Dataset Information

Digital multiple health behaviour change intervention targeting online help seekers: protocol for the COACH randomised factorial trial.

ABSTRACT:

Introduction

Unhealthy lifestyle behaviours continue to be highly prevalent, including alcohol consumption, unhealthy diets, insufficient physical activity and smoking. There is a lack of effective interventions which have a large enough reach into the community to improve public health. Additionally, the common co-occurrence of multiple unhealthy behaviours demands investigation of efforts which address more than single behaviours.

Methods and analysis

The effects of six components of a novel digital multiple health behaviour change intervention on alcohol consumption, diet, physical activity and smoking (coprimary outcomes) will be estimated in a factorial randomised trial. The components are designed to facilitate behaviour change, for example, through goal setting or increasing motivation, and are either present or absent depending on allocation (ie, six factors with two levels each). The study population will be those seeking help online, recruited through search engines, social media and lifestyle-related websites. Included will be those who are at least 18 years of age and have at least one unhealthy behaviour. An adaptive design will be used to periodically make decisions to continue or stop recruitment, with simulations suggesting a final sample size between 1500 and 2500 participants. Multilevel regression models will be used to analyse behavioural outcomes collected at 2 months and 4 months postrandomisation.

Ethics and dissemination

Approved by the Swedish Ethical Review Authority on 2021-08-11 (Dnr 2021-02855). Since participation is likely motivated by gaining access to novel support, the main concern is demotivation and opportunity cost if the intervention is found to only exert small effects. Recruitment began on 19 October 2021, with an anticipated recruitment period of 12 months.

Trial registration number

ISRCTN16420548.

SUBMITTER: Asberg K

PROVIDER: S-EPMC9330315 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Digital multiple health behaviour change intervention targeting online help seekers: protocol for the COACH randomised factorial trial.

Åsberg Katarina K Blomqvist Jenny J Lundgren Oskar O Henriksson Hanna H Henriksson Pontus P Bendtsen Preben P Löf Marie M Bendtsen Marcus M

BMJ open 20220726 7

<h4>Introduction</h4>Unhealthy lifestyle behaviours continue to be highly prevalent, including alcohol consumption, unhealthy diets, insufficient physical activity and smoking. There is a lack of effective interventions which have a large enough reach into the community to improve public health. Additionally, the common co-occurrence of multiple unhealthy behaviours demands investigation of efforts which address more than single behaviours.<h4>Methods and analysis</h4>The effects of six componen ...[more]

PMID: 35882466

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Project description:BackgroundThe ubiquity of Internet connectivity, and widespread unmet needs, requires investigations of digital interventions for people seeking help with their drinking. The objective of this study was to test the effectiveness of a digital alcohol intervention compared to existing online resources for help seekers.MethodsThis parallel randomised controlled trial included 2129 risky drinkers with access to a mobile phone and aged 18 years or older. Randomised sub-studies investigated consent procedures and control group design. Simple computerised randomisation was used. Participants were aware of allocation after randomisation; research personnel were not. The digital intervention was designed around weekly monitoring of alcohol consumption followed by feedback and tools for behaviour change. Primary outcomes were total weekly consumption (TWC) and frequency of heavy episodic drinking (HED), measured 2 and 4 months post-randomisation.ResultsBetween 25/04/2019 and 26/11/2020, 2129 participants were randomised (intervention: 1063, control: 1066). Negative binomial regression was used to contrast groups, with both Bayesian and maximum likelihood inference. The posterior median incidence rate ratio (IRR) of TWC was 0.89 (95% CI = 0.81;0.99, 98.2% probability of effect, P-value = 0.033) at 2 months among 1557 participants and 0.77 (95% CI = 0.69;0.86, > 99.9% probability of effect, P-value < 0.001) at 4 months among 1429 participants. For HED, the IRR was 0.83 (95% CI = 0.75;0.93, > 99.9% probability of effect, P-value = 0.0009) at 2 months among 1548 participants and 0.71 (95% CI = 0.63;0.79, probability of effect > 99.9%, P-value < 0.0001) at 4 months among 1424 participants. Analyses with imputed data were not markedly different.ConclusionsA digital alcohol intervention produced self-reported behaviour change among online help seekers in the general population. The internal and external validity of this trial is strong, subject to carefully considered study limitations arguably inherent to trials of this nature. Limitations include higher than anticipated attrition to follow-up and lack of blinding.Trial registrationThe trial was prospectively registered ( ISRCTN48317451 ).

Project description:BackgroundSmoking continues to be a leading risk factor for several diseases globally. We hypothesised that an intervention delivered via text messages could help individuals who were looking to quit.MethodsA two-arm, parallel-groups, randomised controlled trial was employed. Both groups received treatment as usual, with the intervention group also receiving a 12-week text messaging intervention. Participants were adult, weekly or more frequent smokers, recruited online and in primary health care centres. Research personnel were blinded, while participants were not. Primary outcomes were prolonged abstinence and point prevalence of abstinence, 3 and 6 months post-randomisation. All randomised participants were included in analyses.ResultsBetween 18 September 2020 and 16 June 2022, we randomised 1012 participants (intervention: 505, control: 507). Outcome data was available for 67% (n = 682) of participants at 3 months and 64% (n = 643) at 6 months. At 3 months, the odds ratio (OR) of prolonged abstinence was 2.15 (95% compatibility interval [CoI] = 1.51; 3.06, probability of effect [POE] > 99.9%, p < 0.0001), and for point prevalence of abstinence, it was 1.70 (95% CoI = 1.18; 2.44, POE = 99.8%, p = 0.0034) in favour of the text messaging intervention. At 6 months, the OR of prolonged abstinence was 2.38 (95% CoI = 1.62; 3.57, POE > 99.9%, p = < 0.0001), and for point prevalence, it was 1.49 (95% CoI = 1.03; 2.14, POE = 98.3%, p = 0.0349) in favour of the text messaging intervention. Analyses with imputed data were not markedly different.ConclusionsAmongst general population help-seekers-who on average had smoked for 25 years-access to a 12-week text messaging intervention produced higher rates of self-reported smoking abstinence in comparison to treatment as usual only. The intervention could be part of the societal response to the burden which smoking causes; however, findings are limited by risk of bias due to attrition, self-reported outcomes, and lack of blinding.Trial registrationThe trial was preregistered in the ISRCTN registry on 27/07/2020 (ISRCTN13455271).

Project description:ObjectivesThe aim was to conduct a process evaluation of a multicomponent behaviour change intervention to reduce dental caries in secondary school children in the UK. The intervention was evaluated in the BRIGHT randomised controlled trial which investigated clinical and cost-effectiveness. The trial involved 4680 participants from 42 schools with a follow-up period of 2.5 years. Schools with an above-average proportion of free school meal (FSM) eligibility, an indicator of low household income, were recruited. The intervention, an oral health classroom-based session (CBS) delivered by school staff and twice-daily text messages aimed to improve toothbrushing frequency with fluoride toothpaste.MethodsKey components of process evaluations were examined: Implementation (fidelity, dose delivered, adaptations and reach), mechanisms of impact (acceptability and dose received) and influential contextual factors. Data collection ran alongside that of the outcome evaluation. Mixed-methods data collection comprised pupil self-reported questionnaires, staff feedback questionnaires, CBS and text message delivery logs and semi-structured interviews/focus groups with school staff and pupils. Quantitative data were summarised descriptively, while framework analysis was applied to the qualitative data.ResultsThe intervention was generally implemented as intended, albeit with some schools not confirming CBS delivery and a technical problem resulting in text messages being stopped prematurely. Some adaptations to the CBS were made by school staff. In terms of reach, 21.9% (n = 1025) of participants were FSM-eligible. At baseline, 77.6% (n = 3631) of randomised participants reported brushing at least twice daily with no difference over time in the social cognitive determinants of toothbrushing behaviour. The intervention was generally found to be acceptable with varying levels of participant responsiveness reported. The actual dose received was unclear; some schools did not provide a CBS attendance register, and some participants reported blocking or muting the text messages.ConclusionsThis evaluation raises the question of whether the intervention dose and quality of delivery were sufficient to support the required behaviour change mechanisms. Moreover, a high proportion of participants brushed twice daily at baseline; this also calls into question the intervention's ability to bring about significant change. The trial findings did not favour the implementation of the two-component intervention (CBS and text messages) within a school setting. However, with oral health as part of the general health school curriculum, the BRIGHT CBS could be adopted within the UK curriculum as it was co-developed with young people and was found acceptable to pupils and teachers.Trial registrationISRCTN number: 12139369.

Project description:BackgroundDigital harm-reduction interventions typically focus on people with severe drug-use problems, yet these interventions have moderate effectiveness on drug-users with lower levels of risk of harm. The difference in effectiveness may be explained by differences in behavioural patterns between the two groupings. Harnessing behavioural theories to understand what is at the core of drug-use behaviours and mapping the content of new interventions, may improve upon the effectiveness of interventions for lower-risk drug-users. To the best of our knowledge, this is the first study to systematically apply the Behaviour Change Wheel (BCW) approach to understand the components, influencing capabilities, opportunities, and motivations (COM-B) of higher education students to change their drug-use behaviors. It is also the first study which identifies specific patterns of behaviours that are more responsive to harm reduction practices through the use of the Theoretical Domain Framework (TDF).MethodsWe employed an explanatory sequential mix-method design. We first conducted an on-line survey and a Delphi exercise to understand the factors influencing COM-B components of higher education students to change their drug-use. Subsequently, we mapped all evidence onto the COM-B components and the TDF domains to identify clusters of behaviours to target for change, using a pattern-based discourse analysis. Finally, a series of multidisciplinary group meetings identified the intervention functions-the means by which the intervention change targeted behaviours and the Behavioural Change Techniques (BCTs) involved using the behaviour change technique taxonomy (v.1).ResultsTwenty-nine BCTs relevant to harm-reduction practices were identified and mapped across five intervention functions (education, modelling, persuasion, incentivization, and training) and five policy categories (communication/marketing, guidelines, regulation, service provision, and environmental/social planning). These BCTs were distributed across eight identified saturated clusters of behaviours MyUSE intervention attempts to change.ConclusionsThe BCTs, identified, will inform the development of a digitally delivered behaviour change intervention that focuses on increasing mindful decision-making with respect to drug-use and promotes alternatives to drug-use activities. The findings can also inform implementation scientists in applying context-specific harm-reduction practices in higher education. We present examples of how the eight identified clusters of target behaviours are mapped across the COM-B components and the TDF, along with suggestions of implementation practices for harm reduction at student population level.

Project description:BackgroundA core outcome set (COS) for trials and evaluations of the effectiveness and efficacy of alcohol brief interventions (ABIs) has recently been established through international consensus to address the variability of outcomes evaluated.ObjectiveThis is a protocol for studies to assess if there are order effects among the questions included in the COS.MethodsThe 10 items of the COS are organized into 4 clusters. A factorial design will be used with 24 arms, where each arm represents 1 order of the 4 clusters. Individuals searching online for help will be asked to complete a questionnaire, and consenting participants will be randomized to 1 of the 24 arms (double-blind with equal allocation). Participants will be included if they are 18 years or older. The primary analyses will (1) estimate how the order of the clusters of outcomes affects how participants respond and (2) investigate patterns of abandonment of the questionnaire.ResultsData collection is expected to commence in November 2020. A Bayesian group sequential design will be used with interim analyses planned for every 50 participants completing the questionnaire. Data collection will end no more than 24 months after commencement, and the results are expected to be published no later than December 2023.ConclusionsHomogenizing the outcomes evaluated in studies of ABIs is important to support synthesis, and the COS is an important step toward this goal. Determining whether there may be issues with the COS question order may improve confidence in using it and speed up its dissemination in the research community. We encourage others to adopt the protocol as a study within their trial as they adopt the ORBITAL (Outcome Reporting in Brief Intervention Trials: Alcohol) COS to build a worldwide repository and provide materials to support such analysis.Trial registrationISRCTN Registry ISRCTN17954645; http://www.isrctn.com/ISRCTN17954645.International registered report identifier (irrid)PRR1-10.2196/24175.

Dataset Information

Digital multiple health behaviour change intervention targeting online help seekers: protocol for the COACH randomised factorial trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Digital multiple health behaviour change intervention targeting online help seekers: protocol for the COACH randomised factorial trial.

Similar Datasets

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