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Benefits of temporary alcohol restriction: a feasibility randomized trial.

ABSTRACT: Background:Participation in temporary alcohol abstinence campaigns such as 'Dry January' may prompt enduring reductions in alcohol consumption. A randomized controlled trial (RCT) is required to establish any long-term benefits or negative consequences of temporary abstinence. In the present study, we randomized heavy drinkers to complete or intermittent alcohol abstinence for 4 weeks, in order to evaluate the feasibility of conducting a large-scale RCT. Methods:This was a mixed methods feasibility study in which we explored recruitment and retention to a randomized trial, compliance with alcohol abstinence instructions and barriers to compliance, and acceptability of study procedures (primary feasibility outcomes). A community sample of women aged between 40 and 60 who drank in excess of 28 alcohol units per week were randomized to abstain from alcohol for 4 weeks either completely or intermittently (at least four abstinent days per week). To monitor compliance, both groups provided regular breath samples on a cellular breathalyser. A subsample completed a semi-structured interview that probed barriers to compliance with abstinence instructions and acceptability of study procedures. Results:Within 5 months, we recruited, screened and randomized 25 participants (20% of participants who responded to advertisements: 14 in the complete abstinence group, 11 in the intermittent abstinence group), 24 of whom were retained throughout the 28-day intervention period. Participants in both groups tended to comply with the instructions: the median number of breathalyser-verified abstinent days was 24 (IQR?=?15.5-25.0; 86% of target) in the complete abstinence group versus 12 (IQR?=?10-15; 75% of target) in the intermittent abstinence group. Semi-structured interviews identified some barriers to compliance and methodological issues that should be considered in future research. No adverse events were reported. Conclusions:It is feasible to recruit heavy drinking women from community settings and randomize them to either complete or intermittent abstinence from alcohol for 4 weeks. The majority of participants were retained in the study and compliance with the abstinence instructions was good, albeit imperfect. A comprehensive RCT to compare temporary alcohol abstinence with other alcohol reduction strategies on long-term alcohol consumption is feasible. Findings from such a trial would inform implementation of alcohol campaigns and interventions.

SUBMITTER: Field M

PROVIDER: S-EPMC6995140 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Benefits of temporary alcohol restriction: a feasibility randomized trial.

Field Matt M Puddephatt Jo-Anne JA Goodwin Laura L Owens Lynn L Reaves Danielle D Holmes John J

Pilot and feasibility studies 20200131

<h4>Background</h4>Participation in temporary alcohol abstinence campaigns such as 'Dry January' may prompt enduring reductions in alcohol consumption. A randomized controlled trial (RCT) is required to establish any long-term benefits or negative consequences of temporary abstinence. In the present study, we randomized heavy drinkers to complete or intermittent alcohol abstinence for 4 weeks, in order to evaluate the feasibility of conducting a large-scale RCT.<h4>Methods</h4>This was a mixed m ...[more]

PMID: 32021698

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Project description:Aims/hypothesis: Dietary restriction (DR) reduces adiposity and improves metabolism in patients with one or more symptoms of the metabolic syndrome. Nonetheless, it remains elusive whether the benefits of DR in humans are mediated by calorie or nutrient restriction. This study was conducted to identify whether isocaloric dietary protein restriction is sufficient to confer the beneficial effects of dietary restriction in patients with metabolic syndrome. Methods: We performed a prospective, randomized controlled dietary intervention under constant nutritional and medical supervision. A total of 21 individuals diagnosed with the metabolic syndrome was randomly assigned for caloric restriction (CR; n = 11, mean age 49 ± 8.5 years, female 63%; diet of 5,941 ± 686 KJ per day) or isocaloric dietary protein restriction (PR; n = 10, mean age 51.6 ± 8.9 years, female 50%; diet of 8,409 ± 2,360 KJ per day) and followed for 27 days. Results: Like CR, PR promoted weight loss (-6.6%, P= 0.0041) due to reduction in adiposity (-9.9%, P= 0.0007), associated with reductions in blood glucose (-52.7%, P= 0.0002), lipid levels (cholesterol, -35.4%, P= 0.0010; triglycerides, -39.5% P= 0.0022) and blood pressure (systolic, -37.7 P< 0.0001; diastolic, -73.2% P< 0.0001). PR resulted in enrichment of metabolic pathways related to the immune system such as B cell proliferation, lymphocyte proliferation and leukocyte proliferation in subcutaneous adipose tissue. Hence, a reduction in calorie intake or changes in the gut microbiome are not necessary to confer the metabolic benefits of DR. Instead, a reduction in protein intake with a mild increase in carbohydrate intake to maintain the isocaloric balance of the diet is sufficient to improve metabolic control. Conclusions/interpretation: Protein restriction is sufficient to confer almost the same clinical outcomes as calorie restriction without the need for a reduction in calorie intake. The isocaloric characteristic of the PR intervention makes this approach a more attractive and less drastic dietary strategy in clinical settings and has greater potential to be used as adjuvant therapy for people with the metabolic syndrome.

Project description:Background and aimsHIV-infected people with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare (1) XR-NTX treatment initiation, (2) retention and (3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics.DesignNon-blinded randomized trial of XR-NTX versus pharmacotherapy TAU.SettingHIV primary care clinics in Vancouver, BC, Canada and Chicago, IL, USA.ParticipantsFifty-one HIV-infected patients seeking treatment for OUD (n = 16), AUD (n = 27) or both OUD and AUD (n = 8).MeasurementsPrimary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression [HIV RNA polymerase chain reaction (pcr) < 200 copies/ml] and safety.FindingsTwo-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. In comparison, 96% of TAU participants initiated treatment, but only 50% were retained on medication at 16 weeks. Mean days of opioid use in past 30 days decreased from 17.3 to 4.1 for TAU and from 20.3 to 7.7 for XR-NTX. Mean heavy drinking days decreased from 15.6 to 5.7 for TAU and 12.5 to 2.8 for XR-NTX. Among those with OUD, HIV suppression improved from 67 to 80% for XR-NTX and 58 to 75% for TAU. XR-NTX was well tolerated, with no precipitated withdrawals and one serious injection-site reaction.ConclusionsExtended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual (clinicaltrials.gov NCT01908062).

Project description:BackgroundThe adherence to cardiac rehabilitation is low. Social media has been used to improve motivation and cardiac rehabilitation completion, but the authors did not find Facebook interventions for these purposes in the literature.ObjectiveThe purpose of this study was to determine the feasibility of the Cardiac Rehabilitation Facebook Intervention (Chat) for affecting changes in exercise motivation and need satisfaction and adherence to cardiac rehabilitation.MethodsThe Behavioral Regulation in Exercise Questionnaire-3 and Psychological Need Satisfaction for Exercise were used to measure motivation and need satisfaction (competence, autonomy, and relatedness) before and after the Chat intervention. To support need satisfaction, the intervention included educational posts, supportive posts, and interaction with peers. The feasibility measures included recruitment, engagement, and acceptability. Groups were compared using analysis of variance and Kruskal-Wallis tests. Paired t tests were used to assess motivation and need satisfaction change, and Pearson or Spearman correlations were used for continuous variables.ResultsA total of 32 participants were lost to follow-up and 22 were included in the analysis. Higher motivation at intake (relative autonomy index 0.53, 95% CI 0.14-0.78; P=.01) and change in need satisfaction-autonomy (relative autonomy index 0.61, 95% CI 0.09-0.87; P=.02) were associated with more completed sessions. No between-group differences were found. Engagement included "likes" (n=210) and "hits" (n=157). For acceptability, mean scores on a 1 (not at all) to 5 (quite a bit) Likert scale for feeling supported and in touch with providers were 4.6 and 4.4, respectively.ConclusionsAcceptability of the Chat group was high; however, intervention feasibility could not be determined due to the small sample size. Those with greater motivation at intake completed more sessions, indicating its importance in cardiac rehabilitation completion. Despite challenges with recruitment and engagement, important lessons were learned.Trial registrationClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813.International registered report identifier (irrid)RR2-10.2196/resprot.7554.

Project description:IntroductionYoung smokers always partake in both smoking and drinking. However, drinking undermines their likelihood to attempt quitting smoking or to successfully abstain from smoking. Hence, this trial will examine the feasibility of implementing an integrated smoking cessation and alcohol intervention in young Hong Kong Chinese people. Effect sizes of the integrated intervention (II) on self-reported and biochemically validated quit rates will also be calculated.MethodsThe study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with alcohol drinking. Participants will be randomized into a standard treatment (ST), II, or control arm. The ST group will receive a brief smoking cessation intervention based on the 5A (Ask, Assess, Advice, Assist, Arrange) and 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) models. The II group will receive brief advice on alcohol use based on the FRAMES (Feedback, Responsibility, Advice, Menu, Empathy, Efficacy) model in addition to the brief smoking cessation intervention. Both the ST and II groups will receive booster interventions at 1-week, 1-month, 3-month, and 6-month follow-up. The control group will receive leaflets on smoking cessation and alcohol reduction. Self-reported quitters at 6-month follow-up will be invited for biochemical validation. The primary outcomes are feasibility measures. The secondary outcomes are effect size of II on self-reported and biochemically validated quit rates at 6 months relative to control and ST. Outcomes will be assessed at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups.AnalysisDescriptive statistics will be used to calculate the feasibility measures. The three arms will be compared using analysis of variance for continuous variables and chi-square test for categorical variables. Effect sizes of II for self-reported and biochemically validated quit rates at 6 months will be determined using the generalized estimating equation model.

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Benefits of temporary alcohol restriction: a feasibility randomized trial.

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Benefits of temporary alcohol restriction: a feasibility randomized trial.

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