An Adaptive Behavioral Intervention for Weight Loss Management: A Randomized Clinical Trial.

Importance: Lifestyle interventions for weight loss are difficult to implement in clinical practice. Self-managed mobile health implementations without or with added support after unsuccessful weight loss attempts could offer effective population-level obesity management. Objective: To test whether a wireless feedback system (WFS) yields noninferior weight loss vs WFS plus telephone coaching and whether participants who do not respond to initial treatment achieve greater weight loss with more vs less vigorous step-up interventions. Design, Setting, and Participants: In this noninferiority randomized trial, 400 adults aged 18 to 60 years with a body mass index of 27 to 45 were randomized in a 1:1 ratio to undergo 3 months of treatment initially with WFS or WFS plus coaching at a US academic medical center between June 2017 and March 2021. Participants attaining suboptimal weight loss were rerandomized to undergo modest or vigorous step-up intervention. Interventions: The WFS included a Wi-Fi activity tracker and scale transmitting data to a smartphone app to provide daily feedback on progress in lifestyle change and weight loss, and WFS plus coaching added 12 weekly 10- to 15-minute supportive coaching calls delivered by bachelor's degree-level health promotionists viewing participants' self-monitoring data on a dashboard; step-up interventions included supportive messaging via mobile device screen notifications (app-based screen alerts) without or with coaching or powdered meal replacement. Participants and staff were unblinded and outcome assessors were blinded to treatment randomization. Main Outcomes and Measures: The primary outcome was the between-group difference in 6-month weight change, with the noninferiority margin defined as a difference in weight change of -2.5 kg; secondary outcomes included between-group differences for all participants in weight change at 3 and 12 months and between-group 6-month weight change difference among nonresponders exposed to modest vs vigorous step-up interventions. Results: Among 400 participants (mean [SD] age, 40.5 [11.2] years; 305 [76.3%] women; 81 participants were Black and 266 were White; mean [SD] body mass index, 34.4 [4.3]) randomized to undergo WFS (n = 199) vs WFS plus coaching (n = 201), outcome data were available for 342 participants (85.5%) at 6 months. Six-month weight loss was -2.8 kg (95% CI, -3.5 to -2.0) for the WFS group and -4.8 kg (95% CI, -5.5 to -4.1) for participants in the WFS plus coaching group (difference in weight change, -2.0 kg [90% CI, -2.9 to -1.1]; P < .001); the 90% CI included the noninferiority margin of -2.5 kg. Weight change differences were comparable at 3 and 12 months and, among nonresponders, at 6 months, with no difference by step-up therapy. Conclusions and Relevance: A wireless feedback system (Wi-Fi activity tracker and scale with smartphone app to provide daily feedback) was not noninferior to the same system with added coaching. Continued efforts are needed to identify strategies for weight loss management and to accurately select interventions for different individuals to achieve weight loss goals. Trial Registration: ClinicalTrials.gov Identifier: NCT02997943.

Scalable Telehealth Cancer Care: integrated healthy lifestyle program to live well after cancer treatment.

Northwestern University's Center for Scalable Telehealth Cancer Care (STELLAR) is 1 of 4 Cancer Moonshot Telehealth Research Centers of Excellence programs funded by the National Cancer Institute to establish an evidence base for telehealth in cancer care. STELLAR is grounded in the Institute of Medicine's vision that quality cancer care includes not only disease treatment but also promotion of long-term health and quality of life (QOL). Cigarette smoking, insufficient physical activity, and overweight and obesity often co-occur and are associated with poorer treatment response, heightened recurrence risk, decreased longevity, diminished QOL, and increased treatment cost for many cancers. These risk behaviors are prevalent in cancer survivors, but their treatment is not routinely integrated into oncology care. STELLAR aims to foster patients' long-term health and QOL by designing, implementing, and sustaining a novel telehealth treatment program for multiple risk behaviors to be integrated into standard cancer care. Telehealth delivery is evidence-based for health behavior change treatment and is well suited to overcome access and workflow barriers that can otherwise impede treatment receipt. This paper describes STELLAR's 2-arm randomized parallel group pragmatic clinical trial comparing telehealth-delivered, coach-facilitated multiple risk behavior treatment vs self-guided usual care for the outcomes of reach, effectiveness, and cost among 3000 cancer survivors who have completed curative intent treatment. This paper also discusses several challenges encountered by the STELLAR investigative team and the adaptations developed to move the research forward.

Dynamic models of stress-smoking responses based on high-frequency sensor data.

Self-reports indicate that stress increases the risk for smoking; however, intensive data from sensors can provide a more nuanced understanding of stress in the moments leading up to and following smoking events. Identifying personalized dynamical models of stress-smoking responses can improve characterizations of smoking responses following stress, but techniques used to identify these models require intensive longitudinal data. This study leveraged advances in wearable sensing technology and digital markers of stress and smoking to identify person-specific models of stress and smoking system dynamics by considering stress immediately before, during, and after smoking events. Adult smokers (n = 45) wore the AutoSense chestband (respiration-inductive plethysmograph, electrocardiogram, accelerometer) with MotionSense (accelerometers, gyroscopes) on each wrist for three days prior to a quit attempt. The odds of minute-level smoking events were regressed on minute-level stress probabilities to identify person-specific dynamic models of smoking responses to stress. Simulated pulse responses to a continuous stress episode revealed a consistent pattern of increased odds of smoking either shortly after the beginning of the simulated stress episode or with a delay, for all participants. This pattern is followed by a dramatic reduction in the probability of smoking thereafter, for about half of the participants (49%). Sensor-detected stress probabilities indicate a vulnerability for smoking that may be used as a tailoring variable for just-in-time interventions to support quit attempts.

Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research.

BACKGROUND: Mobile messaging is often used in behavioral weight loss interventions, yet little is known as to the extent to which they contribute to weight loss when part of a multicomponent treatment package. The multiphase optimization strategy (MOST) is a framework that researchers can use to systematically investigate interventions that achieve desirable outcomes given specified constraints. OBJECTIVE: This study describes the use of MOST to develop a messaging intervention as a component to test as part of a weight loss treatment package in a subsequent optimization trial. METHODS: On the basis of our conceptual model, a text message intervention was created to support self-regulation of weight-related behaviors. We tested the messages in the ENLIGHTEN feasibility pilot study. Adults with overweight and obesity were recruited to participate in an 8-week weight loss program. Participants received a commercially available self-monitoring smartphone app, coaching calls, and text messages. The number and frequency of text messages sent were determined by individual preferences, and weight was assessed at 8 weeks. RESULTS: Participants (n=9) in the feasibility pilot study lost 3.2% of their initial body weight over the 8-week intervention and preferred to receive 1.8 texts per day for 4.3 days per week. Researcher burden in manually sending messages was high, and the cost of receiving text messages was a concern. Therefore, a fully automated push notification system was developed to facilitate sending tailored daily messages to participants to support weight loss. CONCLUSIONS: Following the completion of specifying the conceptual model and the feasibility pilot study, the message intervention went through a final iteration. Theory and feasibility pilot study results during the preparation phase informed critical decisions about automation, frequency, triggers, and content before inclusion as a treatment component in a factorial optimization trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT01814072; https://clinicaltrials.gov/ct2/show/NCT01814072.

Acceptability of smartphone technology to interrupt sedentary time in adults with diabetes.

Breaking up sitting time with light- or moderate-intensity physical activity may help to alleviate some negative health effects of sedentary behavior, but few studies have examined ways to effectively intervene. This feasibility study examined the acceptability of a new technology (NEAT!) developed to interrupt prolonged bouts (≥20 min) of sedentary time among adults with type 2 diabetes. Eight of nine participants completed a 1-month intervention and agreed that NEAT! made them more conscious of sitting time. Most participants (87.5 %) expressed a desire to use NEAT! in the future. Sedentary time decreased by 8.1 ± 4.5 %, and light physical activity increased by 7.9 ± 5.5 % over the 1-month period. The results suggest that NEAT! is an acceptable technology to intervene on sedentary time among adults with type 2 diabetes. Future studies are needed to examine the use of the technology among larger samples and determine its effects on glucose and insulin levels.