scholarly journals Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II)

JMIR Cancer ◽  
10.2196/31576 ◽  
2022 ◽  
Vol 8 (1) ◽  
pp. e31576
Author(s):  
Erin L Van Blarigan ◽  
Anand Dhruva ◽  
Chloe E Atreya ◽  
Stacey A Kenfield ◽  
June M Chan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Walk Test ◽  
Randomized Controlled ◽  
6 Minute Walk Test ◽  
Minute Walk

Background We conducted a pilot 2-arm randomized controlled trial to assess the feasibility of a digital health intervention to increase moderate-to-vigorous physical activity in patients with colorectal cancer (CRC) during chemotherapy. Objective This study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC. Methods Potentially eligible patients with CRC expected to receive at least 12 weeks of chemotherapy were identified in person at the University of California, San Francisco, and on the web through advertising. Eligible patients were randomized 1:1 to a 12-week intervention (Fitbit Flex, automated SMS text messages) versus usual care. At 0 and 12 weeks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-minute walk test. Participants could not be masked to their intervention arm, but people assessing the body size and 6-minute walk test outcomes were masked. The primary outcomes were adherence (eg, Fitbit wear and text response rate) and self-assessed acceptability of the intervention. The intervention would be considered feasible if we observed at least 80% complete follow-up and 70% adherence and satisfaction, a priori. Results From 2018 to 2020, we screened 240 patients; 53.3% (128/240) of patients were ineligible and 26.7% (64/240) declined to participate. A total of 44 patients (44/240, 18%) were randomized to the intervention (n=22) or control (n=22) groups. Of these, 57% (25/44) were women; 68% (30/44) identified as White and 25% (11/44) identified as Asian American or Pacific Islander; and 77% (34/44) had a 4-year college degree. The median age at enrollment was 54 years (IQR 45-62 years). Follow-up at 12 weeks was 91% (40/44) complete. In the intervention arm, patients wore Fitbit devices on a median of 67 out of 84 (80%) study days and responded to a median of 17 out of 27 (63%) questions sent via SMS text message. Among 19 out of 22 (86%) intervention patients who completed the feedback survey, 89% (17/19) were satisfied with the Fitbit device; 63% (12/19) were satisfied with the SMS text messages; 68% (13/19) said the SMS text messages motivated them to exercise; 74% (14/19) said the frequency of SMS text messages (1-3 days) was ideal; and 79% (15/19) said that receiving SMS text messages in the morning and evening was ideal. Conclusions This pilot study demonstrated that many people receiving chemotherapy for CRC are interested in participating in digital health physical activity interventions. Fitbit adherence was high; however, participants indicated a desire for more tailored SMS text message content. Studies with more socioeconomically diverse patients with CRC are required. Trial Registration ClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716

scholarly journals Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II) (Preprint)

2021 ◽  
Author(s):  
Erin L Van Blarigan ◽  
Anand Dhruva ◽  
Chloe E Atreya ◽  
Stacey A Kenfield ◽  
June M Chan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Walk Test ◽  
Randomized Controlled ◽  
6 Minute Walk Test ◽  
Minute Walk

BACKGROUND We conducted a pilot 2-arm randomized controlled trial to assess the feasibility of a digital health intervention to increase moderate-to-vigorous physical activity in patients with colorectal cancer (CRC) during chemotherapy. OBJECTIVE This study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC. METHODS Potentially eligible patients with CRC expected to receive at least 12 weeks of chemotherapy were identified in person at the University of California, San Francisco, and on the web through advertising. Eligible patients were randomized 1:1 to a 12-week intervention (Fitbit Flex, automated SMS text messages) versus usual care. At 0 and 12 weeks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-minute walk test. Participants could not be masked to their intervention arm, but people assessing the body size and 6-minute walk test outcomes were masked. The primary outcomes were adherence (eg, Fitbit wear and text response rate) and self-assessed acceptability of the intervention. The intervention would be considered feasible if we observed at least 80% complete follow-up and 70% adherence and satisfaction, a priori. RESULTS From 2018 to 2020, we screened 240 patients; 53.3% (128/240) of patients were ineligible and 26.7% (64/240) declined to participate. A total of 44 patients (44/240, 18%) were randomized to the intervention (n=22) or control (n=22) groups. Of these, 57% (25/44) were women; 68% (30/44) identified as White and 25% (11/44) identified as Asian American or Pacific Islander; and 77% (34/44) had a 4-year college degree. The median age at enrollment was 54 years (IQR 45-62 years). Follow-up at 12 weeks was 91% (40/44) complete. In the intervention arm, patients wore Fitbit devices on a median of 67 out of 84 (80%) study days and responded to a median of 17 out of 27 (63%) questions sent via SMS text message. Among 19 out of 22 (86%) intervention patients who completed the feedback survey, 89% (17/19) were satisfied with the Fitbit device; 63% (12/19) were satisfied with the SMS text messages; 68% (13/19) said the SMS text messages motivated them to exercise; 74% (14/19) said the frequency of SMS text messages (1-3 days) was ideal; and 79% (15/19) said that receiving SMS text messages in the morning and evening was ideal. CONCLUSIONS This pilot study demonstrated that many people receiving chemotherapy for CRC are interested in participating in digital health physical activity interventions. Fitbit adherence was high; however, participants indicated a desire for more tailored SMS text message content. Studies with more socioeconomically diverse patients with CRC are required. CLINICALTRIAL ClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716

scholarly journals A secondary analysis of data from the OPTICARE randomized controlled trial investigating the effects of extended cardiac rehabilitation on functional capacity, fatigue, and participation in society

2019 ◽  
Vol 33 (8) ◽  
pp. 1355-1366
Author(s):  
Nienke ter Hoeve ◽  
Madoka Sunamura ◽  
Henk J Stam ◽  
Ron T van Domburg ◽  
Rita JG van den Berg-Emons
Keyword(s):  
Cardiac Rehabilitation ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Walk Test ◽  
Face To Face ◽  
Randomized Controlled ◽  
After Care ◽  
6 Minute Walk Test ◽  
Minute Walk

Objective: In this secondary analysis of data from the OPTICARE trial, we compared the effects of two behavioral interventions integrated into cardiac rehabilitation to standard rehabilitation with regard to functional capacity, fatigue, and participation in society. Design: This is a randomized controlled trial. Setting: This study was conducted in a cardiac rehabilitation setting. Subjects: A total of 740 patients with acute coronary syndrome were recruited for this study. Interventions: Patients were randomized to (1) three months of standard rehabilitation; (2) cardiac rehabilitation plus nine months after-care with face-to-face group lifestyle counseling; or (3) cardiac rehabilitation plus nine months after-care with individual lifestyle telephone counseling. Main measures: Functional capacity (6-minute walk test), fatigue (Fatigue Severity Scale), and participation in society (Utrecht Scale for Evaluation of Rehabilitation-Participation) were measured at randomization, 3, 12, and 18 months. Results: Additional face-to-face sessions resulted at 12 months in 12.49 m more on the 6-minute walk test compared to standard rehabilitation ( P = .041). This difference was no longer present at 18 months. Prevalence of fatigue decreased from 30.2% at baseline to 11.9% at 18 months compared to an improvement from 37.3% to 24.9% after standard rehabilitation (between-group difference: odds ratio = 0.47; P = .010). The additional improvements in functional capacity seemed to be mediated by increases in daily physical activity. No mediating effects were found for fatigue. No additional improvements were seen for participation in society. Additional telephonic sessions did not result in additional intervention effects. Conclusion: Extending cardiac rehabilitation with a face-to-face behavioral intervention resulted in additional long-term improvements in fatigue and small improvements in functional capacity up to 12 months. A telephonic behavioral intervention provided no additional benefits.

scholarly journals Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Sofian Berrouiguet ◽  
Mark Erik Larsen ◽  
Catherine Mesmeur ◽  
Michel Gravey ◽  
Romain Billot ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Suicide Prevention ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Suicide Intervention ◽  
Randomized Controlled ◽  
Crisis Support ◽  
The Impact

BACKGROUND Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting. OBJECTIVE The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up. METHODS SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period. RESULTS Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message. CONCLUSIONS This text message–based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing suicidal ideation as well as in a period after receiving messages. As follow-up phone calls over an extended period of time may not be feasible, this intervention has the potential to offer simple technological support for individuals following discharge from the ED. CLINICALTRIAL ClinicalTrials.gov NCT02106949; https://clinicaltrials.gov/ct2/show/NCT02106949 (Archived by WebCite at http://www.webcitation.org/6wMtAFL49)

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)

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.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial

Gerontology ◽  
2018 ◽  
Vol 65 (3) ◽  
pp. 299-307 ◽  
Author(s):  
Changhong Wang ◽  
Rahul Goel ◽  
Hadi Rahemi ◽  
Qianzi Zhang ◽  
Brian Lepow ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Fear Of Falling ◽  
Controlled Trial ◽  
Foot Orthoses ◽  
Female Age ◽  
Randomized Controlled ◽  
Custom Made ◽  
Ankle Foot Orthoses

Background: Foot problems are prevalent in older adults, which may increase the risk and concern for falls. Ankle-foot orthoses (AFO) have been shown to be effective in the stabilization of lower extremities, but their long-term effectiveness in improving balance and their potential to encourage older adults to become more physically active are still debated. Objective: This randomized controlled trial investigated the effectiveness of daily use of a custom-made AFO on balance, fear of falling, and physical activity in older adults. Study Design: Forty-four older adults with concern about or at risk for falling were randomly allocated to either the control group (CG; 77.3% female, age 75.6 ± 6.5 years, BMI 29.3 ± 6.4) or the intervention group (IG; 63.6% female, age 73.7 ± 6.3 years, BMI = 27.8 ± 4.8). The IG received walking shoes and bilateral custom-made AFO. The CG received only walking shoes. At the baseline and 6-month follow-ups, balance and physical activity were assessed using validated wearable instrumentation and fear of falling was assessed using the Fall Efficacy Scale-International (FES-I). Adherence and acceptability toward wearing the AFO were assessed using self-reported questionnaires at the 6-month follow-up. Results: No significant between-group difference was observed at baseline (p = 0.144–0.882). Compared to baseline and the CG, hip, ankle, and center-of-mass (COM) sways were significantly reduced at the 6-month follow-up in the IG while standing with the feet together during the eyes-open condition (p = 0.005–0.040). Within the IG, the FES-I was reduced significantly (p = 0.036) and there was an increasing trend in the number of walking bouts with a medium effect size (d = 0.52, p = 0.440) compared to baseline. However, there were no significant changes in FES-I and physical activity measures in the CG (p = 0.122–0.894). The reduction in COM sway in the IG was moderately correlated with adherence (r = –0.484, p = 0.047) and strongly correlated with baseline COM sway (r = –0.903, p < 0.001). Conclusion: Results suggest that bilateral custom-made AFO plus walking shoes is effective in improving balance compared to walking shoes alone, and it significantly reduces the fear of falling, with a nonsignificant but noticeable positive trend in physical activity, compared to baseline. The results also suggest that older adults with poor balance at baseline and higher daily adherence to using the AFO will gain more benefit from the AFO intervention.

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

2018 ◽  
Vol 89 (2) ◽  
pp. 262-267 ◽  
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.

scholarly journals Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study)

10.2196/13005 ◽  
2019 ◽  
Vol 7 (8) ◽  
pp. e13005
Author(s):  
Lianne Gonsalves ◽  
Winnie Wangari Njeri ◽  
Megan Schroeder ◽  
Jefferson Mwaisaka ◽  
Peter Gichangi
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Health Interventions ◽  
World Health ◽  
Intervention Period ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Client Side

Background Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. Objective This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. Methods This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. Results Two study team decisions had significant implications for the success of the trial’s enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were “stuck” at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. Conclusions The ARMADILLO study’s implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. Clinical Trial International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148

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