Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss

ObjectivesTo examine the acceptability and feasibility of narrative text messages with or without financial incentives to support weight loss for men.DesignIndividually randomised three-arm feasibility trial with 12 months’ follow-up.SettingTwo sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD).ParticipantsMen with obesity (n=105) recruited through community outreach and general practitioner registers.InterventionsParticipants randomised to: (A) narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control.OutcomesAcceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data at 3, 6 and 12 months.Results105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2). Retention at 12 months was 74%. Fewer SMS+I participants (64%) completed 12-month assessments compared with SMS only (79%) and control (83%). Narrative texts were acceptable to many men, but some reported negative reactions. No evidence emerged that level of disadvantage was related to acceptability of narrative texts. Eleven SMS+I participants (31%) successfully met or partially met weight loss targets. The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30). Incentives were acceptable, but improving health was reported as the key motivator for weight loss. All groups lost weight (SMS+I: −2.51 kg (SD=4.94); SMS only: −1.29 kg (SD=5.03); control: −0.86 kg (SD=5.64) at 12 months).ConclusionsThis three-arm weight management feasibility trial recruited and retained men from across the socioeconomic spectrum, with the majority from areas of disadvantage, was broadly acceptable to most participants and feasible to deliver.Trial registration numberNCT03040518.

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Tailored Medication Adherence Incentives Using mHealth for Children With High-Risk Asthma (TAICAM): Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/16711 ◽

2020 ◽

Vol 9 (8) ◽

pp. e16711

Author(s):

Brittney R Henderson ◽

Carina M Flaherty ◽

G Chandler Floyd ◽

Jack You ◽

Rui Xiao ◽

...

Keyword(s):

High Risk ◽

Financial Incentives ◽

Financial Incentive ◽

Controlled Trial ◽

Text Message ◽

Inhaled Corticosteroid ◽

Target Sample Size ◽

Sustained Effects ◽

System Use ◽

High Adherence

Background Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown. Objective The aim of this study is to determine the marginal effects of a financial incentive–based intervention on inhaled corticosteroid adherence, health care system use, and costs. Methods Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain–framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent. Results Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023. Conclusions This study will provide data that will help to determine whether a financial incentive–based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods. Trial Registration Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410 International Registered Report Identifier (IRRID) DERR1-10.2196/16711

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Tailored Medication Adherence Incentives Using mHealth for Children With High-Risk Asthma (TAICAM): Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.16711 ◽

2019 ◽

Author(s):

Brittney R Henderson ◽

Carina M Flaherty ◽

G Chandler Floyd ◽

Jack You ◽

Rui Xiao ◽

...

Keyword(s):

High Risk ◽

Financial Incentives ◽

Financial Incentive ◽

Controlled Trial ◽

Text Message ◽

Inhaled Corticosteroid ◽

Target Sample Size ◽

Sustained Effects ◽

System Use ◽

High Adherence

BACKGROUND Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown. OBJECTIVE The aim of this study is to determine the marginal effects of a financial incentive–based intervention on inhaled corticosteroid adherence, health care system use, and costs. METHODS Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain–framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent. RESULTS Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023. CONCLUSIONS This study will provide data that will help to determine whether a financial incentive–based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods. CLINICALTRIAL Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16711

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Mobile telephone delivered contingency management for encouraging adherence to supervised methadone consumption: feasibility study for an RCT of clinical and cost-effectiveness (TIES)

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00761-4 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

N. Metrebian ◽

E. Carr ◽

K. Goldsmith ◽

T. Weaver ◽

S. Pilling ◽

...

Keyword(s):

Medication Adherence ◽

Financial Incentives ◽

Controlled Trial ◽

Contingency Management ◽

Text Message ◽

Text Messages ◽

Mobile Telephone ◽

Opioid Use ◽

Future Trial ◽

Debit Card

Abstract Background Prescription methadone or buprenorphine enables people with opioid use disorder to stop heroin use safely while avoiding withdrawal. To ensure methadone is taken as prescribed and to prevent diversion onto the illicit market, people starting methadone take their daily dose under a pharmacist’s supervision. Many patients miss their daily methadone dose risking withdrawal, craving for heroin and overdose due to loss of heroin tolerance. Contingency management (CM) can improve medication adherence, but remote delivery using technology may be resource-light and cost-effective. We developed an innovative way to deliver CM by mobile telephone. Software monitors patients’ attendance and supervised methadone consumption through an internet self-login at the pharmacy and sends reinforcing text messages to patients’ mobile telephones. A linked system sends medication adherence reports to prescribers and provides early warning alerts of missed doses. A pre-paid debit card system provides financial incentives. Methods A cluster randomised controlled trial design was used to test the feasibility of conducting a future trial of mobile telephone CM to encourage adherence to supervised methadone in community pharmacies. Each cluster (drug service/3 allied pharmacies) was randomly allocated to provide patient’s presenting for a new episode of opiate agonist treatment (OAT) with either (a) mobile telephone text message CM, (b) mobile telephone text message reminders, or (c) no text messages. We assessed acceptability of the interventions, recruitment, and follow-up procedures. Results Four drug clinics were approached and three recruited. Thirty-three pharmacists were approached and 9 recruited. Over 3 months, 173 individuals were screened and 10 enrolled. Few patients presented for OAT and high numbers were excluded due to receiving buprenorphine or not attending participating pharmacies. There was 96% consistency in recording medication adherence by self-login vs. pharmacy records. In focus groups, CM participants were positive about using self-login, the text messages, and debit card. Prescribers found weekly reporting, time saving, and allowed closer monitoring of patients. Pharmacists reported that the tablet device was easy to host. Conclusion Mobile telephone CM worked well, but a planned future trial will use modified eligibility criteria (existing OAT patients who regularly miss their methadone/buprenorphine doses) and increase the number of participating pharmacies. Trial registration The trial is retrospectively registered, ISRCTN 58958179.

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Abstract P386: Design of a Tailored Text-message Intervention for Weight Loss

Circulation ◽

10.1161/circ.125.suppl_10.ap386 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Julia Kolodziejczyk ◽

Anglica Barrera ◽

Kevin Patrick ◽

Lindsay Dillon ◽

Simon Marshall ◽

...

Keyword(s):

Weight Loss ◽

Behavior Change ◽

Weight Management ◽

Large Scale ◽

Controlled Trial ◽

Self Regulation ◽

Text Message ◽

User Preferences ◽

Text Messages ◽

Text Message Intervention

Introduction: Tailoring information is a commonly used health communication technique to individualize behavior change programs. However, few studies have applied individualized tailoring to a text-message intervention. Using tailoring with text-messages may be a powerful behavior change tool as this technology is inexpensive, asynchronous, and is ubiquitous across socio-economic segments. We developed a tailored, “push/pull,” text-message intervention for overweight/obese English and Spanish-speaking participants that targets weight management behaviors. The development of the theory-driven logic rules for individualized text-messages is described. Methods: A robust web-based participant intake system was developed to gather and store the data needed to individualize the messages by personalization, feedback, and content matching. Feedback and content matching was based on both a baseline weight management behavior survey and continual text message-based assessments related to individual behaviors and perceived barriers. The system is designed so that participants who show rapid and sustained progress can advance through the content, while those having difficulties can receive additional tips and suggestions. Participants will be scheduled to receive 3-4 interactive messages per day from our library of over 6,000 text messages. We categorized the messages into five groups: 1) Subject matter: Content related to nutrition and physical activity behaviors; 2) Behavioral core strategies based on Self-Regulation Theory (e.g. self-monitoring, goal setting); 3) Message type (e.g. reminder, feedback); 4) Personalization (e.g. favorite restaurants, friends’ names); and 5) Location related messages. We also developed a “like/ don’t like” feature so that the system can continuously learn user preferences for message types and adjust the type of future messages sent accordingly. Conclusion: A large-scale randomized controlled trial is underway to evaluate the efficacy of this text-message intervention. While this intervention is aimed at weight loss, our tailoring technique will likely apply to other health behaviors as well.

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Temporal Dynamics of Treatment Receipt in a Text Message Intervention for Physical Activity: Single-Group, Within-Person Trial

JMIR mhealth and uhealth ◽

10.2196/14270 ◽

2020 ◽

Vol 8 (4) ◽

pp. e14270

Author(s):

David E Conroy ◽

Chih-Hsiang Yang ◽

Stephanie T Lanza ◽

Joshua M Smyth ◽

Constantino M Lagoa

Keyword(s):

Financial Incentives ◽

Temporal Dynamics ◽

Financial Incentive ◽

Text Message ◽

Text Messages ◽

Community Dwelling ◽

Just In Time ◽

Message Delivery ◽

Message Content ◽

Health Behavior Interventions

Background Mobile technology has increased the reach of health behavior interventions but raised new challenges in assessing the fidelity of treatment receipt. Fidelity can be compromised if participant fatigue or burden reduces engagement, leading to missed or delayed treatments for just-in-time interventions. Objective This study aimed to investigate the temporal dynamics of text message receipt confirmations. Methods Community-dwelling adults (N=10) were sent five text messages daily for 4 months (5598 messages sent in total), with a financial incentive to confirm receipt of 75% or more messages. Results Overall, the message receipt confirmation rate was very high (5504/5598, 98.32%) and timely (eg, two-thirds of confirmations within 2 min). Confirmation times were slightly slower on weekends (vs weekdays) and as a function of the cumulative time in the study. Neither time of message delivery nor message content was associated with message confirmation latencies. Conclusions Participants receiving financial incentives to confirm text message receipt exhibit extremely high and fast confirmation rates, although receipt confirmations were somewhat less timely on weekends (vs weekdays) and later in the intervention. The social calendar and treatment fatigue should be considered when planning text message–based interventions, especially if treatments are intended for a just-in-time delivery that requires extended engagement and precise timing.

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Log2Lose: Development and Lessons Learned From a Mobile Technology Weight Loss Intervention (Preprint)

10.2196/preprints.11972 ◽

2018 ◽

Author(s):

Ryan Shaw ◽

Erica Levine ◽

Martin Streicher ◽

Elizabeth Strawbridge ◽

Jennifer Gierisch ◽

...

Keyword(s):

Weight Loss ◽

Real Time ◽

Mobile Technology ◽

Mobile Health ◽

Financial Incentives ◽

Text Messages ◽

Lessons Learned ◽

Security And Privacy ◽

Feasibility Trial ◽

Self Monitoring

BACKGROUND Providing financial incentives has gained popularity as a strategy to promote weight loss, but questions remain about how best to utilize them. A promising mobile health strategy provides users with near-real-time financial incentives based on both the process of weight loss (behavioral modification) and actual weight loss. To maximize the impact of this strategy, a methodology is needed to close the gap between the desired behavior and the financial incentive. Leveraging mobile health tools—such as mobile phone apps, cellular body weight scales that transmit data to physicians and researchers, and text messaging for instructions and encouragement—has the potential to close this gap. OBJECTIVE This study aimed to describe the development of an innovative technology-based solution and lessons learned from a feasibility trial—Log2Lose—that encouraged individuals to lose weight by providing near-real-time financial incentives for weight loss and/or dietary self-monitoring. METHODS We recruited participants (N=96) with a body mass index greater than or equal to 30 kg/m2 for a 24-week weight loss trial. Participants received a behavioral intervention of biweekly, in-person group sessions and were instructed to log a minimum number of daily calories in MyFitnessPal and to step on the BodyTrace cellular scale at least twice per week. In a 2×2 design, participants were randomized into 4 groups to receive financial incentives for the following: (group 1) weekly weight loss and dietary self-monitoring, (group 2) dietary self-monitoring only, (group 3) weekly weight loss only, or (group 4) no financial incentives. Diet and weight data from the devices were obtained through application programming interfaces. Each week, we applied algorithms to participants’ data to determine whether they qualified for a monetary incentive (groups 1-3). A text message notified these participants of whether they met weight loss and/or self-monitoring requirements to earn an incentive and the amount they earned or would have earned. The money was uploaded to a debit card. RESULTS Our custom-engineered software platform analyzed data from multiple sources, collated and processed the data to send appropriate text messages automatically, and informed study staff of the appropriate incentives. We present lessons learned from the development of the software system and challenges encountered with technology, data transmission, and participants (eg, lost connections or delayed communication). CONCLUSIONS With consistent and constant validation checks and a robust beta test run, the process of analyzing data and determining eligibility for weekly incentives can be mostly automated. We were able to accomplish this project within an academic health system, which required significant security and privacy safeguards. Our success demonstrates how this methodology of automated feedback loops can provide health interventions via mobile technology. CLINICALTRIAL ClinicalTrials.gov NCT02691260; https://clinicaltrials.gov/ct2/show/NCT02691260

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Efficacy and Impact of an mHealth Intervention to promote Mental Wellness for American Indian and Alaska Native Teens and Young Adults: A Randomized Controlled Trial of the BRAVE Study (Preprint)

10.2196/preprints.26158 ◽

2020 ◽

Author(s):

Stephanie Craig Rushing ◽

Allyson Kelley ◽

Sheana Bull ◽

David Stephens ◽

Julia Wrobel ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Young Adults ◽

Alaska Native ◽

Help Seeking ◽

Culturally Relevant ◽

Controlled Trial ◽

Text Message ◽

Text Messages ◽

Randomized Controlled ◽

Mental Wellness

BACKGROUND Culturally-relevant interventions are needed to help American Indian and Alaska Native (AI/AN) teens and young adults navigate common risky situations involving family and friends, including drug and alcohol misuse, dating violence, and suicidality. We R Native – a multimedia health resource for Native teens and young adults – designed an intervention for Native youth, delivered via text message, that includes role model videos, mental wellness strategies, and links to culturally-relevant resources (hotlines, chat-lines, websites, etc.) and social support. OBJECTIVE This study aims to test the efficacy of BRAVE to improve participant’s physical, mental, and spiritual health, their use of mental wellness strategies, their help-seeking skills, and associated factors, including cultural resilience, identity, and cultural pride. METHODS The randomized controlled trial was carried out by the Northwest Portland Area Indian Health Board and the mHealth Impact Lab. The team recruited 2,334 AI/AN teens and young adults nationwide (15-24 years old) via social media channels and text message and enrolled 1,044 to participate. AI/AN teens and young adults enrolled in the study received either: 8 weeks of BRAVE text messages designed to improve mental health, help-seeking skills, and cultural resilience; or 8 weeks of STEM text messages, designed to elevate and re-affirm Native voices in science, technology, engineering, math and medicine (STEM); and then received the other set of messages. Primary and secondary outcomes were tested using linear mixed-effect models and linear regressions. RESULTS A total of 833 AI/AN teens and young adults were included in the analysis. Individuals in the BRAVE and STEM arms showed significant positive trends over the course of the study for all primary outcomes except cultural identity and help seeking behavior. Mean scores were significantly different for health (P<.001), resilience (P<.001), negative coping (P=.027), positive coping (P<.001), self-efficacy (P=.021), and self-esteem (P<.001). Changes in help-seeking self-efficacy were significant for those exhibiting risky behavior at baseline to exit (P=.01). Those who reported positive coping scores at baseline also reported better health on average, but no difference in risky drug and alcohol use (P<.001). The number of participants that used text messages to help themselves increased from 69% at 3-months (427/618) to 75% at 8-months (381/501) (P<.001). Similarly, the number of participants that used text messages to help a friend or family member increased from 22% at 3-months (138/616) to 55% at 8-months (272/498). CONCLUSIONS This is the first nationwide randomized controlled trial for AI/AN teens and young adults to test the efficacy of an mHealth intervention on mental wellness. The findings suggest that culturally-relevant multimedia, mHealth interventions can improve help-seeking behavior. Lessons learned from this study may help other AI/AN-serving organizations, prevention programs, policymakers, researchers, and educators as they support the next generation of AI/AN change-makers.

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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Effect of automated messaging on oral hygiene in adolescent orthodontic patients: A randomized controlled trial

The Angle Orthodontist ◽

10.2319/040618-260.1 ◽

2018 ◽

Vol 89 (2) ◽

pp. 262-267 ◽

Cited By ~ 4

Author(s):

Mike C. Ross ◽

Phillip M. Campbell ◽

Larry P. Tadlock ◽

Reginald W. Taylor ◽

Peter H. Buschang

Keyword(s):

Randomized Controlled Trial ◽

Oral Hygiene ◽

Treatment Time ◽

Controlled Trial ◽

Text Message ◽

Text Messages ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Orthodontic Patients ◽

Hygiene Compliance

ABSTRACTObjective:To determine whether automated text messages sent daily to adolescent orthodontic patients improves oral hygiene more than weekly reminders.Materials and Methods:A blinded, prospective, randomized controlled trial was designed to evaluate the effects of automated messages on oral hygiene. Subjects were recruited from patients undergoing orthodontic treatment at the Texas A&M University College of Dentistry, Department of Orthodontics. They were being treated with a variety of fixed full appliances in both arches. Subjects were randomly assigned to either a once-a-week text message group or a daily text message group. There were 52 females and 27 males who were 12 to 17 years of age. Oral hygiene was measured at the beginning of the study and again 8.6 ± 0.9 weeks later.Results:The daily reminder group (N = 42) had significantly greater improvements in oral hygiene compliance than the weekly reminder group (N = 37). The daily score decreases were 48%, 21% and 19% for the bleeding index (BI), plaque index (PI), and gingival index (GI), respectively. The weekly score decreases were 27%, 14% and 13% for the BI, PI, and GI. There were no sex differences in hygiene changes during the study. The 42% of patients who completed the survey at the end of the study wanted more frequent messages and reported that messages related to decreasing treatment time were the most effective, while those related to oral hygiene were the least effective.Conclusions:Daily text messages are more effective at improving oral hygiene than weekly text messages.

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Incentives in Diabetic Eye Assessment by Screening (IDEAS) trial: a three-armed randomised controlled trial of financial incentives

Health Services and Delivery Research ◽

10.3310/hsdr05150 ◽

2017 ◽

Vol 5 (15) ◽

pp. 1-60 ◽

Cited By ~ 4

Author(s):

Gaby Judah ◽

Ara Darzi ◽

Ivo Vlaev ◽

Laura Gunn ◽

Derek King ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Health Services ◽

Financial Incentives ◽

Financial Incentive ◽

Controlled Trial ◽

Fixed Group ◽

Screening Uptake ◽

Invitation Letter ◽

Screening Attendance ◽

Randomised Controlled

BackgroundThe UK national diabetic eye screening (DES) programme invites diabetic patients aged > 12 years annually. Simple and cost-effective methods are needed to increase screening uptake. This trial tests the impact on uptake of two financial incentive schemes, based on behavioural economic principles.ObjectivesTo test whether or not financial incentives encourage screening attendance. Secondarily to understand if the type of financial incentive scheme used affects screening uptake or attracts patients with a different sociodemographic status to regular attenders. If financial incentives were found to improve attendance, then a final objective was to test cost-effectiveness.DesignThree-armed randomised controlled trial.SettingDES clinic within St Mary’s Hospital, London, covering patients from the areas of Kensington, Chelsea and Westminster.ParticipantsPatients aged ≥ 16 years, who had not attended their DES appointment for ≥ 2 years.Interventions(1) Fixed incentive – invitation letter and £10 for attending screening; (2) probabilistic (lottery) incentive – invitation letter and 1% chance of winning £1000 for attending screening; and (3) control – invitation letter only.Main outcome measuresThe primary outcome was screening attendance. Rates for control versus fixed and lottery incentive groups were compared using relative risk (RR) and risk difference with corresponding 95% confidence intervals (CIs).ResultsA total of 1274 patients were eligible and randomised; 223 patients became ineligible before invite and 1051 participants were invited (control,n = 435; fixed group,n = 312; lottery group,n = 304). Thirty-four (7.8%, 95% CI 5.29% to 10.34%) control, 17 (5.5%, 95% CI 2.93% to 7.97%) fixed group and 10 (3.3%, 95% CI 1.28% to 5.29%) lottery group participants attended. Participants offered incentives were 44% less likely to attend screening than controls (RR 0.56, 95% CI 0.34 to 0.92). Examining incentive groups separately, the lottery group were 58% less likely to attend screening than controls (RR 0.42, 95% CI 0.18 to 0.98). No significant differences were found between fixed incentive and control groups (RR 0.70, 95% CI 0.35 to 1.39) or between fixed and lottery incentive groups (RR 1.66, 95% CI 0.65 to 4.21). Subgroup analyses showed no significant associations between attendance and sociodemographic factors, including gender (female vs. male, RR 1.25, 95% CI 0.77 to 2.03), age (≤ 65 years vs. > 65 years, RR 1.26, 95% CI 0.77 to 2.08), deprivation [0–20 Index of Multiple Deprivation (IMD) decile vs. 30–100 IMD decile, RR 1.12, 95% CI 0.69 to 1.83], years registered [mean difference (MD) –0.13, 95% CI –0.69 to 0.43], and distance from screening location (MD –0.18, 95% CI –0.65 to 0.29).LimitationsDespite verification, some address details may have been outdated, and high ethnic diversity may have resulted in language barriers for participants.ConclusionsThose receiving incentives were not more likely to attend a DES than those receiving a usual invitation letter in patients who are regular non-attenders. Both fixed and lottery incentives appeared to reduce attendance. Overall, there is no evidence to support the use of financial incentives to promote diabetic retinopathy screening. Testing interventions in context, even if they appear to be supported by theory, is important.Future workFuture research, specifically in this area, should focus on identifying barriers to screening and other non-financial methods to overcome them.Trial registrationCurrent Controlled Trials ISRCTN14896403.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 5, No. 15. See the NIHR Journals Library website for further project information.

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