Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1)

IntroductionMultiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1–2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS.Methods and analysisA web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses.Ethics and disseminationThe study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars.Trial registration numberClinicalTrials.gov Registry (NCT03968172); Pre-results.

Child health behaviour and parent priorities for a school-based healthy lifestyle programme

Objective: The purpose of this study was to characterise parents’ concerns for their children’s health behaviour and perceptions of motivators and barriers to positive child health behaviour change, and to determine associations between motivators and barriers and parents’ priorities for a school-based healthy lifestyle programme. Design: Cross-sectional study of 46 parents who had completed an un-validated survey distributed during school-wide events. Setting: School for children aged 5–14 years in The Bronx, New York City, USA. Methods: Wilcoxon Rank Sum tests compared motivators and barriers to positive child health behaviour change by heath behaviour concern; Spearman’s correlation assessed associations between motivators and barriers and programme priorities. Results: Parents concerned about child weight significantly ranked keeping up with others and decreasing clothing size as motivators, while parents concerned about child food choices significantly ranked improving food choices and decreasing body mass index (BMI) and clothing size as motivators. Food-, play-, and self-esteem-related motivators were associated with nutrition education ( rs ⩾ .41, p ⩽ .01), physical activity classes ( rs ⩾ .29, p ⩽ .04) and child involvement in programme decision-making ( rs ⩾ .43, p ⩽ .01) priorities. Consistency-, child resistance- and home rules-related barriers were associated with nutrition education ( rs ⩾ .37, p = .02), physical activity classes ( rs ⩾ .32, p = .02) and child involvement ( rs ⩾ .40, p ⩽ .02) priorities. Conclusions: Despite the study sample size, selection bias, and generalisability limitations, prioritising nutrition, physical activity and child involvement in programme decision-making may enhance parent support for school-based healthy lifestyle programmes.

Uptake and effectiveness of a tailor-made online lifestyle programme targeting modifiable risk factors for dementia among middle-aged descendants of people with recently diagnosed dementia: study protocol of a cluster randomised controlled trial (Demin study)

IntroductionDescendants of patients with dementia have a higher risk to develop dementia. This study aims to investigate the uptake and effectiveness of an online tailor-made lifestyle programme for dementia risk reduction (DRR) among middle-aged descendants of people with recently diagnosed late-onset dementia.Methods and analysisDemin is a cluster randomised controlled trial, aiming to include 21 memory clinics of which 13 will be randomly allocated to the passive (poster and flyer in a waiting room) and 8 to the active recruitment strategy (additional personal invitation by members of the team of the memory clinic). We aim to recruit 378 participants (40–60 years) with a parent who is recently diagnosed with Alzheimer’s disease or vascular dementia at one of the participating memory clinics. All participants receive a dementia risk assessment (online questionnaire, physical examination and blood sample) and subsequently an online tailor-made lifestyle advice regarding protective (Mediterranean diet, low/moderate alcohol consumption and high cognitive activity) and risk factors (physical inactivity, smoking, loneliness, cardiovascular diseases (CVD), hypertension, high cholesterol, diabetes, obesity, renal dysfunction and depression) for dementia. The primary outcome is the difference in uptake between the two recruitment strategies. Secondary outcomes are change(s) in (1) the Lifestyle for Brain Health score, (2) individual health behaviours, (3) health beliefs and attitudes towards DRR and (4) compliance to the tailor-made lifestyle advice. Outcomes will be measured at 3, 6, 9 and 12 months after baseline. The effectiveness of this online tailor-made lifestyle programme will be evaluated by comparing Demin participants to a matched control group (lifelines cohort).Ethics and disseminationThis study has been approved by the Dutch Ministry of Health, Welfare and Sport according to the Population Screening Act. All participants have to give online informed consent using SMS-tan (transaction authentication number delivered via text message). Findings will be disseminated through peer-reviewed journals and (inter)national conferences.Trial registration numberNTR7434.

Determining barriers and facilitators to engagement for families in a family-based, multicomponent healthy lifestyles intervention for children and adolescents: a qualitative study

ObjectivesRecruitment and retention in child and adolescent healthy lifestyle intervention services for childhood obesity is challenging, and inequalities across social groups are persistent. This study aimed to understand the barriers and facilitators to engagement in a multicomponent assessment-and-intervention healthy lifestyle programme for children and their families, based in the home and community.DesignQualitative interview-based study of past users (n=76) of a family-based multicomponent healthy lifestyle programme in a mixed urban–rural region of New Zealand. Semistructured, home-based interviews were conducted and thematically analysed with peer debriefing for validity.ParticipantsFamilies were selected through stratified random sampling to include a range of levels of engagement, including those who declined their referral, with equal numbers of interviews with Indigenous and non-Indigenous families.ResultsThree interactive and compounding determinants were identified as influencing engagement in Whānau Pakari: acute and chronic life stressors, societal norms of weight and body size and historical experiences of healthcare. These determinants were present across societal, system and healthcare service levels. A negative referral experience to Whānau Pakari often resulted in participants declining further input or disengaging from the programme. A fourth domain, respectful and compassionate healthcare, was identified as a mitigator of these three themes, facilitating participant engagement despite previous negative experiences.ConclusionsWhile participant engagement in healthy lifestyle programmes is affected by determinants which appear to operate outside immediate service provision, the programme is an opportunity to acknowledge past instances of stigma and the wider challenges of healthy lifestyle change. The experience of the referral to Whānau Pakari is important for setting the scene for future engagement in the programme. Respectful, compassionate care is critical to enhanced retention in multidisciplinary healthy lifestyle programmes and ongoing engagement in healthcare services overall.

Willingness to pay for a telemedicine-delivered healthy lifestyle programme

Introduction Effective weight-management interventions require frequent interactions with specialised multidisciplinary teams of medical, nutritional and behavioural experts to enact behavioural change. However, barriers that exist in rural areas, such as transportation and a lack of specialised services, can prevent patients from receiving quality care. Methods We recruited patients from the Dartmouth-Hitchcock Weight & Wellness Center into a single-arm, non-randomised study of a remotely delivered 16-week evidence-based healthy lifestyle programme. Every 4 weeks, participants completed surveys that included their willingness to pay for services like those experienced in the intervention. A two-item Willingness-to-Pay survey was administered to participants asking about their willingness to trade their face-to-face visits for videoconference visits based on commute and copay. Results Overall, those with a travel duration of 31–45 min had a greater willingness to trade in-person visits for telehealth than any other group. Participants who had a travel duration less than 15 min, 16–30 min and 46–60 min experienced a positive trend in willingness to have telehealth visits until Week 8, where there was a general negative trend in willingness to trade in-person visits for virtual. Participants believed that telemedicine was useful and helpful. Conclusions In rural areas where patients travel 30–45 min a telemedicine-delivered, intensive weight-loss intervention may be a well-received and cost-effective way for both patients and the clinical care team to connect.

Improving the assessment and management of obesity in UK children and adolescents: the PROMISE research programme including a RCT

Background Five linked studies were undertaken to inform identified evidence gaps in the childhood obesity pathway. Objectives (1) To scope the impact of the National Child Measurement Programme (NCMP) (study A). (2) To develop a brief evidence-based electronic assessment and management tool (study B). (3) To develop evidence-based algorithms for identifying the risk of obesity comorbidities (study B). (4) To conduct an efficacy trial of the Healthy Eating and Lifestyle Programme (HELP) (study C). (5) To improve the prescribing of anti-obesity drugs in UK adolescents (study D). (6) To investigate the safety, outcomes and predictors of outcome of adolescent bariatric surgery in the UK (study E). Methods Five substudies – (1) a parental survey before and after feedback from the National Childhood Measurement Programme, (2) risk algorithm development and piloting of a new primary care management tool, (3) a randomised controlled trial of the Healthy Eating and Lifestyle Programme, (4) quantitative and qualitative studies of anti-obesity drug treatment in adolescents and (5) a prospective clinical audit and cost-effectiveness evaluation of adolescent bariatric surgery in one centre. Results Study A – before the National Childhood Measurement Programme feedback, three-quarters of parents of overweight and obese children did not recognise their child to be overweight. Eighty-seven per cent of parents found the National Childhood Measurement Programme feedback to be helpful. Feedback had positive effects on parental knowledge, perceptions and intentions. Study B – risk estimation models for cardiovascular and psychosocial comorbidities of obesity require further development. An online consultation tool for primary care practitioners is acceptable and feasible. Study C – the Healthy Eating and Lifestyle Programme, when delivered in the community by graduate mental health workers, showed no significant effect on body mass index at 6 months (primary outcome) when compared with enhanced usual care. Study D – anti-obesity drugs appear efficacious in meta-analysis, and their use has expanded rapidly in the last decade. However, the majority of prescriptions are rapidly discontinued after 1–3 months of treatment. Few young people described positive experiences of anti-obesity drugs. Prescribing was rarely compliant with the National Institute for Health and Care Excellence guidance. Study E – bariatric surgery appears safe, effective and highly cost-effective in adolescents in the NHS. Future work and limitations Work is needed to evaluate behaviour and body mass index change in the National Childhood Measurement Programme more accurately and improve primary care professionals’ understanding of the National Childhood Measurement Programme feedback, update and further evaluate the Computer-Assisted Treatment of CHildren (CATCH) tool, investigate delivery of weight management interventions to young people from deprived backgrounds and those with significant psychological distress and obtain longer-term data on anti-obesity drug use and bariatric surgery outcomes in adolescence. Trial registration Current Controlled Trials ISRCTN99840111. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 3. See the NIHR Journals Library website for further project information.