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

NCT ID: NCT03553979

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2019-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation Smoking, Cigarette Smoking Stress Stress, Psychological Health Behavior Smoking, Tobacco

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stress management program (SM) Stress management and Buddy program (SM-B)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stress management program (SM)

Intervention Type BEHAVIORAL

Participants follow the SM program.

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.

Group Type EXPERIMENTAL

Stress management + Buddy program (SM-B)

Intervention Type BEHAVIORAL

In addition to receiving the SM, participants in the SM-B will also receive one-to-one support through a buddy.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stress management program (SM)

Participants follow the SM program.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indigo Rijnmond, the Netherlands

UNKNOWN

Sponsor Role collaborator

Avant Sanare, The Netherlands

UNKNOWN

Sponsor Role collaborator

Erasmus University Rotterdam

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ingmar Franken

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus University College

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Astrid Schop-Etman, Dr.

Role: primary

0031657779496

Sara Shagiwal, MSc.

Role: backup

0031650744268

References

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Shagiwal SS, Schop-Etman A, Bergwerff I, Vrencken W, Denktas S. The BeHealthyR Study: a randomized trial of a multicomponent intervention to reduce stress, smoking and improve financial health of low-income residents in Rotterdam. BMC Public Health. 2018 Jul 18;18(1):891. doi: 10.1186/s12889-018-5728-7.

Reference Type DERIVED
PMID: 30021551 (View on PubMed)

Other Identifiers

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FNO projectnr. 102291

Identifier Type: -

Identifier Source: org_study_id

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