Designing Ruby: Protocol for a 2-Arm, Brief, Digital Randomized Controlled Trial for Internalized Weight Bias.

BACKGROUND: Weight bias internalization, also known as weight self-stigma, is a serious health concern for individuals with higher body weight. Weight bias internalization is associated with the greater avoidance of health care and health-promoting activities, disordered eating, social isolation, and weight gain. Elevated weight bias internalization has been associated with low self-compassion, yet few investigations have explored self-compassion as a potential mechanism for reducing internalized weight bias. OBJECTIVE: Ruby is a 2-arm randomized controlled trial that was designed to test the efficacy of a 4-week digital self-compassion intervention to reduce internalized weight bias compared with a wait-list control. METHODS: Adults with elevated internalized weight bias and a BMI of >30 kg/m2 (N=80) were recruited. Ruby is a standalone digital trial that will be delivered entirely via a smartphone and will involve web-based data collection and text messages. The intervention content will include psychoeducation and daily mindfulness practices with a focus on self-compassion and body concerns. We will use intent-to-treat analyses to examine changes in weight bias internalization throughout time by treatment arm. The analyses will be conducted by using one-way analysis of covariance models and linear mixed models. RESULTS: The protocol was designed in May 2020 and approved in December 2020. Data collection is currently underway. CONCLUSIONS: Ruby will be the first digital standalone, self-compassion-based intervention designed to reduce internalized weight bias. Owing to its standalone digital delivery, Ruby may be a highly scalable treatment for internalized weight bias that can be delivered on its own or combined with other treatments. We expect Ruby to be accessible to many, as participants can access the digital intervention at times of the day that are the most convenient in their schedule and are not burdened by in-person time commitments, which can be a barrier for participants with competing demands on their time and resources. If efficacious, Ruby will be poised to expand a burgeoning body of literature related to psychological intervention in this area. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678973; https://clinicaltrials.gov/ct2/show/NCT04678973. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31307.

Consistent self-monitoring in a commercial app-based intervention for weight loss: results from a randomized trial.

Self-monitoring is the strongest predictor of success in lifestyle interventions for obesity. In this secondary analysis of the GoalTracker trial, we describe outcomes of consistently self-monitoring in a standalone weight loss intervention. The 12-week intervention focused on daily self-monitoring of diet and/or body weight in a commercial app (MyFitnessPal). Participants (N = 100; 21-65 years; BMI 25-45 kg/m2) were categorized as Consistent Trackers if they tracked ≥ 6 out of 7 days for at least 75% of the targeted weeks. One-fourth of participants were Consistent Trackers. This subset was more likely to be married or living with a partner, be non-Hispanic White, and have higher health literacy than Inconsistent Trackers (ps < .05). Consistent tracking was associated with greater weight change than inconsistent tracking at 1 month (mean difference [95% CI] - 1.11 kg [- 2.12, - 0.10]), 3 months (- 2.42 kg [- 3.80, - 1.04]), and 6 months (- 2.13 kg [- 3.99, - 0.27]). Over 3 times as many Consistent Trackers as Inconsistent Trackers achieved ≥ 5% weight loss at 3 months (48 vs. 13%) and at 6 months (54 vs. 15%; ps < .001). Though causality cannot be determined by the present study, tracking weight and/or diet nearly every day per week for 12 weeks in a commercial app may serve as an effective strategy for weight loss. Strategies are needed to promote greater consistency in tracking.

The Emotional and Behavioral Impact of Delivering Bad News to Virtual versus Real Standardized Patients: A Pilot Study.

Phenomenon: Virtual standardized patients (vSPs) are becoming increasingly common in medical education, though one limitation of vSPs is the artificiality of computer-based simulators. Past research on the use of vSPs has not clearly established whether learners have different emotional responses to real SPs (rSPs) compared with vSPs; however, understanding learners' emotional responses to vSPs is important in providing realistic learning experiences and establishing the validity of this teaching and assessment tool. This study compared the emotional experiences of individuals who interacted with rSPs and vSPs. Approach: Sixty medical students at a medical school in the southeastern United States participated in the study. Participants were randomly assigned to deliver bad news to an rSP or vSP. The vSP for this study used a hybrid intelligence model that allowed a person to "inhabit" the vSP. Salivary cortisol and a self-report measure of mood-the Profile of Mood States, Second Edition (POMS 2)-were gathered before and after delivering the bad news. The SP and 2 independent evaluators rated the behavioral performance of each participant in real and virtual conditions. Participants also rated the performance of the SP. Findings: Participants in both conditions reported increased negative emotionality on the POMS 2 following the SP interaction. There were no significant between-group differences on the POMS 2 or salivary cortisol concentration following the SP interaction. Ratings by the SP and independent evaluators indicated that participants performed similarly on most interpersonal dimensions, except tone of voice. Participants perceived the vSP as less realistic than the rSP. Insights: These results suggest that medical students may have similar emotional and behavioral responses when delivering bad news to a vSP when compared to an rSP. These findings provide support for the continued use of vSPs in training learners to deliver bad news and other communication-based skills and to assess their performance on these tasks.

Comparing Self-Monitoring Strategies for Weight Loss in a Smartphone App: Randomized Controlled Trial.

BACKGROUND: Self-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes. OBJECTIVE: This study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement. METHODS: GoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ≥800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires. RESULTS: At baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean -2.7 kg, 95% CI -3.9 to -1.5) and either the App-Only arm (-2.4 kg, -3.7 to -1.2; P=.78) or the Simultaneous arm (-2.8 kg, -4.0 to -1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms. CONCLUSIONS: Regardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).

Strategies used by older adults with asthma for adherence to inhaled corticosteroids.

BACKGROUND: Older adults with asthma have low levels of adherence to their prescribed inhaled corticosteroids (ICS). While prior research has identified demographic and cognitive factors associated with ICS adherence among elderly asthmatics, little is known about the strategies that older adults use to achieve daily use of their medications. Identifying such strategies could provide clinicians with useful advice for patients when counseling their patients about ICS adherence. OBJECTIVE: To identify medication use strategies associated with good ICS adherence in older adults. PARTICIPANTS: English-speaking and Spanish-speaking adults ages 60 years and older with moderate or severe asthma were recruited from primary care and pulmonary practices in New York City, NY, and Chicago, IL. Patients with chronic obstructive pulmonary disease, other chronic lung diseases or a smoking history of greater than 10 pack-years were excluded. MAIN MEASURES: Medication adherence was assessed with the Medication Adherence Rating Scale (MARS). Medication use strategies were assessed via open-ended questioning. "Good adherence" was defined as a mean MARS score of 4.5 or greater. KEY RESULTS: The rate of good adherence to ICS was 37 %. We identified six general categories of medication adherence strategies: keeping the medication in a usual location (44.2 %), integrating medication use with a daily routine (32.6 %), taking the medication at a specific time (21.7 %), taking the medication with other medications (13.4 %), using the medication only when needed (13.4 %), and using other reminders (11.9 %). The good adherence rate was greater among individuals who kept their ICS medication in the bathroom (adjusted odds ration [AOR] 3.05, 95 % CI 1.03-9.02, p = 0.04) or integrated its use into a daily routine (AOR 3.77, 95 % CI: 1.62-8.77, p = 0.002). CONCLUSIONS: Keeping ICS medications in the bathroom and integrating them into daily routines are strategies associated with good ICS adherence. Clinicians concerned with adherence should consider recommending these strategies to their older asthmatic patients, although additional research is needed to determine whether such advice would improve adherence behaviors.