Immediate effects of a very brief planning intervention on fruit and vegetable consumption: A randomized controlled trial

Abstract

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Plan pursuit in the context of daily fruit and vegetable consumption: The importance of cue detection and the execution of the planned behaviour for overall behaviour change

“…This study reports secondary analyses of an intensive longitudinal two‐condition randomized controlled trial (RCT; Domke et al., 2021) aiming to increase FV consumption by a very brief action planning intervention. The RCT was conducted between August 2011 and November 2012 and consisted of a baseline questionnaire (Day‐14), a 13‐days end‐of‐day diary (i.e., pre‐intervention diary), after which an action planning intervention (for participants assigned to the planning condition; Day 0) was conducted.…”

“…No prompts or reminders were sent to participants. More information regarding the recruitment approach, study design, participant flow, and procedures are provided elsewhere (Domke et al., 2021).…”

Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions

“…3 4 However, it is important to recognise the application of surrogates in the wider setting of healthcare evaluation (including trials of public health, diagnostic, surgical, mental health, primary care, rehabilitation interventions) and the use of so-called intermediate outcomes (outcome on the causal path for PRFO that can be measured earlier and are predictive) as surrogates, for example, hospice enrolment for mortality with an intervention aimed at improving end of life care 5 ; fruit and vegetable consumption for cardiovascular events for a behavioural intervention designed to improve cardiovascular risk. 6 Despite their benefits, the use of surrogates in evaluation and regulatory approval of health interventions remains controversial. First, some therapies, approved based on surrogates, have failed to deliver improved PRFOs, and in some cases, cause more overall harm than good, treatment effects are often not all mediated through the surrogate-PRFO causal pathway.…”

“…Over the last two decades, drug licensing in the USA and Europe has allowed the use of biomarkers (an objectively measured molecular, histologic, radiographic or physiologic characteristic) as surrogates in the approval of new therapies, for example, systolic blood pressure and/glycosylated haemoglobin (HbA1c) for cardiovascular death, HIV viral load for development of AIDS and tumour response for overall survival 3 4. However, it is important to recognise the application of surrogates in the wider setting of healthcare evaluation (including trials of public health, diagnostic, surgical, mental health, primary care, rehabilitation interventions) and the use of so-called intermediate outcomes (outcome on the causal path for PRFO that can be measured earlier and are predictive) as surrogates, for example, hospice enrolment for mortality with an intervention aimed at improving end of life care5; fruit and vegetable consumption for cardiovascular events for a behavioural intervention designed to improve cardiovascular risk 6…”

Surrogate endpoints in trials—a call for better reporting

“…However, it is important to acknowledge the potential application of surrogates in the wider setting of non-drug trials and the use of intermediate outcomes that may lie more distally on the causal pathway to a final outcome e.g. hospice enrolment for mortality with an intervention aimed at improving end of life care4; fruit and vegetable consumption for cardiovascular events for a behavioural intervention designed to improve cardiovascular risk 5…”