Web-based alcohol screening and brief intervention for university students: a randomized trial

IMPORTANCE: Unhealthy alcohol use is a leading contributor to the global burden of disease, particularly among young people. Systematic reviews suggest efficacy of web-based alcohol screening and brief intervention and call for effectiveness trials in settings where it could be sustainably delivered. OBJECTIVE: To evaluate a national web-based alcohol screening and brief intervention program. DESIGN, SETTING, AND PARTICIPANTS: A multisite, double-blind, parallel-group, individually randomized trial was conducted at 7 New Zealand universities. In April and May of 2010, invitations containing hyperlinks to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screening test were e-mailed to 14,991 students aged 17 to 24 years. INTERVENTIONS: Participants who screened positive (AUDIT-C score ≥4) were randomized to undergo screening alone or to 10 minutes of assessment and feedback (including comparisons with medical guidelines and peer norms) on alcohol expenditure, peak blood alcohol concentration, alcohol dependence, and access to help and information. MAIN OUTCOMES AND MEASURES: A fully automated 5-month follow-up assessment was conducted that measured 6 primary outcomes: consumption per typical occasion, drinking frequency, volume of alcohol consumed, an academic problems score, and whether participants exceeded medical guidelines for acute harm (binge drinking) and chronic harm (heavy drinking). A Bonferroni-corrected significance threshold of .0083 was used to account for the 6 comparisons and a sensitivity analysis was used to assess possible attrition bias. RESULTS: Of 5135 students screened, 3422 scored 4 or greater and were randomized, and 83% were followed up. There was a significant effect on 1 of the 6 prespecified outcomes. Relative to control participants, those who received intervention consumed less alcohol per typical drinking occasion (median 4 drinks [interquartile range {IQR}, 2-8] vs 5 drinks [IQR 2-8]; rate ratio [RR], 0.93 [99.17% CI, 0.86-1.00]; P = .005) but not less often (RR, 0.95 [99.17% CI, 0.88-1.03]; P = .08) or less overall (RR, 0.95 [99.17% CI, 0.81-1.10]; P = .33). Academic problem scores were not lower (RR, 0.91 [99.17% CI, 0.76-1.08]; P = .14) and effects on the risks of binge drinking (odds ratio [OR], 0.84 [99.17% CI, 0.67-1.05]; P = .04) and heavy drinking (OR, 0.77 [99.17% CI, 0.56-1.05]; P = .03) were not significantly significant. In a sensitivity analysis accounting for attrition, the effect on alcohol per typical drinking occasion was no longer statistically significant. CONCLUSIONS AND RELEVANCE: A national web-based alcohol screening and brief intervention program produced no significant reductions in the frequency or overall volume of drinking or academic problems. There remains a possibility of a small reduction in the amount of alcohol consumed per typical drinking occasion. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12610000279022.

Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation

OBJECTIVE: To investigate the efficacy and effects of transcranial direct current stimulation (tDCS) on motor imagery brain-computer interface (MI-BCI) with robotic feedback for stroke rehabilitation. DESIGN: A sham-controlled, randomized controlled trial. SETTING: Patients recruited through a hospital stroke rehabilitation program. PARTICIPANTS: Subjects (N=19) who incurred a stroke 0.8 to 4.3 years prior, with moderate to severe upper extremity functional impairment, and passed BCI screening. INTERVENTIONS: Ten sessions of 20 minutes of tDCS or sham before 1 hour of MI-BCI with robotic feedback upper limb stroke rehabilitation for 2 weeks. Each rehabilitation session comprised 8 minutes of evaluation and 1 hour of therapy. MAIN OUTCOME MEASURES: Upper extremity Fugl-Meyer Motor Assessment (FMMA) scores measured end-intervention at week 2 and follow-up at week 4, online BCI accuracies from the evaluation part, and laterality coefficients of the electroencephalogram (EEG) from the therapy part of the 10 rehabilitation sessions. RESULTS: FMMA score improved in both groups at week 4, but no intergroup differences were found at any time points. Online accuracies of the evaluation part from the tDCS group were significantly higher than those from the sham group. The EEG laterality coefficients from the therapy part of the tDCS group were significantly higher than those of the sham group. CONCLUSIONS: The results suggest a role for tDCS in facilitating motor imagery in stroke.

Randomized controlled trial of proactive web-based alcohol screening and brief intervention for university students

BACKGROUND: University students drink more heavily than their nonstudent peers and are often unaware that their drinking is risky and exceeds normative levels. We tested the efficacy of a proactive Web-based alcohol screening and brief intervention program. METHODS: A randomized controlled trial was conducted at an Australian university in 2007. Invitations were sent to 13 000 undergraduates (age range, 17-24 years) to complete a Web-based Alcohol Use Disorders Identification Test. Of 7237 students who responded, 2435 scored in the hazardous/harmful range (> or =8) and were randomized, and 2050 (84%) completed at least 1 follow-up assessment. Intervention was 10 minutes of Web-based motivational assessment and personalized feedback. Controls received only screening. Follow-up assessments were conducted at 1 and 6 months with observers and participants blinded to allocation. Outcome measures were drinking frequency, typical occasion quantity, overall volume, number of personal problems, an academic problems score, prevalence of binge drinking, and prevalence of heavy drinking. RESULTS: Mean (SD) baseline Alcohol Use Disorders Identification Test scores for control and intervention groups were 14.3 (5.1) and 14.2 (5.1), respectively. After 1 month, participants receiving intervention drank less often (rate ratio [RR], 0.89; 95% confidence interval [CI], 0.83-0.94), smaller quantities per occasion (RR, 0.93; 95% CI, 0.88-0.98), and less alcohol overall (RR, 0.83; 95% CI, 0.78-0.90) than did controls. Differences in alcohol-related harms were nonsignificant. At 6 months, intervention effects persisted for drinking frequency (RR, 0.91; 95% CI, 0.85-0.97) and overall volume (RR, 0.89; 95% CI, 0.82-0.96) but not for other variables. CONCLUSION: Proactive Web-based screening and intervention reduces drinking in undergraduates, and such a program could be implemented widely.

A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial

BACKGROUND: Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodology of the MINSTOP (Mobile-based Intervention Intended to Stop Obesity in Preschoolers) trial.

METHODS/DESIGN: A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline).

DISCUSSION: This novel study will evaluate the effectiveness of a mHealth program for mitigating gain in body fatness among 4-year-old children. If the intervention proves effective it has great potential to be implemented in child-health care to counteract childhood overweight and obesity.

A mHealth cardiac rehabilitation exercise intervention: findings from content development studies

BACKGROUND: Involving stakeholders and consumers throughout the content and study design ensures interventions are engaging and relevant for end-users. The aim of this paper is to present the content development process for a mHealth (mobile phone and internet-based) cardiac rehabilitation (CR) exercise intervention.

METHODS: An innovative mHealth intervention was developed with patient input using the following steps: conceptualization, formative research, pre-testing, and pilot testing. Conceptualization, including theoretical and technical aspects, was undertaken by experts. For the formative component, focus groups and interviews with cardiac patients were conducted to discuss their perceptions of a mHealth CR program. A general inductive thematic approach identified common themes. A preliminary library of text and video messages were then developed. Participants were recruited from CR education sessions to pre-test and provide feedback on the content using an online survey. Common responses were extracted and compiled. An iterative process was used to refine content prior to pilot testing and conduct of a randomized controlled trial.

RESULTS: 38 CR patients and 3 CR nurses participated in the formative research and 20 CR patients participated in the content pre-testing. Participants perceived the mHealth program as an effective approach to inform and motivate patients to exercise. For the qualitative study, 100% (n = 41) of participants thought it to be a good idea, and 11% of participants felt it might not be useful for them, but would be for others. Of the 20 participants who completed the online survey, 17 out of 20 (85%) stated they would sign up to a program where they could receive information by video messages on a website, and 12 out of 20 (60%) showed interest in a texting program. Some older CR patients viewed technology as a potential barrier as they were unfamiliar with text messaging or did not have mobile phones. Steps to instruct participants to receive texts and view the website were written into the study protocol. Suggestions to improve videos and wording of texts were fed back to the content development team and refined.

CONCLUSIONS: Most participants thought a mHealth exercise program was an effective way to deliver exercise-based CR. The results were used to develop an innovative multimedia exercise intervention. A randomized controlled trial is currently underway.

A theory-based video messaging mobile phone intervention for smoking cessation: randomized controlled trial

BACKGROUND: Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques.

OBJECTIVE: The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation.

METHODS: A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks.

RESULTS: The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated.

CONCLUSIONS: This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation.

An internet-supported physical activity intervention delivered in secondary schools located in low socio-economic status communities : study protocol for the activity and motivation in physical education (AMPED) cluster randomized controlled trial

BACKGROUND: School-based physical education is an important public health initiative as it has the potential to provide students with regular opportunities to participate in moderate-to-vigorous physical activity (MVPA). Unfortunately, in many physical education lessons students do not engage in sufficient MVPA to achieve health benefits. In this trial we will test the efficacy of a teacher professional development intervention, delivered partially via the Internet, on secondary school students' MVPA during physical education lessons. Teaching strategies covered in this training are designed to (i) maximize opportunities for students to be physically active during lessons and (ii) enhance students' autonomous motivation towards physical activity. METHOD: A two-arm cluster randomized controlled trial with allocation at the school level (intervention vs. usual care control). Teachers and Year 8 students in government-funded secondary schools in low socio-economic areas of the Western Sydney region of Australia will be eligible to participate. During the main portion of the intervention (6 months), teachers will participate in two workshops and complete two implementation tasks at their school. Implementation tasks will involve video-based self-reflection via the project's Web 2.0 platform and an individualized feedback meeting with a project mentor. Each intervention school will also complete two group peer-mentoring sessions at their school (one per term) in which they will discuss implementation with members of their school physical education staff. In the booster period (3 months), teachers will complete a half-day workshop at their school, plus one online implementation task, and a group mentoring session at their school. Throughout the entire intervention period (main intervention plus booster period), teachers will have access to online resources. Data collection will include baseline, post-intervention (7-8 months after baseline) and maintenance phase (14-15 months after baseline) assessments. Research assistants blinded to group allocation will collect all data. The primary outcome will be the proportion of physical education lesson time that students spend in MVPA. Secondary outcomes will include leisure-time physical activity, subjective well-being, and motivation towards physical activity.
DISCUSSION: The provision of an online training platform for teachers could help facilitate more widespread dissemination of evidence-based interventions compared with programs that rely exclusively on face-to-face training.

Characteristics of European adults who dropped out from the Food4Me internet-based personalised nutrition intervention

OBJECTIVE: To characterise participants who dropped out of the Food4Me Proof-of-Principle study.

DESIGN: The Food4Me study was an Internet-based, 6-month, four-arm, randomised controlled trial. The control group received generalised dietary and lifestyle recommendations, whereas participants randomised to three different levels of personalised nutrition (PN) received advice based on dietary, phenotypic and/or genotypic data, respectively (with either more or less frequent feedback).

SETTING: Seven recruitment sites: UK, Ireland, The Netherlands, Germany, Spain, Poland and Greece.

SUBJECTS: Adults aged 18-79 years (n 1607).

RESULTS: A total of 337 (21 %) participants dropped out during the intervention. At baseline, dropouts had higher BMI (0·5 kg/m2; P<0·001). Attrition did not differ significantly between individuals receiving generalised dietary guidelines (Control) and those randomised to PN. Participants were more likely to drop out (OR; 95 % CI) if they received more frequent feedback (1·81; 1·36, 2·41; P<0·001), were female (1·38; 1·06, 1·78; P=0·015), less than 45 years old (2·57; 1·95, 3·39; P<0·001) and obese (2·25; 1·47, 3·43; P<0·001). Attrition was more likely in participants who reported an interest in losing weight (1·53; 1·19, 1·97; P<0·001) or skipping meals (1·75; 1·16, 2·65; P=0·008), and less likely if participants claimed to eat healthily frequently (0·62; 0·45, 0·86; P=0·003).

CONCLUSIONS: Attrition did not differ between participants receiving generalised or PN advice but more frequent feedback was related to attrition for those randomised to PN interventions. Better strategies are required to minimise dropouts among younger and obese individuals participating in PN interventions and more frequent feedback may be an unnecessary burden.

Research protocol for a digital intervention to reduce stigma among males with a personal experience of suicide in the Australian farming community

BACKGROUND: Australian farming communities have up to twice the suicide rate of the general population. Men, particularly, demonstrate debilitating self- and perceived-stigma associated with an experience of suicide. The Ripple Effect is aimed to reduce suicide stigma within the social, cultural, geographical and psychological contexts in which it occurs.

METHODS: A mixed-method design with multi-level evaluation will be effected following the development and delivery of a personalised website experience (combining shared stories, education, personal goal setting and links to resources) to farming men, aged 30-64 years, with an experience of suicide. Pre- and post-surveys will be used to assess changes in self- and perceived-stigma and suicide literacy. Online feedback from participants and semi-structured interviews during follow-up will be thematically analysed.

DISCUSSION: This project will provide information about increasingly accessible, innovative approaches to reducing the debilitating health and wellbeing effects of suicide stigma on a population of Australia's farmers.

TRIAL REGISTRATION: This research protocol was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN: ACTRN12616000289415 ) on 7(th) March, 2016.