Effects of a Digital Intervention to Improve DASH and Blood Pressure Among US Adults.

Background: Dietary Approaches to Stop Hypertension (DASH) is a recommended first-line treatment for adults with hypertension, yet adherence to DASH is low.

Purpose: To evaluate the efficacy of a digital health intervention (DHI), compared with attention control, on changes in DASH adherence and blood pressure among adults with hypertension.

Methods: Nourish was a 12-month, parallel, 2-arm, randomized controlled trial of a virtually delivered DHI.

Sociodemographic predictors of successful screening and subsequent randomization in a digital health hypertension intervention.

Introduction: Clinical trials often enroll nonrepresentative participant samples, limiting generalizability of trial findings. The current analysis explores the influences of remote recruitment and screening protocols on participation in a digital health intervention (DHI) to promote the evidence-based Dietary Approaches to Stop Hypertension (DASH) eating pattern.

Methods: Nourish was a 12-month randomized controlled trial comparing the effectiveness of a DHI to an attention control arm among US adults with hypertension.

Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial.

Background: The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials.

Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial.

Background: While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa.

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.

Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial.

Background: While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa.

"We bleed for our community:" A qualitative exploration of the implementation of a pragmatic weight gain prevention trial from the perspectives of community health center professionals.

Background: Clinical trial implementation continues to shift toward pragmatic design, with the goal of increasing future adoption in clinical practice. Yet, few pragmatic trials within clinical settings have qualitatively assessed stakeholder input, especially from those most impacted by research implementation and outcomes, i.e.

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.

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.

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.

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.

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.

A Digital Behavioral Weight Gain Prevention Intervention in Primary Care Practice: Cost and Cost-Effectiveness Analysis.

Background: Obesity is one of the largest drivers of health care spending but nearly half of the population with obesity demonstrate suboptimal readiness for weight loss treatment. Black women are disproportionately likely to have both obesity and limited weight loss readiness. However, they have been shown to be receptive to strategies that prevent weight gain.

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.

Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment.

Background: Primary care-based digital health weight loss interventions offer promise for addressing obesity in underserved populations.

Objectives: To determine if primary care providers' weight counseling is associated with weight change during a weight loss intervention.

Design: This is a secondary analysis of a randomized clinical trial testing a 12-month primary care-based digital health weight loss intervention.

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.

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.

Effectiveness of an App and Provider Counseling for Obesity Treatment in Primary Care.

Introduction: Obesity treatment is less successful for socioeconomically disadvantaged populations, particularly when delivered in primary care. Digital health strategies can extend the reach of clinical obesity treatments to care settings serving patients at highest risk.

Methods: Track was an effectiveness RCT of a 12-month digital weight-loss intervention, embedded within a community health center system.

The effect of a weight gain prevention intervention on moderate-vigorous physical activity among black women: the Shape Program.

Background: Rates of physical inactivity are high among Black women living in the United States with overweight or obesity, especially those living in the rural South. This study was conducted to determine if an efficacious weight gain prevention intervention increased moderate-vigorous physical activity (MVPA).

Methods: The Shape Program, a weight gain prevention intervention implemented in community health centers in rural North Carolina, was designed for socioeconomically disadvantaged Black women with overweight or obesity.

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.

Linking patients with community resources: use of a free YMCA membership among low-income black women.

Given the increasing interest in expanding obesity prevention efforts to cover community-based programs, we examined whether individuals would access a YMCA for physical activity promotion. We provided a no-cost 12-month YMCA membership to socioeconomically disadvantaged black women who were randomized to the intervention arm of a weight gain prevention trial (n = 91). Analyses examined associations of membership activation and use with baseline psychosocial, contextual, health-related, and sociodemographic factors.

Health Literacy and Weight Change in a Digital Health Intervention for Women: A Randomized Controlled Trial in Primary Care Practice.

In the United States, 90 million adults have low health literacy. An important public health challenge is developing obesity treatment interventions suitable for those with low health literacy. The objective of this study was to examine differences in sociodemographic and clinical characteristics as well as weight and intervention engagement outcomes by health literacy.

Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

Introduction: Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings.

Methods: Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system.