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

Åsberg, Katarina; Blomqvist, Jenny; Lundgren, Ove; Henriksson, Hanna; Bendtsen, Preben; Löf, Marie; Bendtsen, Marcus

doi:10.1136/bmjopen-2022-061024

Cited by 4 publications

(1 citation statement)

References 55 publications

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“…To avoid under-and overrecruitment, which occurs when using fixed sample sizes, is an important mitigation, and Bayesian sequential designs allow for exactly this. Examples of their use in behavioral intervention trials can be found in the literature [19][20][21][22], and when appropriate, they should become standard procedure.…”

Section: Discussionmentioning

confidence: 99%

Avoiding Under- and Overrecruitment in Behavioral Intervention Trials Using Bayesian Sequential Designs: Tutorial

Bendtsen

2022

J Med Internet Res

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Reducing research waste and protecting research participants from unnecessary harm should be top priorities for researchers studying interventions. However, the traditional use of fixed sample sizes exposes trials to risks of under- and overrecruitment by requiring that effect sizes be determined a priori. One mitigating approach is to adopt a Bayesian sequential design, which enables evaluation of the available evidence continuously over the trial period to decide when to stop recruitment. Target criteria are defined, which encode researchers’ intentions for what is considered findings of interest, and the trial is stopped once the scientific question is sufficiently addressed. In this tutorial, we revisit a trial of a digital alcohol intervention that used a fixed sample size of 2129 participants. We show that had a Bayesian sequential design been used, the trial could have ended after collecting data from approximately 300 participants. This would have meant exposing far fewer individuals to trial procedures, including being allocated to the waiting list control condition, and the evidence from the trial could have been made public sooner.

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Section: Discussionmentioning

confidence: 99%

Avoiding Under- and Overrecruitment in Behavioral Intervention Trials Using Bayesian Sequential Designs: Tutorial

Bendtsen

2022

J Med Internet Res

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Co-occurrence of unhealthy lifestyle behaviours in middle-aged adults: findings from the Swedish CArdioPulmonary bioImage Study (SCAPIS)

Klompstra,

Löf,

Björkelund

et al. 2024

Sci Rep

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Middle-aged adults engaging in unhealthy lifestyle behaviors are at higher risk of chronic diseases. However, little is known about the co-occurrence of these behaviors and their determinants. This cohort study examined the co-occurrence of unhealthy lifestyle behaviors (alcohol consumption, diet, physical inactivity, and smoking) in 30,154 middle-aged adults and their associations with sociodemographic factors, social support, and disease history. Alcohol use was measured by the AUDIT, diet by the MiniMeal-Q, and physical inactivity and smoking by single questions. Participants had a mean age of 58 years, with 51% being female. Of them, 14% had no unhealthy behaviors, 38% had one, 36% had two, 10% had three, and 2% had all four. The most common co-occurrence was between physical inactivity and poor diet (38%). Higher education decreased the likelihood of having three or four unhealthy behaviors, while financial difficulties, having no one around who appreciated one’s efforts, and suffering of a lung disease increased it. In conclusion, middle-aged adults exhibit varying levels of unhealthy lifestyle behaviors. Higher education is linked to reduced engagement in multiple unhealthy behaviors, whereas financial strain, lower quality of social support, and lung disease increase the risk.

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

et al. 2022

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IntroductionUnhealthy 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 analysisThe 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 disseminationApproved 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 numberISRCTN16420548.

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

Cited by 4 publications

References 55 publications

Avoiding Under- and Overrecruitment in Behavioral Intervention Trials Using Bayesian Sequential Designs: Tutorial

Avoiding Under- and Overrecruitment in Behavioral Intervention Trials Using Bayesian Sequential Designs: Tutorial

Co-occurrence of unhealthy lifestyle behaviours in middle-aged adults: findings from the Swedish CArdioPulmonary bioImage Study (SCAPIS)

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

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