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Results
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Compared to viewing positive images, viewing negative images resulted in significantly greater perceived harm of nicotine (
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PMC10540020
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Conclusions
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Negative imagery in Instagram posts about EVALI may convey the risks of vaporized product use and discourage young adults from this behavior, regardless of the valence of the post’s text. Public health messaging regarding EVALI on Instagram should emphasize the risk of cannabis vaporizer use, as young adults may otherwise believe that only nicotine vaporizer use increases their risk for EVALI.
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PMC10540020
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Introduction
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Lung Injury
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DISEASES
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The prevalence of nicotine vaporizer use (ie, e-cigarette use, commonly called nicotine “vaping”) is higher among young (versus older) adults [Concerns about the health effects of nicotine vaporizer use rose during an outbreak of e-cigarette or Vaping Associated Lung Injury (EVALI) that made headlines in 2019 and 2020 [Social media has great potential to disseminate information about diseases such as EVALI to young adults, with 84% of US young adults reporting social media use in 2021 [Viewing EVALI-related imagery in Instagram posts may discourage nicotine or cannabis vaporizer use, which is similar to pictorial warning labels on tobacco products. A systematic review of experimental studies concluded that compared to text-only warnings, pictorial warnings attracted greater attention, elicited negative attitudes about the product, and may reduce intentions to smoke among youth and young adults [We experimentally tested the impact of viewing Instagram posts about EVALI, which varied in image and text valence, on young adults’ perceived harmfulness of different vaporizer products, and perceived riskiness of and intentions to use nicotine and cannabis vaporizers. We hypothesized that (1) compared with exposure to EVALI-related Instagram posts featuring positive images (H1), exposure to Instagram posts featuring negative images would result in greater perceived risks of nicotine vaporizer use (H1a), greater perceived risks of cannabis vaporizer use (H1b), greater perceived harm of nicotine vaporizer use (H1c), greater perceived harm of cannabis vaporizer use (H1d), lower intentions to use nicotine vaporizers (H1e), and lower intentions to use cannabis vaporizers (H1f); (2) compared with exposure to EVALI-related Instagram posts featuring positive text (H2), exposure to Instagram posts featuring negative text would result in greater perceived risks of nicotine vaporizer use (H2a), greater perceived risks of cannabis vaporizer use (H2b), greater perceived harm of nicotine vaporizer use (H2c), greater perceived harm of cannabis vaporizer use (H2d), lower intentions to use nicotine vaporizers (H2e), and lower intentions to use cannabis vaporizers (H2f); (3) effects of image valence (H1) on perceived risk and harm and intentions to use nicotine vaporizers and cannabis vaporizers will be greater than effects of text valence (H2). Analyses included image valence by text valence interaction terms to explore whether the effect of image valence was dependent on text valence and vice versa.
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PMC10540020
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Methods
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PMC10540020
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Participants
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We recruited participants (N=1229) aged 18 to 25 (mean 21.40, SD 2.22) years through Qualtrics Research Services, oversampling participants who reported ever using nicotine or cannabis vaporizers (618/1229, 50.3%). To be eligible, participants also had to be 18-25 years old and report using Instagram at least weekly.
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PMC10540020
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Ethics Approval
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This study was reviewed and approved by the University of California, San Francisco institutional review board (IRB 11-06516). All participants read and provided electronic informed consent on Qualtrics before proceeding with the survey and random assignment to an experimental condition. Participants were assured confidentiality. The researchers received deidentified data from Qualtrics Research Services. Participants were compensated by their survey panel providers in accordance with their preexisting agreement with the panel provider.
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PMC10540020
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Experimental Stimuli
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POSITIVE
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We derived the 3 Instagram posts that participants viewed from images and text posted on Instagram by 3 young adults in the United States whose experiences with EVALI had been featured in news media. We contacted the young adults using Instagram direct messages to inform them of the study and gave them an opportunity to opt out of having their images and text used in research. We edited the text for brevity and clarity. Positive images were attractive and aesthetically pleasing selfies. Positive text was supportive and uplifting (Image and text valence per condition.
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PMC10540020
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Measures
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PMC10540020
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Outcomes
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With 4 items, participants rated the
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PMC10540020
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Participant Characteristics
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We used 1 item adapted from the Facebook Intensity Scale [Participants reported their age, sex assigned at birth, education, current student status, and race and ethnicity (coded as non-Hispanic White; non-Hispanic Black; Hispanic; Asian, including Native Hawaiian/Pacific Islander; or other/unreported race or ethnicity) (
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PMC10540020
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Statistical Analysis
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We compared participant characteristics by condition using chi-square and
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PMC10540020
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Results
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PMC10540020
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Discussion
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PMC10540020
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Principal Findings
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lung injuries
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In this study, we found that EVALI-related Instagram posts with negative imagery increased young adults’ perceived harmfulness of nicotine and cannabis vaporizer products, increased perceived risks of nicotine vaporizer products, and decreased intentions to use nicotine vaporizers. Regardless of the Instagram post text, posts about EVALI that use negative imagery may better convey the harms of nicotine vaporizer use, as well as discourage young adults from nicotine vaporizer use, compared with those using positive imagery. These findings suggest that in Instagram posts, negative imagery may be more powerful than positive imagery and imagery may have a stronger impact than text on perceived risk of, perceived harmfulness of, and intentions to use nicotine vaporizers. While we are not aware of other studies comparing the valence of image and text in tobacco-related messages on Instagram, these findings are consistent with experimental studies on graphic warning labels, which found images were more effective than text in increasing perceived harmfulness of nicotine and cannabis vaporizer use [In this study, text was less effective in influencing general harm perceptions, perceived risk of vaporizer use, and use intentions than images (supporting H3). This finding is somewhat inconsistent with the literature finding that text-based fear appeal messages are effective [The study also found that negative imagery was associated with increased general perceived harmfulness of cannabis vaporizer products, although participants who saw negative images were not more likely to agree that vaping cannabis causes lung injuries. In addition, those who viewed negative images reported lower nicotine vaporizer use intentions but not lower cannabis vaporizer use intentions. The lack of effect on cannabis perceptions may be because the link between EVALI and illicit cannabis cartridges was found after the initial reports of the outbreak, which at the time communicated exposure to an unknown substance [
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PMC10540020
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Limitations and Future Directions
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This study has several limitations. First, we recruited a web-based convenience sample, which may not be representative of all US young adults. Yet, quota sampling increased the sample diversity to match US census data. Second, we used real Instagram posts about EVALI from young adults with lived experience. Although this approach maximized ecological validity, it resulted in some loss of experimental control over the images and text.The study results suggest that negative images from young adult social media users’ posts may be an effective way to communicate the harms of nicotine vaporizer use. Youth-oriented campaigns like “Truth” and Food and Drug Administration’s (FDA) “The Real Cost” have worked with social media influencers to encourage tobacco cessation in social media [Third, a more realistic Instagram interface, such as allowing users to scroll Instagram posts on a mobile phone, could more closely match how the posts would be viewed if individuals were using Instagram. To further increase ecological validity, future studies could post experimental stimuli on an Instagram account for participants to view. Also, the placement of the text below the images is commonly used on Instagram posts and may impact attention to images. Future studies might examine the impact of simple text-only messages placed in the image field of Instagram posts to increase attention to both images and text.Lastly, our study was cross-sectional and did not explore the long-term impact of images and text messages on perceptions or actual vaping behavior. A longitudinal design would allow us to assess if the messages reduced nicotine and cannabis vaporizer use, unintentionally increased nicotine and cannabis vaporizer use, or both. As the use of cannabis and nicotine continues to be common, these messages need to address the use of nicotine and cannabis vaporizer products. More research is needed to understand why cannabis vaporizers were perceived as less risky than nicotine vaporizers and whether the perceived riskiness of vaporizers changes over time after exposure to antivaporizer messages. Although cannabis legalization is now widespread across the United States [
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PMC10540020
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Conclusions
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PML
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ABUSE, RECRUITMENT, PML
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Instagram posts that use negative imagery may discourage young adults from nicotine vaporizer use. Negative imagery in public education campaigns and on vaporizer product warning labels may better convey harms than text. Young adult Instagram users may be promising partners for communicating messages about health risks or the harms of consumer products. In 2016, the FDA adopted a policy requiring the advertisements of nicotine vaporizers in media (eg, social media) to include a warning statement about the addictiveness of nicotine [This research was supported in part by (NIH/ 5T32CA113710-15) and by the National Institute on Drug Abuse (K01DA055073).Authors' Contributions: KDL served as the principal investigator of the funded project (NIH/R01 CA141661). PML and EAV developed the study methodology, supervised the study, study recruitment, and reviewed and edited the iterations of the manuscript. JG developed the study methodology, reviewed, and edited the iterations of the manuscript. KDL assisted in performing statistical analyses, led the writing and response to reviews, and revised all versions of the manuscripts.Conflicts of Interest: None declared.Participant characteristics by experimental condition.
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PMC10540020
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Abbreviations
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e-cigarette or vaping-associated lung injuryFood and Drug AdministrationMonitoring the Futureodds ratiotetrahydrocannabinol
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PMC10540020
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Data Availability
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The data sets generated and analyzed during this study are available from the corresponding author on reasonable request.
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PMC10540020
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Background
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INTERMITTENT CLAUDICATION
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Supervised exercise is an integral part of the recommended first-line treatment for patients with intermittent claudication (IC). By reflecting the patients’ perspectives, patient-reported outcome measurements provide additional knowledge to the biomedical endpoints and are important outcomes to include when evaluating exercise interventions in patients with IC. We aimed to evaluate the one-year impact of three strategies: unsupervised Nordic pole walk advice (WA), WA + six months of home-based structured exercise (HSEP) or WA + six months of hospital-based supervised exercise (SEP) on health-related quality of life and patient-reported physical function in patients with IC.
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PMC10594797
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Methods
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SECONDARY
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This secondary exploratory analysis of a multi-center, randomized clinical trial compared three exercise strategies. The primary outcome of the secondary analysis was the one-year change in the 36-Item Short-Form (SF-36). Secondary outcomes were three- and six-months SF-36 changes alongside three, six- and 12-months changes in the disease-specific Vascular Quality of Life instrument (VascuQoL) and the Patient-Specific Functional Scale (PSFS). The Kruskal–Wallis test with Bonferroni-adjusted post-hoc tests were used for between-group comparisons. Effect size calculations were used to describe the size of observed treatment effects, and the clinical meaningfulness of observed changes in the VascuQoL summary score at one year was studied using established minimally important difference (MID) thresholds.
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PMC10594797
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Results
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A total of 166 patients with IC, mean age: 72.1 (SD 7.4) years, 41% women, were randomized. No significant between-group differences were observed over time for the SF-36 or the PSFS scores whereas some significant between-group differences were observed in the VascuQoL domain and summary scores over time, favoring SEP and/or HSEP over WA. The observed SF-36 and VascuQoL domain and summary score effect sizes were small to moderate, and many domain score effect sizes also remained unchanged over time. A significantly higher proportion of the patients in the SEP group reached the VascuQoL summary score MID of improvement in one year.
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PMC10594797
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Conclusion
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Clinically important improvements were observed in SEP using the VascuQoL, while we did not observe any significant between-group differences using the SF-36. Whereas effect sizes for the observed changes over time were generally small, a significantly higher proportion of patients in SEP reached the VascuQoL MID of improvement.
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PMC10594797
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Trial registration
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NCT02341716, January 19, 2015 (retrospectively registered).
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PMC10594797
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Supplementary Information
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The online version contains supplementary material available at 10.1186/s12955-023-02198-8.
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PMC10594797
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Keywords
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Open access funding provided by University of Gothenburg.
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PMC10594797
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Background
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lower limb peripheral arterial occlusive disease, PAOD
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INTERMITTENT CLAUDICATION
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Patients with lower limb peripheral arterial occlusive disease (PAOD) and symptoms of intermittent claudication (IC) often experience functional impairments [Patient-reported outcome measurements (PROMs) is an umbrella term for self-rating instruments that measure concepts such as health status, HRQoL, well-being, patient satisfaction, patient symptoms and functioning [Living with IC can impact many aspects of daily life [In the recently published randomized clinical SUNFIT trial (Supervised or UNsupervised exercise training For Intermittent claudicaTion), we determined the comparative effectiveness of three different treatment strategies on walking performance and lower limb muscle endurance [
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PMC10594797
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Study procedure
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DISEASE
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At baseline, all patients received verbal and written disease information, best medical treatment, and a free pair of walking poles [
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PMC10594797
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Treatment strategies
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PMC10594797
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Walk advice (WA)
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This strategy included best medical treatment and the unsupervised WA of Nordic pole walking for at least 30 min, three times weekly.
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PMC10594797
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Home-based structured exercise program (HSEP)
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This strategy included the WA and an additional HSEP with aerobic walking exercises and resistance exercises. Patients were instructed to perform three 50-min exercise sessions weekly at home, for a total program duration of one year. The first six months was structured, with feedback from the physiotherapist by biweekly phone calls and two face-to-face visits. For the remaining six months, patients were instructed to continue with the prescribed HSEP but without further feedback.
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PMC10594797
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Hospital-based supervised exercise program (SEP)
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This strategy included the WA and an additional SEP. The SEP comprised the same exercise content and dose as HSEP but was undertaken as group sessions at the hospital under supervision from the physiotherapist (0–6 months). In accordance with HSEP, for the remaining six months, patients were instructed to continue with the prescribed program at home without further supervision or feedback.
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PMC10594797
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Patient-reported outcome measurements
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PMC10594797
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The 36-item Short-Form (SF-36)
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MH, pain
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The SF-36 is a valid and reliable generic questionnaire that includes 36 items covering different aspects of HRQoL in eight different domains: PF = physical functioning; RP = role physical; BP = bodily pain; GH = general health; VT = vitality; SF = social functioning; RE = role emotional and MH = mental health. The results are also presented in two summary components scores: the physical component summary (PCS) and the mental component summary (MCS) [
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PMC10594797
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The Vascular Quality of life (VascuQoL)
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Pain
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The VascuQoL is a disease-specific HRQoL questionnaire, designed and frequently used to evaluate treatment effects in patients with IC. The VascuQoL includes 25 items, categorized into five domains: Pain, Symptoms, Activities, Emotional, and Social. The VascuQoL Summary score is the sum of all items mean scores, divided by 25. The item responses range from 1 (worst HRQoL) to 7 (best HRQoL) [
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PMC10594797
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The Patient-Specific Functional Scale (PSFS)
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Physical function is defined as the capacity of an individual to carry out the physical activities of daily living. Physical function reflects motor function and control, physical fitness, and habitual physical activity [
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PMC10594797
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Statistical methods
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SECONDARY
|
All patients that attended follow-up and completed the SF-36, VascuQoL and PSFS questionnaires were included in this exploratory superiority analysis comparing the three treatment strategies (WA, WA + HSEP and WA + SEP). For all outcomes, the full data set was used without any imputation and all analyses were based on the initial treatment assignment. The principal outcome measure in this secondary analysis was change in the SF-36 scores from baseline to one year. Other outcomes of interest were the change in the SF-36 scores from baseline to three and six months, respectively, and the change in the VascuQoL and the PSFS scores from baseline to three, six and 12 months. The primary analysis in the SUNFIT trial had a non-inferiority design, and the sample size was based on the primary hypothesis that HSEP would be non-inferior to SEP regarding 6MWT change, presented in detail elsewhere [
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PMC10594797
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Results
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PMC10594797
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Patient-reported outcome measurements
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PROM
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At baseline, no significant between-group differences were observed for any of the PROM questionnaires.
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PMC10594797
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The Vascular Quality of Life
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Baseline data and changes at three, six and 12 months in the VascuQoL score data are presented by group in Table Figure Proportion of patients reaching a threshold for important deterioration or improvement in the VascuQoL Summary score change from baseline to 1 year
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PMC10594797
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Discussion
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PROM, low back pain, Pain
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While the previously reported primary endpoint results in the SUNFIT trial (6MWT) did not differ between treatment strategies [At three months, a significant difference was observed, in favor of both SEP and HSEP versus WA, in the VascuQoL Emotional domain as well as in the overall Summary score. In the VascuQoL Summary score, this significant difference in favor of SEP versus WA also remained at six months. Additionally at six months, a significant difference was observed in the VascuQoL Pain domain, in favor of SEP as compared with the other offered treatment strategies. While the observed effect sizes were generally small to moderate, these exploratory findings might still be related to important treatment differentials that were not evident when assessed by objective walking tests such as maximal- and pain-free walking distance as reported in the primary analysis of the SUNFIT trial [At three and six months, we observed significant between-group results regarding some VascuQoL domain and summary items favoring SEP and HSEP as compared with WA. In addition to the exercise performed in SEP and HSEP, the potential benefits of the exercise encouragement, support and feedback given by the physiotherapists [A significantly higher proportion of patients in the SEP group (compared with HSEP and WA) reached the VascuQoL summary score MID for improvement at the one-year follow-up visit. The MID thresholds calculated by Conjin et al. [Moreover, it is important to consider the context in which these thresholds were derived. Compared with our one-year result, Conjin and colleagues had a shorter follow-up period of three to four months. Also, the IC treatment offered differed in the studied population and included SEP, percutaneous transluminal angioplasty (PTA), and surgical revascularization while some patients only received best medical treatment (antiplatelet drug and a statin, unsupervised walk advice and advice on lifestyle changes). However, the MID values can be applied irrespective of sample size and are thus useful in both individual care and research settings [The fact that the SF36 is a generic PROM that provides a wider HRQoL measure than PAOD-specific PROMs [To the best of our knowledge, this is the first study evaluating exercise programs with the PSFS in patients with IC. The impact of exercise has previously been evaluated with the PSFS in patients with low back pain [There are many different questionnaires evaluating HRQoL in patients with IC and the use of these tools in a research context is inconsistent and non-standardized [
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PMC10594797
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Conclusion
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PROM, intermittent claudication
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INTERMITTENT CLAUDICATION
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Potentially important treatment differentials were revealed when analyzing the disease-specific VascuQoL, while we did not observe any significant between-group differences for the SF-36. Whereas effect sizes for the observed changes in the SF-36 and the VascuQoL over time were generally small, a significantly higher proportion of patients in the SEP group reached the minimally important difference threshold for improvement in the VascuQoL Summary score at one year. Our study demonstrates the importance of including disease-specific instruments when evaluating PROM endpoints in patients with intermittent claudication and also emphasize the potential importance of integrating PROMs alongside more traditional endpoints in clinical trials.
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PMC10594797
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Acknowledgements
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We would like to thank Monica Broeren and Jenny Östlund, research nurses at the Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. We would like to thank Peta Cook, Ingrid Eliasson, Madeleine Ivarsson, Jenny Snickars and Susanna Wittboldt, physical therapists at the Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden and Karin Olsson and Frida Lindström, physical therapists at the Karlstad Central Hospital, Karlstad, Sweden.
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PMC10594797
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Authors’ contributions
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LJ, JN, ÅC, MB and AS developed the concept, idea and study design. All authors contributed with data collection, data analysis and interpretation of the results. AS conducted the statistical analyses with guidance from JN and MB. AS drafted the first version of the manuscript, which was critically reviewed by all authors. All authors read and approved the final version of the manuscript.
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PMC10594797
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Funding
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ALF
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HEART, LUNG
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Open access funding provided by University of Gothenburg. This study was supported by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF agreement (ALFGBG-785741 and ALFGBG-822921) and the Swedish Heart–Lung Foundation (20190194 and 20200258).
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PMC10594797
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Availability of data and materials
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The dataset generated and analyzed during the current study is not available due to ethical considerations and General Data Protection Regulation (GDPR). Processed summary data are however available on reasonable request. The primary article for this randomized clinical trial: (DOI number: 10.1093/eurjcn/zvac070.)
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PMC10594797
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Declarations
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PMC10594797
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Ethics approval and consent to participate
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The study protocol was approved by the Regional Ethical Review Board in Gothenburg (entry no. 349–14, T789-16). Informed, written consent was obtained from all participants.
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PMC10594797
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Consent for publication
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Not applicable.
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PMC10594797
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Competing interests
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The authors declare no competing interests.
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PMC10594797
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References
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PMC10594797
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2. Materials and Methods
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PMC10304042
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2.1. Study Design and Ethical Details
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We designed a single-center prospective randomized pilot study at the Urology Unit of the University of Campania “Luigi Vanvitelli” (Naples, Italy) that was conducted between April 2019 and June 2020. No placebo or blinding was applied. The study was approved by the local Ethics Committee. The research was conducted according to the Declaration of Helsinki on the ethical principles for medical research involving human subjects [
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PMC10304042
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2.2. Patient Enrollment
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diabetes mellitus, allergy, phimosis, tumors, UTIs
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CHRONIC PROSTATITIS, URETHRAL STRICTURES, CARCINOMA IN SITU, INTERSTITIAL CYSTITIS, DIABETES MELLITUS, ALLERGY, URINARY INCONTINENCE, MEATAL STENOSIS, DIFFICULTY SWALLOWING, IMMUNODEFICIENCY DISORDERS, BLADDER STONES, TUMORS, NEUROGENIC BLADDER
|
Patients undergoing cystoscopy for suspected BCa or follow-up after transurethral resection of the bladder (TURB), with negative urine culture, were enrolled. The exclusion criteria were: bladder catheter present or removed in the last 30 days; bladder stones; diagnostic or therapeutic endoscopic procedures on the urinary tract (including TURB) in the last 3 months; bladder biopsy during cystoscopy; intravesical therapy for BCa in the last 30 days; history of interstitial cystitis, recurrent UTIs, or chronic prostatitis; presence of urethral strictures, meatal stenosis, urinary incontinence, neurogenic bladder, or severe phimosis; history of carcinoma in situ or muscle invasive tumors not undergoing radical cystectomy; immunodeficiency disorders; uncompensated diabetes mellitus (HbA1c > 7%); allergy to substances evaluated in the study; and difficulty swallowing tablets.
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PMC10304042
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2.3. Treatment Protocol
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STERILE
|
All cystoscopies were performed by the same expert operator using a 16-Ch flexible cystoscope equipped with a sterile disposable sheath (Vision
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PMC10304042
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2.4. Patient Evaluation
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Demographic data and clinical characteristics were collected for each patient at baseline. A urine culture was prescribed regardless of symptoms 7 days before and 7 days after cystoscopy. The urine culture results were sent by email. The urine culture before cystoscopy had to be negative to allow patients to be included in the study, while the urine culture result after cystoscopy was chosen as the primary outcome. The International Prostatic Symptoms Score (IPSS) [
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PMC10304042
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2.5. Statistics
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The continuous variables were described as medians and the interquartile range (IQR), while the categorical variables were expressed as frequencies and percentages. The Shapiro–Wilk test was applied as a normality test. The Wilcoxon rank-sum and Wilcoxon signed-rank tests were used to analyze continuous variables in independent and related samples, respectively. McNemar and Chi-squared tests were applied to analyze categorical variables in paired and unpaired samples, respectively.
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PMC10304042
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3. Results
|
A total of 32 patients were enrolled in the study and randomized into the two treatment groups. No patients or data were lost after enrollment (
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PMC10304042
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4. Discussion
|
bladder inflammation, infectious complications, infection, inflammation
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HAND INFECTION, INFLAMMATION, ADVERSE EFFECTS, INFECTION, BLADDER INFLAMMATION
|
Cystoscopy, a widely used diagnostic procedure in urology, can be frustrating for patients and is associated with possible infectious complications [Obviously, the uncertainty on the topic and the concern about the resistance and possible adverse effects of antibiotics has prompted the search for possible alternatives to antibiotic prophylaxis. D-Mannose seems effective in the prevention and resolution of bladder inflammation and infection, representing a possible option in patients undergoing cystoscopy [On the other hand, Several other supplements have been evaluated over the years to reduce the inflammation and risk of infection of the lower urinary tract in various clinical settings [Our study evaluated the efficacy of a supplement based on D-Mannose and
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PMC10304042
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Author Contributions
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Conceptualization, C.Q., C.M. and L.S.; methodology, L.N. and A.F.; data collection, C.D., D.A. and A.D.G.; writing—original draft, C.M. and L.S.; writing—review and editing, C.S. and V.I.; visualization, F.B. and R.L.R.; supervision, M.D.S. All authors have read and agreed to the published version of the manuscript.
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PMC10304042
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Institutional Review Board Statement
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The study was conducted in accordance with the Declaration of Helsinki and approved by the local Ethics Committee, University of Naples Federico II. Approval Code: 261/2019. Approval Date: March 2019.
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PMC10304042
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Informed Consent Statement
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Informed consent was obtained from all subjects involved in the study.
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PMC10304042
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Data Availability Statement
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Not applicable.
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PMC10304042
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Conflicts of Interest
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The authors declare no conflict of interest.
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PMC10304042
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References
|
UTIs
|
SECONDARY
|
CONSORT flow diagram.UTIs 7 days after cystoscopy. Group A: D-Mannose (500 mg) plus Baseline characteristics of patients.Group A: D-Mannose (500 mg) plus Evaluation of secondary outcomes.Group A: D-Mannose (500 mg) plus
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PMC10304042
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Background
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Body dissatisfaction is a global issue, particularly among adolescent girls and young women. Effective body image interventions exist but face barriers to scaling up, particularly in lower- and middle-income countries, such as Indonesia, where a need exists.
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PMC10131926
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Objective
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We aimed to evaluate the acceptability and efficacy of
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PMC10131926
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Methods
|
We conducted a web-based, 2-arm randomized controlled trial among 2000 adolescent girls and young women, aged 15 to 19 years, recruited via telephone by an Indonesian research agency. Block randomization (1:1 allocation) was performed. Participants and researchers were not concealed from the randomized arm. Participants completed self-report assessments of trait body satisfaction (primary outcome) and the internalization of appearance ideals, mood, and skin shade dissatisfaction at baseline (before randomization), time 2 (1 day after the intervention [T2]), and time 3 (1 month after the intervention [T3]). Participants also completed state body satisfaction and mood measures immediately before and after each video. Data were evaluated using linear mixed models with an intent-to-treat analysis. Intervention adherence was tracked. Acceptability data were collected.
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PMC10131926
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Results
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There were 1847 participants. Relative to the control condition (n=923), the intervention group (n=924) showed reduced internalization of appearance ideals at T2 (
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PMC10131926
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Trial Registration
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ClinicalTrials.gov NCT05383807, https://clinicaltrials.gov/ct2/show/NCT05383807 ; ISRCTN Registry ISRCTN35483207, https://www.isrctn.com/ISRCTN35483207
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PMC10131926
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International Registered Report Identifier (IRRID)
|
RR2-10.2196/33596
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PMC10131926
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Introduction
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See
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PMC10131926
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Background
|
Globally, many young people, particularly adolescent girls and young women [Interventions have been developed and rigorously evaluated to reduce body dissatisfaction among adolescent girls and young women, with promising findings [
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PMC10131926
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Harnessing Social Media for Body Image Interventions
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A viable solution to increase the scalability of mental health interventions, including those to reduce body dissatisfaction, is the use of social media platforms [
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PMC10131926
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The Indonesian Context
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Indonesia, a Southeast Asian nation, is the world’s largest archipelago and fourth most populous country [
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PMC10131926
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This Study
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In this study, we evaluated the impact of
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PMC10131926
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Methods
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PMC10131926
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Trial Design
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A 2-arm, web-based parallel randomized controlled trial was conducted to evaluate the efficacy of
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Ethics Approval
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WEST
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Ethics approval was obtained from the Faculty of Medicine at Universitas Indonesia (588/UN2.F1/ETIK/PPM.00.002/2021) and the University of the West of England, Bristol (United Kingdom; HAS.21.04.138). The trial protocol was registered (International Registered Report Identifier PRR1-10.2196/33596) [
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PMC10131926
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Participants
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Jakarta-based
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A Jakarta-based research agency recruited and enrolled a sample of adolescent girls and young Indonesian women from 10 cities across the western, central, and eastern regions of Indonesia (Balikpapan, Bandung, Jakarta, Makassar, Manado, Medan, Palembang, Pontianak, Semarang, and Surabaya) offline, evenly split across age and socioeconomic status. Adolescent girls and young women were invited to participate if they met the following inclusion criteria: (1) were between the ages of 15 and 19 years, (2) had their own mobile phone, and (3) visited Facebook or Instagram daily. They were excluded from the study if they (1) followed the Girl Effect brand (Springster) on social media, (2) had previously accessed the Springster website, or (3) did not provide written consent from a parent or guardian (if they were aged <18 years).The research agency recruited participants via phone using an existing database of previous adult participants aged >40 years. Individuals who had a daughter aged between 15 and 17 years were read the parental information sheet. If they had >1 eligible daughter, only one who met the needs of this trial’s age quota was selected; if >1 met the age quota needs, the daughter whose date of birth was closest to the date of the call was selected. Parents who provided verbal consent then supplied information regarding their socioeconomic status. Daughters were then screened by the recruiter to determine if they met the social media use inclusion criteria and whether they had previously accessed the Springster brand on social media and its website (exclusion criteria). If she provided verbal assent to participate, parents once again provided consent for their daughter’s participation, this time written via WhatsApp. A similar process was executed for eligible daughters aged 18 or 19 years, except that they themselves provided verbal and written consent. The identities of the parents and eligible daughters were confirmed on video calls through official photo-based IDs.
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PMC10131926
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Procedure
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All communication between the research agency and the participants took place on the web via WhatsApp. The day before the study was launched (day 0), the research agency distributed data packages to each of the participants to cover internet data costs incurred. Participants completed web-based self-report questionnaires hosted on Qualtrics at 3 time points, that is, baseline (day 1), 1 day after the intervention (day 9), and 1 month after the intervention (day 36). The items in the closed questionnaires were not randomized. Adaptive questioning was used only for the consent question at the beginning of each questionnaire. The questionnaires contained an average of 34 (SD 3.77) screens with 4 to 5 items per page. A “Back” button was included so that participants had the option of reviewing and changing their responses. Questionnaire functionality was tested and verified by the authors (KMG and SH) before sharing the Qualtrics links with the research agency.At 8 AM (Coordinated Universal Time +7) on days 1 (time 1, baseline [T1]), 9 (time 2, 1 day after the intervention [T2]), and 36 (time 3, 1 month after the intervention [T3]), the research agency sent participants a link to the corresponding questionnaire as well as their unique participant identification number (PIN), which participants entered at the beginning of each questionnaire. The participants had 24 hours to complete each self-report assessment. Reminder messages were sent to participants who had not completed the questionnaire within the first 8 hours (these prompts will not be used or available when the intervention is disseminated on social media). Demographic information was collected using the baseline questionnaire.After the participants completed the baseline questionnaire, a researcher not involved in this project was concealed from participant information and condition and generated the allocation sequence (based on a block design) using an automated web-based randomizer [Participants randomized to the intervention condition were sent their PIN and a Qualtrics link with one video and its associated activities on days 3 to 8 at 8 AM (Coordinated Universal Time +7). Included in each link were state measures of body satisfaction and mood to be completed immediately before and after each of the intervention’s videos. Participants had 24 hours to engage with each link (ie, watch the video and complete its associated web-based activities), with reminder messages sent to those who had not engaged with the intervention after 8 hours. Acceptability information was obtained from the intervention group participants at the end of the day 9 questionnaire.The day after the final questionnaire (day 37), all participants received a certificate of participation and debrief document that outlined the study’s objective, included contacts for mental health support, and were provided a link to access the intervention video series. Thereafter, incentives of Rp 125,000 (approximately US $8.75) were given to participants who completed all 3 questionnaires. Winners of the “Your Own Words” activities were awarded their prize within 2 weeks of trial completion. As specified in the trial protocol [
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Measures
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Primary Outcome Measure
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The primary outcome measure for assessing trait body satisfaction was the Body Esteem Scale for Adolescents and Adults (BESAA) [
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Secondary Outcome Measures
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SECONDARY
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Three secondary outcome measures were used. The internalization-general subscale of the Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ-3) [
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State Outcome Measures
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To assess state body satisfaction and mood, single-item measures on a 101-point visual analog scale [
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Intervention Acceptability
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On day 9, the intervention condition participants received 6 self-report items at the end of the T2 questionnaire that assessed the intervention in relation to their overall enjoyment, likability of the characters, understandability, age appropriateness, usefulness, and likelihood of recommending the intervention to a peer. The response options ranged from 1 (
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Adherence
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The level of adherence to the intervention was assessed using various metrics that examined video and activity engagement. The following metrics were collected: the percentage of participants who watched each video and all 6 videos (calculated by the number of participants whose dwell time on the Qualtrics page hosting each video was equal to or longer than the video length), the average number of videos watched, the percentage of participants who completed each activity, the average number of activities completed, and the average amount of time participants engaged in the entire intervention (ie, all 6 videos and their corresponding activities).
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Sample Size
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Similar randomized controlled trials assessing body dissatisfaction using the same outcome measure reported a range of small to medium standardized effect sizes, with Hedges
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Analyses
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Overview
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Analyses were performed using SPSS 28 (IBM Corp). Any duplicate questionnaire entries were identified by the participants’ unique PIN, and the first entry was retained for analysis. To avoid interpretation bias, condition allocation was concealed from the data analyst throughout data preparation and trait outcome hypothesis testing. However, the concealment of condition allocation was not possible during state outcome hypothesis testing because of the within-group design of this study. The data analyst was provided with the state-based measures data file only when the analyses of the trait-based measures were complete.
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Hypotheses Testing and Post Hoc Analyses
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Trait Outcomes
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REGRESSION
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The effect of the intervention on trait outcomes was examined by running 4 linear mixed models (LMMs) on an intention-to-treat basis, with baseline measures at T1 as a covariate, randomized group as a 2-level between-subjects factor, study phase (T2 and T3) as a 2-level repeated measures factor, an unstructured covariance matrix, and the restricted maximum likelihood estimation method. The statistical model was hierarchically balanced, with one 3-way interaction among covariate, phase, and randomized group, three 2-way interactions (covariate × phase, covariate × randomized group, phase × randomized group), and 3 main effects (covariate, phase, and randomized group). For the effect size estimation, we calculated partial eta-squared for each model factor.To estimate whether randomized group significantly contributed to the LMM, we ran four −2 log likelihood (LL) tests comparing the complete LMMs described earlier to LMMs without randomized group and its interactions. This model included baseline measures at T1 as a covariate, the study phase (T2 and T3) as a 2-level repeated measures factor, and one 2-way interaction (covariate × phase). For the −2 LL test, the 2 models were run using an unstructured covariance matrix and the maximum likelihood estimation method.For each trait outcome, 2 preplanned analyses of covariance (ANCOVAs) were run to separately verify the effect of randomized group at T2 and T3. The models included baseline measures as a covariate, randomized group as a fixed factor, and measures at either T2 or T3 as dependent variables. The main conclusions were drawn from these preplanned ANCOVAs.We also ran 2 post hoc repeated measures ANOVAs for each trait outcome, one for the control and one for the intervention group, testing for time trends across all 3 time points.Finally, preplanned dose-response effects were tested in the intervention condition by running multiple regression analyses with each trait outcome at T2 and T3 as a dependent variable and Helmert-coded engagement scores (ie, the number of videos watched) as independent variables. Helmert coding allows the comparison of each level of engagement against the remaining higher levels, thereby identifying potential jump points in the data [
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PMC10131926
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State Outcomes
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For each state outcome, 6 dependent sample To test for cumulative effects across the 6 videos, we ran two 2 × 6 ([prevideo vs postvideo] × [6 videos]) fully repeated measures ANOVA for state body satisfaction and state mood, checking for linear, quadratic, cubic trends, and repeated contrasts. For both state measures, gain scores for each video were calculated (subtracting the prevideo state score from the postvideo state score), and then post hoc dependent sample
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Exploratory Analyses
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After testing the hypotheses and post hoc analyses, we tested an exploratory mediation model with PROCESS Macro for SPSS (model 4) [
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Data Preparation
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REGRESSION, ATTRITION
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The trait outcomes data set across conditions had 0.32% (356/112,667) missing item responses at T1, 4.31% (4858/112,667) missing item responses at T2, and 3.12% (3517/112,667) missing item responses at T3 (Independent sample Moreover, the dropout rate never exceeded 5% between time points for any of the variables, supporting the conclusion that missing data were not concerning for this data set, given the high retention rates [For hypothesis testing, LMMs and post hoc ANCOVAs were conducted on an intention-to-treat basis without performing data imputation. As the percentage of missingness was <5%, LMMs and ANCOVAs were considered robust against a noncomplete data set [The LMMs and ANCOVAs assumptions of the linearity of residuals, continuous dependent variables, homogeneity of regression slopes, homogeneity of covariance matrices, and absence of collinearity were all met for the trait outcomes. The assumption of homoscedasticity was met for all trait outcomes, with only a slight violation of the internalization scores. Despite not meeting perfect normality, all residuals of the trait outcomes at T2 and T3 presented only minimal skewness (−2<skewness<+2) and minimal kurtosis (excess kurtosis <5). Given that ANCOVA is robust against the violation of the normal distribution of residuals when conducted with an appropriate sample size and groups of equal size, the data were neither transformed nor were outlier scores substituted [Attrition rates were also low for state outcomes. For the intervention group only, missing responses on the 1-item state measures ranged between 12.1% (112/924; before video 1) and 13.8% (128/924; after video 6) for body satisfaction and between 12% (111/924; before video 1) and 14% (129/924; after video 6) for mood (
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PMC10131926
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Results
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PMC10131926
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Pilot Study and Protocol Amendments
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RECRUITMENT
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Recruitment for the pilot study was conducted from September 13 to 16, 2021, and executed between September 18 and 26, 2021. A sample spread evenly across age and socioeconomic status (n=150) was obtained from the cities of Jakarta, Medan, and Semarang. As outlined in the trial protocol [
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PMC10131926
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Adherence
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Intervention adherence metrics were also assessed. On average, intervention participants watched 5 of the 6 videos and completed 14 of the 18 activities. See
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Hypotheses Testing and Post Hoc Analyses
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PMC10131926
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Trait Outcomes
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PMC10131926
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Body Satisfaction
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The LMM with baseline body satisfaction as a covariate, randomized group as a 2-level between-subjects factor, study phase (T2 and T3) as a 2-level repeated measures factor, three 2-way interactions, and one 3-way interaction found a nonsignificant effect of randomized group (The preplanned ANCOVAs showed a nonsignificant effect of randomized group on mean body satisfaction at T2 (The post hoc repeated measures ANOVAs showed a nonsignificant effect of time on body satisfaction in the control group (Trait body satisfaction over time for both groups. *Significant analysis of covariance effect of the randomized group at a specific time point.
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PMC10131926
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