Emulation of the Moderate Alcohol and Cardiovascular Health Trial (MACH15)

NCT06583161 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 503325

Last updated 2024-09-03

No results posted yet for this study

Summary

The aim of this study is to assess how long-term alcohol consumption influences health risks by emulating the Moderate Alcohol and Cardiovascular Health Trial (MACH15). In the first step, the protocol of the emulation of MACH15, including eligibility criteria, alcohol regimens and assignment, follow-up, endpoints, causal contrasts of interest, and statistical analysis was specified. In the second step, the investigators will emulate an adapted version of MACH15 following the specified protocol using data from the UK Biobank.

Conditions

Interventions

BEHAVIORAL

Moderate drinking

Drink up to 16 grams of alcohol daily or almost daily \[repeated assessment center visit\] or 8-16 grams of alcohol 4 or more times per week \[web-based mental health questionnaire\]

BEHAVIORAL

Quitting

No alcohol consumption

BEHAVIORAL

Social drinking

Drink up to 16 grams of alcohol 1-2 days per week or drink 1-3 times per month or only on special occasions \[repeated assessment center visit\], or drink 8-16 grams of alcohol 2-3 times per week or drink 4 times per month or less \[web-based mental health questionnaire\]

BEHAVIORAL

Heavy/binge drinking

Drink more than 16 grams of alcohol daily or almost daily or more than 40 grams of alcohol 1-2 days per week \[repeated assessment center visit\], or 24 grams of alcohol or more 4 or more times per week or 40 grams of alcohol or more 2-3 times per week \[web-based mental health questionnaire\]

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2022-11-30
Completion
2022-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06583161 on ClinicalTrials.gov