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Effects of health literacy, screening, and participant choice on action plans for reducing unhealthy snacking in Australia: A randomised controlled trial.

ABSTRACT: BACKGROUND:Low health literacy is associated with poorer health outcomes. A key strategy to address health literacy is a universal precautions approach, which recommends using health-literate design for all health interventions, not just those targeting people with low health literacy. This approach has advantages: Health literacy assessment and tailoring are not required. However, action plans may be more effective when tailored by health literacy. This study evaluated the impact of health literacy and action plan type on unhealthy snacking for people who have high BMI or type 2 diabetes (Aim 1) and the most effective method of action plan allocation (Aim 2). METHODS AND FINDINGS:We performed a 2-stage randomised controlled trial in Australia between 14 February and 6 June 2019. In total, 1,769 participants (mean age: 49.8 years [SD = 11.7]; 56.1% female [n = 992]; mean BMI: 32.9 kg/m2 [SD = 8.7]; 29.6% self-reported type 2 diabetes [n = 523]) were randomised to 1 of 3 allocation methods (random, health literacy screening, or participant selection) and 1 of 2 action plans to reduce unhealthy snacking (standard versus literacy-sensitive). Regression analysis evaluated the impact of health literacy (Newest Vital Sign [NVS]), allocation method, and action plan on reduction in self-reported serves of unhealthy snacks (primary outcome) at 4-week follow-up. Secondary outcomes were perceived extent of unhealthy snacking, difficulty using the plans, habit strength, and action control. Analyses controlled for age, level of education, language spoken at home, diabetes status, baseline habit strength, and baseline self-reported serves of unhealthy snacks. Average NVS score was 3.6 out of 6 (SD = 2.0). Participants reported consuming 25.0 serves of snacks on average per week at baseline (SD = 28.0). Regarding Aim 1, 398 participants in the random allocation arm completed follow-up (67.7%). On average, people scoring 1 SD below the mean for health literacy consumed 10.0 fewer serves per week using the literacy-sensitive action plan compared to the standard action plan (95% CI: 0.05 to 19.5; p = 0.039), whereas those scoring 1 SD above the mean consumed 3.0 fewer serves using the standard action plan compared to the literacy-sensitive action plan (95% CI: -6.3 to 12.2; p = 0.529), although this difference did not reach statistical significance. In addition, we observed a non-significant action plan × health literacy (NVS) interaction (b = -3.25; 95% CI: -6.55 to 0.05; p = 0.054). Regarding Aim 2, 1,177 participants across the 3 allocation method arms completed follow-up (66.5%). There was no effect of allocation method on reduction of unhealthy snacking, including no effect of health literacy screening compared to participant selection (b = 1.79; 95% CI: -0.16 to 3.73; p = 0.067). Key limitations include low-moderate retention, use of a single-occasion self-reported primary outcome, and reporting of a number of extreme, yet plausible, snacking scores, which rendered interpretation more challenging. Adverse events were not assessed. CONCLUSIONS:In our study we observed nominal improvements in effectiveness of action plans tailored to health literacy; however, these improvements did not reach statistical significance, and the costs associated with such strategies compared with universal precautions need further investigation. This study highlights the importance of considering differential effects of health literacy on intervention effectiveness. TRIAL REGISTRATION:Australia and New Zealand Clinical Trial Registry ACTRN12618001409268.

SUBMITTER: Ayre J

PROVIDER: S-EPMC7608866 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Effects of health literacy, screening, and participant choice on action plans for reducing unhealthy snacking in Australia: A randomised controlled trial.

Ayre Julie J Cvejic Erin E Bonner Carissa C Turner Robin M RM Walter Stephen D SD McCaffery Kirsten J KJ

PLoS medicine 20201103 11

<h4>Background</h4>Low health literacy is associated with poorer health outcomes. A key strategy to address health literacy is a universal precautions approach, which recommends using health-literate design for all health interventions, not just those targeting people with low health literacy. This approach has advantages: Health literacy assessment and tailoring are not required. However, action plans may be more effective when tailored by health literacy. This study evaluated the impact of hea ...[more]

PMID: 33141834

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Project description:IntroductionHealth literacy describes the cognitive and social skills that individuals use to access, understand and act on health information. Health literacy interventions typically take the 'universal precautions approach' where all consumers are presented with simplified materials. Although this approach can improve knowledge and comprehension, its impact on complex behaviours is less clear. Systematic reviews also suggest that health literacy interventions underuse volitional strategies (such as planning) that play an important role in behaviour change. A recent study found volitional strategies may need to be tailored to the participant's health literacy. The current study aims to replicate these findings in a sample of people who have diabetes and/or are overweight or obese as measured by body mass index, and to investigate the most effective method of allocating an action plan to a participant to reduce unhealthy snacking.Methods and analysisWe plan to recruit approximately 2400 participants at baseline. Participants will receive one of two alternative online action plans intended to reduce unhealthy snacking ('standard' action plan or 'literacy-sensitive' action plan). Participants will be randomised to a method of allocation to an action plan: (1) random allocation; (2) allocation by health literacy screening tool or (3) allocation by participant selection. Primary outcome is self-reported serves of unhealthy snacks during the previous month. Multiple linear regression will evaluate the impact of health literacy on intervention effectiveness. The analysis will also identify independent contributions of each action plan, method of allocation, health literacy and participant selections on unhealthy snacking at 4-week follow-up.Ethics and disseminationThis study was approved by the University of Sydney Human Research Ethics Committee (2017/793). Findings will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies (Diabetes New South Wales (NSW) & Australian Capital Territory (ACT), and Western Sydney Local Health District).Trial registration numberACTRN12618001409268; Pre-results.

Project description:BACKGROUND:Many young people form unhealthy behavioural habits, such as low intake of fruit and vegetables, high intake of energy-dense snack foods, and excessive sedentary screen-based behaviours. However, there is a shortage of parent-and home-focused interventions to change multiple health behaviours in children. METHODS:Kids FIRST was a 12-week, home- and school-based pilot randomised controlled trial to reduce screen-time and unhealthy snacking with assessments at pre- (baseline) and post-intervention. Four UK schools were randomised to control or one of three interventions targeting reductions in (1) screen-time and unhealthy snacking (ST + Sn), (2) screen-time (ST only), (3) unhealthy snacking (Sn only), and parents with children aged 9-11 years were recruited via schools. Intervention group parents received four online 'sessions' and four packages of resources tailored to each group. Children received four 30-min lessons during school time. Children and parents reported their own screen-time behaviours, children reported their own snacking behaviours. Descriptive analyses were undertaken using principles of intention to treat. RESULTS:Initial feasibility was shown in that this study successfully recruited schools and families into all four study arms and retained them over a period of 13 weeks (retention rate ≥ 74%). Seventy-five children and 64 parents provided full baseline questionnaire data. Reductions in children's school day and weekend day TV/DVD viewing and computer game use were found in the ST + Sn and ST groups, while self-reported smartphone use increased in these groups. Similar results were found for parents' TV/DVD, computer and smartphone use in these groups. Little to no changes were found in reports of the dietary variables assessed in any intervention group for children or parents. CONCLUSIONS:These preliminary findings show some promise for the Kids FIRST intervention. Based on these findings, a future full trial should recruit a more diverse sample of families and optimise the intervention and intervention resources to more fully engage parents with the dietary-based components of the intervention programme, where fewer changes were seen. Although most parents reporting receiving the intervention resources, further development work is required to achieve higher levels of engagement. This might include greater parent and child engagement work early in the development of the project. TRIAL REGISTRATION:Retrospectively registered in June 21st 2019 with ClinicalTrials.gov (number NCT03993652).

Project description:BackgroundClinical trial participants have a right to be informed throughout the entire process of human subject research. As part of this pillar of research ethics, participants and other stakeholders should be made aware of research findings after a trial has been completed. Though participants have both a right, and a desire to be informed of research outcomes, studies show that they rarely receive communication about study findings. Our aim was (1) to understand what, if any, role communication plans play in current global health clinical research protocols and (2) to use our findings to develop a communication plan template tailored to clinical research carried out in low-and-middle-income countries (LMIC) while minimizing colonial assumptions. While the template was drafted in the LMIC context, the principles are universally applicable and should be considered best practices for all global health clinical trials.MethodsWe carried out a mixed-method study over a period of 6 months to understand the role of communication with study participants and other stakeholders in clinical trials. The semiquantitative analysis included mining publicly available clinical trial protocols for communication-related language. Qualitative interviews (n = 7) were used to gather knowledge and insight from clinical trial experts to inform the development of a communication plan template.ResultsNone of the 48 mined clinical trial protocols included a communication plan. Of the 48, 21% (n = 21) protocols included communication-related language, and 10% (n = 5) described plans to share trial results with participants.ConclusionThe use of communication plans in global health clinical trials is lacking. To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. We recommend that researchers utilize the developed communication plan template throughout the entire research process to ensure a human-centered approach to participant communication. This communication plan should apply to all phases of a research trial, with a particular emphasis on plans to share results in an accessible and engaging manner once the trial has been completed.

Dataset Information

Effects of health literacy, screening, and participant choice on action plans for reducing unhealthy snacking in Australia: A randomised controlled trial.

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Effects of health literacy, screening, and participant choice on action plans for reducing unhealthy snacking in Australia: A randomised controlled trial.

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