Clinical trial NCT03553979: Grip&Health: Behavioural Intervention to Reduce Smoking, Stress and Improve Financial Health in Low-SES in Rotterdam
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Smoking, Cigarette
Smoking
Stress
Stress, Psychological
Health Behavior
Smoking, Tobacco
Keywords: stress management
stress intervention
smoking intervention
lower SES
lower income
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Indigo Rijnmond, the Netherlands
name: Avant Sanare, The Netherlands
name: Erasmus University Rotterdam
First posted: 2018-06-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stress management program (SM) Stress management and Buddy program (SM-B)
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Self-reported Stress
timeFrame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
measure: Objective Stress
timeFrame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
measure: Self-reported Smoking
timeFrame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
measure: Dependence of nicotine
timeFrame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
measure: Carbon Monoxide breath test
timeFrame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
measure: Self-perceived health
timeFrame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
measure: Financial health
timeFrame: at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University College
state: Zuid-Holland
Study officials:
References:
citation: 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.