Dietary interventions in family-based treatment for eating disorders: results of a randomized comparative effectiveness study.

Family-based treatment (FBT) is a first-line treatment for adolescents with eating disorders (ED's) for which weight gain early in treatment and caregiver empowerment are predictive of success. A variety of dietary interventions are used in practice, but little is known about their effectiveness. We compared clinical outcomes of patients (N = 100) undergoing eating disorder treatment, and user experience across two virtually delivered interventions: (1) Daily calorie target and (2) Plate-by-Plate™ approach. The calorie group gained more weight on average, though the difference was small (ß = 1.62 [-0.02, 3.26]). Participants in both groups improve their eating disorder symptoms at roughly the same rate (ß = 0.09 [-0.83, 1.04]). Caregivers in the Plate-by-Plate group increased confidence at a slower rate (ß = 0.05 [-0.002, 0.09]). Caregivers rated the daily calorie target as more effective (ß = 2.18 [0.94, 3.6]), and rated the two approaches equally for ease of use (ß = -0.73 [-1.92, 0.48]). The daily calorie target approach was rated as more effective and was preferred overall by caregivers and dietitians. Findings challenge long-standing assumptions underlying FBT and suggest that clinicians should consider using a calorie framework with caregivers to guide renourishment efforts.

Eating Disorder Clinical Presentation and Treatment Outcomes by Gender Identity Among Children, Adolescents, and Young Adults.

PURPOSE: Current eating disorder treatment approaches for youth were developed for use with cisgender girls, which limits the understanding of effectiveness for cisgender boys and transgender and gender expansive (TGE) youth. Here, we compare treatment outcomes for cisgender boys and TGE youth with cisgender girls receiving family-based treatment for an eating disorder. METHODS: Patients were aged 6-24 and either active in treatment or discharged from September 1, 2020, to November 1, 2022 (N = 1,235). Patient exposure to treatment varied given individualized length of treatment. Outcomes include eating disorder symptoms, depression, anxiety, suicidality, caregiver burden, and parental confidence in supervising treatment. Treatment outcomes for cisgender boys and TGE youth were compared with cisgender girls. RESULTS: Patients included n = 975 cisgender girls, n = 152 cisgender boys, and n = 108 TGE youth. Anorexia nervosa was the most common diagnosis. Cisgender boys reported significantly lower eating disorder (b = -2.7 [-4.1, -1.3]), anxiety (b = -1.6 [-2.2, -0.9]), and depression (b = -1.7 [-2.4, -0.9]) symptoms at admission compared with cisgender girls. TGE patients had significantly higher anxiety (b = 1.08 [0.28, 1.91]) and depression (b = 1.72 [0.78, 2.65]) symptoms compared with cisgender girls. Cisgender boys started with significantly lower suicidal ideation (b = -1.28 [-2.19, -0.43]) and TGE patients with significantly higher suicidal ideation (b = 1.63 [0.76, 2.51]) than cisgender girls. All symptoms improved during treatment and improved at similar rates over time in treatment regardless of gender identity. DISCUSSION: Early evidence from this study supports the use of family-based treatment for cisgender boys and TGE youth with eating disorders. Further research is needed on the long-term outcomes of this approach for youth of all genders.

Early weight gain as a predictor of weight restoration in avoidant/restrictive food intake disorder.

BACKGROUND: Previous research has demonstrated that early weight gain in family-based treatment (FBT) is predictive of remission for adolescents with anorexia nervosa (AN). However, no published data has addressed if early weight gain is also predictive of reaching weight restoration (i.e., 95% EBW) in patients with avoidant/restrictive food intake disorder (ARFID). Furthermore, no studies have evaluated the performance of the statistical models used to predict weight restoration at the end of treatment. This study sought to examine whether early weight gain in ARFID is predictive of weight restoration at 20 weeks using ROC analysis. Additionally, this study assessed how accurately the model classified patients and what types of misclassifications occurred. METHODS: Participants (n = 130, 57.7% cisgender female 70.0% white) received virtual outpatient FBT. Receiver operating characteristics (ROC) were used to predict successful weight restoration at end of treatment, using early weight gain as the predictor. Twenty weeks was considered as the end of treatment, to align with the definition of end of treatment in FBT clinical trials. ROC analyses demonstrated that gaining at least 6.2 pounds by week 5 of treatment was the strongest predictor of achieving 95% EBW at 20 weeks (AUC = 0.72 [0.63, 0.81]). ROC analyses misclassified 35% of patients; the most common misclassification was predicting that a patient would not achieve 95% EBW when they actually did (61.6%). A logistical regression model, which included the patients' %EBW at admission in addition to early weight gain as a predictor, outperformed the ROC analyses (AUC = 0.90 [0.85, 0.95]) and provided additional context by showing the probability that a patient would succeed. CONCLUSION: Taken together, research demonstrates that early weight gain is a useful predictor of 95% EBW at 20 weeks of treatment for patients with ARFID who require weight restoration. Furthermore, results suggest that statistical models need to take into account additional information, such as %EBW at admission, along with early weight gain in order to more accurately predict which patients will reach weight restoration at week 20.

Results from this study indicate that when patients with avoidant/restrictive food intake disorder (ARFID) gain weight steadily at the beginning of treatment, it helps them reach 95% expected body weight (EBW) by week 20 of treatment. The more weight the patients gain each week early on, the better their chances of getting to 95% EBW by week 20. However, there are two important things to consider: how much the patients weigh when they start treatment (starting %EBW) and how much weight they gain each week. Both of these factors affect the chances of reaching 95% EBW by week 20. Thus, this study highlights the goals for gaining weight at the start of treatment need to be different for each person, depending on how much they weigh when they begin. This may help patients with ARFID reach the goal of being at 95% EBW within 20 weeks.

The assessment of caregiver self-efficacy in a virtual eating disorder setting.

BACKGROUND: Caregiver self-efficacy is thought to be a key component for successful family-based treatment (FBT) for individuals with eating disorders. As such, interventions aimed at enhancing caregiver self-efficacy, often measured via the Parents Versus Anorexia scale, have been a focal point of FBT literature. However, studies looking at the relationship between caregiver self-efficacy and treatment outcomes have been mixed. We aimed to better understand the influence of caregiver self-efficacy on eating disorder treatment outcomes during FBT. METHODS: Caregiver self-efficacy was measured using the Parents Versus Eating Disorders (PVED) scale, an adapted version of the Parents Versus Anorexia scale, in a sample of 1051 patients with an eating disorder and 1528 caregivers (patients can have more than one caregiver) receiving virtual FBT. Across two multilevel models, we tested how caregiver self-efficacy changed over time and its association with changes in eating disorder symptoms and weight over the first 16 weeks of treatment. RESULTS: Over treatment, PVED scores increased (b = 0.79, SE = 0.04, CI [0.72, 0.86]) and starting PVED scores were predictive of improved eating disorder symptoms (b = - 0.73, SE = 0.22, CI [- 1.15, - 0.30]), but not weight (b = - 0.96, SE = 0.59, CI [- 2.10, 0.19]). We also found that PVED change-from-baseline scores were predictive of weight (b = - 0.48, SE = 0.03, CI [- 0.53, - 0.43]) such that patient weight was lower when caregiver reports of PVED were higher. Likewise, the association between caregiver change in PVED scores and weight varied as a function of treatment time (b = 0.27, SE = 0.01, CI [0.24, 0.29]). Results were consistent when isolating patients with anorexia nervosa. CONCLUSIONS: Caregiver self-efficacy during FBT improved over time but was not robustly associated with treatment outcomes. This may, in part, be due to psychometric properties of the PVED scale. We describe these issues and illustrate the need for development of a new measure of self-efficacy for caregivers supporting their loved ones through eating disorder treatment.

In family-based treatment (FBT) for eating disorders, caregivers play a central role in helping their child recover. Specifically, a caregiver's self-efficacy, or their confidence in their ability to cope with the challenges their child faces during treatment, is believed to be a key to successful treatment outcomes. However, research on the impact caregiver self-efficacy has on patient treatment outcomes is mixed. Using the Parent vs. Eating Disorder (PVED) scale, we looked at the association between caregiver self-efficacy and eating disorder symptoms and weight changes over time in a sample of 1051 patients receiving virtual FBT. Caregiver self-efficacy had little to no significant impact on treatment outcomes. We offer explanations about why our findings challenge existing research that supports the association between caregiver self-efficacy and outcomes. Namely, the PVED scale appears to measure caregiver perceptions of their role in the treatment process (and not self-efficacy). We believe a new measurement tool must be developed and tested for the field to move forward in its understanding of the role caregiver self-efficacy plays in FBT.

When Shepherds Shed: Trajectories of Weight-Related Behaviors in a Holistic Health Intervention Tailored for US Christian Clergy.

Maintaining healthy behaviors is challenging. Based upon previous reports that in North Carolina (NC), USA, overweight/obese clergy lost weight during a two-year religiously tailored health intervention, we described trajectories of diet, physical activity, and sleep. We investigated whether behavior changes were associated with weight and use of health-promoting theological messages. Improvements were observed in sleep, calorie-dense food intake, and physical activity, with the latter two associated with weight loss. While theological messages were well-retained, their relationship with behaviors depended on the specific message, behavior, and timing. Findings offer insights into weight loss mechanisms, including the role of theological messages in religiously tailored health interventions.

Food insecurity among youth seeking eating disorder treatment.

Food Insecurity (FI) is associated with a myriad of mental health concerns in children and adolescents. Eating disorder (ED) risk is higher in youth experiencing FI, and FI in childhood is associated with ED diagnoses later in life. Although a growing body of research has shown that FI is associated with a heightened risk for ED-related symptoms, little is known about how experiencing FI may impact ED treatment, particularly in youth. In this study, we characterize the treatment characteristics of youth aged 6-24 (N = 729) with FI receiving family-based treatment for an ED. FI was defined as self-reported experience of FI (family-level FI) at treatment admission, and living in a low income, low access area according to USDA census tract data. Seventeen patients (2.3 % of sample) self-reported family-level FI at intake and 24 (3.3 % of sample) were designated as living in a low income/low access location. Descriptive analyses only were used to characterize the sample due to sample sizes. Group means on measures of weight, ED symptomatology, depression, anxiety, and caregiver burden were evaluated at admission and after four, eight, 12, 16, and 20 weeks of treatment. Results characterize how FI may impact ED treatment and showcase variation in changes. ED treatment must be responsive to needs related to FI as access to and consumption of food is the very foundation of ED treatment.

Digitally Delivered Dietary Interventions for Patients with Eating Disorders Undergoing Family-Based Treatment: Protocol for a Randomized Feasibility Trial.

BACKGROUND: Eating disorders (EDs) affect 9% of the United States population, and anorexia nervosa (AN), specifically, has the second highest mortality rate of all psychiatric disorders. Yet, only 20% are able to access treatment. Access to care issues include long waitlists, lack of trained specialists, financial, and geographic barriers, all of which highlight the need for effective telehealth interventions. Family-based therapy (FBT) is a first-line treatment for adolescents and young adults with EDs, and weight gain early in treatment is considered a primary predictor of success with FBT. However, nutrition requirements for patients with EDs are uniquely complex. A variety of dietary interventions for guiding the renourishment process are used in practice, but empirical data on the effectiveness and acceptability of the various interventions are sparse. The significance of nutritional restoration and issues with access to first-line treatments underscore the need for further research exploring virtually delivered dietary interventions. OBJECTIVE: Our objective is to compare the effectiveness and acceptability of 2 digitally delivered dietary interventions frequently used in eating disorder treatment settings: (1) calorie-based meal plans and (2) the Plate-by-Plate approach. Specifically, we will explore any potential differences in weight restoration achieved over 8 weeks of treatment as a primary measure of effectiveness, as well as additional treatment outcomes (ED symptoms, anxiety, depression, caregiver burden, and perceived effectiveness and acceptability for both caregivers and clinicians). METHODS: Patients (N=100) with either AN or avoidant restrictive food intake disorders (ARFID) aged 6-24 years seeking treatment at a nationwide virtual eating disorder treatment program, were enrolled between May and August 2022. Upon admission, patients were randomly assigned to receive either the calorie-based intervention or Plate-by-Plate approach from their registered dietitian, all of whom have received training as study interventionists. While we were primarily interested in responses during the first 8 weeks of treatment, patients will be followed for up to 12 months. Descriptive statistics were used to describe patient characteristics and demographics. Weight changes and other treatment outcomes between groups will be compared using generalized linear models. Semistructured caregiver and clinician interview transcripts will undergo qualitative analysis. RESULTS: Enrollment ran from March to August 2022, and we anticipate completion of data collection by November 2022. Analyses will be completed in January 2023. CONCLUSIONS: This study contributes to existing FBT literature by thoroughly exploring the acceptability of dietary interventions and their influence on weight restoration, an area in which research is sparse. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41837.

Effectiveness of delivering evidence-based eating disorder treatment via telemedicine for children, adolescents, and youth.

Barriers limit access to eating disorder treatment. Evidence-based treatment delivered using telemedicine could expand access. This study determined the effectiveness of enhanced Family-Based Treatment (FBT+) delivered using telemedicine for children and adolescents with eating disorders. Participants had a confirmed eating disorder diagnosis, lived in states where treatment was available, and lived with a family member willing to participate. Virtual FBT+ was administered by a five-person team including a therapist, dietitian, medical provider, peer mentor, and family mentor for up to 12 months. Measures were recorded at baseline and varying frequencies throughout treatment. Weight was self-reported. Eating disorder symptoms were assessed with the Eating Disorder Examination-Questionnaire Short Form (EDE-QS) and depression and anxiety were measured using the Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7). Caregiver burden and self-efficacy were measured using the Burden Assessment Scale, and Parent Versus Eating Disorder scale. The majority of patients (N = 210; 6 to 24 years old [mean 16 · 1 years]) were cisgender female (83%) White, (71%), required weight restoration (78%), and had anorexia nervosa, restricting type (63%). After 16 weeks, patients on weight restoration gained on average 11 · 3 [9 · 86, 12 · 8] pounds and the average change in EDE-QS score was -6 · 31 [-8 · 67, -4 · 10] points. Similar reductions were seen for depression (-2 · 62 [-4 · 24, -1 · 04]), anxiety (-1 · 44 [-1 · 12, 0 · 78]), and caregiver burden (-4 · 41 [2 · 45, 6 · 31]). Caregiver self-efficacy increased by 4 · 56 [3 · 53, 5 · 61] points. Patients and caregivers reported satisfaction with treatment. Virtual FBT+ for eating disorders can transcend geographical and psychosocial treatment barriers, expanding access to evidence-based eating disorder treatment.

Evaluating differences in setting expected body weight for children and adolescents in eating disorder treatment.

OBJECTIVE: Weight restoration or weight gain is a common goal in eating disorder treatment. However, approaches to determine expected body weight (EBW) vary. A standardized approach based on normative data for a patient's age and gender uses weight associated with median BMI (mBMI). An individualized approach predicts EBW based on a patient's individual growth trajectory. Little research has examined differences in these approaches. METHOD: Weight and clinical data were collected from patients ages 6-20 enrolled in virtual eating disorder treatment. EBW associated with mBMI was compared with EBW using the individualized approach. Linear mixed effects models examined differences in weight, eating disorder symptoms, depression, and anxiety, and whether EBW approach varied by patient characteristics. RESULTS: Patients (N = 609) were on average age 15.6 (2.29), 85% were cisgender female, and predominantly diagnosed with anorexia nervosa (83.1%). The individualized approach led to significantly higher EBW on average (mean difference = 8.4 lbs [SE: .75]; p < .001) compared to mBMI; 70% of patients had a higher EBW using the individualized approach. Notably, EBW varied based on gender and diagnosis and it took longer on average to achieve individualized EBW. Time was the strongest predictor of changes in psychosocial outcomes and there were no significant differences by EBW approach. DISCUSSION: Results from this study indicate that an individualized approach led to significantly higher EBWs compared with using mBMI. As underestimation of EBW may lead to higher risk of relapse, eating disorder professionals should consider using an individualized approach for setting EBW. PUBLIC SIGNIFICANCE: For eating disorder patients who need to gain weight, accurately estimating target body weight for eating disorder treatment is critical to recovery and preventing relapse. An individualized, patient-centered approach to estimating target body weight more accurately estimated target body weight than the standardized, median body mass index approach. Using an individualized approach to treatment may improve a patient's likelihood of full recovery.

Implementation of an At-home Blood Pressure Measurement Protocol in a Hypertension Management Clinical Trial During the COVID-19 Pandemic.

BACKGROUND: The Dietary Approaches to Stop Hypertension eating plan is an evidence-based treatment of hypertension; however, adherence to the Dietary Approaches to Stop Hypertension is low. To improve adherence to the Dietary Approaches to Stop Hypertension among adults with hypertension, we designed Nourish, a 2-arm, 12-month randomized controlled trial. The COVID-19 pandemic necessitated a change from in-person to remotely delivered visits, requiring substantial protocol modifications to measure blood pressure accurately and safely for secondary outcome data. PURPOSE: The purpose of this article is to describe the implementation of an at-home blood pressure measurement protocol for the Nourish trial. CONCLUSION: Our investigator team and study staff developed and implemented a robust and feasible blood pressure measurement protocol to be executed within an at-home format. CLINICAL IMPLICATIONS: The described blood pressure measurement protocol provides a framework for use in future clinical trials and clinical settings in which a remote visit is preferred or required.

Patterns of Engagement With an Application-Based Dietary Self-Monitoring Tool Within a Randomized Controlled Feasibility Trial.

Introduction: The Dietary Approaches to Stop Hypertension dietary pattern is a proven way to manage hypertension, but adherence remains low. Dietary tracking applications offer a highly disseminable way to self-monitor intake on the pathway to reaching dietary goals but require consistent engagement to support behavior change. Few studies use longitudinal dietary self-monitoring data to assess trajectories and predictors of engagement. We used dietary self-monitoring data from participants in Dietary Approaches to Stop Hypertension Cloud (N=59), a feasibility trial to improve diet quality among women with hypertension, to identify trajectories of engagement and explore associations between participant characteristics. Methods: We used latent class growth modeling to identify trajectories of engagement with a publicly available diet tracking application and used bivariate and regression analyses to assess the associations of classifications of engagement with participant characteristics. Results: We identified 2 latent classes of engagement: consistent engagers and disengagers. Consistent engagers were more likely to be older, more educated, and married or living with a partner. Although consistent engagers exhibited slightly greater changes in Dietary Approaches to Stop Hypertension score, the difference was not significant. Conclusions: This study highlights an important yet underutilized methodologic approach for uncovering dietary self-monitoring engagement patterns. Understanding how certain individuals engage with digital technologies is an important step toward designing cost-effective behavior change interventions. Trial registration: This study is registered at www.clinicaltrials.gov NCT03215472.

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.

The Nourish Protocol: A digital health randomized controlled trial to promote the DASH eating pattern among adults with hypertension.

INTRODUCTION: Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. METHODS: The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120-159 mmHg; a diastolic blood pressure of 80-99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. DISCUSSION: Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875.

Symptom Trajectory among Formerly Abused Women: An Exploratory Study.

Women who have experienced intimate partner violence suffer from symptoms that persist long after the abuse has ended. However, the patterns and trajectory of these symptoms are poorly understood. The objective of this longitudinal research was to explore symptom trajectory typologies. A latent class growth analysis with multi-outcomes modeling was used to explore typologies based on women's (N = 30) trajectories over 4 months. Two distinct symptom typologies were identified: (1) consistently lessening symptom group (n = 16); (2) moderately worsening symptom group (n = 14). Women who experienced severe psychological vulnerability exhibited better symptom trajectories; a potential reflection of resilience in this population.

Perceptions of Using Multiple Mobile Health Devices to Support Self-Management Among Adults With Type 2 Diabetes: A Qualitative Descriptive Study.

PURPOSE: This study identified facilitators and barriers pertaining to the use of multiple mobile health (mHealth) devices (Fitbit Alta® fitness tracker, iHealth® glucometer, BodyTrace® scale) that support self-management behaviors in individuals with type 2 diabetes mellitus (T2DM). DESIGN: This qualitative descriptive study presents study participants' perceptions of using multiple mobile devices to support T2DM self-management. Additionally, this study assessed whether participants found visualizations, generated from each participant's health data as obtained from the three separate devices, useful and easy to interpret. METHODS: Semistructured interviews were completed with a convenience sample of participants (n = 20) from a larger randomized control trial on T2DM self-management. Interview questions focused on participants' use of three devices to support T2DM self-management. A study team member created data visualizations of each interview participant's health data using RStudio. RESULTS: We identified two themes from descriptions of study participants: feasibility and usability. We identified one theme about visualizations created from data obtained from the mobile devices. Despite some challenges, individuals with T2DM found it feasible to use multiple mobile devices to facilitate engagement in T2DM self-management behaviors. DISCUSSION: As mHealth devices become increasingly popular for diabetes self-management and are integrated into care delivery, we must address issues associated with the use of multiple mHealth devices and the use of aggregate data to support T2DM self-management. CLINICAL RELEVANCE: Real-time patient-generated health data that are easily accessible and readily available can assist T2DM self-management and catalyze conversations, leading to better self-management. Our findings lay an important groundwork for understanding how individuals with T2DM can use multiple mHealth devices simultaneously to support self-management.

Optimizing an Obesity Treatment Using the Multiphase Optimization Strategy Framework: Protocol for a Randomized Factorial Trial.

BACKGROUND: Effective weight loss interventions exist, yet few can be scaled up for wide dissemination. Further, none has been fully delivered via text message. We used the multiphase optimization strategy (MOST) to develop multicomponent interventions that consist only of active components, those that have been experimentally determined to impact the chosen outcome. OBJECTIVE: The goal of this study is to optimize a standalone text messaging obesity intervention, Charge, using the MOST framework to experimentally determine which text messaging components produce a meaningful contribution to weight change at 6 months. METHODS: We designed a 6-month, weight loss texting intervention based on our interactive obesity treatment approach (iOTA). Participants are randomized to one of 32 experimental conditions to test which standalone text messaging intervention components produce a meaningful contribution to weight change at 6 months. RESULTS: The project was funded in February 2017; enrollment began in January 2018 and data collection was completed in June 2019. Data analysis is in progress and first results are expected to be submitted for publication in 2021. CONCLUSIONS: Full factorial trials are particularly efficient in terms of cost and logistics when leveraged for standalone digital treatments. Accordingly, MOST has the potential to promote the rapid advancement of digital health treatments. Subject to positive findings, the intervention will be low cost, immediately scalable, and ready for dissemination. This will be of great potential use to the millions of Americans with obesity and the providers who treat them. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254940; https://clinicaltrials.gov/ct2/show/NCT03254940. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/19506.

Feasibility of a Digital Health Intervention to Improve Diet Quality Among Women With High Blood Pressure: Randomized Controlled Feasibility Trial.

BACKGROUND: Over 100 million individuals have high blood pressure, and more than half of them are women. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is a proven lifestyle approach to lower blood pressure, yet population-level adherence is poor. Innovative strategies that promote DASH are needed. OBJECTIVE: This paper aims to improve adherence to the DASH diet among women with hypertension or prehypertension. METHODS: We conducted a 3-month randomized controlled feasibility trial comparing app-based diet tracking (active comparator) to app-based diet tracking plus feedback on DASH adherence via text message (intervention). The intervention platform extracted nutrient data from the app, compared it to DASH recommendations, and sent tailored feedback text messages. Outcomes included the number of days participants tracked their diet, changes in their DASH adherence score, and blood pressure. RESULTS: The women (N=59) had a mean age of 49.9 (SD 11.9) years and were primarily non-Hispanic White (41/59, 69%) and college educated (49/59, 83%). The mean baseline DASH score was 2.3 (SD 1.3). At 3 months, the intervention and active comparator participants had similar mean days tracked per week (4.2, SD 2.1 days vs 4.6, SD 2.7 days; P=.54) and mean changes in their DASH score (0.8, 95% CI 0.2-1.5 vs 0.8, 95% CI 0.4-1.2; P=.75). Intervention participants had lower systolic (mean difference: -2.8 mmHg, 95% CI -1.8 to 7.4; P=.23) and diastolic (mean difference: -3.6 mmHg, 95% CI -0.2 to 7.3; P=.07) blood pressure compared with active comparator participants. Most intervention participants (23/29, 79%) said they would recommend the DASH Cloud intervention to a friend or family member. However, only 34% (10/59) indicated that the feedback text messages helped them reach their diet goals. CONCLUSIONS: A digital health intervention to improve DASH adherence is feasible and produces moderately high engagement among women with elevated blood pressure. The intervention did not enhance DASH adherence over diet tracking alone but resulted in greater reductions in blood pressure. Larger studies are needed to determine how digital health interventions can improve population-level adherence to DASH. TRIAL REGISTRATION: ClinicalTrials.gov NCT03215472; https://clinicaltrials.gov/ct2/show/study/NCT03215472.

Can Electronic Health Records Validly Estimate the Effects of Health System Interventions Aimed at Controlling Body Weight?

OBJECTIVE: This study aimed to compare weight collected at clinics and recorded in the electronic health record (EHR) with primary study-collected trial weights to assess the validity of using EHR data in future pragmatic weight loss or weight gain prevention trials. METHODS: For both the Track and Shape obesity intervention randomized trials, clinic EHR weight data were compared with primary trial weight data over the same time period. In analyzing the EHR weights, intervention effects were estimated on the primary outcome of weight (in kilograms) with EHR data, using linear mixed effects models. RESULTS: EHR weight measurements were higher on average and more variable than trial weight measurements. The mean difference and 95% CI were similar at all time points between the estimates using EHR and study-collected weights. CONCLUSIONS: The results of this study can be used to help guide the planning of future pragmatic weight-related trials. This study provides evidence that body weight measurements abstracted from the EHR can provide valid, efficient, and cost-effective data to estimate treatment effects from randomized clinical weight loss and weight management trials. However, care should be taken to properly understand the data-generating process and any mechanisms that may affect the validity of these estimates.

Digital Phenotyping Self-Monitoring Behaviors for Individuals With Type 2 Diabetes Mellitus: Observational Study Using Latent Class Growth Analysis.

BACKGROUND: Sustained self-monitoring and self-management behaviors are crucial to maintain optimal health for individuals with type 2 diabetes mellitus (T2DM). As smartphones and mobile health (mHealth) devices become widely available, self-monitoring using mHealth devices is an appealing strategy in support of successful self-management of T2DM. However, research indicates that engagement with mHealth devices decreases over time. Thus, it is important to understand engagement trajectories to provide varying levels of support that can improve self-monitoring and self-management behaviors. OBJECTIVE: The aims of this study were to develop (1) digital phenotypes of the self-monitoring behaviors of patients with T2DM based on their engagement trajectory of using multiple mHealth devices, and (2) assess the association of individual digital phenotypes of self-monitoring behaviors with baseline demographic and clinical characteristics. METHODS: This longitudinal observational feasibility study included 60 participants with T2DM who were instructed to monitor their weight, blood glucose, and physical activity using a wireless weight scale, phone-tethered glucometer, and accelerometer, respectively, over 6 months. We used latent class growth analysis (LCGA) with multitrajectory modeling to associate the digital phenotypes of participants' self-monitoring behaviors based on their engagement trajectories with multiple mHealth devices. Associations between individual characteristics and digital phenotypes on participants' self-monitoring behavior were assessed by analysis of variance or the Chi square test. RESULTS: The engagement with accelerometers to monitor daily physical activities was consistently high for all participants over time. Three distinct digital phenotypes were identified based on participants' engagement with the wireless weight scale and glucometer: (1) low and waning engagement group (24/60, 40%), (2) medium engagement group (20/60, 33%), and (3) consistently high engagement group (16/60, 27%). Participants that were younger, female, nonwhite, had a low income, and with a higher baseline hemoglobin A1c level were more likely to be in the low and waning engagement group. CONCLUSIONS: We demonstrated how to digitally phenotype individuals' self-monitoring behavior based on their engagement trajectory with multiple mHealth devices. Distinct self-monitoring behavior groups were identified. Individual demographic and clinical characteristics were associated with different self-monitoring behavior groups. Future research should identify methods to provide tailored support for people with T2DM to help them better monitor and manage their condition. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13517.