Using mHealth to promote parents’ brushing of preschool children’s teeth: a protocol for a randomized factorial trial using the Multi-phase Optimization Strategy (MOST)

Background Early childhood caries is a highly prevalent disease affecting young children. Parental brushing of children’s teeth is recommended during preschool years. Interventions to promote parental brushing of children’s teeth are assessed as a package in randomized clinical trials and the efficacy of separate components is not known. Methods and analysis The aim of this study is to develop an optimized behavior modification intervention to increase parents’ brushing of their pre-school children’s teeth using the multi-phase optimization strategy (MOST) guided by the Theory of Planned Behavior. Behavior change will be assessed by the percent reduction in children’s dental plaque index after 6 months and parents reporting of toothbrushing frequency. Two phases of MOST will be carried out. First, the preparation phase comprises the development of a conceptual framework, identifying candidate components, conducting a feasibility pilot study to assess the acceptability and the design features of three intervention components (motivational interviewing (MI), and two mobile health (mHealth) components: oral health promotion messages and storytelling videos delivered using WhatsApp messenger) in addition to setting an optimization objective. Second, the optimization phase constitutes a factorial trial assessing the three intervention components and developing the intervention by selecting the most effective components within the optimization constraint. Each component will be set at two levels: yes (the intervention is applied) and no (the intervention is not applied). A linear regression model will be used to assess the effect of the intervention components on the percent reduction in dental plaque index (primary outcome measure). The secondary outcome measure is the change in the frequency of parents’ brushing of the child’s teeth. The combination of components making up the new optimized intervention will be selected. Discussion This will be the first study to apply the MOST framework in the field of dentistry. The results of this study can guide the development of an optimized behavior modification interventions using mHealth and MI. Trial registration ClinicalTrials.gov, NCT04923581, Registered 11 June 2021.

EnTraP: A factorial randomised controlled trial embedded within world hip trauma evaluation eight COPAL investigating the effect of an enhanced trainee principal investigator package and digital nudge on recruitment rates

Background Randomised controlled trials (RCTs) often struggle with various aspects of participant recruitment, including engaging clinicians to recruit effectively, and subsequently fail to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. The RCTs embedded into the World Hip Trauma Evaluation (WHiTE) cohort study use Trainee Principal Investigators (TPIs) to help manage and drive recruitment at trial sites. No formalised training or support is provided by central trials units to the TPIs. Additionally, trial recruiters receive a generic automated email confirming randomisation to the trial with no other communication to influence or incentivise their behaviour to further recruit. The primary aim of this factorial trial was to evaluate the effectiveness of an educational intervention to TPIs and a positive reinforcement intervention via an email (digital) nudge on increasing recruitment. Secondary aims included feasibility of implementing the interventions and surveying TPIs on the educational package quality of content, delivery and ongoing support. Design This was a multicentre, open, cluster, 2x2 factorial RCT embedded in the WHiTE 8 COPAL RCT, in which research sites were randomised 1:1:1:1 to receive the enhanced TPI package, the digital nudge intervention, both, or neither. Results 1215 patients were recruited to the WHiTE 8 COPAL trial across 20 sites during the SWAT between August 2018 and March 2019. There was a statistically significant interaction between the interventions (IRR 2.09, 95% CI 1.64 to 2.68, p < 0.001). There was a statistically significant benefit on recruitment (IRR 1.23 95% 1.09 to 1.40, p=0.001) from utilizing an enhanced TPI education intervention. The digital nudge intervention had no significant impact on recruitment (IRR 0.89 95% CI 0.79 to 1.01, p=0.07). Within enhanced TPI package sites, the digital nudge had a beneficial effect, while in the standard practice TPI sites it had a detrimental effect. Feasibility analysis showed the median time to site digital nudge and enhanced TPI set up were one day and 17 days, respectively. 353 digital nudges were created taking an average of 12 min to construct, log the activity and then disseminate to recruiters. Median induction time for enhanced TPI was 32 min and 100% of the groups were extremely satisfied with the induction content, delivery and ongoing support. Discussion An education and support programme targeted at surgical TPIs involving a digital education package, 1:1 telephone induction and subsequent support package was effective in increasing recruitment in the first 6 months of trial commencement. There was no evidence for the effectiveness of the digital nudge intervention in isolation, although our results show that when combined with an education programme, it leads to enhanced effectiveness of that programme.

Lean Mass Improvement from Nutrition Education and Protein Supplementation among Rural Indian Women Living with HIV/AIDS: Results from Cluster Randomized Factorial Trial at 18-Month Follow-Up

Loss of lean muscle mass impairs immunity and increases mortality risk among individuals with HIV/AIDS. We evaluated the relative contributions of protein supplementation and nutrition education on body composition among 600 women living with HIV/AIDS in rural Andhra Pradesh, India. We conducted a cluster randomized controlled 2 × 2 factorial trial lasting six months with follow up at twelve and eighteen months. Interventions occurred in the Nellore and Prakasam regions of Andhra Pradesh by trained village women, ASHA (Accredited Social Health Activists), and included: (1) the usual supportive care from ASHA (UC); (2) UC plus nutrition education (NE); (3) UC plus nutritional protein supplementation (NS); (4) combined UC plus NE plus NS. A Bioimpedance Analyzer Model 310e measured body composition. SAS 9.4 analyzed all data. Mixed models using repeated measures evaluated lean mass change from baseline as primary and fat weight and total weight as secondary outcomes. Lean mass change was significantly associated with NS (p = 0.0001), NE (p = 0.0001), and combined NS plus NE (p = 0.0001), with similar associations for secondary outcomes. Stronger associations for total weight were observed with greater ART adherence. Nutritional interventions may improve physiologic response to HIV. Significant increases in lean mass resulted from independent and combined protein supplementation and nutrition education.

Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition

Background Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. Here, we describe the updated protocol, including a supplemental study, Reach Out Cognition. Reach Out Cognition is a remote study that will assess the acceptability, feasibility, and satisfaction of digital, self-administered cognitive assessments and Bluetooth-enabled, self-measured blood pressure monitoring in the Reach Out population. We will also estimate the prevalence of mild cognitive impairment in Reach Out participants. Methods Reach Out Cognition includes remote enrollment and follow-up assessments. Reach Out Cognition extends Reach Out data collection past the current 12 months to 15 and 18 months. Participants will be Reach Out participants who complete their 12-month outcome assessments and opt to continue in the cohort study. Participants will continue to receive the Reach Out intervention, consisting of (1) daily healthy behavior text messaging and (2) weekly self-measured blood pressure monitoring. Blood pressure will be measured using Bluetooth-enabled self-measured blood pressure monitoring devices, and cognition will be measured using digital self-administered cognitive assessments at 12, 15, and 18 months. Discussion Reach Out Cognition will explore the potential of remote, digital, self-administered assessments of blood pressure and cognition among predominantly working-age Black Americans. Reach Out Cognition will inform future clinical trials and clinical remote monitoring of blood pressure and cognition that may lead to new approaches to treating and reducing hypertension and cognitive disparities. Trial registration ClinicalTrials.gov NCT03422718. The record was first available to the public on January 30, 2018, prior to the enrollment of patients on March 25, 2019.

Pre-notification and personalisation of text messages to increase questionnaire completion in a smoking cessation pregnancy RCT: an embedded randomised factorial trial

Background: Low completion rates of questionnaires in randomised controlled trials can compromise the reliability of the results, so ways to boost questionnaire completion are often implemented. Although there is evidence to suggest that sending a text message to participants increases completion, there is little evidence around the timing or personalisation of these text messages. Methods: A two-by-two factorial SWAT (study within a trial) was embedded within the MiQuit-3 trial, looking at smoking cessation within pregnant smokers. Participants who reached their 36-week gestational follow-up were randomised to receive a personalised or non-personalised text message, either one week or one day prior to their follow-up. Primary outcomes were completion rate of questionnaire via telephone. Secondary outcomes included: completion rate via any method, time to completion, and number of attempts to contact required. Results In total 194 participants were randomised into the SWAT to receive a text message that was personalised early(n=50), personalised late (n=47), non-personalised early(n=50), or non-personalised late(n=47). There was no evidence that timing of the text message (early: one week before; or late: one day before) had an effect on any of the outcomes. There was evidence that a personalised text message would result in fewer completions compared with a non-personalised text message when data was collected only via the telephone(adjusted OR 0.44, 95% CI 0.22–0.87, p=0.02). However, these results were not significant when looking at completion via any method (adjusted OR 0.61, 95% CI 0.30-1.24, p=0.17). There was no evidence to show that personalisation or not was better for any of the secondary outcomes. Conclusion Timing of the text message does not appear to influence the completion of questionnaires. Personalisation of a text message may be detrimental to questionnaire completion, if data is only collected via the telephone - however, more SWATs should be undertaken in this field.

Pre-notification and personalisation of text-messages to retain participants in a smoking cessation pregnancy RCT: an embedded randomised factorial trial

Background: Low response rates in randomised controlled trials can compromise the reliability of the results, so ways to boost retention are often implemented. Although there is evidence to suggest that sending a text message to participants increases retention, there is little evidence around the timing or personalisation of these messages. Methods: A two-by-two factorial SWAT (study within a trial) was embedded within the MiQuit-3 trial, looking at smoking cessation within pregnant smokers. Participants who reached their 36-week gestational follow-up were randomised to receive a personalised or non-personalised text message, either one week or one day prior to the telephone follow-up. Primary outcomes were completion rate of questionnaire via telephone. Secondary outcomes included: completion rate via any method, time to completion, and number of reminders required. Results In total 194 participants were randomised into the SWAT; 50 to personalised early text, 47 to personalised late text, 50 to non-personalised early text, and 47 to non-personalised late text. There was no evidence that timing of the text message (early: one week before; or late: one day before) had an effect on any of the outcomes. There was evidence that a personalised text would result in fewer completions via telephone compared with a non-personalised text (adjusted OR 0.44, 95% CI 0.22–0.87, p=0.02). However, there was no evidence to show that personalisation or not was better for any of the secondary outcomes. Conclusion Timing of the text message does not appear to influence the retention of participants. Personalisation of a text message may be detrimental to retention; however, more SWATs should be undertaken in this field.