Cross-Cutting mHealth Behavior Change Techniques to Support Treatment Adherence and Self-Management of Complex Medical Conditions: Systematic Review.

Background: Mobile health (mHealth) interventions have immense potential to support disease self-management for people with complex medical conditions following treatment regimens that involve taking medicine and other self-management activities. However, there is no consensus on what discrete behavior change techniques (BCTs) should be used in an effective adherence and self-management-promoting mHealth solution for any chronic illness. Reviewing the extant literature to identify effective, cross-cutting BCTs in mHealth interventions for adherence and self-management promotion could help accelerate the development, evaluation, and dissemination of behavior change interventions with potential generalizability across complex medical conditions. Objective: This study aimed to identify cross-cutting, mHealth-based BCTs to incorporate into effective mHealth adherence and self-management interventions for people with complex medical conditions, by systematically reviewing the literature across chronic medical conditions with similar adherence and self-management demands. Methods: A registered systematic review was conducted to identify published evaluations of mHealth adherence and self-management interventions for chronic medical conditions with complex adherence and self-management demands. The methodological characteristics and BCTs in each study were extracted using a standard data collection form. Results: A total of 122 studies were reviewed; the majority involved people with type 2 diabetes (28/122, 23%), asthma (27/122, 22%), and type 1 diabetes (19/122, 16%). mHealth interventions rated as having a positive outcome on adherence and self-management used more BCTs (mean 4.95, SD 2.56) than interventions with no impact on outcomes (mean 3.57, SD 1.95) or those that used >1 outcome measure or analytic approach (mean 3.90, SD 1.93; P=.02). The following BCTs were associated with positive outcomes: self-monitoring outcomes of behavior (39/59, 66%), feedback on outcomes of behavior (34/59, 58%), self-monitoring of behavior (34/59, 58%), feedback on behavior (29/59, 49%), credible source (24/59, 41%), and goal setting (behavior; 14/59, 24%). In adult-only samples, prompts and cues were associated with positive outcomes (34/45, 76%). In adolescent and young adult samples, information about health consequences (1/4, 25%), problem-solving (1/4, 25%), and material reward (behavior; 2/4, 50%) were associated with positive outcomes. In interventions explicitly targeting medicine taking, prompts and cues (25/33, 76%) and credible source (13/33, 39%) were associated with positive outcomes. In interventions focused on self-management and other adherence targets, instruction on how to perform the behavior (8/26, 31%), goal setting (behavior; 8/26, 31%), and action planning (5/26, 19%) were associated with positive outcomes. Conclusions: To support adherence and self-management in people with complex medical conditions, mHealth tools should purposefully incorporate effective and developmentally appropriate BCTs. A cross-cutting approach to BCT selection could accelerate the development of much-needed mHealth interventions for target populations, although mHealth intervention developers should continue to consider the unique needs of the target population when designing these tools.

The pre-efficacy phase testing for PAfitME™-A behavioral physical activity intervention to manage moderate and severe symptoms among advanced stage cancer patients.

Fatigue and pain are the most frequently reported symptoms among advanced-stage cancer patients. Although physical activity (PA) is known to improve the aforementioned symptoms, few patients demonstrate the physically active behavior that adheres to the clinical guidelines regarding PA. The current article presents an exemplar that used the National Institute of Health's Obesity-Related Behavioral Intervention Trial (ORBIT) model and developed a behavioral intervention known as the personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME™). There were two phases of testing in the ORBIT model presented in the current paper. In Phase I testing, a standardized exergame prescription was evaluated by an advisory board and a single-case study was used to evaluate the personalized exergame prescription with personalization of the fitness levels. In Phase IIa, a within-group pre- and posttest design was used to evaluate the personalized exergame prescriptions with personalization of the fitness levels, self-efficacy, and variation in fatigue/pain. Subsequently, a complete intervention package was developed in accordance with a logic model, driven from the result of the Phase IIa testing with clinically significant findings. Currently, PAfitME™ is under Phase IIb testing in a randomized clinical trial with a control group. PAfitME™ employs a personalized approach to initiate and promote physically active behavior, to facilitate the management of fatigue and pain in cancer patients. Positive results from an efficacy trial would support the use of PAfitME™ in the management of fatigue and pain in advanced-stage cancer patients.

Mila Blooms: A Mobile Phone Application and Behavioral Intervention for Promoting Physical Activity and a Healthy Diet Among Adolescent Survivors of Childhood Cancer.

Objectives: Smartphone applications ("apps") can be used to promote health behavior change and expand the reach of behavioral interventions. To date, only a few existing apps have been developed for health promotion among adolescent survivors of childhood cancer. To address this gap, we developed an app-based intervention, using game design characteristics, theory-based behavioral strategies, and assistance from a health coach to motivate health behavior change for adolescent survivors of childhood cancer. This article describes the development and initial feasibility evaluation of the intervention. Methods: Using a theoretical framework and an extensive formative process, we developed an app-based game ("Mila Blooms") that promotes healthy eating and physical activity among adolescent survivors of childhood cancer. A single-arm 8-week intervention, using this app-based game, with assistance from a health coach, was conducted among a sample of pediatric cancer survivors (n = 15) to evaluate its initial feasibility for promoting health behavior change. Results: Results from the feasibility evaluation were encouraging. The majority of enrolled participants were retained throughout the 8-week intervention (93.8%). Participant satisfaction feedback indicated positive experiences, related to ease of use and enjoyment of the app. Although there was little evidence for behavior change attributable to the app in this first stage of development, there was a solid demonstration of the viability and appeal of the game features, and there were no adverse side effects. Conclusions: Results provide insights into how gamification can be used to promote health behaviors through an app-based intervention. Mila Blooms holds promise for promoting health behavior change. Lessons learned from our experiences could be useful for the future development and implementation of app-based adolescent health interventions.

Digital Health Behavior Change Technology: Bibliometric and Scoping Review of Two Decades of Research.

BACKGROUND: Research on digital technology to change health behavior has increased enormously in recent decades. Due to the interdisciplinary nature of this topic, knowledge and technologies from different research areas are required. Up to now, it is not clear how the knowledge from those fields is combined in actual applications. A comprehensive analysis that systematically maps and explores the use of knowledge within this emerging interdisciplinary field is required. OBJECTIVE: This study aims to provide an overview of the research area around the design and development of digital technologies for health behavior change and to explore trends and patterns. METHODS: A bibliometric analysis is used to provide an overview of the field, and a scoping review is presented to identify the trends and possible gaps. The study is based on the publications related to persuasive technologies and health behavior change in the last 18 years, as indexed by the Web of Science and Scopus (317 and 314 articles, respectively). In the first part, regional and time-based publishing trends; research fields and keyword co-occurrence networks; influential journals; and collaboration network between influential authors, countries, and institutions are examined. In the second part, the behavioral domains, technological means and theoretical foundations are investigated via a scoping review. RESULTS: The literature reviewed shows a clear and emerging trend after 2001 in technology-based behavior change, which grew exponentially after the introduction of the smartphone around 2009. Authors from the United States, Europe, and Australia have the highest number of publications in the field. The three most active research areas are computer science, public and occupational health, and psychology. The keyword "mhealth" was the dominant term and predominantly used together with the term "physical activity" and "ehealth". A total of three strong clusters of coauthors have been found. Nearly half of the total reported papers were published in three journals. The United States, the United Kingdom, and the Netherlands have the highest degree of author collaboration and a strong institutional network. Mobile phones were most often used as a technology platform, regardless of the targeted behavioral domain. Physical activity and healthy eating were the most frequently targeted behavioral domains. Most articles did not report about the behavior change techniques that were applied. Among the reported behavior change techniques, goal setting and self-management were the most frequently reported. CONCLUSIONS: Closer cooperation and interaction between behavioral sciences and technological areas is needed, so that theoretical knowledge and new technological advancements are better connected in actual applications. Eventually, this could result in a larger societal impact, an increase of the effectiveness of digital technologies for health behavioral change, and more insight in the relationship between behavioral change strategies and persuasive technologies' effectiveness.

Comparing the Efficacy of an Identical, Tailored Smoking Cessation Intervention Delivered by Mobile Text Messaging Versus Email: Randomized Controlled Trial.

BACKGROUND: There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone-based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. OBJECTIVE: This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. METHODS: We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. RESULTS: At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. CONCLUSIONS: This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. TRIAL REGISTRATION: ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427.

Predictors of Retention in an Adult Text Messaging Smoking Cessation Intervention Program: Cohort Study.

BACKGROUND: Mobile health tools such as text messaging programs can support smoking cessation. However, high rates of disengagement from these tools decrease their effectiveness. OBJECTIVE: The purpose of this study was to identify user characteristics associated with retention in an adult text messaging smoking cessation intervention. METHODS: Adults initiating a quit attempt using the publicly available program SmokefreeTXT between March 6 and June 21, 2016 (n=6215), were included. Data were collected to assess nicotine dependence, frequency of being around other smokers, time of the day for cigarette cravings, extrinsic and intrinsic motivation to quit smoking, confidence in quitting, and long-term intention to be smoke free. Multivariable survival analysis modeling for time to opt out was conducted to identify characteristics associated with opting out over the course of the intervention, adjusting for age, sex, and smoking frequency, reset of the quit date by the user, and the number of days enrolled before initiating the quit attempt. Among those who opted out, multivariable multinomial logistic regression analysis was used to identify predictors of opting out early (within 3 days and between 4 and 7 days into the quit attempt) compared to opting out late (more than 7 days into the quit attempt), adjusting for the same confounders. RESULTS: Survival analyses indicated that younger age, female sex, higher levels of nicotine dependence, lower intention to be smoke free, and enrolling in SmokefreeTXT ≤1 week before initiating the quit attempt were associated with an increased risk of opting out. For example, users who smoked within 5 minutes of waking up were 1.17 times more likely to opt out than those who smoked more than 5 minutes after waking up (95% CI 1.01-1.35). Among users who opted out from SmokefreeTXT, logistic regression modeling indicated that compared to users who were never or rarely around other smokers, those who were sometimes around other smokers had 1.96 times more likely to opt out within the first 3 days of the quit attempt (95% CI 1.18-3.25). In addition, compared to users with high levels of long-term quit intention, users with lower levels of intention had 1.80 times the odds of opting out between 4 and 7 days into the quit attempt (95% CI 1.02-3.18). Users who reset their quit date after initiating a quit attempt were less likely to opt out at either time point compared with those who did not reset their quit date. CONCLUSIONS: Several user characteristics are associated with retention in an adult text messaging smoking cessation program. These results provide guidance on potential characteristics that should be addressed in future text messaging smoking cessation programs. Providing additional support to users with these characteristics may increase retention in text messaging programs and ultimately lead to smoking cessation.

Behavior Change Content, Understandability, and Actionability of Chronic Condition Self-Management Apps Available in France: Systematic Search and Evaluation.

BACKGROUND: The quality of life of people living with chronic conditions is highly dependent on self-management behaviors. Mobile health (mHealth) apps could facilitate self-management and thus help improve population health. To achieve their potential, apps need to target specific behaviors with appropriate techniques that support change and do so in a way that allows users to understand and act upon the content with which they interact. OBJECTIVE: Our objective was to identify apps targeted toward the self-management of chronic conditions and that are available in France. We aimed to examine what target behaviors and behavior change techniques (BCTs) they include, their level of understandability and actionability, and the associations between these characteristics. METHODS: We extracted data from the Google Play store on apps labelled as Top in the Medicine category. We also extracted data on apps that were found through 12 popular terms (ie, keywords) for the four most common chronic condition groups-cardiovascular diseases, cancers, respiratory diseases, and diabetes-along with apps identified through a literature search. We selected and downloaded native Android apps available in French for the self-management of any chronic condition in one of the four groups and extracted background characteristics (eg, stars and number of ratings), coded the presence of target behaviors and BCTs using the BCT taxonomy, and coded the understandability and actionability of apps using the Patient Education Material Assessment Tool for audiovisual materials (PEMAT-A/V). We performed descriptive statistics and bivariate statistical tests. RESULTS: A total of 44 distinct native apps were available for download in France and in French: 39 (89%) were found via the Google Play store and 5 (11%) were found via literature search. A total of 19 (43%) apps were for diabetes, 10 for cardiovascular diseases (23%), 8 for more than one condition in the four groups (18%), 6 for respiratory diseases (14%), and 1 for cancer (2%). The median number of target behaviors per app was 2 (range 0-7) and of BCTs per app was 3 (range 0-12). The most common BCT was self-monitoring of outcome(s) of behavior (31 apps), while the most common target behavior was tracking symptoms (30 apps). The median level of understandability was 42% and of actionability was 0%. Apps with more target behaviors and more BCTs were also more understandable (ρ=.31, P=.04 and ρ=.35, P=.02, respectively), but were not significantly more actionable (ρ=.24, P=.12 and ρ=.29, P=.054, respectively). CONCLUSIONS: These apps target few behaviors and include few BCTs, limiting their potential for behavior change. While content is moderately understandable, clear instructions on when and how to act are uncommon. Developers need to work closely with health professionals, users, and behavior change experts to improve content and format so apps can better support patients in coping with chronic conditions. Developers may use these criteria for assessing content and format to guide app development and evaluation of app performance. TRIAL REGISTRATION: PROSPERO CRD42018094012; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=94012.

Using Health and Well-Being Apps for Behavior Change: A Systematic Search and Rating of Apps.

BACKGROUND: Smartphones have allowed for the development and use of apps. There is now a proliferation of mobile health interventions for physical activity, healthy eating, smoking and alcohol cessation or reduction, and improved mental well-being. However, the strength or potential of these apps to lead to behavior change remains uncertain. OBJECTIVE: The aim of this study was to review a large sample of healthy lifestyle apps at a single point in time (June to July 2018) to determine their potential for promoting health-related behavior change with a view to sharing this information with the public. In addition, the study sought to test a wide range of apps using a new scale, the App Behavior Change Scale (ABACUS). METHODS: Apps focusing on 5 major modifiable lifestyle behaviors were identified using a priori key search terms across the Australian Apple iTunes and Google Play stores. Lifestyle behavior categories were selected for their impact on health and included smoking, alcohol use, physical activity, nutrition, and mental well-being. Apps were included if they had an average user rating between 3 and 5, if they were updated in the last 18 months, if the description of the app included 2 of 4 behavior change features, and if they were in English. The selected behavior change apps were rated in 2 ways using previously developed rating scales: the Mobile App Rating Scale (MARS) for functionality and the ABACUS for potential to encourage behavior change. RESULTS: The initial search identified 212,352 apps. After applying the filtering criteria, 5018 apps remained. Of these, 344 were classified as behavior change apps and were reviewed and rated. Apps were given an average MARS score of 2.93 out of 5 (SD 0.58, range 1.42-4.16), indicating low-to-moderate functionality. Scores for the ABACUS ranged from 1 to 17, out of 21, with an average score of 7.8 (SD 2.8), indicating a low-to-moderate number of behavior change techniques included in apps. The ability of an app to encourage practice or rehearsal, in addition to daily activities, was the most commonly identified feature across all apps (310/344, 90.1%), whereas the second most common feature was the ability of the user to easily self-monitor behavior (289/344, 84.0%). CONCLUSIONS: The wide variety of apps included in this 2018 study and the limited number of behavior change techniques found in many apps suggest an opportunity for improvement in app design that will promote sustained and significant lifestyle behavior change and, therefore, better health. The use of the 2 scales for the review and rating of the apps was successful and provided a method that could be replicated and tested in other behavior change areas.

Nutrition Education and Dietary Behavior Change Games: A Scoping Review.

Games provide an attractive venue for engaging participants and increasing nutrition-related knowledge and dietary behavior change, but no review has appeared devoted to this literature. A scoping review of nutrition education and dietary behavior change videogames or interactive games was conducted. A systematic search was made of PubMed, Agricola, and Google Scholar. Information was abstracted from 22 publications. To be included, the publication had to include a videogame or interactive experience involving games (a videogame alone, minigames inserted into a larger multimedia experience, or game as part of a human-delivered intervention); game's design objective was to influence dietary behavior, a psychosocial determinant of a dietary behavior, or nutrition knowledge (hereinafter referred to as diet-related); must have been reported in English and must have appeared in a professional publication, including some report of outcomes or results (thereby passing some peer review). This review was restricted to the diet-related information in the selected games. Diversity in targeted dietary knowledge and intake behaviors, targeted populations/audiences, game mechanics, behavioral theories, research designs, and findings was revealed. The diversity and quality of the research in general was poor, precluding a meta-analysis or systematic review. All but one of the studies reported some positive outcome from playing the game(s). One reported that a web-based education program resulted in more change than the game-based intervention. Studies of games may have been missed; a number of dietary/nutrition games are known for which no evaluation is known; and the data presented on the games and research were limited and inconsistent. Conclusions and Implications: A firmer research base is needed to establish the efficacy and effectiveness of nutrition education and dietary behavior change games.

Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial.

INTRODUCTION: One of the most common distressing conditions experienced by breast cancer survivors is fear of cancer recurrence (FCR). There is, however, no standard intervention for ameliorating FCR. Our clinical experience and previous studies have suggested the potential benefits of problem-solving therapy (PST) and behavioural activation (BA). Given the huge number of cancer survivors and limited number of therapists to competently conduct PST and BA, we have developed PST and BA smartphone applications. This study aimed to evaluate the efficacy of the smartphone-based PST (Kaiketsu-App) and BA (Genki-App) apps in reducing FCR in patients with breast cancer. METHODS AND ANALYSIS: The SMartphone Intervention to LEssen fear of cancer recurrence project is an open-label, individually randomised, parallel-group trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be randomised to smartphone-based intervention plus treatment as usual (TAU) or waitlist control with TAU alone. The primary endpoint of the study is the Japanese version of the Concerns About Recurrence Scale, which will be administered as an electronic patient-reported outcome on the patients' smartphone after 8 weeks. ETHICS AND DISSEMINATION: The present study is subject to the ethical guidelines for clinical studies published by Japan's Ministry of Education, Science and Technology and Ministry of Health, Labour and Welfare and the modified Act on the Protection of Personal Information as well as the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171). TRIAL STATUS: The randomised trial, which commenced on 2 April 2018, currently enrols participants. The estimated end date for this study is in March 2020. TRIAL REGISTRATION NUMBER: UMIN000031140; Pre-results.

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain.

OBJECTIVE: Persistent pain is common and inadequately treated in cancer patients. Behavioral pain interventions are a recommended part of multimodal pain treatments, but they are underused in clinical care due to barriers such as a lack of the resources needed to deliver them in person and difficulties coordinating their use with clinical care. Pain coping skills training (PCST) is an evidence-based behavioral pain intervention traditionally delivered in person. Delivering this training via the web would increase access to it by addressing barriers that currently limit its use. We conducted a patient pilot study of an 8-week web-based PCST program to determine the acceptability of this approach to patients and the program features needed to meet their needs. Focus groups with healthcare providers identified strategies for coordinating the use of web-based PCST in clinical care. METHOD: Participants included 7 adults with bone pain due to multiple myeloma or metastasized breast or prostate cancer and 12 healthcare providers (4 physicians and 8 advanced practice providers) who treat cancer-related bone pain. Patients completed web-based PCST at home and then took part in an in-depth qualitative interview. Providers attended focus groups led by a trained moderator. Qualitative analyses identified themes in the patient and provider data. RESULTS: Patients reported strongly favorable responses to web-based PCST and described emotional and physical benefits. They offered suggestions for adapting the approach to better fit their needs and to overcome barriers to completion. Focus groups indicated a need to familiarize healthcare providers with PCST and to address concerns about overburdening patients. Providers would recommend the program to patients they felt could benefit. They suggested applying a broad definition of cancer pain and having various types of providers help coordinate program its use with clinical care. SIGNIFICANCE OF RESULTS: Web-based PCST was acceptable to patients and providers. Our findings suggest that patients could benefit from this approach, especially if patient and provider barriers are addressed.

Behavioral Modification of Intraoperative Hyperglycemia Management with a Novel Real-time Audiovisual Monitor.

BACKGROUND: Hyperglycemia, defined as blood glucose (BG) levels above 200 mg/dl (11.1 mM), is associated with increased postoperative morbidity. Yet, the treatment standard for intraoperative glycemic control is poorly defined for noncardiac surgery. Little is known of the interindividual treatment variability or methods to modify intraoperative glycemic management behaviors. AlertWatch (AlertWatch, USA) is a novel audiovisual alert system that serves as a secondary patient monitor for use in operating rooms. The authors evaluated the influence of use of AlertWatch on intraoperative glycemic management behavior. METHODS: AlertWatch displays historical patient data (risk factors and laboratory results) from multiple networked information systems, combined with the patient's live physiologic data. The authors extracted intraoperative data for 19 months to evaluate the relationship between AlertWatch usage and initiation of insulin treatment for hyperglycemia. Outcome associations were adjusted for physical status, case duration, procedural complexity, emergent procedure, fasting BG value, home insulin therapy, patient age, and primary anesthetist. RESULTS: Overall, 2,341 patients had documented intraoperative hyperglycemia. Use of AlertWatch (791 of 2,341; 33.5%) was associated with 55% increase in insulin treatment (496 of 791 [62.7%] with and 817 of 1,550 [52.7%] without AlertWatch; adjusted odds ratio [95% CI], 1.55 [1.23 to 1.95]; P < 0.001) and 44% increase in BG recheck after insulin administration (407 of 791 [51.5%] with AlertWatch and 655 of 1,550 [42.3%] in controls; adjusted odds ratio [95% CI], 1.44 [1.14 to 1.81]; P = 0.002). CONCLUSION: AlertWatch is associated with a significant increase in desirable intraoperative glycemic management behavior and may help achieve tighter intraoperative glycemic control.

Smoking cessation: present status and future perspectives.

Smoking is the leading cause of premature mortality in western countries and it is important for smokers to stop as early as possible. Several approaches for cessation are available but they lack high levels of efficacy. Consequently, there is a compelling need for more effective approaches and safer medications to aid smokers in achieving long-term abstinence. Expanding knowledge in our understanding of the mechanisms involved in tobacco dependence is leading to the development of novel therapies and vaccines for smoking cessation, many of which are currently in the advanced stage of development and offer promise. Here we will review efficacy and safety data from human clinical trials of current and emerging therapies and tools which are approved or undergoing investigation.

Behavioral alarm treatment for nocturnal enuresis

PURPOSES: To investigate the efficacy of alarm treatment in a sample of Brazilian children and adolescents with nocturnal enuresis and relate treatment success to age and type of clinical support. MATERIALS AND METHODS: During 32 weeks, 84 children and adolescents received alarm treatment together with weekly psychological support sessions for individual families or groups of 5 to 10 families. RESULTS: 71 percent of the participants achieved success, defined as 14 consecutive dry nights. The result was similar for children and adolescents and for individual or group support. The time until success was shorter for participants missing fewer support sessions. CONCLUSIONS: Alarm treatment was effective for the present sample, regardless of age or type of support. Missing a higher number of support sessions, which may reflect low motivation for treatment, increased the risk of failure.

A video system to help children cooperate with motion control for radiation treatment without sedation.

A behavioral program for teaching children to cooperate with radiation treatment without sedation was previously published in this journal. Outcome data from using that program with 11 more children are reported here. For these children, an apparatus was developed to display video cartoons and movies during their behavioral training, radiation therapy planning, and daily treatments. Literature supporting the use of video displays to provide relaxation, distraction, and counterconditioning during medical procedures is highlighted. With behavioral training and the video display, 9 of the 11 children were able to avoid any sedation for daily treatments. A 10th child was able to avoid general anesthesia for his last 10 daily treatments. The advantages and limitations of behavioral training as an alternative to repeated sedation or anesthesia for radiation treatment are discussed.

BEACHES: an observational system for assessing children's eating and physical activity behaviors and associated events.

An integrated system for coding direct observations of children's dietary and physical activity behaviors was developed. Associated environmental events were also coded, including physical location, antecedents, and consequences. To assess the instrument's reliability and validity, 42 children, aged 4 to 8 years, were observed for 8 consecutive weeks at home and at school. Results indicated that four 60-min observations at home produced relatively stable estimates for most of the 10 dimensions. Interobserver reliabilities during live and videotaped observations were high, with the exception of "consequences" categories that occurred in less than 1% of observed intervals. Evidence of validity was provided by findings that antecedents were associated with respective dietary and physical activity behaviors. The five physical activity categories were validated by heartrate monitoring in a second study. The Behaviors of Eating and Activity for Children's Health Evaluation System is appropriate for studying influences on diet and physical activity in children in a variety of settings.