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.

The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.

BACKGROUND: For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina. METHODS: Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network. DISCUSSION: For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care. TRIALS REGISTRATION: NCT03003403 . Registered December 28, 2016.

Digital Weight Loss Intervention for Parents of Children Being Treated for Obesity: A Prospective Cohort Feasibility Trial.

BACKGROUND: The prevalence of childhood obesity continues to increase, and clinic-based treatment options have failed to demonstrate effectiveness. One of the strongest predictors of child weight is parent weight. Parental treatment for weight loss may indirectly reduce obesity in the child. We have previously demonstrated the effectiveness among adults of a fully automated, evidence-based digital weight loss intervention (Track). However, it is unknown if it is feasible to deliver such a treatment directly to parents with obesity who bring their child with obesity to a weight management clinic for treatment. OBJECTIVE: The objective of our study was to evaluate the feasibility of and engagement with a digital weight loss intervention among parents of children receiving treatment for obesity. METHODS: We conducted a 6-month pre-post feasibility trial among parents or guardians and their children aged 4-16 years presenting for tertiary care obesity treatment. Along with the standard family-based treatment protocol, parents received a 6-month digital weight loss intervention, which included weekly monitoring of personalized behavior change goals via mobile technologies. We examined levels of engagement by tracking completed weeks of self-monitoring and feasibility by assessing change in weight. RESULTS: Participants (N=48) were on average 39 years old, mostly female (35/42, 82% ), non-Hispanic Black individuals (21/41, 51%) with obesity (36/48, 75%). Over a quarter had a yearly household income of

Preventing Weight Gain Improves Sleep Quality Among Black Women: Results from a RCT.

BACKGROUND: Obesity and poor sleep are highly prevalent among Black women. PURPOSE: We examined whether a weight gain prevention intervention improved sleep among Black women. METHODS: We conducted a randomized trial comparing a 12-month weight gain prevention intervention that included self-monitoring through mobile technologies and phone coaching to usual care in community health centers. We measured sleep using the Medical Outcomes Study Sleep Scale at baseline, 12 months, and 18 months. The scale examines quantity of sleep, sleep disturbance, sleep adequacy, daytime somnolence, snoring, shortness of breath, and global sleep problems (sleep problem indices I and II). RESULTS: Participants (n = 184) were on average 35.4 years and obese (BMI 30.2 kg/m2); 74% made <$30,000/year. At baseline, average sleep duration was 6.4 (1.5) hours. Controlling for weight change and sleep medication, the intervention group reported greater improvements in sleep disturbance [-8.35 (-16.24, -0.45)] and sleep problems at 12 months: sleep problem index I [-8.35 (-16.24, -0.45)]; sleep problem index II [-8.35 (-16.24, -0.45)]. However, these findings did not persist at 18 months. CONCLUSIONS: Preventing weight gain may afford clinical benefit on improving sleep quality. TRIAL REGISTRATION NUMBER: The trial was registered with the ClinicalTrials.gov database (NCT00938535).

Genetic causal attributions for weight status and weight loss during a behavioral weight gain prevention intervention.

PURPOSE: Emerging evidence suggests that attributing one's weight to genetics may contribute to the adoption of obesogenic behaviors. We investigated whether weight-related genetic attributions were associated with weight change during a weight gain prevention intervention. METHODS: Participants (n = 185) were from a randomized clinical trial of a digital health weight gain prevention intervention for black women ages 25-44 years with body mass index 25.0-34.9 kg/m(2). Weight-related genetic attributions (weight status attribution and weight loss attributions) were measured at baseline and 12 months. RESULTS: Among intervention participants, high genetic attribution for weight loss was associated with greater weight loss at 12 months (-2.7 vs. 0.5 kg) and 18 months (-3.0 vs. 0.9 kg). Among usual-care participants, high genetic attribution for weight status was associated with greater 18-month weight gain (2.9 vs. 0.3 kg). The intervention reduced the likelihood of high genetic attribution for weight loss at 12 months (P = 0.05). Change in the likelihood of genetic attribution was not associated with weight change over 12 months. CONCLUSION: Impact of genetic attributions on weight differs for those enrolled and not enrolled in an intervention. However, weight gain prevention intervention may reduce genetic attribution for weight loss.Genet Med 18 5, 476-482.

The effect of a "maintain, don't gain" approach to weight management on depression among black women: results from a randomized controlled trial.

OBJECTIVES: We evaluated the effect of a weight gain prevention intervention (Shape Program) on depression among socioeconomically disadvantaged overweight and obese Black women. METHODS: Between 2009 and 2012, we conducted a randomized trial comparing a 12-month electronic health-based weight gain prevention intervention to usual primary care at 5 central North Carolina community health centers. We assessed depression with the Patient Health Questionnaire (PHQ-8). We analyzed change in depression score from baseline to 12- and 18-month follow-up across groups with mixed models. We used generalized estimating equation models to analyze group differences in the proportion above the clinical threshold for depression (PHQ-8 score ≥ 10). RESULTS: At baseline, 20% of participants reported depression. Twelve-month change in depression scores was larger for intervention participants (mean difference = -1.85; 95% confidence interval = -3.08, -0.61; P = .004). There was a significant reduction in the proportion of intervention participants with depression at 12 months with no change in the usual-care group (11% vs 19%; P = .035). All effects persisted after we controlled for weight change and medication use. We saw similar findings at 18 months. CONCLUSIONS: The Shape Program, which includes no mention of mood, improved depression among socioeconomically disadvantaged Black women.

Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial.

BACKGROUND: eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. OBJECTIVE: This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. METHODS: The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. RESULTS: Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (-1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference -0.94 kg, 95% CI -1.64 to -0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. CONCLUSIONS: Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. TRIAL REGISTRATION: Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.

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.

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study.

BACKGROUND: Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. OBJECTIVE: This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. METHODS: Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. RESULTS: The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference -2.41 kg, 95% CI -5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=-.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. CONCLUSIONS: Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).

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.

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.

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.

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.

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.

Using a holistic health approach to achieve weight-loss maintenance: results from the Spirited Life intervention.

Weight-loss maintenance is essential to sustain the health benefits of weight loss. Studies with lower intensity intervention supports under real-world conditions are lacking. This study examined changes in weight and cardiometabolic biomarkers among Spirited Life participants following initial 12-month weight loss at 12-24 months and 24-42 months. A total of 719 clergy received a wellness intervention, including a 10-week online weight-loss program in the first 12 months and monthly health coaching throughout 24 months. Mean changes in weight, blood pressure, high-density lipoproteins, and triglycerides were estimated using random effects linear models, accounting for repeated measures. Weight was additionally analyzed in subsamples stratified by body mass index (BMI). At baseline, 17.1% of participants had BMI < 25 kg/m2 and 11.8% had BMI ≥ 40 kg/m2. Mean 12-month weight loss was -2.4 kg (95% CI: -2.8 kg, -2.1 kg). On average, at 42 months, participants regained weight but did not exceed baseline (-0.5 kg, 95% CI: -1.2 kg, 0.2 kg), improvements in triglycerides were completely sustained (-13.9 mg/dL, 95% CI: -18.6 mg/dL, -9.2 mg/dL), and systolic blood pressure improvements remained significant (-1.9 mmHg, 95% CI: -3.0 mmHg, -0.9 mmHg). Participants with a BMI ≥ 40 kg/m2 lost significantly more weight that was sustained at 42 months (-5.8 kg, 95% CI: -8.9 kg, -2.7 kg). The Spirited Life wellness intervention produced weight loss and, for participants with higher levels of obesity, sustained weight-loss maintenance. The intervention was effective for long-term prevention of weight gain among participants with BMI of 25 to ≤40 kg/m2, through 42 months. Wellness interventions such as Spirited Life should be considered for adoption.

Randomization procedures for multicomponent behavioral intervention factorial trials in the multiphase optimization strategy framework: challenges and recommendations.

The multiphase optimization strategy (MOST) is an increasingly popular framework to prepare, optimize, and evaluate multicomponent behavioral health interventions. Within this framework, it is common to use a factorial trial to assemble an optimized multicomponent intervention by simultaneously testing several intervention components. With the possibility of a large number of conditions (unique combinations of components) and a goal to balance conditions on both sample size (for statistical efficiency) and baseline covariates (for internal validity), such trials face additional randomization challenges compared to the standard two-arm trial. The purpose of the current paper is to compare and contrast potential randomization methods for factorial trials in the context of MOST and to provide guidance for the reporting of those methods. We describe the principles, advantages, and disadvantages of several randomization methods in the context of factorial trials. We then provide examples to examine current practice in the MOST-related literature and provide recommendations for reporting of randomization. We identify two key randomization decisions for MOST-related factorial trials: (i) whether to randomize to components or conditions and (ii) whether to use restricted randomization techniques, such as stratification, permuted blocks, and minimization. We also provide a checklist to assist researchers in ensuring complete reporting of randomization methods used. As more investigators use factorial trials within the MOST framework for assembling optimized multicomponent behavioral interventions, appropriate implementation and rigorous reporting of randomization procedures will be essential for ensuring the efficiency and validity of the results.