The iHealth Study in College Students | NCT00183131

Studies
The iHealth Study in College Students

NCT00183131

Sponsor

Boston Medical Center

Status

Completed

Last Update Posted

May 6, 2010Estimated

Enrollment

4,300

Phase

Phase 2

Conditions

Alcohol Abuse
Alcohol Dependence
Unhealthy Alcohol Use
Risky Alcohol Consumption Amounts
Hazardous Alcohol Use

Interventions

Brief Personalized Feedback

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P60AA013759	U.S. NIH Grant/Contract		View source
NIH P60 AA013759

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Nov 2004Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2010

Last Update Posted Date

May 6, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Boston Medical CenterOTHER

Collaborators

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH
Boston University	OTHER

Description Module

Brief Summary

The objective of this project was to test the feasibility of electronic mail recruitment and web screening for hazardous drinking, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study

Detailed Description

This pilot study aims to test the feasibility of electronic mail recruitment and web screening for alcohol problems, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study. To do so, 4300 freshman adult college students will be randomized to receive an electronic mail request to complete a web alcohol screening test using an alcohol-specific or a general wellness approach. The primary outcome is the proportion of respondents who complete alcohol screening. Additional outcomes include readiness to change drinking, help-seeking, alcohol consumption and consequences. The results of this pilot study will provide information useful to 1) colleges deciding how best to implement universal screening for hazardous alcohol use, and 2) in the preparation of a larger study of web-based screening and brief intervention for hazardous drinking in college students.

Conditions Module

Conditions

Alcohol Abuse
Alcohol Dependence
Unhealthy Alcohol Use
Risky Alcohol Consumption Amounts
Hazardous Alcohol Use

Keywords

Alcohol
Alcohol abuse
Alcohol dependence
Alcohol consumption
Unhealthy alcohol use
Screening
Brief Intervention
Effectiveness
Electronic intervention
Web-based intervention
College students

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4,300

Name	Type	Description	Arm Group Labels	Other Names
Brief Personalized Feedback	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the number of times a subject exceeded per occasion limits
Drinking risky amounts
Heavy episodic drinking
Drinks per day
Hazardous drinking

Secondary Outcomes

Measure	Description	Time Frame
Abstinence
Readiness to change alcohol use
Help-seeking

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Full time student
College freshman

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Saitz, M.D., M.P.H.	Boston University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston University		Boston	Massachusetts	02118	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15475031	Background	Saitz R, Helmuth ED, Aromaa SE, Guard A, Belanger M, Rosenbloom DL. Web-based screening and brief intervention for the spectrum of alcohol problems. Prev Med. 2004 Nov;39(5):969-75. doi: 10.1016/j.ypmed.2004.04.011.

ID	Term
D000437	Alcoholism
D000428	Alcohol Drinking

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders