 of them caused by relapsed CML), with a standardized rate of 0.4/100 person years and an observed/expected ratio of 0.48 (95% CI = 0.24–0.85). One-hundred SAE were recorded (rate 3.9/100 person years, most frequent type “heart failure”), with 21% being considered related to imatinib. Second cancers were documented in 28 patients (rate 1.1/100 person years), with an observed/expected ratio of 1.27 (95% CI = 0.84–1.84). Among the 576 NSAE recorded (0.65/patient) the most frequent types were “edema, cramps, skin fragility, diarrhea”; 71% of them were related to imatinib. A total of 12 patients (1.4 %) discontinued imatinib because of toxicities during the period of observation. Thirty-four patients lost CCyR, corresponding to a rate of 1.4/100 person years (1.0 in patients with imatinib as first-line treatment, 1.5 in patients who were treated with imatinib >6 months after diagnosis), with stable or increasing rates over time. Finally, 214 patients (24.5%) developed durable (> 1 year) PCR negativity. In conclusion, the first report from ILTE shows that CML patients on imatinib die unfrequently of CML related causes, do not appear to have substantially higher second cancer rates than the general population, have mortality rates lower than expected in an age/sex matched population and do not show new types of imatinib-related adverse events. They also experience a low but steady rate of loss of CCyR and develop PCR negativity in approximately ¼ of cases. Follow-up and further analysis are ongoing. (Presented on behalf of the ILTE Investigators group)

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Incidence and prognostic factors of knee extension deficits following anterior cruciate ligament reconstruction: A systematic review and meta-analysis of randomised controlled trials

10.1101/2020.11.26.20239046 ◽

2020 ◽

Author(s):

Nalan Ektas ◽

Corey Scholes ◽

Meredith Harrison-Brown ◽

Maha Jegatheesan ◽

Ashwin Rajesh ◽

...

Keyword(s):

Prognostic Factors ◽

Randomised Controlled Trials ◽

Acl Injury ◽

Knee Extension ◽

Cochrane Library ◽

Controlled Trials ◽

Extension Deficit ◽

Eligibility Criteria ◽

Randomised Controlled

ABSTRACTBackground and aimsKnee extension deficits complicate recovery from ACL injury and reconstruction, however the incidence of knee extension loss is not well defined. The aim of this review was to identify the incidence of loss of extension (LOE) following ACL rupture and reconstruction, explore the definitions of knee extension deficits reported and identify prognostic factors affecting LOE incidence.Methods and analysisA systematic search was conducted in Medline, Cochrane Library and PEDro for studies in publication up to September 2019, with no restrictions on publication year. References were screened and assessed for inclusion using predetermined eligibility criteria. Randomised controlled trials (RCTs) that quantified knee angle, loss of extension or incidence of extension deficit were included for quality assessment and data extraction. Statistical summaries were generated and meta-analyses performed in two parts to examine: (i) the probability of a datapoint being zero incidence compared to a non-zero incidence, and (ii) the relationship between the predictors and non-zero LOE incidence.ResultsA sample of 8594 papers were retrieved using the search criteria, with 48 studies meeting eligibility criteria. Pooled results from 4065 participants were included for analysis, with 3965 participants who had undergone ACLR. The proportion of included studies judged at an overall low risk of bias was small (6%). The analysis revealed median LOE incidence of 15.9% (IQR 1.4 - 46.5) at a median follow up from treatment of 4.9 months (IQR 1.9 - 24). Median LOE incidence was 23 % (IQR 8.4 - 50.0) for the subset of studies reporting up to 12 months of follow up. The observed group and study were the most important predictors for whether a datapoint reported an incidence of extension deficit. Time to follow up (P < 0.001) and graft type (P = 0.02) were found to have a significant influence on non-zero LOE incidence (%).ConclusionsThis review examined the definitions for the measurement and interpretation of postoperative knee extension, and established the trajectory of knee extension deficit after ACL injury and reconstruction. While factors associated with loss of extension were identified, the trajectory of knee extension deficits were difficult to infer due to discrepancies in measurement techniques and patient variation. Clinicians should expect up to 1 in 3 patients to present postoperatively with loss of extension of at least 3 degrees, which may partially resolve over time. Future work should focus on the development of a standardised framework for postoperative measurement and reporting of LOE.

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Cognitive effectiveness of high-intensity interval training for individuals with methamphetamine dependence: a study protocol for randomised controlled trial

Trials ◽

10.1186/s13063-021-05615-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Shen Menglu ◽

Yang Suyong ◽

Wang Xiaoyan ◽

Wolfgang I. Schöllhorn ◽

Zhu Dong

Keyword(s):

Cognitive Functions ◽

High Intensity ◽

Interval Training ◽

Moderate Intensity ◽

Good Effect ◽

High Intensity Interval Training ◽

Link Type ◽

Short Period ◽

High Intensity Interval

Abstract Introduction Cognitive deficit is a common syndrome of methamphetamine (MA) dependence. It is related to decision-making, control ability, and social functioning. High-intensity interval training (HIIT) is a training technique that requires people to work out at full intensity during a short period. Many studies have already shown the potential effects of HIIT on cognitive functions. The purpose of this trial is to evaluate the cognitive effects of HIIT on individuals with MA dependence. Methods and analysis A total of 240 individuals with MA dependence will be randomly assigned to the HIIT group, moderate-intensity continuous training (MICT) group and control (CON) group. HIIT will consist of a 24-min HIIT exercise on a treadmill. MICT will consist of a 1-h body–mind exercise. CON will be their traditional intervention. The experimental period will be 12 months with 3 interventions weekly for the first 6 months and follow-up for the next 6 months. All subjects will be given cognitive tests at baseline, after intervention and at follow-up. Cognitive performances will be compared by a mixed-model analysis for repeated measures. Discussion HIIT training may reduce illicit drug cravings amongst individuals with MA dependence; hence, HIIT may have a good effect on the cognitive functions, such as memory and executive function, of individuals with MA dependence. Trial registration Chinese Clinical Trial Registry ChiCTR2000032492. Registered on April 30, 2020 (http://www.chictr.org.cn/edit.aspx?pid=52127&htm=4)

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Posttraumatic Stress Disorder Intervention for People with Severe Mental Illness in a Low-Income Country Primary Care Setting: A Randomized Feasibility Trial Protocol

10.21203/rs.3.rs-149400/v1 ◽

2021 ◽

Author(s):

Lauren Ng ◽

Eyerusalem Getachew Serba ◽

Benyam W. Dubale ◽

Abebaw Fekadu ◽

Charlotte Hanlon

Keyword(s):

Primary Care ◽

Posttraumatic Stress Disorder ◽

Mental Illness ◽

Randomized Controlled Trial ◽

Stress Disorder ◽

Controlled Trial ◽

Feasibility Trial ◽

Intervention Delivery ◽

Randomized Controlled

Abstract BackgroundIn this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization’s guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings. MethodsSpecifically, this study includes a non-randomized pre-pilot (n=5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n=40) to assess trial procedures, acceptability and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, one-month follow-up, and three-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal. DiscussionFindings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings. Trial RegistrationRegistered with ClinicalTrials.gov (NCT04385498) first posted May 13th, 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1.

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The iHealth-T2D study: Statistical analysis plan for a cluster randomised controlled trial with intensive family-based lifestyle modification programme to reduce type 2 diabetes risk amongst South Asians

10.1101/2020.11.12.20229849 ◽

2020 ◽

Author(s):

Mirthe Muilwijk ◽

Marie Loh ◽

Sara Mahmood ◽

Saranya Palaniswamy ◽

Samreen Siddiqui ◽

...

Keyword(s):

Lifestyle Modification ◽

South Asians ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Statistical Analysis Plan ◽

Link Type ◽

Family Based ◽

Randomised Controlled

AbstractBackgroundSouth Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high-costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.MethodsThe iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. A total of 3,682 South Asian men and women with age between 40-70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥95cm in Sri Lanka, or ≥100cm in India, Pakistan and UK) and/or prediabetes (HbA1c ≥6.0%)] were included in the trial. Here we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after three years of follow-up after enrolment to the study, and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after one and three years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.DiscussionThe iHealth-T2D trial will provide evidence whether an intensive family-based lifestyle modification programme in South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.Ethics and disseminationThe trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.Trial registrationEudraCT 2016-001350-18. Registered 14 April 2016 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ihealth-t2d/; ClinicalTrials.govNCT02949739. Registered 31 October 2016, https://clinicaltrials.gov/ct2/show/NCT02949739, First posted 31/10/2016.

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Body mass index and physical activity in seven-year-old children whose mothers exercised during pregnancy: follow-up of a multicentre randomised controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02952-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Karen Alterhaug Bjøntegaard ◽

Signe Nilssen Stafne ◽

Siv Mørkved ◽

Kjell Åsmund Salvesen ◽

Kari Anne I. Evensen

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

University Hospital ◽

Moderate Intensity ◽

Control Group ◽

Exercise Protocol ◽

Moderate Intensity Exercise ◽

Randomised Controlled ◽

Exercise During Pregnancy

Abstract Background There are limited data on long-term outcomes of children whose mothers have followed exercise interventions during pregnancy. The aim of this paper was to investigate whether regular moderate intensity exercise during pregnancy affected the children’s body mass index (BMI) and physical activity (PA) at 7 years of age, and determine the relationship between children’s and mothers’ BMI and PA. Methods This was a follow-up of a multicentre randomised controlled trial, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007–2009 and 2014–2016). Women were randomised to follow a 12-week structured exercise protocol or standard antenatal care during pregnancy. At the 7-year follow-up, parents reported their child’s height, weight, and PA. The mothers also reported their own weight and PA. Main outcome variables were BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA. Results A total of 855 women were randomised to exercise (n = 429) or standard antenatal care (n = 426) during pregnancy. At follow-up, 164 (38.2%) children and mothers in the intervention group and 117 (27.5%) in the control group participated. We found no group differences in the children’s iso-BMI or PA. Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group. Subgroup analyses of children of mothers who adhered to the exercise protocol and sensitivity analyses excluding children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up, did not change the results. Children’s BMI, weekly leisure time MVPA and intensity of PA correlated with mothers’ BMI, daily exercise, and intensity of exercise. Conclusions Regular moderate intensity exercise during pregnancy did not affect BMI or PA of the children at 7 years. Good maternal health should be encouraged as it may influence the health of the next generation. Trial registration The initial RCT study was registered in ClinicalTrials.govNCT00476567.

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