Education and Counseling for Abstinence From Tobacco After Pregnancy
Postpartum Maintenance of Abstinence From Tobacco
調査の概要
状態
詳細な説明
BACKGROUND:
Pregnancy is an ideal time to help underserved young women to stop smoking cigarettes and remain abstinent for life. The field has made great progress in assisting women to quit during this time. Unfortunately, maintenance of this highly significant behavior change is dismal. Up to 75% of those who quit for pregnancy end up returning to smoking after delivery of the newborn. For underserved women, pregnancy is one of the few times that they have an extended contact with the health care system. Therefore, there is an opportunity to help these women quit smoking for the health of their fetus in addition to their own health. To date, there has been insufficient research on how best to maintain abstinence during the critical postpartum period, during which a unique constellation of risk factors (including sleep deprivation, variations in negative mood, and increased stress) heighten the probability of relapse. The potential payoff is enormous. The literature, while not extensive, provides sufficient guidance and justification for the specific approach and intervention components the study has chosen.
DESIGN NARRATIVE:
This study will develop and field test a maintenance of smoking abstinence program to be designed for a predominately low-income, high-risk population of women from a wide variety of ethnic and racial backgrounds who have quit smoking because of (or during) their pregnancy. The study will compare biologically confirmed postpartum smoking relapse rates of women who receive an educational intervention during pregnancy combined with sustained telephone counseling after that intervention, with women who receive only an educational intervention. Participants will begin at 28 weeks prenatal and will be followed through 1, 3, 6, and 12 months postpartum.
The specific aims of the current maintenance study are: 1) to compare biochemically confirmed smoking abstinence rates of women who quit smoking during their pregnancy and who receive an intervention based on telephone counseling using motivational interviewing versus quitters who receive usual care, maintenance of abstinence will be assessed at 1, 3, 6, and 12 months postpartum; and 2) to collect both qualitative and quantitative data to better understand short term and long term maintenance mediators and moderators of abstinence postpartum for women of low socioeconomic status (SES) who quit smoking during pregnancy.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Brown University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Smoked tobacco immediately before pregnancy
Exclusion Criteria:
- Smoked tobacco in the previous 7 days when contacted at 28 weeks gestation
- No telephone access
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:1
Participants will receive an educational intervention during pregnancy combined with a motivational interviewing program using telephone counseling to prevent postpartum relapse to tobacco use.
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Participants will receive up to 5 phone calls.
Educational intervention will be completed during pregnancy.
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アクティブコンパレータ:2
Participants will receive an educational intervention during pregnancy.
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Educational intervention will be completed during pregnancy.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Smoking status
時間枠:Measured at 1, 3, 6, and 12 months postpartum
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Measured at 1, 3, 6, and 12 months postpartum
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ETS exposure
時間枠:Measured at 1, 3, 6, and 12 months postpartum
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Measured at 1, 3, 6, and 12 months postpartum
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Urine cotinine analyses
時間枠:Measured at 1, 3, 6, and 12 months postpartum
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Measured at 1, 3, 6, and 12 months postpartum
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Patricia M. Risica, DrPH、Brown University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。