Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

BACKGROUND: To evaluate the effectiveness of an experimental intervention based on standard diet recommendations plus free Smartphone application (app) and wearable device for weight loss, compared with the standard diet intervention alone, in primary care patients aged 18 years or older who are overweight or obese. METHODS/DESIGN: Multicentre randomized, controlled clinical trial. LOCATION: Primary health care centres in the city of Tarragona and surrounding areas. SUBJECTS: 70 primary care patients, aged 18 years or older, with body mass index of 25 g/m2 or greater who wish to lose weight. Description of the intervention: 12 months of standard diet recommendations without (n = 35) or with (n = 35) assistance of a free Smartphone app that allows the participant to maintain a record of dietary intake and a bracelet monitor that records physical activity. The outcomes will be weight loss at 12 months (primary outcome), changes in physical activity and cardiometabolic risk factors, frequency of app use, and participant satisfaction after 12 months. DISCUSSION: The results of our study will offer evidence of the effectiveness of an intervention using one of the most popular free apps and wearable devices in achieving weight loss among patients who are overweight or obese. If these new technologies are proven effective in our population, they could be readily incorporated into primary care interventions promoting healthy weight. The open design and study characteristics make it impossible for the participants and researchers to be blinded to study group assignment. Researchers responsible for data analysis will be blinded to participant allocation. TRIAL REGISTRATION: Clinical Register: NCT02417623. Registered 26 March 2015.

Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial.

BACKGROUND: Tobacco consumption is the most preventable cause of morbidity-mortality in the world. One aspect of smoking cessation that merits in-depth study is the use of an application designed for smartphones (app), as a supportive element that could assist younger smokers in their efforts to quit. To assess the efficacy of an intervention that includes the assistance of a smoking cessation smartphone application targeted to young people aged 18 to 30 years who are motivated to stop smoking. METHODS/DESIGN: Cluster randomised clinical trial. SETTING: Primary Health Care centres (PHCCs) in Catalonia. Analyses based on intention to treat. PARTICIPANTS: motivated smokers of 10 or more cigarettes per day, aged 18 to 30 years, consulting PHCCs for any reason and who provide written informed consent to participate in the trial. Intervention group will receive a 6-month smoking cessation programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme. Control group will receive the usual care. The outcome measure will be abstinence at 12 months confirmed by exhaled-air carbon monoxide concentration of at least 10 parts per million at each control test. DISCUSSION: To our knowledge this is the first randomised controlled trial of a programme comparing the efficacy of usual care with a smoking cessation intervention involving a mobile app. If effective, the modality could offer a universal public health management approach to this common health concern. TRIAL REGISTRATION: NCT01734421.

Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial.

BACKGROUND: Mobile apps provide an accessible way to test new health-related methodologies. Tobacco is still the primary preventable cause of death in industrialized countries, constituting an important public health issue. New technologies provide novel opportunities that are effective in the cessation of smoking tobacco. OBJECTIVE: This paper aims to evaluate the efficacy and usage of a mobile app for assisting adult smokers to quit smoking. METHODS: We conducted a cluster randomized clinical trial. We included smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app. We carried out follow-up visits at 15, 30, and 45 days, and at 2, 3, 6, and 12 months. Participants of the intervention group had access to the Tobbstop mobile app designed by the research team. The primary outcomes were continuous smoking abstinence at 3 and 12 months. RESULTS: A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day. Of participants in the intervention group, 34.15% (97/284) did not use the app. The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01). Participants in the intervention group who used the app regularly and correctly had a higher probability of not being smokers at 12 months (OR 7.20, 95% CI 2.14-24.20; P=.001) than the participants of the CG. CONCLUSIONS: Regular use of an app for smoking cessation is effective in comparison with standard clinical practice. TRIAL REGISTRATION: Clinicaltrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421.

Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial.

BACKGROUND: Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE: The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS: A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS: Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS: Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. TRIAL REGISTRATION: ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB).

Figure Correction: Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/12835.].

Coping Strategies and Social Support in a Mobile Phone Chat App Designed to Support Smoking Cessation: Qualitative Analysis.

BACKGROUND: Smoking is one of the most significant factors contributing to low life expectancy, health inequalities, and illness at the worldwide scale. Smoking cessation attempts benefit from social support. Mobile phones have changed the way we communicate through the use of freely available message-oriented apps. Mobile app-based interventions for smoking cessation programs can provide interactive, supportive, and individually tailored interventions. OBJECTIVE: This study aimed to identify emotions, coping strategies, beliefs, values, and cognitive evaluations of smokers who are in the process of quitting, and to analyze online social support provided through the analysis of messages posted to a chat function integrated into a mobile app. METHODS: In this descriptive qualitative study, informants were smokers who participated in the chat of Tobbstop. The technique to generate information was documentary through messages collected from September 2014 through June 2016, specifically designed to support a smoking cessation intervention. A thematic content analysis of the messages applied 2 conceptual models: the Lazarus and Folkman model to assess participant's experiences and perceptions and the Cutrona model to evaluate online social support. RESULTS: During the study period, 11,788 text messages were posted to the chat by 101 users. The most frequent messages offered information and emotional support, and all the basic emotions were reported in the chat. The 3 most frequent coping strategies identified were physical activity, different types of treatment such as nicotine replacement, and humor. Beliefs about quitting smoking included the inevitability of weight gain and the notion that not using any type of medications is better for smoking cessation. Health and family were the values more frequently described, followed by freedom. A smoke-free environment was perceived as important to successful smoking cessation. The social support group that was developed with the app offered mainly emotional and informational support. CONCLUSIONS: Our analysis suggests that a chat integrated into a mobile app focused on supporting smoking cessation provides a useful tool for smokers who are in the process of quitting, by offering social support and a space to share concerns, information, or strategies.

Efficacy of a smoking prevention programme in Catalan secondary schools: a cluster-randomized controlled trial in Spain.

AIMS: To evaluate the efficacy of a school-based educational programme in reducing the incidence and prevalence of smoking in secondary school students (compulsory secondary education: CSE) in Catalonia (Spain). DESIGN: Cluster-randomized controlled trial. SETTING: Schools in the Tarragona Health Care Region of Spain. PARTICIPANTS: All students enrolled in the first year of CSE during the 2007-08 school year in the 29 participating schools (n = 2245); 1583 students completed the follow-up over the 4-year study period (804 and 779 in the control and intervention groups, respectively). MEASURES: Self-reported questionnaires were administered during the first quarter of the 2007, 2008, 2009 and 2010 school years. A smoker was defined as 'smoking cigarettes daily or occasionally within the past 30 days'. Multi-level logistic regression analysis was conducted to analyse the prevalence and incidence of smoking between the intervention and control groups. INTERVENTION: A school-based educational programme comprising seven modules, each with a different approach to smoking habits. Each module included activities, work-shops and/or class sessions. FINDINGS: The initial prevalence of smokers in the control and intervention groups who completed the follow-up was 3.9% and 4.2%, respectively. At the end of the study, the prevalence of smokers was 24.4% in the control group and 19.9% in the intervention group. The accumulated incidence of new smokers was 230.57/1000 in the control group and 183.65/1000 in the intervention group. The adjusted odds ratio (OR) comparing the intervention group with the control group was 0.75 [95% confidence interval (CI) = 0.49, 1.15] for smoking prevalence, and 0.74 (95% CI = 0.48, 1.14) for smoking incidence. CONCLUSIONS: A school-based educational intervention for secondary school students in Catalonia, Spain was not found to lead to a statistically significant reduction of smoking prevalence and incidence.