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
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Zuid-Holland
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Rotterdam、Zuid-Holland、荷兰、3011 HP
- 招聘中
- Erasmus University College
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接触:
- Astrid Schop-Etman, Dr.
- 电话号码:0031657779496
- 邮箱:schop@euc.eur.nl
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接触:
- Sara Shagiwal, MSc.
- 电话号码:0031650744268
- 邮箱:s.s.shagiwal@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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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实验性的: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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无干预: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Self-reported Stress
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FNO projectnr. 102291
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