scholarly journals Stress- and smoke free pregnancy study protocol: a randomized controlled trial of a personalized eHealth intervention including heart rate variability-biofeedback to support pregnant women quit smoking via stress reduction

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Willeke van Dijk ◽  
Mirjam Oosterman ◽  
Imke Jansen ◽  
Wieke de Vente ◽  
Anja Huizink
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Perceived Stress ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Heart Rate Variability Biofeedback ◽  
Randomized Controlled ◽  
Ehealth Intervention

Abstract Background Maternal smoking and stress during pregnancy are associated with adverse health effects for women themselves and are risk factors for adverse developmental outcomes of the unborn child. Smoking and stress seem to be intertwined in various ways. First, the majority of smoking pregnant women is of lower socio-economic status, which is associated with higher levels of perceived stress. Second, smoking women often report to smoke because they feel stressed. Third, quitting smoking often increases perceived stress levels initially. Therefore, effective interventions are needed to support women with smoking cessation by reducing stress. The aim of this study is to test the effectiveness of an eHealth intervention on stress reduction and smoking cessation. Methods/design The Stress- and Smoke Free Start of Life (SSFSL) study is a randomized controlled trial (RCT) comparing a personalized eHealth intervention with a control condition. Inclusion criteria for the women are: (1) > 18 years of age, (2) < 28 weeks pregnant at recruitment, (3) currently smoking. Consenting participants will be randomly assigned to the intervention or control group. Participants allocated to the intervention group will receive an 8-week intervention delivered on their smartphone. The application includes psycho-education on pregnancy, stress, and smoking (cessation); stress-management training consisting of Heart Rate Variability-biofeedback; and a personalized stop-smoking-plan. Participants in the control condition will be invited to visit a webpage with information on pregnancy, stress, and smoking (cessation). Study outcomes will be collected via online questionnaires, at four timepoints: pre-intervention (baseline; t0), post-intervention (8 weeks + 1 day after t0; t1), follow up at two weeks after birth (t2), and follow up at three months after birth (t3). The primary outcome measure is self-reported smoking cessation. Secondary outcomes include daily self-reported number of cigarettes smoked, perceived stress, pregnancy experience, birth outcomes, and negative affectivity scores of the baby. Moreover, the mediating effect of stress reduction on smoking cessation will be examined, and possible moderators will be tested. Discussion If the eHealth intervention is effective in smoking cessation among pregnant smoking women, it can be implemented as a tool into the health care in the Netherlands. Trial registration Netherlands Trial Register, ID: NL8156. Registered on 11 November 2019.

scholarly journals A Pilot Randomized Controlled Trial of Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

2020 ◽  
Vol 22 (9) ◽  
pp. 1578-1586
Author(s):  
Erika Litvin Bloom ◽  
Susan E Ramsey ◽  
Ana M Abrantes ◽  
Laura Hunt ◽  
Rena R Wing ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Weight Gain ◽  
Emotional Eating ◽  
Distress Tolerance ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Group Sessions ◽  
Pilot Randomized Controlled Trial

Abstract Introduction The majority of women who smoke cigarettes report that concern about weight gain is a barrier to quitting. We developed an intervention incorporating distress tolerance, appetite awareness, and mindful eating skills to target concerns about post-cessation weight gain and emotional eating (DT-W). In the current study, we conducted a pilot randomized controlled trial of DT-W versus a smoking health education (HE) intervention. Methods Participants (N = 69 adult female, weight-concerned smokers) were recruited in cohorts of 4–11. Cohorts were randomized to DT-W or HE. DT-W and HE were matched on format (single individual session followed by eight group sessions), inclusion of cognitive behavioral therapy for smoking cessation (CBT) content, and pharmacotherapy (nicotine patches). Follow-up assessments occurred at 1-, 3-, and 6-months post-treatment. Results The recruitment goal was met; 61 of the 69 participants attended at least one group session. There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE) (ps &gt; .05), but comprehension ratings were lower in DT-W than in HE (p = .02). Conclusions Overall, these results suggest that the study procedures and interventions were feasible and acceptable, but changes to the DT-W intervention content to improve comprehension should be considered prior to conducting a fully powered trial. Implications A distress tolerance-based treatment targeting fear of weight gain after smoking cessation and post-cessation emotional eating was feasible and acceptable relative to a smoking HE comparison condition, but changes should be considered before conducting a larger trial. Continued innovation in treatment development for weight-concerned smokers is needed.

scholarly journals Prospective, Randomized, Controlled Trial Using Best-Selling Smoking-Cessation Book

2017 ◽  
Vol 96 (7) ◽  
pp. 258-263
Author(s):  
James P. Foshee ◽  
Anita Oh ◽  
Adam Luginbuhl ◽  
Joseph Curry ◽  
William Keane ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Smoking Cessation Counseling ◽  
Randomized Controlled ◽  
Quit Smoking ◽  
Stop Smoking ◽  
Prospective Randomized Controlled Trial

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

Randomized Controlled Trial of an Interactive Internet Smoking Cessation Program with Long-Term Follow-up

2010 ◽  
Vol 39 (1) ◽  
pp. 48-60 ◽  
Author(s):  
Daniel F. Seidman ◽  
J. Lee Westmaas ◽  
Steve Goldband ◽  
Vance Rabius ◽  
Edward S. Katkin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Smoking Cessation Program ◽  
Randomized Controlled ◽  
Long Term Follow Up

scholarly journals Mindfulness-Based Stress Reduction for Systemic Lupus Erythematosus: A Mixed-Methods Pilot Randomized Controlled Trial of an Adapted Protocol

2021 ◽  
Vol 10 (19) ◽  
pp. 4450
Author(s):  
Renen Taub ◽  
Danny Horesh ◽  
Noa Rubin ◽  
Ittai Glick ◽  
Orit Reem ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Stress Reduction ◽  
Lupus Erythematosus ◽  
Controlled Trial ◽  
Systemic Lupus ◽  
Psychological Inflexibility ◽  
Randomized Controlled

Background: The psychological effects of systemic lupus erythematosus (SLE) are tremendous. This pilot mixed-methods randomized controlled trial aimed to evaluate the effects of a mindfulness-based stress reduction (MBSR) adapted protocol on psychological distress among SLE patients. Methods: 26 SLE patients were randomly assigned to MBSR group therapy (n = 15) or a waitlist (WL) group (n = 11). An adapted MBSR protocol for SLE was employed. Three measurements were conducted: pre-intervention, post-intervention and 6-months follow up. A sub-sample (n = 12) also underwent qualitative interviews to assess their subjective experience of MBSR. Results: Compared to the WL, the MBSR group showed greater improvements in quality of life, psychological inflexibility in pain and SLE-related shame. Analysis among MBSR participants showed additional improvements in SLE symptoms and illness perception. Improvements in psychological inflexibility in pain and SLE-related shame remained stable over six months, and depression levels declined steadily from pre-treatment to follow-up. Qualitative analysis showed improvements in mindfulness components (e.g., less impulsivity, higher acceptance), as well as reduced stress following MBSR. Conclusions: These results reveal the significant therapeutic potential of MBSR for SLE patients. With its emphasis on acceptance of negative physical and emotional states, mindfulness practice is a promising treatment option for SLE, which needs to be further applied and studied.

scholarly journals Effect of a Parent-Focused eHealth Intervention on Children’s Fruit, Vegetable, and Discretionary Food Intake (Food4toddlers): Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Margrethe Røed ◽  
Anine C Medin ◽  
Frøydis N Vik ◽  
Elisabet R Hillesund ◽  
Wendy Van Lippevelde ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Fruits And Vegetables ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Differences ◽  
Randomized Controlled ◽  
Ehealth Intervention ◽  
Child Age

BACKGROUND In western countries, children’s diets are often low in fruits and vegetables and high in discretionary foods. Diet in early life tends to track through childhood and youth and even into adulthood. Interventions should, therefore, be delivered in periods when habitual traits are established, as in toddlerhood when children adapt to their family’s diet. OBJECTIVE In this study, we assessed the effect of the Food4toddlers eHealth intervention, which aimed to enhance toddlers’ diets by shaping their food and eating environment. METHODS The Food4toddlers randomized controlled trial was conducted in Norway in 2017-2018. Parent-child dyads were recruited through social media. In total, 298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2). Postintervention questionnaires were completed immediately after the intervention (ie, follow-up 1; mean child age 17.8 months, SD 1.3) and 6 months after the intervention (ie, follow-up 2; mean child age 24.2 months, SD 1.9). The intervention was guided by social cognitive theory, which targets the linked relationship between the person, the behavior, and the environment. The intervention group (148/298, 49.7%) got access to the Food4toddlers website for 6 months from baseline. The website included information on diet and on how to create a healthy food and eating environment as well as activities, recipes, and collaboration opportunities. To assess intervention effects on child diet from baseline to follow-up 1 and from baseline to follow-up 2, we used generalized estimating equations and a time × group interaction term. Between-group differences in changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods were assessed. RESULTS At follow-up 1, a significant time × group interaction was observed for the frequency of vegetable intake (<i>P</i>=.02). The difference between groups in the change from baseline to follow-up 1 was 0.46 vegetable items per day (95% CI 0.06-0.86) in favor of the intervention group. No other significant between-group differences in dietary changes from baseline to follow-up 1 or follow-up 2 were observed. However, there is a clear time trend showing that the intake of discretionary foods increases by time from less than 1 item per week at baseline to more than 4 items per week at 2 years of age (<i>P</i>&lt;.001), regardless of group. CONCLUSIONS A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2. No other between-group effects on diet were observed. eHealth interventions of longer duration, including reminders after the main content of the intervention has been delivered, may be needed to obtain long-terms effects, along with tailoring in a digital or a personal form. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 92980420; https://doi.org/10.1186/ISRCTN92980420

scholarly journals Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Laurie Zawertailo ◽  
Tara Mansoursadeghi-Gilan ◽  
Helena Zhang ◽  
Sarwar Hussain ◽  
Bernard Le Foll ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Real World ◽  
Smoking Status ◽  
Controlled Trial ◽  
Health Study ◽  
Open Label ◽  
Randomized Controlled

BACKGROUND Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. OBJECTIVE The primary objective of the MATCH (Medication Aids for Tobacco Cessation Health) study was to evaluate the real-world, long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers with the utilization of Web-based recruitment and follow-up. In addition, the study aims to investigate the genotypic and phenotypic predictors of cessation. METHODS This is a two-group, parallel block, randomized (1:1) open-label clinical trial. This study will be conducted online with the baseline enrollment through the study’s website and follow-up by emails. In addition, medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Individuals who smoke ≥10 cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario by word-of-mouth and the internet. Eligible participants will receive an email with a prescription for 12-week assigned medication and a letter to take to their physician. The recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. The primary outcome measure is the smoking status after 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted through emails after 4, 8, 12, 26, and 52 weeks of starting the treatment to assess the smoking prevalence and continuous smoking abstinence. In addition, mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Furthermore, personality characteristics will be assessed using the Big Five Aspect Scales. RESULTS The project was funded in 2014 and enrollment was completed in January 2017. Data analysis is currently underway. CONCLUSIONS To the best of our knowledge, this is the first randomized controlled trial to mass distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost effective with quit outcomes that are comparable to published clinical trials. CLINICALTRIAL ClinicalTrials.gov NCT02146911; https://clinicaltrials.gov/ct2/show/NCT02146911 (Archived by WebCite at http://www.webcitation.org/72CZ6AvXZ) REGISTERED REPORT IDENTIFIER RR1-10.2196/10826

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