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The BeHealthyR Study: a randomized trial of a multicomponent intervention to reduce stress, smoking and improve financial health of low-income residents in Rotterdam.

ABSTRACT: BACKGROUND:Compared to higher socioeconomic status (SES) groups, those in lower SES groups are financially strained, experience higher rates of smoking-related morbidity, are in poorer health and have reduced life expectancy. This is especially true for the city of Rotterdam, where a large inequality in health is observed between low and high SES groups. The BeHealthyR study (Dutch: Grip en Gezondheid) is a randomized controlled trial (RCT) which will evaluate the impact of a theory-based multicomponent behavior intervention aiming to reduce stress, smoking, and improve financial health by means of a group-based stress management program combining cognitive and behavioral techniques, and nudges in low-SES residents living in Rotterdam. METHODS:The BeHealthyR study is a three-arm RCT. Between February 2018 and July 2019, low-SES participants who perceive stress, smoke, are financially strained and reside in Rotterdam (one of the four largest cities in The Netherlands) are recruited. Subsequently, participants are randomly assigned to either a stress management condition (SM), stress management with a buddy condition (SM-B) or a control condition (CC). Participants in the SM and SM-B conditions will attend four weekly group sessions (1.5 h/session) and a follow-up session eight weeks later. The SM condition includes psychoeducation and exercises, and cognitive and behavioral intervention techniques. Demographic data and objective measures will be collected at baseline (T0), four weeks post-baseline (T1), and twelve weeks post-baseline (T2). Primary outcome measures are to reduce stress, smoking and improve financial health. We hypothesize that low-SES participants in the intervention conditions, compared with those in the control condition, will experience less stress, smoke less and have improved financial health. DISCUSSION:This study is a group-based intervention which aims to investigate the effects of a theory-based behavioral change intervention employing several components on reducing stress, smoking, and improving financial health in low-SES residents living in Rotterdam. If effective, the findings from the present study will serve to inform future directions of research and clinical practice with regard to behavioral change interventions for low-SES groups. TRIAL REGISTRATION:ClinicalTrials.gov (ID: NCT03553979 ). Registered on January 1 2018.

SUBMITTER: Shagiwal SS

PROVIDER: S-EPMC6052714 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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The BeHealthyR Study: a randomized trial of a multicomponent intervention to reduce stress, smoking and improve financial health of low-income residents in Rotterdam.

Shagiwal Sara S SS Schop-Etman Astrid A Bergwerff Iris I Vrencken Wil W Denktaş Semiha S

BMC public health 20180718 1

<h4>Background</h4>Compared to higher socioeconomic status (SES) groups, those in lower SES groups are financially strained, experience higher rates of smoking-related morbidity, are in poorer health and have reduced life expectancy. This is especially true for the city of Rotterdam, where a large inequality in health is observed between low and high SES groups. The BeHealthyR study (Dutch: Grip en Gezondheid) is a randomized controlled trial (RCT) which will evaluate the impact of a theory-base ...[more]

PMID: 30021551

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Project description:ImportanceHypertension is highly prevalent in low- and middle-income countries, and it is an important preventable risk factor for cardiovascular diseases (CVDs). Understanding the economic benefits of a hypertension control program is valuable to decision-makers.ObjectiveTo evaluate the long-term cost-effectiveness of a multicomponent hypertension management program compared with usual care among patients with hypertension receiving care in public clinics in Argentina from a health care system perspective.Design, setting, and participantsThis economic evaluation used a Markov model to estimate the cost-effectiveness of a hypertension management program among adult patients with uncontrolled hypertension in a low-income setting. Patient-level data (743 individuals for multicomponent intervention; 689 for usual care) from the Hypertension Control Program in Argentina trial (HCPIA) were used to estimate treatment effects and the risk of CVD. Three health states were included in each strategy: (1) low risk of CVD, (2) high risk of CVD, and (3) death. The total time horizon was the lifetime, and each cycle lasted 6 months.Main outcomes and measuresModel inputs were based on trial data and other published sources. Cost and utilities were discounted at a rate of 5% annually. The incremental cost-effectiveness ratio (ICER) between the multicomponent intervention and usual care was calculated using the difference in costs in 2017 international dollars (INT $) divided by the difference in effectiveness in quality-adjusted life-years (QALYs). One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the uncertainty and robustness of the results.ResultsIn the original trial, the 743 participants in the intervention group (349 [47.0%] men) had a mean (SD) age of 56.2 (12.0) years, and the 689 participants in the control group (311 [45.1%] men) had a mean (SD) age of 56.2 (11.7) years. In the base-case analysis, the HCPIA program yielded 8.42 discounted QALYs and accrued INT $3096 discounted costs, while usual care yielded 8.29 discounted QALYs and accrued INT $2473 discounted costs. The ICER for the HCPIA program was INT $4907/QALY gained. The model results remained robust in sensitivity analyses, and the model was most sensitive to parameters of program costs.Conclusions and relevanceIn this study, the HCPIA multicomponent intervention vs usual care was a cost-effective strategy to improve hypertension management and reduce the risk of associated CVD among patients with hypertension who received services at public clinics in Argentina. This intervention program is likely transferable to other settings in Argentina or other lower- and middle-income countries.

Project description:BackgroundEconomic inequity systematically affects Black emerging adults (BEA), aged 18-24, and their healthy trajectory into adulthood. Guaranteed income (GI)-temporary, unconditional cash payments-is gaining traction as a policy solution to address the inequitable distribution of resources sewn by decades of structural racism and disinvestment. GI provides recipients with security, time, and support to enable their transition into adulthood and shows promise for improving mental and physical health outcomes. To date, few GI pilots have targeted emerging adults. The BEEM trial seeks to determine whether providing GI to BEA improves financial wellbeing, mental and physical health as a means to address health disparities.Methods/designUsing a randomized controlled crossover trial design, 300 low-income BEA from San Francisco and Oakland, California, are randomized to receive a $500/month GI either during the first 12-months of follow-up (Phase I) or during the second 12-months of a total of 24-months follow-up (Phase II). All participants are offered enrollment in optional peer discussion groups and financial mentoring to bolster financial capability. Primary intention-to-treat analyzes will evaluate the impact of GI at 12 months among Phase I GI recipients compared to waitlist arm participants using Generalized Estimating Equations (GEE). Primary outcomes include: (a) financial well-being (investing in education/training); (b) mental health status (depressive symptoms); and (c) unmet need for mental health and sexual and reproductive health services. Secondary analyzes will examine effects of optional financial capability components using GEE with causal inference methods to adjust for differences across sub-strata. We will also explore the degree to which GI impacts dissipate after payments end. Study outcomes will be collected via surveys every 3 months throughout the study. A nested longitudinal qualitative cohort of 36 participants will further clarify how GI impacts these outcomes. We also discuss how anti-racism praxis guided the intervention design, evaluation design, and implementation.DiscussionFindings will provide the first experimental evidence of whether targeted GI paired with complementary financial programming improves the financial well-being, mental health, and unmet health service needs of urban BEA. Results will contribute timely evidence for utilizing GI as a policy tool to reduce health disparities.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT05609188.

Project description:BackgroundFinancial distress is a barrier to cessation among low-income smokers.ObjectiveTo evaluate an intervention that integrated financial coaching and benefits referrals into a smoking cessation program for low-income smokers.DesignRandomized waitlist control trial conducted from 2017 to 2019.ParticipantsAdult New York City residents were eligible if they reported past 30-day cigarette smoking, had income below 200% of the federal poverty level, spoke English or Spanish, and managed their own funds. Pregnant or breastfeeding people were excluded. Participants were recruited from two medical centers and from the community.InterventionThe intervention (n = 208) offered smoking cessation coaching, nicotine replacement therapy, money management coaching, and referral to financial benefits and empowerment services. The waitlist control (n=202) was usual care during a 6-month waiting period.Main measuresTreatment engagement, self-reported 7-day abstinence, and financial stress at 6 months.Key resultsAt 6 months, intervention participants reported higher abstinence (17% vs. 9%, P=0.03), lower stress about finances (β, -0.8 [SE, 0.4], P=0.02), and reduced frequency of being unable to afford activities (β, -0.8 [SE, 0.4], P=0.04). Outcomes were stronger among participants recruited from the medical centers (versus from the community). Among medical center participants, the intervention was associated with higher abstinence (20% vs. 8%, P=0.01), higher satisfaction with present financial situation (β, 1.0 [SE, 0.4], P=0.01), reduced frequency of being unable to afford activities (β, -1.0 [SE, 0.5], P=0.04), reduced frequency in getting by paycheck-to-paycheck (β, -1.0 [SE, 0.4], P=0.03), and lower stress about finances in general (β, -1.0 [SE, 0.4], P = 0.02). There were no group differences in outcomes among people recruited from the community (P>0.05).ConclusionsAmong low-income smokers recruited from medical centers, the intervention produced higher abstinence rates and reductions in some markers of financial distress than usual care. The intervention was not efficacious with people recruited from the community.Trial registrationClinicalTrials.gov Identifier: NCT03187730.

Project description:IntroductionSmoking remains the leading preventable cause of death in the USA. Low utilisation of treatments for smoking cessation remains a major barrier for reducing smoking rates. Financial incentives represent an innovative approach to increasing use of therapies for smoking cessation. This paper will describe the rationale and design of the Financial Incentives for Smoking Treatment II (FIESTA II) study, a randomised controlled trial to evaluate the effectiveness and feasibility of goal-directed and outcome-based financial incentives to promote smoking cessation among hospitalised smokers.Methods and analysisWe are recruiting adult participants who smoked tobacco in the 30 days prior to initial interview and are contemplating quitting smoking. These participants will come from two hospitals in underserved communities in New York City and Los Angeles. They will be randomised into one of three arms. The first arm consists of goal-directed financial incentives plus enhanced usual care, which includes hospital-directed information about quitting smoking, nicotine replacement therapy and referral to a Quitline. The second arm involves outcome-based financial incentives plus enhanced usual care. The third arm consists of enhanced usual care alone. Multiple phone interviews with the participants will be completed after randomisation to assess smoking cessation. Participants will earn $20 for each follow-up interview completed and $30 for each smoking cessation test completed. Those who are randomised to the financial incentive groups can earn an additional $700. The participants in the outcome-based group will receive payments solely for exhibiting cessation, whereas the participants in the goal-based group are also eligible for receiving payments after meeting milestones such as speaking with a helpline coach.EthicsHuman research protection committees at New York University School of Medicine and the University of California Los Angeles (UCLA) David Geffen School of Medicine granted ethics approval.Protocol number: IRB#19-000 084.Trial registration numberNCT03979885.

Dataset Information

The BeHealthyR Study: a randomized trial of a multicomponent intervention to reduce stress, smoking and improve financial health of low-income residents in Rotterdam.

Publications

The BeHealthyR Study: a randomized trial of a multicomponent intervention to reduce stress, smoking and improve financial health of low-income residents in Rotterdam.

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