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临床试验/NCT00219336
NCT00219336已完成2 期

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

Nova Southeastern University2 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
354
试验地点
2
主要终点
AEP reduced risk through reduced drinking and effective contraception, or both

研究概览

简要总结

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

详细描述

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:

  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 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.
  4. Disseminate results of the study to health care providers in the local community.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • No alcohol consumption or vaginal intercourse in the 90 days prior to the interview
  • Trying to become pregnant
  • Not able to bear children
  • Using contraception effectively

结局指标

主要结局

AEP reduced risk through reduced drinking and effective contraception, or both

时间窗: 6 months post intervention

Not at risk if a women reported no risky drinking (see definition in outcome 2) or contracepting effectively, or both

AEP reduced risk through effective contraception only

时间窗: 6 months post intervention

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

AEP reduced risk through reduced drinking only

时间窗: 6 months post intervention

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Sobell

Professor

Nova Southeastern University

研究点 (2)

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