Photoaging smartphone app to reduce smoking prevalence in secondary schools: the smokerface randomized trial

Background The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. Objective We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants’ perception regarding the protocol and the use of the app for physical activity qualitatively. Methods We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. Results Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median −198 steps/day [IQR −279 to −103] to 20 steps/day [IQR −204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants’ reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. Conclusions The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. Trial Registration Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.

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Evaluation of a Healthy Relationship Smartphone App With Indigenous Young People: Protocol for a Co-designed Stepped Wedge Randomized Trial (Preprint)

10.2196/preprints.24792 ◽

2020 ◽

Author(s):

Jane Koziol-McLain ◽

Denise Wilson ◽

Alain C Vandal ◽

Moana Eruera ◽

Shyamala Nada-Raja ◽

...

Keyword(s):

New Zealand ◽

Young People ◽

Secondary Schools ◽

Self Efficacy ◽

General Health ◽

Primary Outcome ◽

Well Being ◽

Smartphone App ◽

Stepped Wedge ◽

Partner Relationship

BACKGROUND We co-designed a smartphone app, Harmonised, with taitamariki (young people aged 13-17 years) to promote healthy intimate partner relationships. The app also provides a pathway for friends and family, or whānau (indigenous Māori extended family networks), to learn how to offer better support to taitamariki. OBJECTIVE The aim of our taitamariki- and Māori-centered study is to evaluate the implementation of the app in secondary schools. The study tests the effectiveness of the app in promoting taitamariki partner relationship self-efficacy (primary outcome). METHODS We co-designed a pragmatic, randomized, stepped wedge trial (retrospectively registered on September 12, 2019) for 8 Aotearoa, New Zealand, secondary schools (years 9 through 13). The schools were randomly assigned to implement the app in 1 of the 2 school terms. A well-established evaluation framework (RE-AIM [Reach, Effectiveness, Adoption, Implementation, Maintenance]) guided the selection of mixed data collection methods. Our target sample size is 600 taitamariki enrolled across the 8 schools. Taitamariki will participate by completing 5 web-based surveys over a 15-month trial period. Taitamariki partner relationship self-efficacy (primary outcome) and well-being, general health, cybersafety management, and connectedness (secondary outcomes) will be assessed with each survey. The general effectiveness hypotheses will be tested by using a linear mixed model with nested participant, year-group, and school random effects. The primary analysis will also include testing effectiveness in the Māori subgroup. RESULTS The study was funded by the New Zealand Ministry of Business, Innovation, and Employment in October 2015 and approved by the Auckland University of Technology Ethics Committee on May 3, 2017 (application number: 17/71). CONCLUSIONS This study will generate robust evidence evaluating the impact of introducing a healthy relationship app in secondary schools on taitamariki partner relationship self-efficacy, well-being, general health, cybersafety management, and connectedness. This taitamariki- and indigenous Māori–centered research fills an important gap in developing and testing strengths-based mobile health interventions in secondary schools. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12619001262190; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377584 INTERNATIONAL REGISTERED REPORT RR1-10.2196/24792

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Results of outdoor smoking bans at secondary schools on adolescents smoking behaviour: a quasi-experimental study

European Journal of Public Health ◽

10.1093/eurpub/cky281 ◽

2019 ◽

Vol 29 (4) ◽

pp. 765-771

Author(s):

A D Rozema ◽

J J P Mathijssen ◽

J N van Kesteren ◽

J A M van Oers ◽

M W J Jansen

Keyword(s):

Secondary Schools ◽

Smoking Prevalence ◽

Smoking Behavior ◽

Implementation Fidelity ◽

Smoking Behaviour ◽

Individual Characteristics ◽

Smoking Ban ◽

Future Research ◽

Smoking Bans ◽

School Ground

AbstractBackgroundResearch on the effectiveness of school smoking policies on adolescents’ smoking behaviour remain inconclusive. This study evaluates the results of an outdoor school ground smoking ban at secondary schools on adolescents smoking behaviour, taking individual characteristics into account.MethodsData on 2684 adolescents from 18 Dutch secondary schools (nine with and nine without an outdoor smoking ban) were obtained at two moments. Associations between outdoor school ground smoking bans, individual characteristics, and smoking prevalence and frequency were measured. Multilevel logistic regression analyses were used. At schools with a ban implementation fidelity was checked.ResultsAlthough smoking prevalence and frequency appeared to make a slower increase at schools with an outdoor smoking ban compared with schools without an outdoor smoking ban, the differences were not significant. Differences between schools in the prevalence of smoking behaviour of students could mainly be explained by individual characteristics. Smoking prevalence and frequency were higher among adolescents with a positive attitude towards smoking and when significant others were more positive about smoking. Smoking prevalence and frequency were significantly lower when adolescents perceived it as easy not to smoke. Implementation fidelity was good at schools with a ban.ConclusionsNo short-term effects were found of an outdoor smoking ban. A longer follow-up time than 6 months is needed. In addition, future research should investigate effectiveness in relation to the enforcement of the ban, comprehensiveness of the ban and when it is prohibited to leave school grounds, as smoking behavior might be transferred off school grounds.

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Process Evaluation of a Medical Student–Delivered Smoking Prevention Program for Secondary Schools: Protocol for the Education Against Tobacco Cluster Randomized Trial (Preprint)

10.2196/preprints.13508 ◽

2019 ◽

Author(s):

Titus Josef Brinker ◽

Fabian Buslaff ◽

Janina Leonie Suhre ◽

Marc Philipp Silchmüller ◽

Evgenia Divizieva ◽

...

Keyword(s):

Medical Student ◽

Randomized Trial ◽

Process Evaluation ◽

Smoking Prevalence ◽

Cluster Randomized Trial ◽

Smoking Prevention ◽

School Based ◽

Cluster Randomized ◽

And Control

BACKGROUND Most smokers start smoking during their early adolescence under the impression that smoking entails positive attributes. Given the addictive nature of cigarettes, however, many of them might end up as long-term smokers and suffering from tobacco-related diseases. To prevent tobacco use among adolescents, the large international medical students’ network Education Against Tobacco (EAT) educates more than 40,000 secondary school students per year in the classroom setting, using evidence-based self-developed apps and strategies. OBJECTIVE This study aimed to evaluate the long-term effectiveness of the school-based EAT intervention in reducing smoking prevalence among seventh-grade students in Germany. Additionally, we aimed to improve the intervention by drawing conclusions from our process evaluation. METHODS We conduct a cluster-randomized controlled trial with measurements at baseline and 9, 16, and 24 months postintervention via paper-and-pencil questionnaires administered by teachers. The study groups consist of randomized schools receiving the 2016 EAT curriculum and control schools with comparable baseline data (no intervention). The primary outcome is the difference of change in smoking prevalence between the intervention and control groups at the 24-month follow-up. Secondary outcomes are between-group differences of changes in smoking-related attitudes and the number of new smokers, quitters, and never-smokers. RESULTS A total of 11,268 students of both sexes, with an average age of 12.32 years, in seventh grade of 144 secondary schools in Germany were included at baseline. The prevalence of cigarette smoking in our sample was 2.6%. The process evaluation surveys were filled out by 324 medical student volunteers, 63 medical student supervisors, 4896 students, and 141 teachers. CONCLUSIONS The EAT cluster randomized trial is the largest school-based tobacco-prevention study in Germany conducted to date. Its results will provide important insights with regards to the effectiveness of medical student–delivered smoking prevention programs at school. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13508

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Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial (SMART) (Preprint)

10.2196/preprints.14322 ◽

2019 ◽

Author(s):

Bárbara De Barros Gonze ◽

Ricardo Da Costa Padovani ◽

Maria Do Socorro Simoes ◽

Vinicius Lauria ◽

Neli Leite Proença ◽

...

Keyword(s):

Physical Activity ◽

Randomized Trial ◽

Subsequent Treatment ◽

Smartphone App ◽

Control Group ◽

Tailored Messages ◽

Multiple Assignment ◽

Steps Per Day ◽

Group 2 ◽

Group 1

BACKGROUND The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. OBJECTIVE We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants’ perception regarding the protocol and the use of the app for physical activity qualitatively. METHODS We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. RESULTS Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median −198 steps/day [IQR −279 to −103] to 20 steps/day [IQR −204 to 145]; <i>P</i>=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants’ reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. CONCLUSIONS The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. CLINICALTRIAL Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.

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A Medical Student–Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Brazil: Study Protocol for a Randomized Trial

JMIR Research Protocols ◽

10.2196/resprot.7134 ◽

2017 ◽

Vol 6 (1) ◽

pp. e16 ◽

Cited By ~ 10

Author(s):

Luiz Eduardo De Freitas Xavier ◽

Breno Bernardes-Souza ◽

Oscar Campos Lisboa ◽

Werner Seeger ◽

David Alexander Groneberg ◽

...

Keyword(s):

Medical Student ◽

Secondary Schools ◽

Randomized Trial ◽

Study Protocol ◽

Prevention Program ◽

Smoking Prevention

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A Smartphone App Designed to Help Cancer Patients Stop Smoking: Results From a Pilot Randomized Trial on Feasibility, Acceptability, and Effectiveness (Preprint)

10.2196/preprints.16652 ◽

2019 ◽

Author(s):

Jonathan B Bricker ◽

Noreen L Watson ◽

Jaimee L Heffner ◽

Brianna Sullivan ◽

Kristin Mull ◽

...

Keyword(s):

Smoking Cessation ◽

Randomized Trial ◽

Cancer Patients ◽

Retention Rate ◽

Smartphone App ◽

Depression And Anxiety ◽

Internalized Shame ◽

Cessation Intervention ◽

Stop Smoking

BACKGROUND Persistent smoking after a cancer diagnosis predicts worse treatment outcomes and mortality, but access to effective smoking cessation interventions is limited. Smartphone apps can address this problem by providing a highly accessible, low-cost smoking cessation intervention designed for patients with a recent cancer diagnosis. OBJECTIVE This study aimed to summarize our development process and report the trial design, feasibility, participant acceptability, preliminary effectiveness, and impact on processes of change (eg, cancer stigma) of the first-known smoking cessation smartphone app targeted for cancer patients. METHODS We used an agile, user-centered design framework to develop a fully automated smartphone app called Quit2Heal that provided skills training and stories from cancer survivors focusing on coping with internalized shame, cancer stigma, depression, and anxiety as core triggers of smoking. Quit2Heal was compared with the National Cancer Institute’s QuitGuide, a widely used stop smoking app for the general population, in a pilot double-blinded randomized trial with a 2-month follow-up period. Participants were 59 adult smokers diagnosed with cancer within the past 12 months and recruited through 2 cancer center care networks and social media over a 12-month period. The most common types of cancer diagnosed were lung (21/59, 36%) and breast (10/59, 17%) cancers. The 2-month follow-up survey retention rate was 92% (54/59) and did not differ by study arm (<italic>P</italic>=.15). RESULTS Compared with QuitGuide participants, Quit2Heal participants were more satisfied with their assigned app (90% [19/21] for Quit2Heal vs 65% [17/26] for QuitGuide; <italic>P</italic>=.047) and were more likely to report that the app assigned to them was made for someone like them (86% [18/21] for Quit2Heal vs 62% [16/26] for QuitGuide; <italic>P</italic>=.04). Quit2Heal participants opened their app a greater number of times during the 2-month trial period, although this difference was not statistically significant (mean 10.0, SD 14.40 for Quit2Heal vs mean 6.1, SD 5.3 for QuitGuide; <italic>P</italic>=.33). Self-reported 30-day point prevalence quit rates at the 2-month follow-up were 20% (5/25) for Quit2Heal versus 7% (2/29) for QuitGuide (odds ratio 5.16, 95% CI 0.71-37.29; <italic>P</italic>=.10). Quit2Heal participants also showed greater improvement in internalized shame, cancer stigma, depression, and anxiety, although these were not statistically significant (all <italic>P</italic>>.05). CONCLUSIONS In a pilot randomized trial with a high short-term retention rate, Quit2Heal showed promising acceptability and effectiveness for helping cancer patients stop smoking. Testing in a full-scale randomized controlled trial with a longer follow-up period and a larger sample size is required to test the effectiveness, mediators, and moderators of this promising digital cessation intervention. CLINICALTRIAL ClinicalTrials.gov NCT03600038; https://clinicaltrials.gov/ct2/show/NCT03600038

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Use of a smartphone app combined with gamification to increase the level of physical activity of adults and older adults: protocol of a sequential multiple assignment randomized trial

Trials ◽

10.1186/s13063-019-3879-1 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Maria do Socorro Morais Pereira Simões ◽

Bárbara de Barros Gonze ◽

Neli Leite Proença ◽

Vinicius Tonon Lauria ◽

Vinícius Demarchi Silva Terra ◽

...

Keyword(s):

Physical Activity ◽

Older Adults ◽

Randomized Trial ◽

Cardiovascular Health ◽

Smartphone App ◽

Control Group ◽

Adaptive Intervention ◽

Tailored Messages ◽

Intervention Protocol ◽

Multiple Assignment

Abstract Background There is scientific evidence suggesting that app-based interventions targeted to increase the level of physical activity might be effective, although multicomponent interventions appear to be more effective than app-based interventions alone. Despite the motivating results, it remains unclear whether or not app-based interventions can increase the level of physical activity and cardiovascular health. Our study aims to investigate the effect of a smartphone app combined with gamification on the level of physical activity of adults and older adults. The specific aims are (1) to verify the effects of the intervention on cardiometabolic and cardiovascular health, lung function, and cardiorespiratory fitness; and (2) to verify the relationship between age group and the response rate. Methods/design We will conduct a sequential multiple assignment randomized trial (SMART). The adaptive intervention protocol will last 6 months. After baseline assessments, participants will be randomized into one of three groups (group 1: app + tailored messages; group 2: app + tailored messages + gamification I; control group: physical activity counseling). For 12 weeks, we will record the average number of steps per day of participants from groups 1 and 2. At 6 weeks from initiation of recording, participants will be classified into responders and non-responders according to their increase in the average number of daily steps; all those considered as non-responders will be re-randomized, with the chance to participate in a third group – group 3: app + tailored messages + gamification II. Finally, at 12 weeks, participants will continue using the app but will no longer receive direct intervention from investigators. All participants will be reassessed at 3 and 6 months from baseline. Our pilot SMART will require 42 participants (14 per arm). Following the SMART pilot, we will calculate the sample size for the trial based on the variation of the average number of steps/day, including an up to 40% loss to follow-up and a less optimistic nonresponse rate of 65%. Discussion To our knowledge, this will be the first trial with adaptive intervention to test the effectiveness of using a smartphone app to increase the level of physical activity of adults and older adults. Trial registration Brazilian Clinical Trials Registry: RBR-8xtc9c. Registered on 3 August 2018, http://www.ensaiosclinicos.gov.br; UTN number: U1111–1218-1092.

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