Factors Associated with Higher Body Mass Index, Weight Concern, and Weight Gain in a Multinational Cohort Study of Smokers Intending to Quit

The ATTEMPT cohort study is multi-national, longitudinal study of smokers intending to quit recruited in the U.S.A., Canada, U.K. and France. Data on demographics, medical history, body mass index (BMI), weight concerns and smoking status were collected at baseline and after six months. A total of 2,009 subjects provided data at baseline and 1,303 at six months. High baseline BMI was associated with recent quit attempts, high weight concerns and high cigarette consumption. Weight gain was associated with low income, being single and number of cigarette-free days, but not with baseline weight concerns and confidence in preventing weight gain. Quit attempts were more frequent in subjects with a high baseline BMI and low weight concerns

Associations between weight change over 8 years and baseline body mass index in a cohort of continuing and quitting smokers

AIM: To examine the association between weight change and baseline body mass index (BMI) over 8 years in a cohort of continuing and quitting smokers. DESIGN: Prospective cohort. SETTING: Oxfordshire general practices nicotine patch/placebo trial with 8-year follow-up. PARTICIPANTS: Eighty-five participants were biochemically proven abstinent at 3, 6, 12 months and 8 years (abstainers). A total of 613 smoked throughout the 8 years (smokers), 26 quit for a whole year but were smoking again by 8 years (relapsed); 116 smoked for the first year but were abstinent at 8 years (late abstainers). MEASUREMENTS: Weight and BMI was measured at baseline and at 8 years. Regression models were used to examine weight gain by smoking status and the association of BMI at the time of quitting. FINDINGS: Abstainers gained 8.79kg [standard deviation (SD) 6.36; 95% confidence interval (CI) 7.42, 10.17]. Smokers gained 2.24 kg (SD 6.65; 95% CI 1.7, 2.77). Relapsed smokers gained 3.28 kg (SD 7.16; 95% CI 0.328, 6.24). Late abstainers gained 8.33 kg (SD 8.04; 95% CI 6.85, 9.81). The association between baseline BMI and weight change was modified by smoking status. In smokers there was a negative linear association of BMI, while in abstainers a J-shaped curve fitted best. These models estimated weight change over 8 years in abstainers of +9.8 kg, +7.8kg, +10.2kg, +19.4kg and in smokers of +3.9kg, +2.6kg, 1.0kg and -0.8kg, where BMI was 18, 23, 29 and 36, respectively. CONCLUSION: Obese smokers gain most weight on quitting smoking, while obese continuing smokers are likely to remain stable or lose weight. Obese quitters have the greatest need for interventions to ameliorate weight gain

Integration of mobile health into sickle cell disease care to increase hydroxyurea utilization: Protocol for an efficacy and implementation study

BACKGROUND: Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. OBJECTIVE: This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. METHODS: We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. RESULTS: The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. CONCLUSIONS: If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16319

Adolescent smoking: The relationship between cigarette consumption and BMI

Background:Studies relating cigarette smoking and body weight yield conflicting results. Weight-lowering effects in women and men have been associated with smoking, however, no effects on weight have been proven.This study examined the association between cigarette smoking and relative weight in adolescent males and females as they age into young adults.Methods:Data from the National Longitudinal Survey of Youth—a nationally representative survey conducted annually—was used for this analysis. The sample consists of 4225 males and females observed annually from1997 at age 12 to 17 through 2011 at age 27 to 31. Hierarchical generalized models (HGM) assess the impact of smoking on the likelihood of having higher BMI controlling for demographic, household and environmental impacts. The second estimation considers the possibility that smoking is endogenous and utilizes a multinomial instrument (IV) for smoking level. Results:HGM models reveal a negative association between cigarette smoking and BMI for both males and females. Individuals who smoke more have lower BMI compared to infrequent or non-smokers. General health rating, region of residence and income were used instrument for smoking in a linear two-stage IV specification. The instrument is highly correlated with BMI and results mirror the HGM. Finally, models run on early, middle and advanced adolescents show that the relationship diminishes over time. The relationship between BMI and smoking decreases as females age but increases for males.Conclusions:Empirical models confirm an association cigarette consumption and BMI in both males and females.This negative relationship varies with age. It is important to identify health risks—obesity—and modifiable risk factors—smoking—that contribute to health disparities among adolescents. However, the increase in one risky behavior leading to the decrease in the prevalence of the other, complicates the issue. The higher prevalence of frequent cigarette uses among both adolescents and young adults of lower BMI suggest that smoking could be used curb or suppress appetite

Enhancing the Evidence for Behavioral Counseling A Perspective From the Society of Behavioral Medicine

U.S. Preventive Services Task Force (USPSTF) clinical guidelines at present rarely assign the highest grade recommendation to behavioral counseling interventions for chronic disease prevention or risk reduction because of concerns about the certainty and quality of the evidence base. As a result, the broad integration of behavioral counseling interventions in primary care remains elusive. Thus, there is an urgent need for novel perspectives on how to generate the highest-quality and -certainty evidence for primary care–focused behavioral counseling interventions. As members of the Society of Behavioral Medicine (SBM)—a multidisciplinary scientific organization committed to improving population health through behavior change—we review the USPSTF mandate and current recommendations for behavioral counseling interventions and provide a perspective for the future that calls for concerted and coordinated efforts among SBM, USPSTF, and other organizations invested in the rapid and wider uptake of beneficial, feasible, and referable primary care–focused behavioral counseling interventions. This perspective highlights five areas for further development, including (1) behavioral counseling–focused practice-based research networks; (2) promotion of USPSTF evidence standards and the increased use of pragmatic RCT design; (3) quality control and improvement procedures for behavioral counseling training; (4) systematic research on effective primary care–based collaborative care models; and (5) methodologic innovations that capitalize on disruptive technologies and healthcare transformation. Collective efforts to improve the health of all Americans in the 21st century and beyond must ensure that effective, feasible, and referable behavioral counseling interventions are embedded in modern primary care practice

Electronic health record-embedded individualized pain plans for emergency department treatment of vaso-occlusive episodes in adults with sickle cell disease: Protocol for a preimplementation and postimplementation study

BACKGROUND: Individuals living with sickle cell disease often require aggressive treatment of pain associated with vaso-occlusive episodes in the emergency department. Frequently, pain relief is poor. The 2014 National Heart, Lung, and Blood Institute evidence-based guidelines recommended an individualized treatment and monitoring protocol to improve pain management of vaso-occlusive episodes. OBJECTIVE: This study will implement an electronic health record-embedded individualized pain plan with provider and patient access in the emergency departments of 8 US academic centers to improve pain treatment for adult patients with sickle cell disease. This study will assess the overall effects of electronic health record-embedded individualized pain plans on improving patient and provider outcomes associated with pain treatment in the emergency department setting and explore barriers and facilitators to the implementation process. METHODS: A preimplementation and postimplementation study is being conducted by all 8 sites that are members of the National Heart, Lung, and Blood Institute-funded Sickle Cell Disease Implementation Consortium. Adults with sickle cell disease aged 18 to 45 years who had a visit to a participating emergency department for vaso-occlusive episodes within 90 days prior to enrollment will be eligible for inclusion. Patients will be enrolled in the clinic or remotely. The target analytical sample size of this study is 160 patient participants (20 per site) who have had an emergency department visit for vaso-occlusive episode treatment at participating emergency departments during the study period. Each site is expected to enroll approximately 40 participants to reach the analytical sample size. The electronic health record-embedded individualized pain plans will be written by the patient\u27s sickle cell disease provider, and sites will work with the local informatics team to identify the best method to build the electronic health record-embedded individualized pain plan with patient and provider access. Each site will adopt required patient and provider implementation strategies and can choose to adopt optional strategies to improve the uptake and sustainability of the intervention. The study is informed by the Technology Acceptance Model 2 and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Provider and patient baseline survey, follow-up survey within 96 hours of an emergency department vaso-occlusive episode visit, and selected qualitative interviews within 2 weeks of an emergency department visit will be performed to assess the primary outcome, patient-perceived quality of emergency department pain treatment, and additional implementation and intervention outcomes. Electronic health record data will be used to analyze individualized pain plan adherence and additional secondary outcomes, such as hospital admission and readmission rates. RESULTS: The study is currently enrolling study participants. The active implementation period is 18 months. CONCLUSIONS: This study proposes a structured, framework-informed approach to implement electronic health record-embedded individualized pain plans with both patient and provider access in routine emergency department practice. The results of the study will inform the implementation of electronic health record-embedded individualized pain plans at a larger scale outside of Sickle Cell Disease Implementation Consortium centers. TRIAL REGISTRATION: ClinicalTrials.gov NCT04584528; https://clinicaltrials.gov/ct2/show/NCT04584528. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24818

Barriers to symptom management care pathway implementation in pediatric cancer

BACKGROUND: Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. METHODS: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. RESULTS: Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). CONCLUSIONS: The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology

Trial Protocol: Randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking

Background\ud Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD), individual modest energy restriction, and usual advice on hunger, ketosis, urges to smoke, abstinence and weight gain in overweight smokers trying to quit. \ud \ud Methods\ud This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/$m^2$), daily smokers (CO > 10 ppm); with at least 30 participants in each group. Each group receives identical behavioural support and NRT patches (25 mg(8 weeks),15 mg(2 weeks),10 mg(2 weeks)). The VLCD group receive a 429-559 kcal/day liquid formula beginning 1 week before quitting and continuing for 4 weeks afterwards. The modest energy restricted group (termed individual dietary and activity planning(IDAP)) engage in goal-setting and receive an energy prescription based on individual basal metabolic rate(BMR) aiming for daily reduction of 600 kcal. The control group receive usual dietary advice that accompanies smoking cessation i.e. avoiding feeling hungry but eating healthy snacks. After this, the VLCD participants receive IDAP to provide support for changing eating habits in the longer term; the IDAP group continues receiving this support. The control group receive IDAP 8 weeks after quitting. This allows us to compare IDAP following a successful quit attempt with dieting concurrently during quitting. It also aims to prevent attrition in the unblinded, control group by meeting their need for weight management. Follow-up occurs at 6 and 12 months. \ud \ud Outcome measures include participant acceptability, measured qualitatively by semi-structured interviewing and quantitatively by recruitment and attrition rates. Feasibility of running the trial within primary care is measured by interview and questionnaire of the treatment providers. Adherence to the VLCD is verified by the presence of urinary ketones measured weekly. Daily urges to smoke, hunger and withdrawal are measured using the Mood and Physical Symptoms Scale-Combined (MPSS-C) and a Hunger Craving Score (HCS). 24 hour, 7 day point prevalence and 4-week prolonged abstinence (Russell Standard) is confirmed by CO < 10 ppm. Weight, waist and hip circumference and percentage body fat are measured at each visit. \ud \ud Trial Registration\ud Current controlled trials ISRCTN83865809\ud \u

The tobacco industry’s past role in weight control related to smoking

Background: Smoking is thought to produce an appetite-suppressing effect by many smokers. Thus, the fear of body weight gain often outweighs the perception of health benefits associated with smoking cessation, particularly in adolescents. We examined whether the tobacco industry played a role in appetite and body weight control related to smoking and smoking cessation. Methods: We performed a systematic search within the archives of six major US and UK tobacco companies (American Tobacco, Philip Morris, RJ Reynolds, Lorillard, Brown & Williamson and British American Tobacco) that were Defendants in tobacco litigation settled in 1998. Findings are dated from 1949 to 1999. Results: The documents revealed the strategies planned and used by the industry to enhance effects of smoking on weight and appetite, mostly by chemical modifications of cigarettes contents. Appetite-suppressant molecules, such as tartaric acid and 2-acetylpyridine were added to some cigarettes. Conclusion: These tobacco companies played an active and not disclaimed role in the anti-appetite effects of smoking, at least in the past, by adding appetite-suppressant molecules into their cigarettes