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

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.

Download Full-text

Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

Download Full-text

Lack of effects of evidence-based, individualised counselling on medication use in insured patients with mild hypertension in China: a randomised controlled trial

BMJ evidence-based medicine ◽

10.1136/bmjebm-2019-111197 ◽

2019 ◽

Vol 25 (3) ◽

pp. 102-108

Author(s):

Mengyang Di ◽

Chen Mao ◽

Zuyao Yang ◽

Hong Ding ◽

Qu Liu ◽

...

Keyword(s):

Mild Hypertension ◽

Antihypertensive Drugs ◽

Controlled Trial ◽

Intervention Group ◽

Medication Use ◽

Control Group ◽

Evidence Based ◽

Randomised Controlled ◽

Insured Patients

ObjectiveTo evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China.MethodsWe conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome.ResultsTwo hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes.ConclusionsThe EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians.Trial registration numberChiCTR-TRC-14004169.

Download Full-text

A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke—The LAST Study

Stroke Research and Treatment ◽

10.1155/2012/392101 ◽

2012 ◽

Vol 2012 ◽

pp. 1-7 ◽

Cited By ~ 8

Author(s):

Torunn Askim ◽

Birgitta Langhammer ◽

Hege Ihle-Hansen ◽

Jon Magnussen ◽

Torgeir Engstad ◽

...

Keyword(s):

Motor Function ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Severity ◽

Stroke Patients ◽

Long Term Follow Up ◽

Randomised Controlled

Background. There are no evidence-based strategies that have been shown to be superior in maintaining motor function for months to years after the stroke. The LAST study therefore intends to assess the effect of a long-term follow-up program for stroke patients compared to standard care on function, disability and health.Design. This is a prospective, multi-site randomised controlled trial, with blinded assessment 18 months after inclusion. A total of 390 patients will be recruited and randomised to a control group, receiving usual care, or to an intervention group 10 to 16 weeks after onset of stroke. Patients will be stratified according to stroke severity, age above 80, and recruitment site. The intervention group will receive monthly coaching on physical activity by a physiotherapist for 18 consecutive months after inclusion.Outcomes. The primary outcome is motor function (Motor Assessment Scale) 18 months after inclusion. Secondary outcomes are: dependency, balance, endurance, health-related quality of life, fatigue, anxiety and depression, cognitive function, burden on caregivers, and health costs. Adverse events and compliance to the intervention will be registered consecutively during follow-up.

Download Full-text

Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09878-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lucie Waedel ◽

Anne Daubmann ◽

Antonia Zapf ◽

Olaf Reis

Keyword(s):

Substance Use ◽

Randomised Controlled Trial ◽

Intellectual Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Post Intervention ◽

Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

Download Full-text

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 ◽

10.1136/bmjopen-2020-037303 ◽

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.

Download Full-text

Impact of convex ostomy appliances on leakage frequency, peristomal skin health and stomal protrusion

Gastrointestinal Nursing ◽

10.12968/gasn.2021.19.sup9.s30 ◽

2021 ◽

Vol 19 (Sup9) ◽

pp. S30-S37

Author(s):

Eugenia Rodriguez González ◽

Carmen del Pino Zurita ◽

Gemma Arrontes Caballero ◽

Araceli Hoyo Rodríguez ◽

Eugenia Zapatero Rodríguez ◽

...

Keyword(s):

Patient Satisfaction ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Anova Analysis ◽

Independent Variables ◽

Peristomal Skin ◽

Randomised Controlled ◽

The Impact

Aim: The Convexity in Ostomy (ECOS) study measured the impact of soft convex ostomy appliances on leakage frequency, peristomal skin health, and patient satisfaction, as well as stomal protrusion and body profile. Methods: This prospective non-randomised controlled trial included people with a stoma, divided into a control group using a convex appliance throughout (Alterna Confort Convex or Easiflex Confort Convex Light, Coloplast A/S, Humlebæk, Denmark), and an intervention group who were using a flat appliance at baseline before switching to a convex appliance for the rest of the study. Leakage frequency was counted within the past 2 weeks; peristomal skin health was assessed using the discolouration, erosion and tissue overgrowth (DET) Ostomy Skin Tool; and patient satisfaction was measured with a 0-10 Likert scale of self-reported satisfaction with the appliance. Measurements were taken at three visits: baseline (V1), 2-8 weeks (V2) and 6 months (V3). The Kruskal-Wallis and analysis of variance (ANOVA) tests were used for comparison. Multiple regression analysis was used to evaluate the effect of independent variables on the change in leakage frequency and DET score between baseline and 6 months. Findings: Of 253 participants screened, 245 completed the follow-up, with 151 in the intervention group and 94 in the control group. Mean leakage frequency period went from 5.85 ± 5.55 (V1) to 0.63 ± 1.42 (V2) and 0.23 ± 0.75 (V3) (p<.0001). Mean DET score changed from 4.8 ± 3.47 (V1) to 1.41 ± 2.17 (V2) and 0.54 ± 1.57 (V3) (p<.0001). Mean satisfaction changed from 6.0 ± 2.25 (V1) to 8.6 ± 1.14 (V2) and 9.17 ± 0.93 (V3) (p<.0001). From V1 to V3, the proportion of patients with a depressed peristomal area went from 45.7% to 31.4%, a normal peristomal area went from 45.3% to 65.3%, stoma protrusion went from 31.4% to 47.3% and stoma retraction went from 28.6% to 15.5%. By group, mean leakage frequency decreased in the intervention group by 7.65, from 7.57 to 0.11, and in the control group by 2.37, from 2.94 to 0.46 (p<0.0001). Multiple ANOVA analysis confirmed independent variables in reducing leakage to be initiating convexity and appliance coupling. By group, mean DET score decreased in the intervention group by 4.82, from 5.24 to 0.42, and in the control group by 3.52, from 4.34 to 0.76. Multiple ANOVA analysis showed independent variables for DET score to be initiating convexity, emergency surgery and stoma siting. Conclusion: People with a stoma experiencing repeated leakage benefitted from shifting from a flat to a soft convex appliance in terms of leakage frequency, peristomal skin health, stomal protrusion and body profile.

Download Full-text

Exercise improves long-term social and behavioral rhythms in older adults: Did it play a role during the COVID-19 lockdown?

Journal of Public Health Research ◽

10.4081/jphr.2021.2432 ◽

2021 ◽

Author(s):

Giulia Cossu ◽

Cesar Ivan Abbile Gonzalez ◽

Luigi Minerba ◽

Roberto Demontis ◽

Massimiliano Pau ◽

...

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Exercise Program ◽

Exercise Group ◽

Moderate Intensity ◽

Control Group ◽

Moderate Intensity Exercise ◽

Behavioral Rhythms

The study aimed to verify whether exercise training in older adults can improve social behavioral rhythms (SBR) and if any modification is maintained over time. Older adults (n=120) from a previous randomized controlled trial, were randomly allocated to either a moderate-intensity exercise group or a control group. SBR was evaluated at t0, t26, and t48 weeks (during the COVID-19 lockdown), using the brief social rhythms scale (BSRS). Seventy-nine participants completed the follow-up (age 72.3±4.7, women 55.3%). An improvement in the BSRS score was found in the exercise group at 26 weeks (p=0.035) when the exercise program was concluded, and it was maintained at 48 weeks (p=0.013). No improvements were observed in the control group. To conclude, SBR, previously found as a resilience factor in older adults during COVID-19, appear to improve after a moderate 12 weeks exercise program, and the improvement persisted even after stopping exercise during the COVID-19 lockdown.

Download Full-text

12. YOUNG PEOPLE GET CLUED UP ABOUT CHLAMYDIA: AN INTERNET BASED RANDOMISED CONTROLLED TRIAL

Sexual Health ◽

10.1071/shv4n4ab12 ◽

2007 ◽

Vol 4 (4) ◽

pp. 289

Author(s):

M. Kang ◽

A. Rochford ◽

A. Mindel ◽

S. R. Skinner ◽

M. Webb ◽

...

Keyword(s):

Young People ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Study Participation ◽

Randomized Controlled ◽

Chlamydia Testing ◽

Randomised Controlled ◽

Internet Based Intervention

Young people (16-25 years) are a target group for the prevention of Chlamydia trachomatis in the Australian national STI strategy. This study is a randomized controlled trial of an innovative internet-based intervention which aims to increase Chlamydia testing and treatment among at risk young people living in Australia. Study participation is via a website developed in consultation with young people and linked to an evaluated health promotion website. Young people in the intervention group receive personalised, confidential emails from a nurse or doctor while those in the control group receive automated emails. Follow up at 6 months will measure self-reported Chlamydia testing and other outcomes. By 5 June 2007, 359 young people of a target sample of 1000 were enrolled (83% female). Mean age is 20 years (range 16-25). Participants reside across all states and territories. Thirty percent of participants in the intervention group are in active email dialogue with the research nurse, e.g. “The research and...site was...really good,...it's kinda scared me into getting a test and just to get over the embarrassment... will the test be able to be part of just a normal appointment?” Zero participants in the control group have responded to the automated email. Baseline data and examples of the email interaction will be presented.

Download Full-text

The effect of the Continuous Care Model on treatment adherence in patients with myocardial infarction: a randomised controlled trial

Journal of Research in Nursing ◽

10.1177/1744987119890666 ◽

2020 ◽

Vol 25 (1) ◽

pp. 54-65

Author(s):

Mohammad Ali Zakeri ◽

Zohreh Khoshnood ◽

Mahlagha Dehghan ◽

Farokh Abazari

Keyword(s):

Myocardial Infarction ◽

Randomised Controlled Trial ◽

Treatment Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Care Model ◽

Continuous Care ◽

Randomised Controlled

Background Adherence to treatment is one of the behaviours associated with successful outcomes following a myocardial infarction, which leads to successful treatment in the disease. Aims This study aimed to investigate the effect of the Continuous Care Model (CCM) on treatment adherence in patients with myocardial infarction. Methods This was a randomised controlled trial performed on 82 patients with myocardial infarction. Convenience sampling was used to select the participants, and then they were allocated into two groups by the stratified random method. In the intervention group, a CCM was implemented. In the intervention group, 4–6 educational sessions (1–2 h) were conducted during one month in the form of spoken questions and answers about the presented subjects. The control group received routine care. A questionnaire of demographic information and treatment adherence was completed by samples in the two groups, intervention and control, before and immediately after training and after follow-up. Results The results of this study showed that treatment adherence was significantly higher in the intervention group than in the control group immediately after training and after the follow-up phase (three months) ( p < 0.001). Also, diet, drug and physical activity adherence were significantly higher in the intervention group than in the control group immediately after training and after follow-up ( p < 0.001). Conclusions Implementation of CCM led to an increase in adherence to the treatment in patients with myocardial infarction. Therefore, it is suggested that this model could be used as a nursing intervention to increase treatment adherence in cardiac-rehabilitation programmes.

Download Full-text

OP0209 INTERVAL PROLONGATION IN ETANERCEPT-TREATED PATIENTS WITH RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS: AN OPEN-LABEL, RANDOMISED CONTROLLED TRIAL

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1320 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 130-130

Author(s):

M. J. L’ami ◽

J. Ruwaard ◽

E. L. Kneepkens ◽

C. L. M. Krieckaert ◽

M. Nurmohamed ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Standard Dose ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Interval Prolongation ◽

Open Label ◽

Dosing Interval ◽

Randomised Controlled

Background:The majority of patients with a rheumatic disease treated with etanercept may be overexposed. Data regarding etanercept tapering is scarce, particularly in psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Dose reductions can potentially reduce blood drug levels too much, resulting in loss of effect.Objectives:We compared extending the dose interval to continuation of the standard dose and studied the success rate of etanercept discontinuation. Etanercept concentrations were measured throughout the study.Methods:160 consecutive patients with rheumatoid arthritis (RA), PsA or AS with sustained minimal disease activity (MDA) were enrolled in this 18-month, open-label, randomised controlled trial. The intervention group doubled the dosing-interval at baseline and discontinued etanercept 6 months later. The control group continued the standard dose up to 6 months, after which the dosing-interval was doubled. Primary outcome was the proportion of patients maintaining MDA after 6 months follow-up.Results:At 6 months, MDA status was maintained in 47 (63%) patients in the intervention group and 56 (74%) in the control group (p=0.15), with comparable results in all rheumatic diseases. Median etanercept concentrations decreased from 1.50 µg/mL (25-75thpercentile 1.06-2.65) to 0.46 µg/mL (0.28-0.92) after 6 months of interval prolongation (figure 1). In total, 40% discontinued etanercept successfully with maintained MDA for at least 6 months.Figure 1.Median (with Q1 to Q3 boxplots) etanercept concentrations (per protocol) during the first 6 months of follow-up in the intervention group (prolongation; gray boxplots) and the control group (continuation; white boxplots), separated by disease (RA, PsA, AS). Bars represent 10-90 percentile and outliers are shown separately (dots).Conclusion:As observed in RA, etanercept tapering can be safely attempted in PsA and AS patients in sustained MDA. A substantial proportion of patients could stop etanercept for at least 6 months. In many patients low drug concentrations proved sufficient to control disease activity. However, the risk of minor and major flares is substantial, even in patients continuing standard dosing.References:noneDisclosure of Interests:Merel J. l’Ami Speakers bureau: Novartis, Jill Ruwaard: None declared, Eva L. Kneepkens: None declared, Charlotte L.M. Krieckaert: None declared, Michael Nurmohamed Grant/research support from: Not related to this research, Consultant of: Not related to this research, Speakers bureau: Not related to this research, Femke Hooijberg: None declared, J.C. van Denderen: None declared, Arno Van Kuijk: None declared, Lot Burgemeister: None declared, Maarten Boers: None declared, Gert-Jan Wolbink: None declared

Download Full-text