Quit4Health Intervention in Supporting Smoking Cessation and Preventing Smoking Initiation in Young Adults
Quit4Health: Expanding the Reach of an Innovative Tobacco Control Program for Young Adults
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To evaluate whether smokers randomized to Quit4Health are more likely to quit smoking and remain tobacco-free at 6 months than subjects randomized to the education only control group.
II. To evaluate whether non-smokers who are randomized to Quit4Health are less likely to initiate tobacco usage and remain tobacco-free at 6 months than non-smokers randomized to the education only control group.
SECONDARY OBJECTIVES:
I. To evaluate whether well-established predictors of susceptibility and barriers to cessation (e.g. self-efficacy, knowledge about associated risks, normative beliefs, attitudes, resistance skills, peer pressure) and recently identified predictors of tobacco use (e.g., depression, nicotine dependence, alcohol use, risk-taking propensity) will mediate the effect of the intervention on both onset (for non-smokers) and cessation (for smokers) of tobacco use.
II. To evaluate whether, at the end-of-treatment (EOT) assessment, participants (both smokers and non-smokers) in Quit4Health will report a significantly better perception of Quit4Health (message relevance, tailoring to specific needs based on tobacco use status, motivation to quit, etc.) compared with their counterparts in the education only control arm.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.
GROUP II: Participants read an educational booklet about cigarettes and other tobacco products for 1 month.
After completion of study, participants are followed at 3 and 6 months.
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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Texas
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Houston、Texas、アメリカ、77030
- M D Anderson Cancer Center
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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:
- Be enrolled in at least one class at Houston Community College (HCC) Central campus, West Loop campus or Spring Branch campus (cessation and prevention/advocacy groups)
- Speak and read English (cessation and prevention/advocacy groups)
- Own an Android or iOS smartphone (cessation and prevention/advocacy groups)
- Provide current and relevant contact information (cessation and prevention/advocacy groups)
- Smoked at least one cigarette (or more) in the past 30 days (cessation group)
- Have data and wifi capabilities on their mobile device (cessation and prevention/advocacy groups)
- Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale (prevention/advocacy groups)
Exclusion Criteria:
- People who score 16 or above on the Center for Epidemiologic Studies Depression (CESD) thus showing evidence of major depressive disorder (cessation and prevention/advocacy groups)
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：並列代入
- 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：GROUP I (Quit4Health)
Participants utilize Quit4Health intervention that includes interactive features, coping strategies and games related to cigarettes and other tobacco products for 1 month.
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補助研究
Utilize Quit4Health
他の名前：
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アクティブコンパレータ：Group II (educational booklet)
Participants read an educational booklet about cigarettes and other tobacco products for 1 month.
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補助研究
Read educational booklet
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Abstinence from tobacco
時間枠：At 6 months
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Any abstinence is defined as "subjective reports of abstinence from tobacco for at least 24 hours or more in the past 30 days", the 7-day point prevalence of abstinence at follow-ups will be verified by measurement of saliva cotinine.
The primary analysis will compare the abstinence rates at 6 months in the control and treatment group using a 2-sample test of proportion for all smokers.
A secondary analysis will involve a simple post-test analysis among smokers using logistic regression.
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At 6 months
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Susceptibility to tobacco initiation
時間枠：At 6 months
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Will assess susceptibility to smoking using the measure proposed by Pierce and colleagues.
Will employ similar analytic methods as in primary objective 1 to evaluate the prevalence of susceptibility at the 6-month follow-up in subjects randomized to the experimental intervention condition with respect to subjects assigned to the control condition.
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At 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mediation effect of predictors of smoking and recently identified predictors of tobacco use
時間枠：Up to 6 months
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The mediation effect estimate will be computed as the product of the effect of the treatment on the mediators and the mediators on the outcome controlling for the treatment.
The Bayesian mediation analysis method detailed by Yuan and MacKinnon will be used to estimate and make inference on the mediation effect.
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Up to 6 months
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Behavior modification
時間枠：Up to 6 months
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Will evaluate the motivational appeal, educational relevance and knowledge acquired in specific modules of the app that lead to behavior modification.
Similar assessments will be done among participants in the control condition with educational materials.
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Up to 6 months
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協力者と研究者
捜査官
- 主任研究者：Alexander V Prokhorov、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
その他の研究ID番号
- 2018-0186 (その他の識別子：M D Anderson Cancer Center)
- NCI-2018-03518 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- R42DA035012 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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