scholarly journals Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022382 ◽  
Author(s):  
Wendy Ingram ◽  
Douglas Webb ◽  
Rod S Taylor ◽  
Nana Anokye ◽  
Lucy Yardley ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Health Conditions ◽  
Web Based ◽  
Behavioural Support ◽  
Randomised Controlled ◽  
Exercise Referral

IntroductionPhysical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.Methods and analysisA multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36–39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.Ethics and disseminationApproved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants.Trial registration numberISRCTN15644451; Pre-results.

scholarly journals A new model of exercise referral scheme in primary care: is the effect on adherence to physical activity sustainable in the long term? A 15-month randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e017211 ◽  
Author(s):  
Carme Martín-Borràs ◽  
Maria Giné-Garriga ◽  
Anna Puig-Ribera ◽  
Carlos Martín ◽  
Mercè Solà ◽  
...  
Keyword(s):  
Physical Activity ◽  
Social Support ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Community Resources ◽  
Randomised Controlled ◽  
Exercise Referral ◽  
Exercise Referral Scheme

IntroductionStudies had not yet overcome the most relevant barriers to physical activity (PA) adherence. An exercise referral scheme (ERS) with mechanisms to promote social support might enhance adherence to PA in the long term.SettingA randomised controlled trial in 10 primary care centres in Spain.ObjectiveTo assess the effectiveness of a primary care-based ERS linked to municipal resources and enhancing social support and social participation in establishing adherence to PA among adults over a 15-month period.Participants422 insufficiently active participants suffering from at least one chronic condition were included. 220 patients (69.5 (8.4) years; 136 women) were randomly allocated to the intervention group (IG) and 202 (68.2 (8.9) years; 121 women) to the control group (CG).InterventionsThe IG went through a 12-week standardised ERS linked to community resources and with inclusion of mechanisms to enhance social support. The CG received usual care from their primary care practice.OutcomesThe main outcome measure was self-report PA with the International Physical Activity Questionnaire and secondary outcomes included stages of change and social support to PA practice.Data collectionParticipant-level data were collected via questionnaires at baseline, and at months 3, 9 and 15.BlindingThe study statistician and research assessors were blinded to group allocation.ResultsCompared with usual care, follow-up data at month 15 for the ERS group showed a significant increase of self-reported PA (IG: 1373±1845 metabolic equivalents (MET) min/week, n=195; CG: 919±1454 MET min/week, n=144; P=0.009). Higher adherence (in terms of a more active stage of change) was associated with higher PA level at baseline and with social support.ConclusionsPrescription from ordinary primary care centres staff yielded adherence to PA practice in the long term. An innovative ERS linked to community resources and enhancing social support had shown to be sustainable in the long term.Trial registration numberNCT00714831; Results.

scholarly journals Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e053971
Author(s):  
Katrin Hulme ◽  
Joanna L Hudson ◽  
Federica Picariello ◽  
Natasha Seaton ◽  
Sam Norton ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Conditions ◽  
Anxiety And Depression ◽  
Treatment Allocation ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Anxiety Depression

IntroductionApproximately 30% of people with long-term physical health conditions (LTCs) experience mental health problems, with negative consequences and costs for individuals and healthcare services. Access to psychological treatment is scarce and, when available, often focuses on treating primary mental health problems rather than illness-related anxiety/depression. The aim of this study is to evaluate the clinical efficacy of a newly developed, therapist-supported, digital cognitive-behavioural treatment (COMPASS) for reducing LTC-related psychological distress (anxiety/depression), compared with standard charity support (SCS).Methods and analysisA two-arm, parallel-group randomised controlled trial (1:1 ratio) with nested qualitative study will be conducted. Two-hundred adults with LTC-related anxiety and depression will be recruited through national LTC charities. They will be randomly allocated to receive COMPASS or SCS only. An independent administrator will use Qualtrics randomiser for treatment allocation, to ensure allocation concealment. Participants will access treatment from home over 10 weeks. The COMPASS group will have access to the digital programme and six therapist contacts: one welcome message and five fortnightly phone calls. Data will be collected online at baseline, 6 weeks and 12 weeks post-randomisation for primary outcome (Patient Health Questionnaire Anxiety and Depression Scale) and secondary outcomes (anxiety, depression, daily functioning, COVID-19-related distress, illness-related distress, quality of life, knowledge and confidence for illness self-management, symptom severity and improvement). Analyses will be conducted following the intention-to-treat principle by a data analyst blinded to treatment allocation. A purposively sampled group of COMPASS participants and therapists will be interviewed. Interviews will be thematically analysed.Ethics and disseminationThe study is approved by King’s College London’s Psychiatry, Nursing and Midwifery Research Ethics Subcommittee (reference: LRS-19/20–20347). All participants will provide informed consent to take part if eligible. Findings will be published in peer-reviewed journals and presented at conferences.Trial registration numberNCT04535778.

scholarly journals Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial

2018 ◽  
Vol 214 (2) ◽  
pp. 63-73 ◽  
Author(s):  
Richard I. G. Holt ◽  
Rebecca Gossage-Worrall ◽  
Daniel Hind ◽  
Michael J. Bradburn ◽  
Paul McCrone ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Health Research ◽  
Controlled Trial ◽  
First Episode Psychosis ◽  
First Episode ◽  
Episode Psychosis ◽  
Randomised Controlled ◽  
The University ◽  
Lifestyle Education

BackgroundObesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia.MethodIn this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included.ResultsBetween 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI −1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained.ConclusionsParticipants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

A randomised controlled trial of a web-based educational program in child mental health for schoolteachers

2014 ◽  
Vol 24 (8) ◽  
pp. 931-940 ◽  
Author(s):  
Celina Andrade Pereira ◽  
Chao Lung Wen ◽  
Eurípedes Constantino Miguel ◽  
Guilherme V. Polanczyk
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Child Mental Health ◽  
Educational Program ◽  
Controlled Trial ◽  
Web Based ◽  
Randomised Controlled

scholarly journals Long-Term Follow-Up of a Randomized Controlled Trial to Reduce Excessive Weight Gain in Infancy: Protocol for the Prevention of Overweight in Infancy (POI) Follow-Up Study at 11 Years (Preprint)

2020 ◽  
Author(s):  
Taiwo O Adebowale ◽  
Barry J Taylor ◽  
Andrew R Gray ◽  
Barbara C Galland ◽  
Anne-Louise M Heath ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Controlled Trial ◽  
Electronic Media ◽  
Health And Wellbeing ◽  
Validated Questionnaires ◽  
Follow Up Study ◽  
Randomized Controlled

BACKGROUND The Prevention of Overweight in Infancy (POI) randomized controlled trial assessed the effect of a more conventional food, physical activity, and breastfeeding intervention, with a more novel sleep intervention on weight outcomes at 2 years of age. The trial had 58% uptake at recruitment, and retention was 86% at age 2 years, 77% at age 3.5 years, and 69% at age 5 years. Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention. Importantly, this substantially reduced risk was still apparent at our follow-up at 5 years of age. OBJECTIVE The primary aim of this follow-up at age 11 years is to determine whether differences in BMI z-score and obesity risk remain apparent now that it is at least 9 years since cessation of the sleep intervention. Several secondary outcomes of interest will also be examined including 24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep. METHODS We will seek renewed consent from all 734 of the original 802 POI families who expressed interest in further involvement. Children and parent(s) will attend 2 clinics and 1 home appointment to obtain measures of anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires). RESULTS This follow-up study has full ethical approval from the University of Otago Human Ethics Committee (H19/109) and was funded in May 2019 by the Health Research Council of New Zealand (grant 19/346). Data collection commenced in June 2020, and first results are expected to be submitted for publication in 2022. CONCLUSIONS Long-term outcomes of early obesity intervention are rare. Despite the growing body of evidence linking insufficient sleep with an increased risk of obesity in children, interventions targeting improvements in sleep have been insufficiently explored. Our initial follow-up at 5 years of age suggested that an early sleep intervention may have long-term benefits for effective weight management in children. Further analysis in our now preteen population will provide much-needed evidence regarding the long-term effectiveness of sleep interventions in infancy as an obesity prevention approach. CLINICALTRIAL ClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24968

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