None listed
Conditions
Brief summary
Aim: To investigate the short-term and long-term effects of brief alcohol abstention on behavioural and clinical measures of health and wellbeing among non-dependent drinkers using a randomised controlled trial design under real-world conditions. Hypotheses: Short-term change. We hypothesise that: a) Mean alcohol intake during abstinence pledge periods will be significantly lower compared to usual (baseline) alcohol intake. b) Compared to usual drinking, four consecutive weeks of abstinence will effect significant changes in adiposity, diet, sleep quantity/quality, activity level, mental and physical health, other substance use, behaviour towards others (BTO) and harms from others’ drinking (HFO), biomarkers for CVD (blood pressure, fats, inflammation) and liver function (enzymes). c) Compared to usual drinking and four consecutive weeks of abstinence, Eight weeks of consecutive of abstinence will effect significant changes in adiposity, diet, sleep quantity/quality, activity level, mental and physical health, other substance use, BTO, HFO, biomarkers for CVD and liver function. Long-term change. We hypothesise that: d) Mean alcohol intake one, three and six months after abstinence pledge periods will be significantly lower compared to baseline alcohol intake, and that these differences may be more pronounced among those with higher levels of alcohol consumption at baseline. e) There will be significant changes in adiposity, diet, sleep quantity/quality, activity level, mental and physical health, other substance use, behaviour towards others, harms from the drinking of others, biomarkers for cardiovascular disease and liver function, at three and six months follow-up compared to baseline.
Interventions
The study capitalises on a natural experiment that occurs every year under the Dry July Campaign. Dry July is an annual fundraising event that invites Australians to be alcohol free throughout July in order to raise donations to support adults living with cancer. Registrants seek out sponsors to donate funds in support of their abstinence pledge and the large majority who sign-up honour their obligation. In effect, each year, the Dry July Campaign generates a normative pool of individuals among
The study capitalises on a natural experiment that occurs every year under the Dry July Campaign. Dry July is an annual fundraising event that invites Australians to be alcohol free throughout July in order to raise donations to support adults living with cancer. Registrants seek out sponsors to donate funds in support of their abstinence pledge and the large majority who sign-up honour their obligation. In effect, each year, the Dry July Campaign generates a normative pool of individuals among whom commitment to a brief period of abstinence is facilitated by their pledge and who can be readily accessed for recruitment into a study of the effects of non-dependent alcohol use versus abstinence on health and wellbeing. Our aim is not to evaluate the process (e.g. messaging, delivery) or outcomes of the Dry July Campaign itself rather, we will capitalise on this well established and popular community campaign and apply a randomised controlled trial to investigate the short-term and long-term effects of brief periods of alcohol abstinence on the health and wellbeing of people who usually drink alcohol. Experimental group participants will be randomly allocated to one of three experimental arms. Arm A will abstain from alcohol for four consecutive weeks in July. Arm B will abstain from alcohol for eight weeks during July and August. Arm C will abstain in July, break in August and abstain for a second 4-week period in September. The study will be functionally divided into baseline and five phases. All participants will be measured at baseline and at the end of each phase. Compliance with abstinence will be facilitated by their enrolment with the Dry July Campaign. In addition, attrition will be minimised by a combination of strategies including appropriate compensation for participant time, prize draw retention strategy (at the end of Phases 5 and 6), minimisation of participant burden (e.g. flexible data collection times) and repeated follow-up efforts. To monitor adherence face-to-face detailed surveys will be conducted on alcohol use for all experimental arms and controls. To corroborate self-reported abstinence/alcohol intake among experimental and no-intervention arms phosphatidylethanol will be measured in dried blood spots.
Sponsors
Professor Tanya Chikritzhs
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(i) English speaking males and females aged 18 years and older resident in the WA metropolitan area and surrounds (ii) Current but not alcohol-dependent drinkers (iii) Able to comply with study requirements (e.g., short term abstinence for participants in experimental arms).
Exclusion criteria
(i) Pregnant females and those intending to conceive during the study period (ii) Smokers (for practical purposes as likely to be small numbers and may be difficult to randomise) (iii) Non-drinkers (iv) Drinkers at risk of dependence according to the Alcohol Use Disorders Identification Test (AUDIT > 19)
Outcome results
None listed