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A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)
This study is ongoing, but not recruiting participants.
First Received: September 14, 2005   Last Updated: August 6, 2008   History of Changes
Sponsored by: Nova Southeastern University
Information provided by: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00219336
  Purpose

The study will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP) among women 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.


Condition Intervention Phase
Alcohol Consumption
Fetal Alcohol Syndrome
Behavioral: Self-guided Motivational Intervention
Behavioral: Promoting Healthy Choices
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs)

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • Effective contraception [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol use [ Time Frame: 6 months postintervention ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: November 2005
Estimated Study Completion Date: March 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
A self-guided motivational intervention directed at preventing fetal alcohol syndrome (FAS) will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP).
Behavioral: Self-guided Motivational Intervention
Using a randomized two-group design, a self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The proposed study will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP). Participants will be women 18 to 44 years of age who are at risk of an AEP.
Behavioral: Promoting Healthy Choices
Using a randomized two-group design, a self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The proposed study will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP). Participants will be women 18 to 44 years of age who are at risk of an AEP

Detailed Description:

The proposed project will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP). Participants will be women 18 to 44 years of age who are at risk of an AEP. The community targeted will be Florida. The intervention will be based on the investigators' previous experience in promoting self-change of drinking behavior at a community level and in promoting reduced risk for AEP through the use of a motivational intervention. Using a randomized group design, the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The FAS prevention condition will serve as a 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 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 media-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. If successful, the intervention results can be readily disseminated throughout the local area. Specific objectives are as follows:

  1. 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.
  2. Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs.
  3. Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS.
  4. Disseminate results of the study to health care providers in the local community.
  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:

    1. heterosexually active,
    2. not effectively using contraception, and
    3. drinking either ≥ 8 drinks per week on average or ≥ 5 drinks in a single day or both.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219336

Locations
United States, Florida
Nova Southeastern University
Fort. Lauderdale, Florida, United States, 33314
Sponsors and Collaborators
Nova Southeastern University
Investigators
Principal Investigator: Linda C Sobell, Ph.D. Nova Southeastern University
  More Information

No publications provided

Responsible Party: Dr. Linda C. sobell ( Nova SEU University )
Study ID Numbers: U50/CCU300860, U50/CCU300860
Study First Received: September 14, 2005
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00219336     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
Alcohol Exposed Pregnancies
Reduced Alcohol Used
Self-Guided Motivational Intervention
Effective Contraception
Contraception

Study placed in the following topic categories:
Alcohol-Induced Disorders
Fetal Diseases
Fetal Alcohol Syndrome
Pregnancy Complications
Substance-Related Disorders
Drinking Behavior
Disorders of Environmental Origin
Alcohol-Related Disorders
Alcohol Drinking
Ethanol

Additional relevant MeSH terms:
Alcohol-Induced Disorders
Fetal Diseases
Fetal Alcohol Syndrome
Pathologic Processes
Disease
Pregnancy Complications
Syndrome
Substance-Related Disorders
Drinking Behavior
Disorders of Environmental Origin
Alcohol-Related Disorders
Alcohol Drinking

ClinicalTrials.gov processed this record on September 01, 2009