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Grip&Health: Behavioural Intervention to Reduce Smoking, Stress and Improve Financial Health in Low-SES in Rotterdam (Grip&Health)

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ClinicalTrials.gov Identifier: NCT03553979
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Indigo Rijnmond, the Netherlands
Avant Sanare, The Netherlands
Erasmus University College, The Netherlands
Information provided by (Responsible Party):
Ingmar Franken, Erasmus Medical Center

Brief Summary:
Grip&Health: randomised trial which will examine the effect of theory-based multicomponent behavioural intervention for reducing stress, smoking and improving financial health and perceived health of low-SES residents in Rotterdam. Between January 2018 and July 2018, a total of 300 participants will be recruited and randomised either to a stress management program (SM), stress management with a buddy program (SM-B) or a control condition. The investigators hypothesise that compared to participants in the control condition, participants in the intervention arms will demonstrate reduced stress, reduced smoking and improved financial health and perceived health.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Cigarette Smoking Stress Stress, Psychological Health Behavior Smoking, Tobacco Behavioral: Stress management program (SM) Behavioral: Stress management + Buddy program (SM-B) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stress management program (SM) Stress management and Buddy program (SM-B)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Smoking

Arm Intervention/treatment
Experimental: 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.
Behavioral: Stress management program (SM)
Participants follow the SM program.

Experimental: 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.
Behavioral: Stress management + Buddy program (SM-B)
In addition to receiving the SM, participants in the SM-B will also receive one-to-one support through a buddy.

No Intervention: 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.



Primary Outcome Measures :
  1. Self-reported Stress [ Time Frame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2) ]

    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).


  2. Objective Stress [ Time Frame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2) ]

    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


  3. Self-reported Smoking [ Time Frame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2) ]

    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.


  4. Dependence of nicotine [ Time Frame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2) ]

    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.


  5. Carbon Monoxide breath test [ Time Frame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2) ]

    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.


  6. Self-perceived health [ Time Frame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2) ]

    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.


  7. Financial health [ Time Frame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2) ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553979


Locations
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Netherlands
Erasmus University College Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3011 HP
Contact: Astrid Schop-Etman, Dr.    0031657779496    schop@euc.eur.nl   
Contact: Sara Shagiwal, MSc.    0031650744268    s.s.shagiwal@gmail.com   
Sponsors and Collaborators
Erasmus Medical Center
Indigo Rijnmond, the Netherlands
Avant Sanare, The Netherlands
Erasmus University College, The Netherlands

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ingmar Franken, Professor, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03553979     History of Changes
Other Study ID Numbers: FNO projectnr. 102291
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ingmar Franken, Erasmus Medical Center:
stress management
stress intervention
smoking intervention
lower SES
lower income
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms