Grip&Health: Behavioural Intervention to Reduce Smoking, Stress and Improve Financial Health in Low-SES in Rotterdam (Grip&Health)
Project Grip&Health: A Behavioural Intervention Which Uses an Integral Approach to Reduce Stress, Smoking, Improve Financial Health and Self-perceived Health of Low SES-residents in Rotterdam
調査の概要
状態
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Zuid-Holland
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Rotterdam、Zuid-Holland、オランダ、3011 HP
- 募集
- Erasmus University College
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コンタクト:
- Astrid Schop-Etman, Dr.
- 電話番号:0031657779496
- メール:schop@euc.eur.nl
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コンタクト:
- Sara Shagiwal, MSc.
- 電話番号:0031650744268
- メール:s.s.shagiwal@gmail.com
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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:
- perceive stress
- smoke
- poor financial health
Exclusion Criteria:
- follow other stress management course
- follow smoking cessation course
- receive help from debt services for their financial problems
- have health problems which hamper their ability to take part in the study
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:順次割り当て
- 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:Stress management program (SM)
The stress management program (SM) is a program which has been tailored to meet the specific needs of low-SES participants.
The SM consists of 4-weekly sessions (1.5hours/session) and a follow-up session 8 weeks later.
A core element of SM is its group-based format in which psycho-educative topics on stress responses and coping and motivation to stop smoking link up with cognitive and behavioural technique activities.
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Participants follow the SM program.
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実験的:Stress management + Buddy program (SM-B)
The stress management + buddy program (SM-B) includes the same psycho-educative topics and exercises, cognitive and behavioural technique activities as the SM condition.
The SM-B in addition to SM utilises one-to-one support through a buddy selected by a participant.
A buddy, 18 year or older is a student or a volunteer who is recruited and trained by Indigo Rijnmond.
The buddy pairs up with a participant and provides the following: supports participant in managing and filling in tax/welfare papers; 2) helps a participant to get a grip over his/her personal finances; and 3) helps a participant to overcome daily barriers (eg.
arranging childcare).
Over the duration of the course, the buddy meets up 6 times with a participant every second week in a public area.
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In addition to receiving the SM, participants in the SM-B will also receive one-to-one support through a buddy.
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介入なし:Control
Participants in the control condition are instructed to continue with their normal daily behaviour.
They will be invited to complete the questionnaires and objective measurements at the equivalent times as the intervention groups, thus at baseline, 4 weeks after baseline and 12 weeks after baseline.
After the control period, participants in the control condition will be offered the intervention.
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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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Self-reported Stress
時間枠:at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Change in self-reported Stress. The Depression, Anxiety and Stress (DASS) questionnaire will be used to measure change in self-reported stress from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2). The DASS is a 21-item questionnaire with three self-report scales (Depression, Anxiety and Stress). Scores for depression, anxiety and stress are determined by summing the scores of the 21 items. Ranges for depression, anxiety and stress are 0-28, 0-20, and 0-33, respectively. Lower scores indicate less severity. In this study participants will be asked to complete the DASS-21 questionnaire at three different time points (T0, T1 and T2). This is done so the investigators can assess the change in scores of self-reported stress across time points (T0, T1 and T2). |
at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Objective Stress
時間枠:at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Change in objective evaluations of stress based on heart rate variability (HRV) from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2). HRV indicates variability of time intervals between two consecutive heartbeats with each heartbeat having a R-wave which peaks in the R peak. The variations between two RR intervals are defined as HRV. A higher HRV value reflects a greater variation of the RR whereas a lower HRV indicates small variation. Participants beat-to-beat heart rate is measured using wrist wearables provided by Philips. During the measurements, the wearables are mounted on a participant's wrist and the participant is instructed to sit in a resting state for five minutes while the beat-to-beat heart rate is recorded. HRV analysis is derived from the recorded data using an appropriate software program. To assess change over time points (T0, T1 and T2), participants's beat-to-beat heart rate will be measured at three time points |
at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Self-reported Smoking
時間枠:at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Change in self-reported Smoking. The Global Adult Tobacco Survey (GATS) questionnaire will be used to measure change in self-reported smoking from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2). Participants will be asked to complete the questionnaire at three time points (T0, T1 and T2). This is done so the investigators can assess the change in self-reported smoking across time points. |
at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Dependence of nicotine
時間枠:at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Fagerstrom Test for Nicotine Dependence (FTND) questionnaire will be used to measure change in level of nicotine dependence from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2). The FTND test is used to assess the intensity of physical addiction to nicotine. The test is designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluates the quantity of cigarette consumption, the compulsion to use and dependence. Yes/No items on FTND are scores from 0-1 and multiple choice items are scores from 0-3. The items are summed to yield a total score of 0-10. The higher the FTND, the more intense a participant's physical dependence on nicotine. In this study, participants will be asked to complete the FTND at three time points (T0, T1 and T2). This is done so the investigators can assess the change in the level of nicotine dependence across time points. |
at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Carbon Monoxide breath test
時間枠:at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Change in exhaled Carbon Monoxide (CO) levels from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2). The CO breath test is a biological method used to verify smoking or non-smoking status of participants. In this study, participants's exhaled CO levels will be measured (Micro SmokeLyzer; Bedfont, UK). A CO level ≥10 ppm reflects a heavy smoker. During the measurements, participants are instructed to hold their breath for 15 seconds and subsequently to slowly exhale into a mouthpiece connected to the SmokeLyzer device until their lungs are empty. Participants CO levels will be recorded at three time points (T0, T1 and T2). This is done so the investigators can assess the change in C0 levels across time points. |
at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Self-perceived health
時間枠:at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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The Short Form Health Survey version 2 (SF-12v2) questionnaire will be used to measure change in self-perceived health from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2). The SF-12v2 is a 12-item with three dimensions both for functioning (physical, social and role) and for wellbeing (mental health, general health perceptions and pain). In this study, participants will be asked to rate their general health on a Likert-type scale (1=poor, 2=fair, 3= good, 4= very good, and 5=excellent). Low scores (poor) on the general health scale represent a person who believes his/her health to be poor and high score (excellent) represents someone who sees his/her health as excellent. Participants will be asked to complete the SF-12v2 questionnaire at three time points (T0, T1 and T2). This is done so the investigators can assess the change in health perceptions across time points. |
at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Financial health
時間枠:at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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Change in participant's's financial health will be measured from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2). In this study, participants's financial health will be measured by asking them to report: 1) their total monthly income; 2) their spouse/partner's total monthly income; and 3) money shortages experienced in the past month. Participants will be asked to fill this questionnaire in at three time points (T0, T1 and T2). This is done to assess changes in financial health across time points. |
at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
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協力者と研究者
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 (予想される)
研究の完了 (予想される)
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
- FNO projectnr. 102291
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米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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