A Participatory Health Promotion Mobile App Addressing Alcohol Use Problems (The Daybreak Program): Protocol for a Randomized Controlled Trial.
BACKGROUND
At-risk patterns of alcohol use are prevalent in many countries with significant costs to individuals, families, and society. Screening and brief interventions, including with Web delivery, are effective but with limited translation into practice to date. Previous observational studies of the Hello Sunday Morning approach have found that their unique Web-based participatory health communication method has resulted in a reduction of at-risk alcohol use between baseline and 3 months. The Hello Sunday Morning blog program asks participants to publicly set a personal goal to stop drinking or reduce their consumption for a set period of time, and to record their reflections and progress on blogs and social networks. Daybreak is Hello Sunday Morning's evidence-based behavior change program, which is designed to support people looking to change their relationship with alcohol.


OBJECTIVE
This study aims to systematically evaluate different versions of Hello Sunday Morning's Daybreak program (with and without coaching support) in reducing at-risk alcohol use.


METHODS
We will use a between groups randomized control design. New participants enrolling in the Daybreak program will be eligible to be randomized to receive either (1) the Daybreak program, including peer support plus behavioral experiments (these encourage and guide participants in developing new skills in the areas of mindfulness, connectedness, resilience, situational strategies, and health), or (2) the Daybreak program, including the same peer support plus behavioral experiments, but with online coaching support. We will recruit 467 people per group to detect an effect size of f=0.10. To be eligible, participants must be resident in Australia, aged ≥18 years, score ≥8 on the alcohol use disorders identification test (AUDIT), and not report prior treatment for cardiovascular disease.


RESULTS
The primary outcome measure will be reduction in the AUDIT-Consumption (AUDIT-C) scores. Secondary outcomes include mental health (Kessler's K-10), days out of role (Kessler), alcohol consumed (measured with a 7-day drinking diary in standard 10 g drinks), and alcohol-related harms (CORE alcohol and drug survey). We will collect data at baseline and 1, 3, and 6 months and analyze them with random effects models, given the correlated data structure.


CONCLUSIONS
A randomized trial is required to provide robust evidence of the impact of the online coaching component of the Daybreak program, including over an extended period.


TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry ACTRN12618000010291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373110 (Archived by WebCite at http://www.webcitation.org/6zKRmp0aC).


REGISTERED REPORT IDENTIFIER
RR1-10.2196/9982.
['Tait|Robert J|RJ|http://orcid.org/0000-0003-0648-3093', 'Kirkman|Jessica J L|JJL|http://orcid.org/0000-0002-6804-3811', 'Schaub|Michael P|MP|http://orcid.org/0000-0002-8375-4005']
health promotion alcohol drinking evaluation studies internet social marketing