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

[This corrects the article DOI: 10.2196/50330.].

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. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care. OBJECTIVE: This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers. METHODS: Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point. RESULTS: We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points). CONCLUSIONS: In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6926-7.

Behavioral Medicine Research Council (BMRC) statement papers: A new approach to consensus building in behavioral medicine science.

The BMRC has initiated a new initiative, the Behavioral Medicine Research Council (BMRC) Scientific Statement papers. The statement papers will move the field forward by guiding efforts to improve the quality of behavioral medicine research and practice and facilitate the dissemination and translation of behavioral medicine research. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

"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., providers and staff. Within this context, we conducted a qualitative study of the implementation of a pragmatic digital health obesity trial with employees at a Federally qualified health center (FQHC) network in central North Carolina. METHODS: Participant recruitment was conducted through purposive sampling of FQHC employees from a variety of backgrounds. Two researchers conducted semi-structured qualitative interviews and collected demographic data. Interviews were digitally recorded, professionally transcribed and double-coded by two independent researchers using NVivo 12. Coding discrepancies were reviewed by a third researcher until intercoder consensus was reached. Responses were compared within and across participants to elucidate emergent themes. RESULTS: Eighteen qualitative interviews were conducted, of whom 39% provided direct medical care to patients and 44% worked at the FQHC for at least seven years. Results illuminated the challenges and successes of a pragmatically designed obesity treatment intervention within the community that serves medically vulnerable patients. Although limited time and staffing shortages may have challenged recruitment processes, respondents described early buy-in from leadership; an alignment of organizational and research goals; and consideration of patient needs as facilitators to implementation. Respondents also described the need for personnel power to sustain novel research interventions and considerations of health center resource constraints. CONCLUSIONS: Results from this study contribute to the limited literature on pragmatic trials utilizing qualitative methods, particularly in community-based obesity treatment. To continue to merge the gaps between research implementation and clinical care, qualitative assessments that solicit stakeholder input are needed within pragmatic trial design. For maximum impact, researchers may wish to solicit input from a variety of professionals at trial onset and ensure that shared common goals and open collaboration between all partners is maintained throughout the trial. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT03003403) on December 28, 2016.

Recruitment of diverse community health center patients in a pragmatic weight gain prevention trial.

Introduction: Pragmatic trials are needed to establish evidence-based obesity treatment in primary care settings, particularly in community health centers (CHCs) that serve populations at heightened risk of obesity. Recruiting a representative trial sample is a critical first step to informing care for diverse communities. We described recruitment strategies utilized in a pragmatic obesity trial and assessed the sociodemographic characteristics and odds of enrollment by recruitment strategy. Methods: We analyzed data from Balance, a pragmatic trial implemented within a network of CHCs. We recruited participants via health center-based and electronic health record (EHR)-informed mail recruitment. We analyzed associations between sociodemographic characteristics and the return rate of patient authorization forms (required for participation) from EHR-informed mail recruitment. We also compared sociodemographic characteristics and randomization odds by recruitment strategy after returning authorization forms. Results: Of the individuals recruited through EHR-informed mail recruitment, females were more likely than males to return authorization forms; however, there were no differences in rates of return by preferred language (English/Spanish) or age. Females; underrepresented racial and ethnic groups; Spanish speakers; younger adults; and those with lower education levels were recruited more successfully in the health center. In contrast, their counterparts were more responsive to mail recruitment. Once authorization forms were returned, the odds of being randomized did not significantly differ by recruitment method. Conclusion: Health center-based recruitment was essential to meeting recruitment targets in a pragmatic weight gain prevention trial, specifically for Hispanic and Spanish-speaking communities. Future pragmatic trials should consider leveraging in-person recruitment for underrepresented groups in research.

Feasibility, Acceptability, and Initial Efficacy of a Digital Intervention to Improve Consumption of Foods Received within a National Nutrition Assistance Program.

Many mothers are vulnerable to poor diet quality, particularly those living in low-income households. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provides nutrient-rich foods through its benefits packages, but many WIC participants are not redeeming them. We assessed the feasibility and acceptability of a digital intervention to support redemption and consumption of WIC-approved foods to ultimately improve diet quality. We enrolled 54 maternal-child dyads receiving WIC benefits to receive three to four weekly text messages for 12 weeks focused on behavioral goals to improve consumption of WIC-approved foods. We assessed engagement with weekly tracking messages and satisfaction and collected 24 h dietary recalls to assess preliminary efficacy on dietary intake. Participants were mostly non-Hispanic white (63%) and working (63%), and responded to 7.4 (standard deviation: 4.6) of the 12 weekly messages. Half (n = 27) were high engagers (responded to 80% or more of weekly messages), with 28% (n = 15) responding to all messages. Most felt the feedback (94%) and tips (87%) were helpful and would recommend the program (91%). More were consuming leafy green vegetables compared to baseline (p = 0.01). Mothers of children enrolled in WIC found a text messaging intervention focused on consumption of WIC-approved foods enjoyable and helpful.

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.

Adverse Childhood Experiences and Cardiovascular Health: An Exploration of Protective Social Determinants Among Young Adult Black Women.

This study sought to advance the literature on Black women's cardiovascular health (CVH) by examining maternal relationship, religion and spirituality, and social connections as potential protective social determinants that buffer the stress of adverse childhood experiences (ACEs). The outcome was the American Heart Association's ideal CVH score. Neither maternal relationship nor religion/spirituality was able to buffer the stress of ACEs on ideal CVH. Findings are discussed in terms of cultural aspects of potential protective factors that are critical for future research. Identifying protective factors that may buffer the influence of ACEs on CVH remains a priority to promote health equity.

Using Interactive Text Messaging to Improve Diet Quality and Increase Redemption of Foods Approved by the Special Supplemental Nutrition Program for Women, Infants, and Children: Protocol for a Cohort Feasibility Study.

BACKGROUND: Children in the United States eat too few fruits, vegetables, and whole grains and too many energy-dense foods; these dietary behaviors are associated with increased risk of obesity. Maternal diet plays a key role in shaping children's diets; however, many mothers have poor diet quality, especially those living in low-income households. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is a federal nutrition assistance program that provides mothers and children with nutrient-dense foods, and those who participate have better diet quality. However, many mothers do not redeem all their WIC-approved foods. Thus, there is a need to create effective interventions to improve diet quality, especially among low-income children and families. OBJECTIVE: This paper aims to describe the development and protocol for a study to evaluate the feasibility, satisfaction, and preliminary efficacy of a fully automated text messaging intervention as a strategy to improve maternal diet quality and the redemption of WIC-approved foods. METHODS: We describe the use of the framework developed for the description of nonrandomized feasibility studies. Using an observational, prospective cohort study design, we will recruit mothers enrolled in WIC with a child aged ≤2 years. Participants will receive automated SMS text messages aimed at improving the redemption of WIC-approved foods to improve the participants' diet quality for 12 weeks. All outcome measures will be analyzed using descriptive and inferential statistics. Qualitative data will be analyzed using thematic analysis. RESULTS: Data collection for this study began in March 2021. We expect the study results to be available within 9 months of study commencement. The results will shed light on the feasibility, acceptability, and effectiveness of using automated text messages as a behavior change strategy for mothers enrolled in WIC. CONCLUSIONS: The results of this pilot study will explore whether this digital behavioral intervention, which will deliver nutrition guidance in accordance with the Dietary Guidelines for Americans using interactive self-monitoring and feedback, is feasible and acceptable. This will lay the foundation for a larger evaluation to determine efficacy for improving diet quality in those most at risk for obesity. TRIAL REGISTRATION: ClinicalTrials.gov NCT04098016; https://clinicaltrials.gov/ct2/show/NCT04098016. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32441.

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.

The Patient's Point of View: Characterizing Patient-Level Factors Associated with Perceptions of Health Care.

Purpose: We explored the association between perception of care, as measured by the Interpersonal Processes of Care (IPC) survey, and patient-level factors, including (1) Trust in physicians; (2) Perceived empathy; (3) Stereotype threat; (4) Perceived everyday discrimination; and (5) Self-Reported Health. Methods: Fifty participants from diverse racial backgrounds and education levels were surveyed. We examined the associations between the five patient-level factors and each subdomain of the IPC using multiple linear regression. We added a race interaction term to assess whether associations between IPC subdomains and predictors differed by race. We tested for correlation among factors found to be significantly associated with the IPC. Results: In adjusted analyses, trust in the physician, perceived empathy from the provider, and perceived everyday discrimination were significantly associated with most subdomains of the IPC. There was no significant race interaction. Conclusion: This exploratory study suggests that empathy, trust, and perceived everyday discrimination are significantly linked to patient perception of quality care, which are linked to clinical outcomes. Results present modifiable factors that may potentially improve patient care. Practice Implications: Increased efforts to improve clinician communication of empathy and general communication skill may have a positive effect on quality of care.

Self-Monitoring via Digital Health in Weight Loss Interventions: A Systematic Review Among Adults with Overweight or Obesity.

OBJECTIVE: Self-monitoring is a core component of behavioral obesity treatment, but it is unknown how digital health has been used for self-monitoring, what engagement rates are achieved in these interventions, and how self-monitoring and weight loss are related. METHODS: This systematic review examined digital self-monitoring in behavioral weight loss interventions among adults with overweight or obesity. Six databases (PubMed, Embase, Scopus, PsycInfo, CINAHL, and ProQuest Dissertations & Theses) were searched for randomized controlled trials with interventions ≥ 12 weeks, weight outcomes ≥ 6 months, and outcomes on self-monitoring engagement and their relationship to weight loss. RESULTS: Thirty-nine studies from 2009 to 2019 met inclusion criteria. Among the 67 interventions with digital self-monitoring, weight was tracked in 72% of them, diet in 81%, and physical activity in 82%. Websites were the most common self-monitoring modality, followed by mobile applications, wearables, electronic scales, and, finally, text messaging. Few interventions had digital self-monitoring engagement rates ≥ 75% of days. Rates were higher in digital- than in paper-based arms in 21 out of 34 comparisons and lower in just 2. Interventions with counseling had similar rates to standalone interventions. Greater digital self-monitoring was linked to weight loss in 74% of occurrences. CONCLUSIONS: Self-monitoring via digital health is consistently associated with weight loss in behavioral obesity treatment.

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.

A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial.

Evidence-based behavioral weight loss treatment is under-utilized. To increase initiation of treatment, we developed a single-session, online, primary care-based intervention ("mobilization tool"). We evaluated the mobilization tool's acceptability for primary care patients with obesity, trial design feasibility, and signal of an effect of the tool on treatment initiation. In this cluster randomized feasibility trial, primary care providers (PCPs) were randomized to a mobilization tool or comparator tool arm. Patients with obesity and a scheduled appointment with a randomized PCP were assigned to complete the mobilization or comparator tool prior to their appointment. The online mobilization tool asks patients to answer questions about a variety of weight-related topics and then provides automated, tailored feedback that addresses psychosocial determinants of weight loss treatment initiation. The comparator tool provided a nontailored description of treatments. All participants were offered free enrollment in behavioral weight loss treatments. Six PCPs were randomized. Sixty patients (57% female; 66% white; aged 55 ± 13 years) participated in this study of 296 contacted for eligibility evaluation (20.2%). Six-month follow-up assessments were completed by 65% (22/34) of the mobilization and 73% (19/26) of comparator tool participants. Participants completing the acceptability survey reported that the mobilization tool was usable, enjoyable, informative, and useful. Weight loss treatment was initiated by 59% (n = 19) of mobilization and 33% (n = 8) of comparator tool participants. The mobilization tool shows promise for increasing treatment initiation among primary care patients, which may increase population weight loss. Trial Registration: Clinicaltrials.gov identifier: NCT02708121.

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.