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A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)

Primary Purpose

Alcohol Consumption, Fetal Alcohol Syndrome Disorders, Students

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-guided Motivational Intervention
Informational Only
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption focused on measuring Prevent Alcohol Exposed Pregnancies, Reduced Alcohol Used, Self-Guided Motivational Intervention, Effective Contraception, Contraception, College Students

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women aged 18 to 44 years who are not pregnant, not trying to become pregnant, and able to bear children. At risk for an alcohol exposed pregnancy 90 days prior to the interview defined as: had heterosexual vaginal intercourse with ineffective contraception not effectively using contraception drinking either ≥ 8 drinks per week on average or ≥ 5 drinks in a single day or both returned their informed consent and assessment materials within 60 days after it was mailed to them Exclusion Criteria: No alcohol consumption or vaginal intercourse in the 90 days prior to the interview Pregnant Trying to become pregnant Not able to bear children Using contraception effectively

Sites / Locations

  • Nova Southeastern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-motivational Choices

Information Only

Arm Description

Students and nonstudents were mailed a brochure prepared as part of the PHC study intervention, Making Healthy Choices for a Healthy Baby in English or Mujeres y Salud Eligiendo Opciones Saludables in Spanish. This brochure allows women to make informed decisions about preventing an AEP. The MF materials included nonstigmatizing messages about drinking and contraception embedded among other health messages. Similar to Project CHOICES, this group also received a brochure on birth control practices.

Students and nonstudents were mailed a brochure prepared by the CDC. The brochure (English: Think Before You Drink: You Can Hurt Your Unborn Baby; Spanish: Piénselo Antes de Beber: Puede Lastimar a Su Futuro Bebe), available at the CDC website, targets women of childbearing-age, discusses FAS and the negative effects of a mother's drinking on her unborn child, and recommends calling Alcoholics Anonymous or an alcohol treatment program for help to stop drinking. The CDC brochure did not contain information about how to contracept effectively.

Outcomes

Primary Outcome Measures

AEP reduced risk through reduced drinking and effective contraception, or both
Not at risk if a women reported no risky drinking (see definition in outcome 2) or contracepting effectively, or both
AEP reduced risk through reduced drinking only
Reduced risk drinking defined as ≤ 7 standard drinks (SDs) per week and ≤ 4 SDs on any day during the 6-month follow-up interval; 1 SD = 14 g absolute alcohol.
AEP reduced risk through effective contraception only
The effectiveness of birth control methods was evaluated using algorithms (e.g., If you missed a pill during this time period, did you take both pills the next day and did you use a back up method other than rhythm or withdrawal until you started your next packet of pills?) from Project CHOICES

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
September 29, 2016
Sponsor
Nova Southeastern University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00219336
Brief Title
A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)
Official Title
A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and non-students 18 to 44 years of age living in Florida. The investigators hypothesize that the motivational intervention will significantly reduce more women's risk of an AEP than will an informational intervention aimed at preventing fetal alcohol syndrome. Materials will be available in Spanish and English
Detailed Description
The proposed project will evaluate the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) among students and non-students. Participants will be women 18 to 44 years of age who are at risk of an AEP. The community targeted will be the state of Florida. Materials were available in Spanish and English The intervention will be based on the investigators' previous experience in (a) promoting self-change of drinking behavior at a community level and (b) preventing reduced risk for AEP through the use of a motivational interventional materials used in Project CHOICES. Using a 2 group randomized design, the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The FAS prevention condition, a brochure developed by the CDC, served as the standard treatment control group in that most information available at the community level concerning the effects of alcohol on the developing fetus relate to FAS (e.g., warning labels on alcoholic beverage containers). It is suggested that many women, particularly college students, at risk for AEP do not view themselves as at risk for FAS and therefore do not view FAS-oriented prevention messages as personally relevant. The proposed experimental design will evaluate a mail-based strategy that could be easily implemented throughout communities. The proposed study design will have more methodological rigor and allow a more careful evaluation than would be possible if the intervention was initially targeted at the entire community. The follow-up will be the entire 6-months post-intervention.If successful, this low-cost intervention can be readily disseminated throughout the local area. Specific objectives are as follows: Develop an evidence-based intervention to reduce alcohol-exposed pregnancies that can be easily disseminated at a community level through the mail and other media outlets. Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs. Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS using the 3 primary outcome measures in previous Project CHOICES studies: (a) AEP reduced risk through reduced drinking or effective contraception, or both; (b) AEP reduced risk through drinking only; and (c) reduced risk through effective contraception only. Disseminate results of the study to health care providers in the local community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Fetal Alcohol Syndrome Disorders, Students
Keywords
Prevent Alcohol Exposed Pregnancies, Reduced Alcohol Used, Self-Guided Motivational Intervention, Effective Contraception, Contraception, College Students

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-motivational Choices
Arm Type
Experimental
Arm Description
Students and nonstudents were mailed a brochure prepared as part of the PHC study intervention, Making Healthy Choices for a Healthy Baby in English or Mujeres y Salud Eligiendo Opciones Saludables in Spanish. This brochure allows women to make informed decisions about preventing an AEP. The MF materials included nonstigmatizing messages about drinking and contraception embedded among other health messages. Similar to Project CHOICES, this group also received a brochure on birth control practices.
Arm Title
Information Only
Arm Type
Active Comparator
Arm Description
Students and nonstudents were mailed a brochure prepared by the CDC. The brochure (English: Think Before You Drink: You Can Hurt Your Unborn Baby; Spanish: Piénselo Antes de Beber: Puede Lastimar a Su Futuro Bebe), available at the CDC website, targets women of childbearing-age, discusses FAS and the negative effects of a mother's drinking on her unborn child, and recommends calling Alcoholics Anonymous or an alcohol treatment program for help to stop drinking. The CDC brochure did not contain information about how to contracept effectively.
Intervention Type
Behavioral
Intervention Name(s)
Self-guided Motivational Intervention
Intervention Description
Using a randomized two-group design, a self-guided motivational intervention based on Project CHOICES will be compared to an informational only intervention, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS.
Intervention Type
Behavioral
Intervention Name(s)
Informational Only
Intervention Description
Using a randomized two-group design, an informational intervention using a brochure from the CDC will be compared to a self-guided motivational intervention based on Project CHOICES, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS
Primary Outcome Measure Information:
Title
AEP reduced risk through reduced drinking and effective contraception, or both
Description
Not at risk if a women reported no risky drinking (see definition in outcome 2) or contracepting effectively, or both
Time Frame
6 months post intervention
Title
AEP reduced risk through reduced drinking only
Description
Reduced risk drinking defined as ≤ 7 standard drinks (SDs) per week and ≤ 4 SDs on any day during the 6-month follow-up interval; 1 SD = 14 g absolute alcohol.
Time Frame
6 months post intervention
Title
AEP reduced risk through effective contraception only
Description
The effectiveness of birth control methods was evaluated using algorithms (e.g., If you missed a pill during this time period, did you take both pills the next day and did you use a back up method other than rhythm or withdrawal until you started your next packet of pills?) from Project CHOICES
Time Frame
6 months post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 18 to 44 years who are not pregnant, not trying to become pregnant, and able to bear children. At risk for an alcohol exposed pregnancy 90 days prior to the interview defined as: had heterosexual vaginal intercourse with ineffective contraception not effectively using contraception drinking either ≥ 8 drinks per week on average or ≥ 5 drinks in a single day or both returned their informed consent and assessment materials within 60 days after it was mailed to them Exclusion Criteria: No alcohol consumption or vaginal intercourse in the 90 days prior to the interview Pregnant Trying to become pregnant Not able to bear children Using contraception effectively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda C Sobell, Ph.D.
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Southeastern University
City
Fort. Lauderdale
State/Province
Florida
ZIP/Postal Code
33314
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26675247
Citation
Gioia CJ, Sobell LC, Sobell MB, Agrawal S. Craigslist versus print newspaper advertising for recruiting research participants for alcohol studies: Cost and participant characteristics. Addict Behav. 2016 Mar;54:24-32. doi: 10.1016/j.addbeh.2015.11.008. Epub 2015 Nov 19.
Results Reference
derived

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A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)

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