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

30 maggio 2018 aggiornato da: Ingmar Franken, Erasmus Medical Center

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

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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Anticipato)

300

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Olanda, 3011 HP
        • Reclutamento
        • Erasmus University College
        • Contatto:
          • Astrid Schop-Etman, Dr.
          • Numero di telefono: 0031657779496
          • Email: schop@euc.eur.nl
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Participants follow the SM program.
Sperimentale: 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.
In addition to receiving the SM, participants in the SM-B will also receive one-to-one support through a buddy.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-reported Stress
Lasso di tempo: 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).

at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
Objective Stress
Lasso di tempo: 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

at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
Self-reported Smoking
Lasso di tempo: 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.

at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
Dependence of nicotine
Lasso di tempo: 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.

at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
Carbon Monoxide breath test
Lasso di tempo: 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.

at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
Self-perceived health
Lasso di tempo: 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.

at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
Financial health
Lasso di tempo: 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.

at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 gennaio 2018

Completamento primario (Anticipato)

1 ottobre 2018

Completamento dello studio (Anticipato)

1 maggio 2019

Date di iscrizione allo studio

Primo inviato

8 gennaio 2018

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2018

Primo Inserito (Effettivo)

12 giugno 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FNO projectnr. 102291

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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