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Digital Technology to Deliver a Lifestyle-Integrated Exercise Intervention in Young Seniors—The PreventIT Feasibility Randomized Controlled Trial

ABSTRACT: Background: Behavioral change is the key to alter individuals' lifestyle from sedentary to active. The aim was to assess the feasibility of delivering a Lifestyle-integrated Functional Exercise programme and evaluate the delivery of the intervention by use of digital technology (eLiFE) to prevent functional decline in 61–70 year-old adults. Methods: This multicentre, feasibility randomized controlled trial was run in three countries (Norway, Germany, and the Netherlands). Out of 7,500 potential participants, 926 seniors (12%) were screened and 180 participants randomized to eLiFE (n = 61), aLiFE (n = 59), and control group (n = 60). eLiFE participants used an application on smartphones and smartwatches while aLiFE participants used traditional paper-based versions of the same lifestyle-integrated exercise intervention. Participants were followed for 12 months, with assessments at baseline, after a 6 month active trainer-supported intervention, and after a further 6 months of unsupervised continuation of the programme. Results: At 6 months, 87% of participants completed post-test, and 77% completed the final assessment at 12 months. Participants were willing to be part of the programme, with compliance and reported adherence relatively high. Despite small errors during start-up in the technological component, intervention delivery by use of technology appeared acceptable. No serious adverse events were related to the interventions. All groups improved regarding clinical outcomes over time, and complexity metrics show potential as outcome measure in young seniors. Conclusion: This feasibility RCT provides evidence that an ICT-based lifestyle-integrated exercise intervention, focusing on behavioral change, is feasible and safe for young seniors. Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT03065088. Registered on 14 February 2017.

SUBMITTER: Taraldsen K

PROVIDER: S-EPMC8521904 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPhysical inactivity and unhealthy dietary habits are known to be disadvantageous for the development of late adverse effects in survivors of childhood, adolescent, and young adult cancer. To make interventions, aimed at improving lifestyle, fit into the daily life of survivors, interventions should be designed and delivered in a person-centred way with a limited time burden. As part of the European PanCareFollowUp project, an eHealth intervention was developed to support sustainable changes to physical activity levels and/or diet of childhood, adolescent, and young adult cancer survivors. This feasibility study aims to gain insight into the feasibility and potential effect sizes of the PanCareFollowUp lifestyle intervention.MethodsThe PanCareFollowUp lifestyle intervention consists of person-centred 3-6 screen-to-screen sessions with a certified lifestyle coach. The intervention will be evaluated with a single-arm pre-post feasibility study conducted at two survivorship care clinics in the Netherlands. A total of 60 participants who are (i) diagnosed with cancer <25 years, (ii) ≥ 5 years post-treatment, (iii) aged 16-55 years, and (iv) have a low physical activity level and/or unhealthy dietary intake manifested by overweight will be recruited. Using reports, hospital records, and questionnaires for survivors, coaches, and late effect doctors, feasibility will be based on (i) adherence to intervention, (ii) acceptability, (iii) practicality, (iv) integration/implementation, (v) demand, and (vi) attrition. The potential effect sizes of the intervention will be explored by determining the percentage of survivors that reach the personalized lifestyle goals that were set with the coach. Physical activity level, dietary intake, BMI, general self-efficacy, self-management, and motivation level will be assessed at three time points with questionnaires, reports, and/or an accelerometer.DiscussionData of this study will be gathered to assess the feasibility and potential effect sizes. This will allow for further intervention refinement as needed as well as to inform a future large-scale intervention study and a manual for implementation at other centres.Trial registrationInternational Clinical Trial Registry Platform (ICTRP) number: NL8932 (ICTRP Search Portal (who.int)). Registered on September 29, 2020.

Project description:BackgroundNo evidence-based support has been offered to young people (YP) who have experienced technology-assisted sexual abuse (TASA). Interventions aimed at improving mentalization (the ability to understand the mental states of oneself and others) are increasingly being applied to treat YP with various clinical issues. Digital technology use among YP is now common. A digital intervention aimed at improving mentalization in YP who have experienced TASA may reduce the risk of revictimization and future harm and make YP more resilient and able to manage distress that might result from TASA experiences.ObjectiveIn this paper, we describe a protocol for determining the feasibility of the i-Minds trial and the acceptability, safety, and usability of the digital intervention (the i-Minds app) and explore how to best integrate i-Minds into existing routine care pathways.MethodsThis is a mixed methods nonrandomized study aimed to determine the feasibility, acceptability, safety, and usability of the intervention. Participants aged between 12 and 18 years who report distress associated with TASA exposure will be recruited from the United Kingdom from the National Health Service (NHS) Trust Child and Adolescent Mental Health Services, sexual assault referral centers, and a web-based e-therapy provider. All participants will receive the i-Minds app for 6 weeks. Coproduced with YP and a range of stakeholders, the i-Minds app focuses on 4 main topics: mentalization, TASA and its impact, emotional and mental health, and trauma. A daily prompt will encourage YP to use the app, which is designed to be used in a stand-alone manner alongside routine care. We will follow participants up after the intervention and conduct interviews with stakeholders to explore the acceptability of the app and trial procedures and identify areas for improvement. Informed by the normalization process theory, we will examine barriers and enablers relevant to the future integration of the intervention into existing care pathways, including traditional clinic-based NHS and NHS e-therapy providers.ResultsThis study was approved by the Research Ethics Board of Scotland. We expect data to be collected from up to 60 YP. We expect to conduct approximately 20 qualitative interviews with participants and 20 health care professionals who referred YP to the study. The results of this study have been submitted for publication.ConclusionsThis study will provide preliminary evidence on the feasibility of recruiting YP to a trial of this nature and on the acceptability, safety, and usability of the i-Minds app, including how to best integrate it into existing routine care. The findings will inform the decision to proceed with a powered efficacy trial.Trial registrationInternational Standard Randomised Controlled Trial Number Registry (ISRCTN) ISRCTN43130832; https://www.isrctn.com/ISRCTN43130832.International registered report identifier (irrid)DERR1-10.2196/40539.

Project description:Background: Chinese young adults experience barriers to mental health treatment, including the lack of treatment providers and stigma around treatment seeking. Evidence-based digital mental health interventions are promising and scalable alternatives to face-to-face treatment for this population, but lack rigorous evidence to support scale-up in China. Aim: The study was a feasibility study for a large-scale RCT of Step-by-Step, a behavioral activation-based, mental health intervention to address depression and anxiety symptoms in Chinese young adults. It sought to assess feasibility of recruitment and of delivery of Step-by-Step in a University setting, to assess acceptability of the intervention, and to examine potential effectiveness. Method: An uncontrolled, feasibility trial was conducted to assess the feasibility and acceptability of Chinese Step-by-Step for Chinese University students with elevated depressive symptoms (PHQ-9 scores at or above 10) in Macao, China. Data was collected at two different time points (i.e., baseline and 8-weeks after baseline), administered via questionnaires embedded in an interventional mobile application. Participation rate and dropout rate were measured. Depressive and anxiety symptom severity, well-being, and self-defined stress were assessed. Satisfaction with the program was assessed using qualitative interviews. Results: A total of 173 students were screened, 22.0% (n = 38) were eligible, and 63.2% of them (n = 24) started the intervention. The dropout rate by post-test was 45.8%. Results from completers showed that Step-by-Step was potentially effective in reducing depressive and anxiety symptom severity, and self-defined stress. Students were generally satisfied with the program, but also offered suggestions for continued improvement. Qualitative feedback was reported within the RE-AIM framework, covering recruitment, effectiveness, adoption, implementation, and maintenance. Amendments to the program were made according to the feedback (e.g., adding notification for new session, modify the time zone). Conclusion: A minimally guided Step-by-Step protocol and the study procedure were successfully pilot tested for use for Chinese University students. The intervention was acceptable and no adverse events were reported. The results support the potential effectiveness and feasibility of a large-scale evaluation of the program.

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Digital Technology to Deliver a Lifestyle-Integrated Exercise Intervention in Young Seniors—The PreventIT Feasibility Randomized Controlled Trial

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