The Effect of Tailored, Daily, Smartphone Feedback to Lifestyle Self-Monitoring on Weight Loss at 12 Months: the SMARTER Randomized Clinical Trial.

BACKGROUND: Self-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials. OBJECTIVE: The aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m2. METHODS: All participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants' dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal). RESULTS: Participants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m2. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: -2.12%, 95% CI -3.04% to -1.21%, P<.001; SM: -2.39%, 95% CI -3.32% to -1.47%; P<.001), but no difference between the groups (-0.27%; 95% CI -1.57% to 1.03%; t =-0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=-0.10; 95% CI -0.13 to -0.07; t =-5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001). CONCLUSIONS: There were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools. TRIAL REGISTRATION: Clinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936.

Data Collection and Management of mHealth, Wearables, and Internet of Things in Digital Behavioral Health Interventions With the Awesome Data Acquisition Method (ADAM): Development of a Novel Informatics Architecture.

Unlabelled: The integration of health and activity data from various wearable devices into research studies presents technical and operational challenges. The Awesome Data Acquisition Method (ADAM) is a versatile, web-based system that was designed for integrating data from various sources and managing a large-scale multiphase research study. As a data collecting system, ADAM allows real-time data collection from wearable devices through the device's application programmable interface and the mobile app's adaptive real-time questionnaires. As a clinical trial management system, ADAM integrates clinical trial management processes and efficiently supports recruitment, screening, randomization, data tracking, data reporting, and data analysis during the entire research study process. We used a behavioral weight-loss intervention study (SMARTER trial) as a test case to evaluate the ADAM system. SMARTER was a randomized controlled trial that screened 1741 participants and enrolled 502 adults. As a result, the ADAM system was efficiently and successfully deployed to organize and manage the SMARTER trial. Moreover, with its versatile integration capability, the ADAM system made the necessary switch to fully remote assessments and tracking that are performed seamlessly and promptly when the COVID-19 pandemic ceased in-person contact. The remote-native features afforded by the ADAM system minimized the effects of the COVID-19 lockdown on the SMARTER trial. The success of SMARTER proved the comprehensiveness and efficiency of the ADAM system. Moreover, ADAM was designed to be generalizable and scalable to fit other studies with minimal editing, redevelopment, and customization. The ADAM system can benefit various behavioral interventions and different populations.

Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic.

OBJECTIVES: To automatically populate the case report forms (CRFs) for an international, pragmatic, multifactorial, response-adaptive, Bayesian COVID-19 platform trial. METHODS: The locations of focus included 27 hospitals and 2 large electronic health record (EHR) instances (1 Cerner Millennium and 1 Epic) that are part of the same health system in the United States. This paper describes our efforts to use EHR data to automatically populate four of the trial's forms: baseline, daily, discharge, and response-adaptive randomization. RESULTS: Between April 2020 and May 2022, 417 patients from the UPMC health system were enrolled in the trial. A MySQL-based extract, transform, and load pipeline automatically populated 499 of 526 CRF variables. The populated forms were statistically and manually reviewed and then reported to the trial's international data coordinating center. CONCLUSIONS: We accomplished automatic population of CRFs in a large platform trial and made recommendations for improving this process for future trials.

A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan.

BACKGROUND: High flow nasal cannula (HFNC) has been increasingly adopted in the past 2 decades as a mode of respiratory support for children hospitalized with bronchiolitis. The growing use of HFNC despite a paucity of high-quality data regarding the therapy's efficacy has led to concerns about overutilization. We developed an electronic health record (EHR) embedded, quality improvement (QI) oriented clinical trial to determine whether standardized management of HFNC weaning guided by clinical decision support (CDS) results in a reduction in the duration of HFNC compared to usual care for children with bronchiolitis. METHODS: The design and summary of the statistical analysis plan for the REspiratory SupporT for Efficient and cost-Effective Care (REST EEC; "rest easy") trial are presented. The investigators hypothesize that CDS-coupled, standardized HFNC weaning will reduce the duration of HFNC, the trial's primary endpoint, for children with bronchiolitis compared to usual care. Data supporting trial design and eventual analyses are collected from the EHR and other real world data sources using existing informatics infrastructure and QI data sources. The trial workflow, including randomization and deployment of the intervention, is embedded within the EHR of a large children's hospital using existing vendor features. Trial simulations indicate that by assuming a true hazard ratio effect size of 1.27, equivalent to a 6-h reduction in the median duration of HFNC, and enrolling a maximum of 350 children, there will be a > 0.75 probability of declaring superiority (interim analysis posterior probability of intervention effect > 0.99 or final analysis posterior probability of intervention effect > 0.9) and a > 0.85 probability of declaring superiority or the CDS intervention showing promise (final analysis posterior probability of intervention effect > 0.8). Iterative plan-do-study-act cycles are used to monitor the trial and provide targeted education to the workforce. DISCUSSION: Through incorporation of the trial into usual care workflows, relying on QI tools and resources to support trial conduct, and relying on Bayesian inference to determine whether the intervention is superior to usual care, REST EEC is a learning health system intervention that blends health system operations with active evidence generation to optimize the use of HFNC and associated patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05909566. Registered on June 18, 2023.

Effect of tailored, daily feedback with lifestyle self-monitoring on weight loss: The SMARTER randomized clinical trial.

OBJECTIVE: This study aimed to test the efficacy of self-monitoring and feedback (SM+FB) versus SM without FB (SM) in a behavioral weight-loss intervention at 6 months. METHODS: This was a randomized clinical trial. Eligibility criteria included the following: ≥18 years of age, BMI ≥ 27 and ≤43, smartphone user, and ability to engage in moderate physical activity. All participants received a 90-minute 1:1 counseling session, a Fitbit Charge 2, and a digital scale for SM. SM+FB participants were provided access to a customized smartphone application that provided three daily FB messages. The primary outcome was percentage of weight change from 0 to 6 months. RESULTS: The sample (N = 502) was 45 (SD 14.4) years old, BMI was 33.7 (SD 4.00) kg/m2 , 79.5% of participants were female (n = 399), and 84.3% were White (n = 423). At 6 months, there was 85.86% retention and a significant percentage of weight change in both groups (SM+FB: -3.16%, 95% CI: -3.85% to -2.47%, p < 0.0001; SM: -3.20%, 95% CI: -3.86% to -2.54%, p < 0.0001) but no significant between-group mean difference (-0.04%, 95% CI: -0.99% to 0.91%, p = 0.940). A ≥5% weight loss was achieved by 31.9% of the SM+FB group and 28.3% of the SM group. CONCLUSIONS: There was no significant between-group difference in weight loss at 6 months.

The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.

BACKGROUND: Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors. PURPOSE: Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older. METHODS: Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months. CONCLUSIONS: If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring.

Self-monitoring (SM) of food intake is central to weight loss treatment. Technology makes it possible to reinforce this behavior change strategy by providing real-time feedback (FB) tailored to the diary entry. To test the feasibility of providing 1-4 daily FB messages tailored to dietary recordings via a smartphone, we conducted a 12-week pilot randomized clinical trial in Pittsburgh, PA in US in 2015. We compared 3 groups: SM using the Lose It! smartphone app (Group 1); SM + FB (Group 2); and SM + FB + attending three in-person group sessions (Group 3). The sample (N = 39) was mostly white and female with a mean body mass index of 33.76 kg/m2. Adherence to dietary SM was recorded daily, weight was assessed at baseline and 12 weeks. The mean percentage of days adherent to dietary SM was similar among Groups 1, 2, and 3 (p = 0.66) at 53.50% vs. 55.86% vs. 65.33%, respectively. At 12 weeks, all groups had a significant percent weight loss (p < 0.05), with no differences among groups (- 2.85% vs. - 3.14% vs. - 3.37%) (p = 0.95); 26% of the participants lost ≥ 5% of their baseline weight. Mean retention was 74% with no differences among groups (p = 0.37). All groups adhered to SM at levels comparable to or better than other weight loss studies and lost acceptable amounts of weight, with minimal intervention contact over 12 weeks. These preliminary findings suggest this 3-group approach testing SM alone vs. SM with real-time FB messages alone or supplemented with limited in-person group sessions warrants further testing in a larger, more diverse sample and for a longer intervention period.

The SELF trial: A self-efficacy-based behavioral intervention trial for weight loss maintenance.

OBJECTIVE: The SELF Trial examined the effect of adding individual self-efficacy (SE) enhancement sessions to standard behavioral weight loss treatment (SBT). METHODS: Participants were randomly assigned to SBT or SBT plus SE sessions (SBT+SE). Outcome measures were weight loss maintenance, quality of life, intervention adherence, and self-efficacy at 12 and 18 months. RESULTS: The sample (N = 130) was female (83.08%) with a mean (SD) body mass index of 33.15 (4.11) kg m(2) . There was a significant time effect for percent weight change (P = 0.002) yet no significant group or group-by-time effects. The weight loss for the SBT+SE group was 8.38% (7.48) at 12 months and 8.00% (7.87) at 18 months, with no significant difference between the two time points (P = 0.06). However, weight loss for the SBT group was 6.95% (6.67) at 12 months and 5.96% (7.35) at 18 months, which was significantly different between the two time points (P = 0.005), indicating that the SBT group had significant weight regain. CONCLUSIONS: Both groups achieved clinically significant weight loss. The group receiving an intervention targeting enhanced self-efficacy had greater weight loss maintenance whereas the SBT group demonstrated significant weight regain possibly related to the greater attention provided to the SBT+SE group.