scholarly journals Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017159 ◽  
Author(s):  
Lynsay Matthews ◽  
Juliana Pugmire ◽  
Laurence Moore ◽  
Mark Kelson ◽  
Alex McConnachie ◽  
...  
Keyword(s):  
Social Support ◽  
Weight Loss ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Intervention Group ◽  
Ethics Committee ◽  
Feasibility Trial ◽  
Control Group ◽  
Weight Loss Intervention ◽  
Randomised Controlled

IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)>30 kg/m2and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.

scholarly journals Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Dietary Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Weight Loss Intervention ◽  
Traditional Group ◽  
Traditional Diet ◽  
Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

scholarly journals A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. A. Greidanus ◽  
A. E. de Rijk ◽  
A. G. E. M. de Boer ◽  
M. E. M. M. Bos ◽  
P. W. Plaisier ◽  
...  
Keyword(s):  
Return To Work ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Work Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Secondary Effect ◽  
Quality Of Working Life ◽  
Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

PREVENTING EXCESSIVE POSTNATAL WEIGHT LOSS IN HEALTHY NEW-BORNS. WILL CONTINUOUS TEMPERATURE MONITORING HELP?

2019 ◽  
Vol 3 (11) ◽  
Author(s):  
Dr. Kavita Sreekumar ◽  
Miss Pallavi Nachinolkar ◽  
Dr. M.P. Silveira
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Temperature Monitoring ◽  
Control Group ◽  
Random Allocation ◽  
Vaginal Deliveries ◽  
The Mean ◽  
Randomised Controlled ◽  
Continuous Temperature

Objective: To study if continuous temperature monitoring helps to prevent excessive postnatal weight loss in healthy newborns during hospital stay. Design: Prospective randomised controlled trial Setting: Postnatal ward of a tertiary level hospital in south-west India, between July 2018 and October 2018. Participants: 515 healthy newborns born in the hospital during the study. Intervention: Mothers were given the BEMPU device within 24 hours of delivery and  taught to recognize alarms and take measures to treat hypothermia when the device alarmed till the baby was discharged from the hospital. All healthy newborns born in the hospital were included in the study and random allocation was done to either the intervention or control group.  Babies who were sick and admitted in NICU and babies with congenital anomalies were excluded.  IEC approval was obtained prior to the study.  Outcome measures: postnatal weight loss. Results:  515 babies were included in the analysis.  For vaginal deliveries; 163 babies were in the intervention group and 168 were in the control group. The mean lowest weight was higher and the mean weight loss was lower for the intervention group. For caesarean deliveries, 91 babies were in the intervention and 93 were in the control groups. The mean lowest weight was higher and the mean weight loss was lower for the intervention group for cesarean deliveries as well. Conclusions: Continuous monitoring of the temperature helps to prevent excessive postnatal weight loss in healthy babies born by spontaneous vaginal deliveries. Keywords: Hypothermia, Newborn, Temperature, Weight loss

scholarly journals A multicentre, pragmatic, cluster randomised, controlled feasibility trial of the POD system of care

2020 ◽  
Vol 49 (4) ◽  
pp. 640-647
Author(s):  
John Young ◽  
John Green ◽  
Amanda Farrin ◽  
Michelle Collinson ◽  
Suzanne Hartley ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Assessment Method ◽  
System Of Care ◽  
Feasibility Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
New Onset

Abstract Objective to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. Design cluster randomised and controlled feasibility trial. Setting sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. Participants patients 65 years and over admitted to participating wards during the trial period. Interventions participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. Results out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37–1.26); P = 0.2225). Conclusions based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.

scholarly journals Tailored digital behaviour change intervention with e-referral system to increase attendance at NHS stop smoking services (the MyWay project): study protocol for a randomised controlled feasibility trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e028721
Author(s):  
Emily Fulton ◽  
Katie Newby ◽  
Kajal Gokal ◽  
Kayleigh Kwah ◽  
Lauren Schumacher ◽  
...  
Keyword(s):  
Behaviour Change ◽  
Service Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Feasibility Trial ◽  
Control Group ◽  
Behaviour Change Intervention ◽  
Stop Smoking ◽  
Stop Smoking Services ◽  
Randomised Controlled

IntroductionIn the UK, smokers who use stop smoking services (SSSs) are four times more likely to stop smoking than smokers who do not. Attendance has declined, warranting the development of interventions to address this. StopApp is a novel, brief online behaviour change intervention designed to address common barriers to SSS attendance. It links to widely commissioned service management software that enables instant appointment booking at a user’s location and time of choice.Methods and analysisA two-arm parallel group, individual participant feasibility randomised controlled trial of StopApp (intervention) compared with the standard promotion of and referral to SSSs (control). The study includes a nested qualitative process evaluation to assess the acceptability of the research processes, with a subsample of participants. Smokers aged over 16 years will be recruited via three routes: General Practice (GP), community settings and online. After consenting and the collection of baseline data, participants will be randomised to control or intervention groups. Participants in the intervention group receive a link to StopApp and those in the control group receive standard web-based information about the SSSs. All participants are told they can book a SSS appointment but are under no obligation to do so. Online follow-up 2 months post randomisation includes data on SSS use and carbon monoxide verified 4-week quit rates. The study aims to recruit 162 smokers.Ethics and disseminationEthics approval has been granted by the West Midlands—Edgbaston NHS Research Ethics Committee. The findings will be reported in conferences and peer-reviewed publications; and will be used to design the parameters necessary for a definitive trial to ascertain the effectiveness of StopApp at increasing booking and attendance at SSSs compared with existing methods for encouraging uptake.

scholarly journals Efficacy of a Multi-component m-Health Weight-loss Intervention in Overweight and Obese Adults: A Randomised Controlled Trial

2020 ◽  
Vol 17 (17) ◽  
pp. 6200
Author(s):  
Mitch Duncan ◽  
Sasha Fenton ◽  
Wendy Brown ◽  
Clare Collins ◽  
Nicholas Glozier ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Body Weight ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Obese Adults ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. Methods: Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19–65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. Results: Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = −0.92, (95% CI −3.33, 1.48)) or 12 months (0.00, (95% CI −2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (−1037.03, (−2028.84, −45.22)), and improved insomnia symptoms at 12 months (−2.59, (−4.79, −0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (−1.08, (−1.86, −0.29)). No other significant differences were observed between groups. Conclusions: Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.

scholarly journals Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035196
Author(s):  
Mandy Ho ◽  
Pui Hing Chau ◽  
Esther Yee Tak Yu ◽  
Michael Tin-cheung Ying ◽  
Cindy Lo Kuen Lam
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Control Group ◽  
Chinese Adults ◽  
Intervention Programme ◽  
Community Based ◽  
Randomised Controlled

IntroductionType 2 diabetes mellitus (T2DM) is one of the world’s fastest growing health problems. Asians have a strong ethnic predisposition for T2DM, developing T2DM at a lower degree of obesity and at younger ages than other ethnic groups. T2DM has a gradual onset, with most individuals progressing through a pre-diabetic state, providing an opportunity to prevent T2DM and its complications. This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes.Methods and analysisThis study is a 12-month, assessor-blinded randomised controlled trial. Adults with pre-diabetes (aged 40–64 years, n=180) with pre-diabetes are randomised into either an intervention group (receiving group-based lifestyle interventions) or a control group (receiving text messages containing health information). The intervention programme targets a weight loss of 5% during the first 6 months by restricting caloric intake and increasing physical activity. Participants in the intervention group will attend six group sessions and two individual face-to-face diet counselling sessions during the first 6 months, followed by monthly telephone support during the 6-month maintenance phase. Participants in the control group will receive monthly text messages containing general health information only. The primary outcome is weight loss (%). Secondary outcomes include insulin sensitivity (assessed using fasting insulin level and homeostatic model assessment of insulin resistance), glycaemic control (assessed using glycated haemoglobin level), lipid profile, blood pressure, carotid artery thickness, dietary intake and level of physical activity. Intention-to-treat analysis will be conducted using a generalised linear mixed effects model with a logit link and linear mixed models.Ethics and disseminationThis study has been approved by the relevant research ethics committee. The results will be disseminated through peer-reviewed journals and scientific presentations.Trial registration numberNCT03609697.

scholarly journals Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial

2017 ◽  
Vol 21 (72) ◽  
pp. 1-312 ◽  
Author(s):  
Gail Gilchrist ◽  
Davina Swan ◽  
April Shaw ◽  
Ada Keding ◽  
Sarah Towers ◽  
...  
Keyword(s):  
People Who Inject Drugs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Technology ◽  
Feasibility Trial ◽  
Control Group ◽  
Risk Behaviours ◽  
Post Intervention ◽  
Information Booklet ◽  
Randomised Controlled

Background Opioid substitution therapy and needle exchanges have reduced blood-borne viruses (BBVs) among people who inject drugs (PWID). Some PWID continue to share injecting equipment. Objectives To develop an evidence-based psychosocial intervention to reduce BBV risk behaviours and increase transmission knowledge among PWID, and conduct a feasibility trial among PWID comparing the intervention with a control. Design A pragmatic, two-armed randomised controlled, open feasibility trial. Service users were Steering Group members and co-developed the intervention. Peer educators co-delivered the intervention in London. Setting NHS or third-sector drug treatment or needle exchanges in Glasgow, London, Wrexham and York, recruiting January and February 2016. Participants Current PWID, aged ≥ 18 years. Interventions A remote, web-based computer randomisation system allocated participants to a three-session, manualised, psychosocial, gender-specific group intervention delivered by trained facilitators and BBV transmission information booklet plus treatment as usual (TAU) (intervention), or information booklet plus TAU (control). Main outcome measures Recruitment, retention and follow-up rates measured feasibility. Feedback questionnaires, focus groups with participants who attended at least one intervention session and facilitators assessed the intervention’s acceptability. Results A systematic review of what works to reduce BBV risk behaviours among PWID; in-depth interviews with PWID; and stakeholder and expert consultation informed the intervention. Sessions covered improving injecting technique and good vein care; planning for risky situations; and understanding BBV transmission. Fifty-six per cent (99/176) of eligible PWID were randomised: 52 to the intervention group and 47 to the control group. Only 24% (8/34) of male and 11% (2/18) of female participants attended all three intervention sessions. Overall, 50% (17/34) of men and 33% (6/18) of women randomised to the intervention group and 47% (14/30) of men and 53% (9/17) of women randomised to the control group were followed up 1 month post intervention. Variations were reported by location. The intervention was acceptable to both participants and facilitators. At 1 month post intervention, no increase in injecting in ‘risky’ sites (e.g. groin, neck) was reported by participants who attended at least one session. PWID who attended at least one session showed a trend towards greater reduction in injecting risk behaviours, a greater increase in withdrawal planning and were more confident about finding a vein. A mean cost of £58.17 per participant was calculated for those attending one session, £148.54 for those attending two sessions and £270.67 for those attending all three sessions, compared with £0.86 in the control group. Treatment costs across the centres vary as a result of the different levels of attendance, as total session costs are divided by attendees to obtain a cost per attendee. The economic analysis suggests that a cost-effectiveness study would be feasible given the response rates and completeness of data. However, we have identified aspects where the service use questionnaire could be abbreviated given the low numbers reported in several care domains. No adverse events were reported. Conclusions As only 19% of participants attended all three intervention sessions and 47% were followed up 1 month post intervention, a future definitive randomised controlled trial of the intervention is not feasible. Exposure to information on improving injecting techniques did not encourage riskier injecting practices or injecting frequency, and benefits were reported among attendees. The intervention has the potential to positively influence BBV prevention. Harm reduction services should ensure that the intervention content is routinely delivered to PWID to improve vein care and prevent BBVs. Future work The intervention did not meet the complex needs of some PWID, more tailoring may be needed to reach PWID who are more frequent injectors, who are homeless and female. Limitations Intervention delivery proved more feasible in London than other locations. Non-attendance at the York trial site substantially influenced the results. Trial registration Current Controlled Trials ISRCTN66453696 and PROSPERO 014:CRD42014012969. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 72. See the NIHR Journals Library website for further project information.

scholarly journals INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e029185
Author(s):  
Richard Collings ◽  
Jennifer A Freeman ◽  
Jos Latour ◽  
Patricia Jane Vickery ◽  
Sam Glasser ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Control Group ◽  
Foot Ulceration ◽  
Randomised Controlled

IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.

scholarly journals Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040108
Author(s):  
Rowan W Johnson ◽  
Sian A Williams ◽  
Daniel F Gucciardi ◽  
Natasha Bear ◽  
Noula Gibson
Keyword(s):  
Exercise Prescription ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Programme ◽  
Home Exercise ◽  
Control Group ◽  
Neurodevelopmental Disabilities ◽  
Home Exercise Programme ◽  
Exercise Programmes ◽  
Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

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