NCT04893044

Brief Summary

A pilot trial among ship-board US Navy personnel surrounding a holiday weekend tested an evidence-based video on responsible drinking. Service members \>18 years were eligible to volunteer if they were aboard during data collection. Participants were randomized to intervention or control arms, with all given a brief survey before (T1) and after (T2) the weekend. The intervention arm viewed a 3-minute video at T1. A urine specimen collected at T1 and T2 for ethyl glucuronide (EtG) measurement used \>100ng/ml for significant alcohol use. Multivariable regression measured odds of detecting EtG at T2, controlling for T1 EtG detectability, age, and alcohol misuse at baseline per AUDIT-C. 86 subjects participated at T1, and 100 at T2, with complete data for 72 (control, n=34; intervention, n=38) who participated in both T1 and T2 were analyzed. Average age was 28 years with 25% and 32% reporting white or black/African-American, 54% married and 84% \<E6. At T1, 22% (n=16) and T2, 32% (n=23) had EtG\>100ng/ml. At T1, 50% and 55% in control and intervention arms respectively, screened positive for alcohol misuse by AUDIT-C; T1 AUDIT-C screen positivity was significantly associated with detecting EtG\>100ng/ml at T1 (p=0.04). Control arm EtG\>100ng/ml participants increased 1.7-fold over the weekend, from n=7 at T1 to n=12 at T2; the intervention arm had no increase in EtG\>100ng/ml participants, with n=11 at T1 and n=11 at T2.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

18 days

First QC Date

April 27, 2021

Last Update Submit

May 14, 2021

Conditions

Keywords

Military

Outcome Measures

Primary Outcomes (1)

  • Urinary ethyl glucuronide (EtG)

    Alcohol metabolite

    3 days

Secondary Outcomes (1)

  • Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) score

    3 days

Study Arms (2)

Exposure

EXPERIMENTAL

These participants watched a 3 minute long video prior to a long weekend. The intent was to see if watching the video altered their alcohol consumption compared to a group that did not watch the video. Urine alcohol metabolites were measured before and after the weekend.

Behavioral: Video

Control

NO INTERVENTION

These participants did not watch a video, and their urine alcohol metabolites were measures at the same dates as the exposure group above.

Interventions

VideoBEHAVIORAL

The video was a 3 minutes and based on "inoculation theory" to modify behavior towards moderating the effect of alcohol use as opposed to advising no use at all.

Exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All members of selected US Navy ship are eligible

You may not qualify if:

  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Navy

San Diego, California, 92136, United States

Location

Related Publications (1)

  • McDonell MG, Skalisky J, Leickly E, McPherson S, Battalio S, Nepom JR, Srebnik D, Roll J, Ries RK. Using ethyl glucuronide in urine to detect light and heavy drinking in alcohol dependent outpatients. Drug Alcohol Depend. 2015 Dec 1;157:184-7. doi: 10.1016/j.drugalcdep.2015.10.004. Epub 2015 Oct 9.

MeSH Terms

Conditions

Alcohol DrinkingAlcoholism

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized pilot trial of video intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 19, 2021

Study Start

August 16, 2019

Primary Completion

September 3, 2019

Study Completion

October 10, 2019

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations