Improving oral health and oral health care are important public health goals. Tobacco users and smokers are at particularly high risk for oral disease and warrant targeted intervention efforts. We assessed the need for and acceptability of targeting tobacco quitline callers for an oral health promotion intervention.
We surveyed 816 Washington State Quitline callers to assess their oral health, relevant self-care behaviors, and interest in oral health promotion intervention.
Most respondents were female, cigarette smokers, of low socioeconomic status, with no dental insurance. Of the respondents, 79.3% (n=647) had some or all of their natural teeth (e.g., dentate); however, most of these respondents failed to meet recommendations for daily oral hygiene (brushing and flossing) (83.9%, n=543) and had no dental visits in the past year (52.6%, n=340). Similar findings were observed among respondents with no insurance. Many respondents were interested in learning more about how to improve their oral health (57.4%, n=468), willing to speak with a quitline coach about improving their oral health (48.2%, n=393), and open to receiving additional oral health information by mail (62.7%, n=512) or the Internet (50.0%, n=408). People who were receptive to learning how to improve their oral health were significantly more likely to be nonwhite, have a low income, have no dental insurance, and not have visited a dentist in the past year.
There is a need and an opportunity to target quitline callers for oral health promotion services, as those most in need of these services were open to receiving them.
Accurately estimating the period of time that individuals are exposed to online intervention content is important for understanding program engagement. This can be calculated from time-stamped data reflecting navigation to and from individual webpages. Prolonged periods of inactivity are commonly handled with a time-out feature and assigned a prespecified exposure duration. Unfortunately, this practice can lead to biased results describing program exposure.
The aim of the study was to describe how multiple imputations can be used to better account for the time spent viewing webpages that result in a prolonged period of inactivity or a time-out.
To illustrate this method, we present data on time-outs collected from the Q2 randomized smoking cessation trial. For this analysis, we evaluate the effects on intervention exposure of receiving content written in a prescriptive versus motivational tone. Using multiple imputations, we created five complete datasets in which the time spent viewing webpages that resulted in a time-out were replaced with values estimated with imputation models. We calculated standard errors using Rubin’s formulas to account for the variability due to the imputations. We also illustrate how current methods of accounting for time-outs (excluding timed-out page views or assigning an arbitrary viewing time) can influence conclusions about participant engagement.
A total of 63.00% (1175/1865) of participants accessed the online intervention in the Q2 trial. Of the 6592 unique page views, 683 (10.36%, 683/6592) resulted in a time-out. The median time spent viewing webpages that did not result in a time-out was 1.07 minutes. Assuming participants did not spend any time viewing a webpage that resulted in a time-out, no difference between the two message tones was observed (ratio of mean time online: 0.87, 95% CI 0.75-1.02). Assigning 30 minutes of viewing time to all page views that resulted in a time-out concludes that participants who received content in a motivational tone spent less time viewing content (ratio of mean time online: 0.86, 95% CI 0.77-0.98) than those participants who received content in a prescriptive tone. Using multiple imputations to account for time-outs concludes that there is no difference in participant engagement between the two message tones (ratio of mean time online: 0.87; 95% CI 0.75-1.01).
The analytic technique chosen can significantly affect conclusions about online intervention engagement. We propose a standardized methodology in which time spent viewing webpages that result in a time-out is treated as missing information and corrected with multiple imputations.
Clinicaltrials.gov NCT00992264; http://clinicaltrials.gov/ct2/show/NCT00992264 (Archived by WebCite at http://www.webcitation.org/6Kw5m8EkP).
online interventions; engagement; time spent online; multiple imputations; automatic time-out; smoking cessation; utilization; behavioral research; Internet
Comparative risk perceptions may rival other types of information in terms of effects on health behavior decisions.
We examined associations between comparative risk perceptions, affect, and behavior while controlling for absolute risk perceptions and actual risk.
Women at an increased risk of breast cancer participated in a program to learn about tamoxifen which can reduce the risk of breast cancer. Women reported comparative risk perceptions of breast cancer and completed measures of anxiety, knowledge, and tamoxifen-related behavior intentions. Three months later, women reported their behavior.
Comparative risk perceptions were positively correlated with anxiety, knowledge, intentions, and behavior three months later. After controlling for participants’ actual risk of breast cancer and absolute risk perceptions, comparative risk perceptions predicted anxiety and knowledge, but not intentions or behavior.
Comparative risk perceptions can affect patient outcomes like anxiety and knowledge independently of absolute risk perceptions and actual risk information.
comparative risk perception; breast cancer; behavioral decision-making; tamoxifen; decision aid
Although tamoxifen can prevent primary breast cancer, few women use it as a preventive measure. A second option, raloxifene, has recently been approved. The objective of the study was to determine women’s interest in tamoxifen and raloxifene after reading a decision aid describing the risks and benefits of each medication. Women with 5-year risk of breast cancer ≥1.66 from two large health maintenance organizations were randomized to receive a decision aid versus usual care. After reading an on-line decision aid that discussed the risks and benefits of tamoxifen and raloxifene, women completed measures of risk perception, decisional conflict, behavioral intentions and actual behavior related to tamoxifen and raloxifene. 3 months following the intervention, 8.1% of participants had looked for additional information about breast cancer prevention drugs and 1.8% had talked to their doctor about tamoxifen and/or raloxifene. The majority, 54.7%, had decided to not take either drug, 0.5% had started raloxifene, and none had started tamoxifen. Participants were not particularly worried about taking tamoxifen or raloxifene and did not perceive significant benefits from taking these drugs. Over 50% did not perceive a change in their risk of getting breast cancer if they took tamoxifen or raloxifene. After reading a DA about tamoxifen and raloxifene, few women were interested in taking either breast cancer prevention drug.
decision aids; patient education; tamoxifen; raloxifene; breast cancer prevention
Tamoxifen reduces primary breast cancer incidence, yet has serious side effects. To date, few women with increased breast cancer risk have elected to use tamoxifen for chemoprevention. The objective of the study was to determine women’s knowledge of and attitudes toward tamoxifen following exposure to a tailored decision aid (DA).
632 women with a 5-year risk of breast cancer ≥1.66% (Mean=2.56, range=1.7-17.3) were recruited from 2 healthcare organizations. Participants viewed an online DA that informed them about their 5-year risk of breast cancer and presented individually-tailored content depicting the risks/benefits of tamoxifen prophylaxis. Outcome measures included behavioral intentions (to seek additional information about tamoxifen, to talk to a physician about tamoxifen, and to take tamoxifen); knowledge; and perceived risks and benefits of tamoxifen.
After viewing the DA, 29% of participants said they intended to seek more information or talk to their doctor about tamoxifen, and only 6% believed they would take tamoxifen. Knowledge was considerable, with 63% of women answering at least 5 of 6 knowledge questions correctly. Participants were concerned about the risks of tamoxifen and many believed that the benefits of tamoxifen did not outweigh the risks.
This study is the largest to date to test women’s preferences for taking tamoxifen and one of the largest to have tested the impact of a tailored decision aid. After viewing the DA, women demonstrated good understanding of tamoxifen’s risks and benefits, but most were not interested in taking tamoxifen for breast cancer chemoprevention.
decision aids; patient education; tamoxifen; breast cancer prevention
We compared long-term outcomes among smokers with and without impaired lung functioning who received brief counseling highlighting their spirometric test results.
Participants in this analysis all received a brief motivational intervention for smoking cessation including spirometric testing and feedback (~20 minutes), were advised to quit smoking, offered free access to a phone-based smoking cessation program, and followed for one year. Outcomes were analyzed for smokers with (n = 99) and without (n = 168) impaired lung function.
Participants with lung impairment reported greater use of self-help cessation materials at 6 months, greater use of non-study-provided counseling services at 6 and 12 months, higher 7-day PPA rates at 6 months, and were more likely to talk with their doctor about their spirometry results.
Further research is warranted to determine if spirometry feedback has a differential treatment effect among smokers with and without lung impairment.
It is premature to make practice recommendations based on these data.
smoking cessation; spirometry; motivation; tobacco; health risk assessment; lung age; carbon monoxide; proactive treatment
Prior research demonstrated a need and opportunity to target smokers calling a free, state-funded tobacco quitline to provide behavioral counseling for oral health promotion; however, it is unclear whether these results generalize to tobacco quitline callers of higher socioeconomic status receiving services through commercially-funded quitlines. This knowledge will inform planning for a future public oral health promotion program targeted to tobacco quitline callers.
We surveyed smokers (n = 455) who had recently received tobacco quitline services through their medical insurance. Participants were asked about their self-reported oral health indicators, key behavioral risk factors for oral disease, motivation for changing their oral self-care behavior, and interest in future oral health promotion services. Where applicable, results were compared against those from a representative sample of callers to a free, state-funded quitline (n = 816) in the same geographic region.
Callers to a commercially-funded quitline had higher socioeconomic status, were more likely to have dental insurance, and reported better overall oral health indicators and routine self-care (oral hygiene, dental visits) than callers to a state-funded quitline. Nevertheless opportunities for oral health promotion were identified. Nearly 80% of commercial quitline callers failed to meet basic daily hygiene recommendations, 32.8% had not visited the dentist in more than a year, and 63.3% reported daily alcohol consumption (which reacts synergistically with tobacco to increase oral cancer risk). Nearly half (44%) were interested in learning how to improve their oral health status and, on average, moderately high levels of motivation for oral health care were reported. Many participants also had dental insurance, eliminating an important barrier to professional dental care.
Future public oral health promotion efforts should focus on callers to both free state-supported and commercially-funded tobacco quitlines. While differences exist between these populations, both groups report behavioral risk factors for oral disease which represent important targets for intervention.
Oral health promotion; Smoking; Tobacco; Oral disease
Multivariable cardiovascular disease (CVD) risk calculators, such as the Framingham risk equations, can be used to identify populations most likely to benefit from treatments to decrease risk.
To determine the proportion of adults within an electronic health record (EHR) for whom Framingham CVD risk scores could be calculated using cholesterol (lab-based) and/or BMI (BMI-based) formulae.
EHR data were used to identify patients aged 30–74 years with no CVD and at least 2 years continuous enrollment prior to April 1, 2010 and relevant data from the preceding 5-year time frame. Analyses were conducted between 2010 and 2011 to determine the proportion of patients with a lab- or BMI-based risk score, the data missing, and the concordance between scores.
Of 122,270 eligible patients, 59.7% (n=73,023) had sufficient data to calculate the lab-based risk score and 84.1% (102,795) the BMI-based risk score. Risk categories were concordant in 78.2% of patients. When risk categories differed, BMI-based risk was almost always in a higher category, with 20.3% having a higher and 1.4% a lower BMI- than lab-based risk score. Concordance between lab- and BMI-based risk was greatest among those at lower estimated risk, including people who were younger, female, without diabetes, not obese, and those not on blood pressure –or lipid-lowering medications
EHR data can be used to classify CVD risk for most adults aged 30–74 years. In the population for the current study, CVD risk scores based on BMI could be used to identify those at low risk for CVD and potentially reduce unnecessary laboratory cholesterol testing.
This study is registered at clinicaltrials.gov NCT01077388.
This study evaluated association between common and rare sequence variants in 10 nicotinic acetylcholine receptor subunit genes and the severity of nausea 21 days after initiating the standard, FDA-approved varenicline regimen for smoking cessation. Included in the analysis were 397 participants from a randomized clinical effectiveness trial with complete clinical and DNA resequencing data (mean age = 49.2 years; 68.0% female). Evidence for significant association between common sequence variants in CHRNB2 and nausea severity was obtained after adjusting for age, gender, and correlated tests (all PACT<.05). Individuals with the minor allele of CHRNB2 variants experienced less nausea than did those without the minor allele, consistent with previously reported findings for CHRNB2 and the occurrence of nausea and dizziness as a consequence of first smoking attempt in adolescents, and with the known neurophysiology of nausea. As nausea is the most common reason for discontinuance of varenicline, further pharmacogenetic investigations are warranted.
varenicline; nausea; smoking cessation; adherence
Few studies have rigorously evaluated whether providing biologically-based health risk feedback increases smokers’ motivation to quit and long-term abstinence above standard interventions.
Randomized controlled trial conducted from 2005-2008. Data were analyzed in 2008.
Smokers (n = 536) were recruited from the community, regardless of their interest in quitting smoking.
Smokers received brief (~20 minutes), personally-tailored counseling based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions versus generic smoking risk information and personalized counseling about their diet, BMI, and physical activity. All were advised to quit smoking and offered access to a free phone-counseling program.
MAIN OUTCOME MEASURES
Treatment utilization and abstinence at 6 and 12 months post-intervention.
Experimental participants demonstrated no greater motivation to quit, use of treatment services, or abstinence compared to controls at either follow-up. In fact, controls reported greater motivation to quit at 12 months (mean 3.42 vs. 3.20, P = .03), use of pharmacotherapy at 6 months (37.8% vs. 28.0%, P = .02), and 30 day PPA at 6 months after controlling for relevant covariates (10.8% vs. 6.4%, adjusted P = .04).
The present study found no support for adding a personalized health risk assessment emphasizing lung health and CO exposure to generic cessation advice and counseling for community-based smokers not otherwise seeking treatment.
smoking cessation; spirometry; motivation; tobacco; health risk assessment; lung age; carbon monoxide
Providing smokers with biologically based evidence of smoking-related disease risk or physical impairment may be an effective way to motivate cessation.
Smokers were recruited for a free health risk assessment and randomized to receive personally tailored feedback based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions or generic information about the risks of smoking and personalized counseling based on their diet, body mass index, and physical activity. All (n = 536) were advised to quit smoking and offered access to a free telephone cessation program. Participants were surveyed immediately after intervention and 1 month later to assess the impact on various indices of motivation to quit.
Immediately posttreatment, experimental participants rated themselves as more likely to try to quit (p = .02) and reported a greater mean increase in their motivation to quit than controls (p = .04). At 1-month follow-up, however, we found no significant group differences on any motivational indices. In post-hoc analyses comparing smokers in the experimental group with and without lung impairment, persons with impaired lung functioning had a greater change from baseline in posttreatment motivation to quit (adjusted p = .05) and perceived risk of developing a smoking-related disease (p = .03) compared with persons with no lung impairment, but we found no significant treatment effect on any motivational indices at 1 month.
The results suggest that the intervention had a small, temporary effect, but we found no clear evidence that the intervention increased motivation to quit smoking during the first month postintervention.
Aversive symptoms of abstinence from nicotine have been posited to lead to smoking relapse and research on temporal patterns of abstinence symptoms confirms this assumption. However, little is known about the association of symptom trajectories early after quitting with post-cessation smoking or about the differential effects of tonic (background) versus phasic (temptation-related) symptom trajectories on smoking status. The current study examined trajectories of urge and negative mood among 300 women using the nicotine patch during the first post-cessation week. Ecological momentary assessments collected randomly and during temptation episodes were analyzed using hierarchical linear modeling yielding four individual trajectory parameters: intercept (initial symptom level), linear slope (direction and rate of change), quadratic coefficient (curvature), and volatility (scatter). Early lapsers, who lapsed during the first post-cessation week, exhibited more severe tonic urge and phasic negative mood immediately after quitting, and more volatile tonic and phasic urge compared to abstainers. Late lapsers, who were abstinent during the first week but lapsed by 1 month, exhibited more severe tonic urge immediately after quitting compared to abstainers. These results demonstrate the importance of early post-cessation urge and negative affect and highlight the value of examining both tonic and phasic effects of abstinence from nicotine.
Early post-cessation symptoms; Withdrawal trajectory; Volatility; Urge; Negative Mood; Lapser; Ecological Momentary Assessment
The current study evaluated the efficacy of an individualized, hand-held Computer-Delivered Treatment (CDT) versus Standard Treatment (ST) for the maintenance of smoking abstinence following a quit attempt.
Participants were 303 adult daily smokers randomized to CDT or ST, plus pharmacotherapy. Abstinence though one year was examined using logistic random intercept models, a type of generalized linear mixed model regression.
Results did not support the efficacy of the CDT program through one year post-quit in analyses adjusted for time and study site [OR = .84, 95% CI = .55–1.30], or after further adjusting for race/ethnicity, age, gender, education, marital status, and the number of cigarettes smoked per day before quitting [OR = .89, 95% CI = .57–1.39].
CDT did not increase short- or long-term abstinence rates over ST in this study.
Findings differ from some in the literature and suggest the need for continued research on the use of CDT for smoking cessation.
Phone counseling has become standard for behavioral smoking cessation treatment. Newer options include Web and integrated phone–Web treatment. No prior research, to our knowledge, has systematically compared the effectiveness of these three treatment modalities in a randomized trial. Understanding how utilization varies by mode, the impact of utilization on outcomes, and predictors of utilization across each mode could lead to improved treatments.
One thousand two hundred and two participants were randomized to phone, Web, or combined phone–Web cessation treatment. Services varied by modality and were tracked using automated systems. All participants received 12 weeks of varenicline, printed guides, an orientation call, and access to a phone supportline. Self-report data were collected at baseline and 6-month follow-up.
Overall, participants utilized phone services more often than the Web-based services. Among treatment groups with Web access, a significant proportion logged in only once (37% phone–Web, 41% Web), and those in the phone–Web group logged in less often than those in the Web group (mean = 2.4 vs. 3.7, p = .0001). Use of the phone also was correlated with increased use of the Web. In multivariate analyses, greater use of the phone- or Web-based services was associated with higher cessation rates. Finally, older age and the belief that certain treatments could improve success were consistent predictors of greater utilization across groups. Other predictors varied by treatment group.
Opportunities for enhancing treatment utilization exist, particularly for Web-based programs. Increasing utilization more broadly could result in better overall treatment effectiveness for all intervention modalities.
Patient adherence to smoking cessation medications can impact their effectiveness. It is important to understand the extent to which prescribed medications are actually taken by smokers, how this influences smoking cessation outcomes, and what factors may influence adherence.
Smokers recruited from a large health plan were randomized to receive different modes of cessation counseling in combination with varenicline (Swan, G. E., McClure, J. B., Jack, L. M., Zbikowski, S. M., Javitz, H. S., Catz, S. L., et al. 2010.Behavioral counseling and varenicline treatment for smoking cessation. American Journal of Preventive Medicine, 38, 482–490). One thousand one hundred and sixty-one participants were mailed a 28-day varenicline supply when they set a quit date and were able to request up to two refills from the health plan pharmacy at no cost. Pharmacy fill records were obtained and telephone surveys completed at baseline, 21 days, 12 weeks, and 6 months post target quit date.
Good adherence to varenicline (≥80% of days taken) was associated with a twofold increase in 6-month quit rates compared with poor adherence (52% vs. 25%). Smokers were more likely than nonsmokers to stop varenicline early. Purposeful nonadherence was associated with smoking at 12 weeks and was predicted in multivariate analyses by age, gender, adherence self-efficacy, and initial medication side effect severity.
Innovative methods for increasing adherence to smoking cessation medications are needed, particularly early in the quit process. Simple metrics of adherence such as number of days cessation medication is taken can and should be routinely incorporated in effectiveness trials and reported to advance future attempts to understand and reduce nonadherence.
There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling (PTC) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy. We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a randomized trial of current smokers from a large health system. Eligible participants were randomized to one of three smoking cessation interventions: Web-based counseling (n=401), PTC (n=402), or combined PTC-Web counseling (n=399). All participants received a standard 12-week course of varenicline. The primary outcome was a 7-day point prevalent nonsmoking at the 6month follow-up. The Web intervention was the least expensive followed by the PTC and PTC-Web groups. Costs per additional 6-month nonsmoker and per additional lifetime quitter were $1,278 and $2,601 for Web, $1,472 and $2,995 for PTC, and $1,617 and $3,291 for PTC-Web. Cost per life-year (LY) and quality-adjusted life-year (QALY) saved were $1,148 and $1,136 for Web, $1,320 and $1,308 for PTC, and $1,450 and $1,437 for PTC-Web. Based on the cost per LY and QALY saved, these interventions are among the most cost-effective life-saving medical treatments. Web, PTC, and combined PTC-Web treatments were all highly cost-effective, with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments.
Smoking cessation; Varenicline; Cost-effectiveness; Quality-adjusted life-years saved; Behavioral intervention
Common single-nucleotide polymorphisms (SNPs) at nicotinic acetylcholine receptor (nAChR) subunit genes have previously been associated with measures of nicotine dependence. We investigated the contribution of common SNPs and rare single-nucleotide variants (SNVs) in nAChR genes to Fagerström test for nicotine dependence (FTND) scores in treatment-seeking smokers. Exons of 10 genes were resequenced with next-generation sequencing technology in 448 European-American participants of a smoking cessation trial, and CHRNB2 and CHRNA4 were resequenced by Sanger technology to improve sequence coverage. A total of 214 SNP/SNVs were identified, of which 19.2% were excluded from analyses because of reduced completion rate, 73.9% had minor allele frequencies <5%, and 48.1% were novel relative to dbSNP build 129. We tested associations of 173 SNP/SNVs with the FTND score using data obtained from 430 individuals (18 were excluded because of reduced completion rate) using linear regression for common, the cohort allelic sum test and the weighted sum statistic for rare, and the multivariate distance matrix regression method for both common and rare SNP/SNVs. Association testing with common SNPs with adjustment for correlated tests within each gene identified a significant association with two CHRNB2 SNPs, eg, the minor allele of rs2072660 increased the mean FTND score by 0.6 Units (P=0.01). We observed a significant evidence for association with the FTND score of common and rare SNP/SNVs at CHRNA5 and CHRNB2, and of rare SNVs at CHRNA4. Both common and/or rare SNP/SNVs from multiple nAChR subunit genes are associated with the FTND score in this sample of treatment-seeking smokers.
Fagerström test for nicotine dependence; single-nucleotide polymorphism; candidate gene association scan; treatment-seeking smokers; addiction & substance abuse; clinical pharmacology; clinical trials; neurogenetics; acetylcholine
Treatment outcomes were compared across smokers enrolled in the COMPASS cessation trial with (PH+, n = 271) and without (PH-, n = 271) a diagnosis of psychiatric history based on medical record evidence of anxiety, depression, psychotic disorder, or bipolar disorder Everyone received behavioral counseling plus varenicline and was followed for 6 months post-quit date. PH+ smokers took varenicline for fewer days on average (59.4 vs. 68.5, P ≤ .01), but did not differ in their use of behavioral treatment. PH+ smokers were more likely to report anxiety and depression, but side-effect intensity ratings did not differ after adjusting for multiple comparisons. Overall, all side-effects were rated as moderate intensity or less. Groups had similar 30 day abstinence rates at 6 months (31.5% PH+ vs. 35.4% PH-, P = .35). In sum, having a psychiatric diagnosis in this trial did not predict worse treatment outcome or worse treatment side-effects.
varenicline; smoking cessation; depression; anxiety; psychiatric illness; side-effects
Smoking remains the primary preventable cause of death and illness in the U.S. Effective, convenient treatment programs are needed to reduce smoking prevalence.
This study compared the effectiveness of three modalities of a behavioral smoking-cessation program in smokers using varenicline.
Current treatment seeking smokers (n=1202) were recruited from a large healthcare organization between October 2006 and October 2007. Eligible participants were randomized to one of three smoking-cessation interventions: web-based counseling (n=401), proactive telephone-based counseling (PTC; n=402), or combined PTC and web counseling (n=399). All participants received a standard 12-week FDA-approved course of varenicline. Self-report determined the primary outcomes (7-day point prevalent abstinence at 3- and 6-month follow-up), the number of days varenicline was taken, and treatment-related symptoms. Behavioral measures determined utilization of both the web- and phone-based counseling.
Intent-to-treat analyses revealed relatively high percentages of abstinence at 3 months (38.9%, 48.5%, 43.4%) and at 6 months (30.7%, 34.3%, 33.8%) for the web, PTC, and PTC web groups, respectively. The PTC group had a significantly higher percentage of abstinence than the web group at 3 months, OR=1.48, 95% CI 1.12–1.96, but no between-group differences in abstinence outcomes were seen at 6 months.
Phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, but the absence of differences at 6 months suggests that any of the interventions hold promise when used in conjunction with varenicline.
Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity.
Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months.
The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction) in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05) and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004)
Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field.
The trial is registered with ClinicalTrials.gov (NCT00644995).
There is a lack of evidence of the relative cost-effectiveness of proactive telephone counseling (PTC) and Web-based delivery of smoking cessation services in conjunction with pharmacotherapy. We calculated the differential cost-effectiveness of three behavioral smoking cessation modalities with varenicline treatment in a randomized trial of current smokers from a large health system. Eligible participants were randomized to one of three smoking cessation interventions: Web-based counseling (n = 401), PTC (n = 402), or combined PTC-Web counseling (n = 399). All participants received a standard 12-week course of varenicline. The primary outcome was a 7-day point prevalent nonsmoking at the 6 month follow-up. The Web intervention was the least expensive followed by the PTC and PTC-Web groups. Costs per additional 6-month nonsmoker and per additional lifetime quitter were $1,278 and $2,601 for Web, $1,472 and $2,995 for PTC, and $1,617 and $3,291 for PTC-Web. Cost per life-year (LY) and quality-adjusted life-year (QALY) saved were $1,148 and $1,136 for Web, $1,320 and $1,308 for PTC, and $1,450 and $1,437 for PTC-Web. Based on the cost per LY and QALY saved, these interventions are among the most cost-effective life-saving medical treatments. Web, PTC, and combined PTC-Web treatments were all highly cost-effective, with the Web treatment being marginally more cost-effective than the PTC or combined PTC-Web treatments.
Smoking cessation; Varenicline; Cost-effectiveness; Quality-adjusted life-years saved; Behavioral intervention
We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing–based counseling via e-mail (arm 3).
We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire.
Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high.
This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions.
To use focus groups to inform a web-based educational intervention for increased fruit and vegetable (FV) consumption.
Twelve groups (participants =137, aged 21–65) were recruited from four geographically diverse health systems. Four groups were stratified by gender and eight by race (white and African American) and gender. Questions included perceptions of healthy eating, factors that encourage or serve as barriers to FV consumption and features preferred for a web-based educational intervention.
Though knowledgeable about healthy eating, participants did not know how to achieve or always care about healthy nutritional choices. Motivators for FV consumption included being role models and health concerns. Barriers included: lack of time, expense and FV availability. Website preferences included: visuals, links, tailored materials, menu suggestions, goal setting assistance, printable summaries and built in motivation. The developers incorporated nearly all suggestions.
Focus groups provided needs-based tactical strategies for an online, education intervention targeting factors to improve FV consumption.
Focus groups can provide valuable input to inform interventions. Further, web-based programs’ abilities to offer information without time or geographic constraints, with capacity for tailoring and tracking progress makes them a valuable addition in the arsenal of efforts to promote healthy behaviors.
Fruit and Vegetable Consumption; Patient education; Internet; Focus Groups; Web-based interventions; Health Maintenance Organization
This paper examines reported symptoms, nonsmoking rates, and medication use among 1018 smokers using varenicline in a randomized trial comparing three forms of behavioral support for smoking cessation (phone, web, or phone + web). One month after beginning varenicline, 168 people (17%) had discontinued the medication. Most (53%) quit due to side-effects and other symptoms. The most common side-effect among all users was nausea (reported by 57% of users). At one month post medication initiation, those not taking varenicline were more likely to report smoking than those who continued the medication (57% vs. 16%, p<.001). Women reported more symptoms but did not discontinue medication at higher rates. Participants who received any telephone counseling (n=681) were less likely to discontinue their medication than those with web support only (15% vs. 21%, p<.01). Counseling may improve tolerance of this medication and reduce the rate of discontinuation due to side-effects. (149 words)
Varenicline; smoking cessation; tobacco dependence treatment