A Randomized Trial of Wearable UV dosimeter for Skin Cancer Prevention

Background Non-melanoma skin cancer (NMSC) is the most prevalent cancer in the United States, affecting 5 million people and costing $8.1 billion per year. Despite well-defined guidelines on ultraviolet radiation (UVR) avoidance, it remains difficult for people to assess their individual exposure, as UVR is invisible and the onset of symptoms due to UVR damage are delayed. Methods In a prospective, randomized-controlled trial, 97 patients with a history of actinic keratoses were enrolled from March 2018 to July 2018 and followed over 6 months. 50 patients were given a wearable device that measured UV exposure and a smartphone application that provided both real-time and cumulative UV exposure information, and 47 patients were provided with UV protection counseling by a dermatologist. Results We observed a significant decrease in the incidence rate of NMSC in the intervention group compared to the control group over 3 months (p = 0.02). We did not observe a significant decrease in the incidence rate of actinic keratoses (AK) in the intervention group compared to the control group. The observed clinical benefit was not accompanied by psychological side effects such as anxiety and depression. Conclusions This study suggests that providing real-time UV exposure data using a wearable UV dosimeter is a safe and effective behavioral change strategy to prevent NMSC. (Funded by the National Cancer Institute, contract HHSN261201700005C; ClinicalTrials.gov number NCT03315286.)

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A Random Controlled Trial to Examine the Efficacy of Blank Slate: A Novel Spaced Retrieval Tool with Real-Time Learning Analytics

Education Sciences ◽

10.3390/educsci11030090 ◽

2021 ◽

Vol 11 (3) ◽

pp. 90

Author(s):

Douglas McHugh ◽

Richard Feinn ◽

Jeff McIlvenna ◽

Matt Trevithick

Keyword(s):

Real Time ◽

Controlled Trial ◽

Knowledge Retention ◽

The United States ◽

Individual Performance ◽

Control Group ◽

Software Application ◽

Spaced Retrieval ◽

Time Investment ◽

Blank Slate

Learner-centered coaching and feedback are relevant to various educational contexts. Spaced retrieval enhances long-term knowledge retention. We examined the efficacy of Blank Slate, a novel spaced retrieval software application, to promote learning and prevent forgetting, while gathering and analyzing data in the background about learners’ performance. A total of 93 students from 6 universities in the United States were assigned randomly to control, sequential or algorithm conditions. Participants watched a video on the Republic of Georgia before taking a 60 multiple-choice-question assessment. Sequential (non-spaced retrieval) and algorithm (spaced retrieval) groups had access to Blank Slate and 60 digital cards. The algorithm group reviewed subsets of cards daily based on previous individual performance. The sequential group reviewed all 60 cards daily. All 93 participants were re-assessed 4 weeks later. Sequential and algorithm groups were significantly different from the control group but not from each other with regard to after and delta scores. Blank Slate prevented anticipated forgetting; authentic learning improvement and retention happened instead, with spaced retrieval incurring one-third of the time investment experienced by non-spaced retrieval. Embedded analytics allowed for real-time monitoring of learning progress that could form the basis of helpful feedback to learners for self-directed learning and educators for coaching.

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Efficacy of a Just-in-Time Adaptive Intervention to Promote HIV Risk Reduction Behaviors Among Young Adults Experiencing Homelessness: Pilot Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/26704 ◽

2021 ◽

Vol 23 (7) ◽

pp. e26704

Author(s):

Diane Santa Maria ◽

Nikhil Padhye ◽

Michael Businelle ◽

Yijiong Yang ◽

Jennifer Jones ◽

...

Keyword(s):

Young Adults ◽

Drug Use ◽

Hiv Prevention ◽

Real Time ◽

Risk Behaviors ◽

Hiv Risk ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Adaptive Intervention

Background People experiencing homelessness have higher rates of HIV than those who are stably housed. Mental health needs, substance use problems, and issues unique to homelessness such as lack of shelter and transiency need to be considered with regard to HIV prevention. To date, HIV prevention interventions for young adults experiencing homelessness have not specifically addressed modifiable real-time factors such as stress, sexual or drug use urge, or substance use, or been delivered at the time of heightened risk. Real-time, personalized HIV prevention messages may reduce HIV risk behaviors. Objective This pilot study tested the initial efficacy of an innovative, smartphone-based, just-in-time adaptive intervention that assessed predictors of HIV risk behaviors in real time and automatically provided behavioral feedback and goal attainment information. Methods A randomized attention control design was used among young adults experiencing homelessness, aged 18-25 years, recruited from shelters and drop-in centers in May 2019. Participants were randomized to either a control or an intervention group. The intervention (called MY-RID [Motivating Youth to Reduce Infection and Disconnection]) consisted of brief messages delivered via smartphone over 6 weeks in response to preidentified predictors that were assessed using ecological momentary assessments. Bayesian hierarchical regression models were used to assess intervention effects on sexual activity, drug use, alcohol use, and their corresponding urges. Results Participants (N=97) were predominantly youth (mean age 21.2, SD 2.1 years) who identified as heterosexual (n=51, 52%), male (n=56, 57%), and African American (n=56, 57%). Reports of sexual activity, drug use, alcohol use, stress, and all urges (ie, sexual, drug, alcohol) reduced over time in both groups. Daily drug use reduced by a factor of 13.8 times over 6 weeks in the intervention group relative to the control group (Multimedia Appendix 4). Lower urges for sex were found in the intervention group relative to the control group over the duration of the study. Finally, there was a statistically significant reduction in reports of feeling stressed the day before between the intervention and control conditions (P=.03). Conclusions Findings indicate promising intervention effects on drug use, stress, and urges for sex in a hard-to-reach, high-risk population. The MY-RID intervention should be further tested in a larger randomized controlled trial to further investigate its efficacy and impact on sexual risk behaviors. Trial Registration ClinicalTrials.gov NCT03911024; https://clinicaltrials.gov/ct2/show/NCT03911024

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SSHeW study protocol: does slip resistant footwear reduce slips among healthcare workers? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-026023 ◽

2018 ◽

Vol 8 (11) ◽

pp. e026023 ◽

Cited By ~ 1

Author(s):

Sarah Cockayne ◽

Caroline Fairhurst ◽

Gillian Frost ◽

Catherine Hewitt ◽

Mark Liddle ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Incidence Rate ◽

Controlled Trial ◽

Intervention Group ◽

Text Messages ◽

Hospital Environment ◽

Control Group ◽

Dress Code ◽

Randomised Controlled

IntroductionSlips, trips and falls are common causes of injuries in the workplace. It is estimated that in Great Britain, nearly 1 million days are taken off work due to these injuries. There is some evidence to suggest this accident burden could be reduced by the use of slip resistant footwear. This protocol describes a multicentre trial investigating the effectiveness and cost-effectiveness of slip resistant footwear to prevent slips in National Health Service (NHS) staff working in clinical, general or catering environments.Methods and analysisA two-arm, randomised controlled trial conducted within England, with 4400 NHS staff, aged 18 years and above, who adhere to a dress code policy and work in a clinical, catering or general hospital environment. Participants will be randomised 1:1 to the intervention or waiting list control group. The intervention group will be offered a pair of 5-star GRIP rated slip resistant footwear. The control group will be offered the footwear at the end of the trial. The primary outcome is the incidence rate of self-reported slips in the workplace over a 14-week period, as reported via weekly text messages. Secondary outcomes include: time to first slip/fall, proportion of participants who slip and fall over 14 weeks and incidence rate of falls resulting from and not resulting from a slip in the workplace over 14 weeks. An economic evaluation will assess cost-effectiveness, in terms of cost per quality-adjusted life year gained. A nested qualitative study will explore the acceptability of the footwear and compliance.Ethics and disseminationThis protocol received a favourable ethical opinion from the University of York, Department of Health Sciences Research Governance Committee. The trial results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants.Trial registration numberISRCTN33051393; Pre results.

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A Promising Food-Coaching Intervention Program to Achieve Optimal Gestational Weight Gain in Overweight and Obese Pregnant Women: Pilot Randomized Controlled Trial of a Smartphone App (Preprint)

10.2196/preprints.13013 ◽

2018 ◽

Author(s):

Ling-Jun Li ◽

Izzuddin M Aris ◽

Wee Meng Han ◽

Kok Hian Tan

Keyword(s):

Weight Gain ◽

Pregnant Women ◽

Real Time ◽

Gestational Weight Gain ◽

Controlled Trial ◽

Intervention Group ◽

Smartphone App ◽

Control Group ◽

Gestational Weight ◽

Randomized Controlled

BACKGROUND Traditional dietary recommendations for achieving optimal gestational weight gain are ineffective for pregnant women due to the lack of real-time communication and tedious consultation processes. OBJECTIVE In this pilot study, we aimed to determine the feasibility of a novel food-coaching smartphone app for controlling gestational weight gain and macronutrient intake among overweight and obese pregnant women. METHODS We designed a randomized controlled trial and recruited 30 overweight and obese pregnant women (1:1 ratio) during 18-20 weeks of gestation and followed them up after 4 and 8 weeks, respectively. Both groups received standard pregnancy dietary orientation at recruitment, while the intervention group received 8 weeks of real-time food coaching via a smartphone app. This food-coaching smartphone app (Glycoleap, Holmusk, Singapore) aimed to improve care and outcomes for people with diabetes. Pregnant women using this app were able to upload food images (eg, a picture of a meal, a drink, or a dessert) and received real-time and detailed food-coaching comments and guidance provided by professional dietitians during the day (8 AM to 8 PM). We recorded detailed characteristics during recruitment and examined anthropometry at all visits. We compared the mean differences of the 8-week gestational weight gain and macronutrient intake between the two groups. RESULTS Upon study completion, three subjects dropped out from the intervention, and one gave birth prematurely in the control group. The acceptance rate of the smartphone app was 90%. More participants achieved optimal gestational weight gain per week in the intervention group (8/12, 67%) than in the control group (5/14, 36%). After the 8-week intervention, women in the intervention group appeared to have lower gestational weight gain (mean difference=–0.08 kg; 95% CI –1.80 to 1.63) and cholesterol intake (mean difference=–31.73 mg; 95% CI –102.91 to 39.45) than those in the control group. CONCLUSIONS Our findings showed that this food-coaching smartphone app is feasible and favorable for weight gain control and cholesterol intake control among overweight and obese pregnant women. Although our results were not significant (perhaps, attributed to the small sample size), it provided proof of concept for the feasibility of applying such technology in future randomized controlled trials with a larger sample size, an earlier intervention onset, and a longer follow-up for overweight and obese pregnant women.

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A Promising Food-Coaching Intervention Program to Achieve Optimal Gestational Weight Gain in Overweight and Obese Pregnant Women: Pilot Randomized Controlled Trial of a Smartphone App

JMIR Formative Research ◽

10.2196/13013 ◽

2019 ◽

Vol 3 (4) ◽

pp. e13013 ◽

Cited By ~ 1

Author(s):

Ling-Jun Li ◽

Izzuddin M Aris ◽

Wee Meng Han ◽

Kok Hian Tan

Keyword(s):

Weight Gain ◽

Pregnant Women ◽

Real Time ◽

Gestational Weight Gain ◽

Controlled Trial ◽

Intervention Group ◽

Smartphone App ◽

Control Group ◽

Gestational Weight ◽

Randomized Controlled

Background Traditional dietary recommendations for achieving optimal gestational weight gain are ineffective for pregnant women due to the lack of real-time communication and tedious consultation processes. Objective In this pilot study, we aimed to determine the feasibility of a novel food-coaching smartphone app for controlling gestational weight gain and macronutrient intake among overweight and obese pregnant women. Methods We designed a randomized controlled trial and recruited 30 overweight and obese pregnant women (1:1 ratio) during 18-20 weeks of gestation and followed them up after 4 and 8 weeks, respectively. Both groups received standard pregnancy dietary orientation at recruitment, while the intervention group received 8 weeks of real-time food coaching via a smartphone app. This food-coaching smartphone app (Glycoleap, Holmusk, Singapore) aimed to improve care and outcomes for people with diabetes. Pregnant women using this app were able to upload food images (eg, a picture of a meal, a drink, or a dessert) and received real-time and detailed food-coaching comments and guidance provided by professional dietitians during the day (8 AM to 8 PM). We recorded detailed characteristics during recruitment and examined anthropometry at all visits. We compared the mean differences of the 8-week gestational weight gain and macronutrient intake between the two groups. Results Upon study completion, three subjects dropped out from the intervention, and one gave birth prematurely in the control group. The acceptance rate of the smartphone app was 90%. More participants achieved optimal gestational weight gain per week in the intervention group (8/12, 67%) than in the control group (5/14, 36%). After the 8-week intervention, women in the intervention group appeared to have lower gestational weight gain (mean difference=–0.08 kg; 95% CI –1.80 to 1.63) and cholesterol intake (mean difference=–31.73 mg; 95% CI –102.91 to 39.45) than those in the control group. Conclusions Our findings showed that this food-coaching smartphone app is feasible and favorable for weight gain control and cholesterol intake control among overweight and obese pregnant women. Although our results were not significant (perhaps, attributed to the small sample size), it provided proof of concept for the feasibility of applying such technology in future randomized controlled trials with a larger sample size, an earlier intervention onset, and a longer follow-up for overweight and obese pregnant women.

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Efficacy of a Just-in-Time Adaptive Intervention to Promote HIV Risk Reduction Behaviors Among Young Adults Experiencing Homelessness: Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.26704 ◽

2020 ◽

Author(s):

Diane Santa Maria ◽

Nikhil Padhye ◽

Michael Businelle ◽

Yijiong Yang ◽

Jennifer Jones ◽

...

Keyword(s):

Young Adults ◽

Drug Use ◽

Hiv Prevention ◽

Real Time ◽

Risk Behaviors ◽

Hiv Risk ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Adaptive Intervention

BACKGROUND People experiencing homelessness have higher rates of HIV than those who are stably housed. Mental health needs, substance use problems, and issues unique to homelessness such as lack of shelter and transiency need to be considered with regard to HIV prevention. To date, HIV prevention interventions for young adults experiencing homelessness have not specifically addressed modifiable real-time factors such as stress, sexual or drug use urge, or substance use, or been delivered at the time of heightened risk. Real-time, personalized HIV prevention messages may reduce HIV risk behaviors. OBJECTIVE This pilot study tested the initial efficacy of an innovative, smartphone-based, just-in-time adaptive intervention that assessed predictors of HIV risk behaviors in real time and automatically provided behavioral feedback and goal attainment information. METHODS A randomized attention control design was used among young adults experiencing homelessness, aged 18-25 years, recruited from shelters and drop-in centers in May 2019. Participants were randomized to either a control or an intervention group. The intervention (called MY-RID [Motivating Youth to Reduce Infection and Disconnection]) consisted of brief messages delivered via smartphone over 6 weeks in response to preidentified predictors that were assessed using ecological momentary assessments. Bayesian hierarchical regression models were used to assess intervention effects on sexual activity, drug use, alcohol use, and their corresponding urges. RESULTS Participants (N=97) were predominantly youth (mean age 21.2, SD 2.1 years) who identified as heterosexual (n=51, 52%), male (n=56, 57%), and African American (n=56, 57%). Reports of sexual activity, drug use, alcohol use, stress, and all urges (ie, sexual, drug, alcohol) reduced over time in both groups. Daily drug use reduced by a factor of 13.8 times over 6 weeks in the intervention group relative to the control group (<xref ref-type="supplementary-material" rid="app4">Multimedia Appendix 4</xref>). Lower urges for sex were found in the intervention group relative to the control group over the duration of the study. Finally, there was a statistically significant reduction in reports of feeling stressed the day before between the intervention and control conditions (<i>P</i>=.03). CONCLUSIONS Findings indicate promising intervention effects on drug use, stress, and urges for sex in a hard-to-reach, high-risk population. The MY-RID intervention should be further tested in a larger randomized controlled trial to further investigate its efficacy and impact on sexual risk behaviors. CLINICALTRIAL ClinicalTrials.gov NCT03911024; https://clinicaltrials.gov/ct2/show/NCT03911024

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Impact of a School-Based Gardening, Cooking, Nutrition Intervention on Diet Intake and Quality: The TX Sprouts Randomized Controlled Trial

Nutrients ◽

10.3390/nu13093081 ◽

2021 ◽

Vol 13 (9) ◽

pp. 3081

Author(s):

Matthew J. Landry ◽

Alexandra E. van den Berg ◽

Deanna M. Hoelscher ◽

Fiona M. Asigbee ◽

Sarvenaz Vandyousefi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Dietary Intake ◽

Controlled Trial ◽

Intervention Group ◽

The United States ◽

Healthy Eating Index ◽

Dietary Quality ◽

Control Group ◽

Randomized Controlled ◽

School Based

School gardens have become common school-based health promotion strategies to enhance dietary behaviors in the United States. The goal of this study was to examine the effects of TX Sprouts, a one-year school-based gardening, cooking, and nutrition cluster randomized controlled trial, on students’ dietary intake and quality. Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to control (i.e., delayed intervention) over three years (2016–2019). The intervention arm received: formation and training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly in the teaching garden during school hours; and nine parent lessons, taught monthly. Dietary intake data via two 24 h dietary recalls (24 hDR) were collected on a random subsample (n = 468). Dietary quality was calculated using the Healthy Eating Index 2015 (HEI-2015). The intervention group compared to control resulted in a modest increase in protein intake as a percentage of total energy (0.4% vs. −0.3%, p = 0.021) and in HEI-2015 total vegetables component scores (+4% vs. −2%, p = 0.003). When stratified by ethnicity/race, non-Hispanic children had a significant increase in HEI-2015 total vegetable scores in the intervention group compared to the control group (+4% vs. −8%, p = 0.026). Both the intervention and control groups increased added sugar intake; however, to a lesser extent within the intervention group (0.3 vs. 2.6 g/day, p = 0.050). School-based gardening, cooking, and nutrition interventions can result in significant improvements in dietary intake. Further research on ways to scale and sustain nutrition education programs in schools is warranted. The trial is registered at ClinicalTrials.gov (NCT02668744).

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Slip-resistant footwear reduces slips among National Health Service workers in England: a randomised controlled trial

Occupational and Environmental Medicine ◽

10.1136/oemed-2020-106914 ◽

2021 ◽

pp. oemed-2020-106914 ◽

Cited By ~ 1

Author(s):

Sarah Cockayne ◽

Caroline Fairhurst ◽

Gillian Frost ◽

Mark Liddle ◽

Rachel Cunningham-Burley ◽

...

Keyword(s):

National Health Service ◽

Randomised Controlled Trial ◽

Health Service ◽

Incidence Rate ◽

National Health ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled

ObjectivesAssess the effectiveness of 5* GRIP-rated slip-resistant footwear in preventing slips in the workplace compared to usual footwear (control group).MethodsA multicentre, randomised controlled trial; 4553 National Health Service (NHS) staff were randomised 1:1 to the intervention group (provided with 5* GRIP-rated slip-resistant footwear) or the control group. The primary outcome of incidence rate of self-reported slips in the workplace over 14 weeks was analysed using a mixed-effects negative binomial model. Secondary outcome measures included incidence rate of falls from a slip, falls not from a slip, proportion of participants reporting a slip, fall or fracture and time to first slip and fall.Results6743 slips were reported: 2633 in the intervention group (mean 1.16 per participant, range 0 to 36) and 4110 in the control group (mean 1.80 per participant, range 0 to 83). There was a statistically significant reduction in slip rate in the intervention group relative to the control group (incidence rate ratio (IRR) 0.63, 95% CI 0.57 to 0.70, p<0.001). Statistically significant differences, in favour of the intervention group, were observed in falls from a slip (IRR 0.51, 95% CI 0.28 to 0.92, p=0.03), the proportion of participants who reported a slip (OR 0.58, 95% CI 0.50 to 0.66, p<0.001) or fall (OR 0.73, 95% CI 0.54 to 0.99, p=0.04) and time to first slip (HR 0.73, 95% CI 0.67 to 0.80, p<0.001).ConclusionsThe offer and provision of 5* GRIP-rated footwear reduced slips in NHS staff in the workplace.Trial registration numberISRCTN33051393.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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