Evaluation of a cluster-randomized controlled trial: Communities for Healthy Living, family-centered obesity prevention program for Head Start parents and children.

BACKGROUND: This study reports the outcomes of Communities for Healthy Living (CHL), a cluster randomized obesity prevention trial implemented in partnership with Head Start, a federally-funded preschool program for low-income families. METHODS: Using a stepped wedge design, Head Start programs (n = 16; Boston, MA, USA) were randomly assigned to one of three intervention start times. CHL involved a media campaign and enhanced nutrition support. Parents were invited to join Parents Connect for Healthy Living (PConnect), a 10-week wellness program. At the beginning and end of each school year (2017-2019), data were collected on the primary outcome of child Body Mass Index z-score (BMIz) and modified BMIz, and secondary outcomes of child weight-related behaviors (diet, physical activity, sleep, media use) and parents' weight-related parenting practices and empowerment. Data from 2 years, rather than three, were utilized to evaluate CHL due to the COVID-19 pandemic. We used mixed effects linear regression to compare relative differences during intervention vs. control periods (n = 1274 vs. 2476 children) in (1) mean change in child BMIz and modified BMIz, (2) the odds of meeting child health behavior recommendations, (3) mean change in parenting practices, and (4) mean change in parent empowerment. We also compared outcomes among parents who chose post-randomization to participate in PConnect vs. not (n = 55 vs. 443). RESULTS: During intervention periods (vs. control), children experienced greater increases in BMIz and modified BMIz (b = 0.06, 95% CI = 0.02,0.10; b = 0.07, 95% CI = 0.03, 0.12), yet were more likely to meet recommendations related to three of eight measured behaviors: sugar-sweetened beverage consumption (i.e., rarely consume; Odds Ratio (OR) = 1.5, 95% CI = 1.2,2.3), water consumption (i.e., multiple times per day; OR = 1.6, 95% CI = 1.2,2.3), and screen time (i.e., ≤1 hour/day; OR = 1.4, 95% CI = 1.0,1.8). No statistically significant differences for intervention (vs. control) periods were observed in parent empowerment or parenting practices. However, parents who enrolled in PConnect (vs. not) demonstrated greater increases in empowerment (b = 0.17, 95% CI = 0.04,0.31). CONCLUSIONS: Interventions that emphasize parent engagement may increase parental empowerment. Intervention exposure was associated with statistically, but not clinically, significant increases in BMIz and increased odds of meeting recommendations for three child behaviors; premature trial suspension may explain mixed results. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03334669 , Registered October 2017.

Communities for Healthy Living (CHL) A Community-based Intervention to Prevent Obesity in Low-Income Preschool Children: Process Evaluation Protocol.

BACKGROUND: Process evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process evaluation methods and results. Community-based participatory research (CBPR) requires that process evaluation methods be developed to (a) prioritize community members' power to adapt the program to local needs over strict adherence to intervention protocols, (b) share process evaluation data with implementers to maximize benefit to participants, and (c) ensure partner organizations are not overburdened. Co-designed with low-income parents using CBPR, Communities for Healthy Living (CHL) is a family-centered intervention implemented within Head Start to prevent childhood obesity and promote family well-being. We are currently undertaking a randomized controlled trial to test the effectiveness of CHL in 23 Head Start centers in the greater Boston area. In this protocol paper, we outline an embedded process evaluation designed to monitor intervention adherence and adaptation, support ongoing quality improvement, and examine contextual factors that may moderate intervention implementation and/or effectiveness. METHODS: This mixed methods process evaluation was developed using the Pérez et al. framework for evaluating adaptive interventions and is reported following guidelines outlined by Grant et al. Trained research assistants will conduct structured observations of intervention sessions. Intervention facilitators and recipients, along with Head Start staff, will complete surveys and semi-structured interviews. De-identified data for all eligible children and families will be extracted from Head Start administrative records. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated using triangulation methods to assess intervention adherence, monitor adaptations, and identify moderators of intervention implementation and effectiveness. DISCUSSION: A diverse set of quantitative and qualitative data sources are employed to fully characterize CHL implementation. Simultaneously, CHL's process evaluation will provide a case study on strategies to address the challenges of process evaluation for CBPR interventions. Results from this process evaluation will help to explain variation in intervention implementation and outcomes across Head Start programs, support CHL sustainability and future scale-up, and provide guidance for future complex interventions developed using CBPR. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03334669 . Registered on October 10, 2017.

Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.

BACKGROUND: Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. This protocol paper outlines the design, content, implementation, and evaluation of CHL. METHODS/DESIGN: CHL integrates a parenting program co-led by Head Start staff and parents, enhanced nutrition support, and a media campaign. CHL content and implementation are informed by the Family Ecological Model, Psychological Empowerment Theory, and Organizational Empowerment Theory. The intervention is directed by community-based participatory research and implementation science principles, such as co­leadership with parents and staff, and implementation in a real world context. CHL is evaluated in a three-year pragmatic cluster-randomized trial with a stepped wedge design. The primary outcome is change in child Body Mass Index z-score. Secondary outcomes include children's weight-related behaviors (i.e., diet, physical activity, screen use, and sleep), parenting practices targeted at these behaviors (e.g., food parenting), and parent empowerment. The evaluation capitalizes on routine health data collected by Head Start (e.g., child height and weight, diet) coupled with parent surveys completed by subsamples of families. DISCUSSION: CHL is an innovative childhood obesity prevention program grounded in theory and implementation science principles. If successful, CHL is positioned for sustained implementation and nationwide Head Start scale-up.

Emergence of racial/ethnic differences in infant sleep duration in the first six months of life.

OBJECTIVE: Examine the emergence of differences in sleep duration between infants from different racial/ethnic backgrounds and extent to which differences are explained by socioeconomic status (SES) and sleep continuity. METHODS: Sleep duration and continuity (number of night wakings and longest nighttime stretch of sleep) were assessed for 394 infants in the Rise & Sleep Health in Infancy & Early Childhood (SHINE) birth cohort at one- and six-months using the Brief Infant Sleep Questionnaire (BISQ). Multivariable regression was used to estimate associations of race/ethnicity with sleep duration adjusting for individual-level covariates, SES, and sleep continuity. RESULTS: The sample was 40% non-Hispanic white, 33% Hispanic, 11% Black, and 15% Asian. Mean (SD) durations for daytime, nighttime, and total sleep at one-month were 6.3 (2.0), 8.9 (1.5), and 15.2 (2.7) hours, respectively. Corresponding durations at six-months were 3.0 (1.4), 9.9 (1.3), and 13.0 (1.9) hours. At one-month, Hispanic infants had shorter nighttime sleep than white infants [ß: -0.44 h (95% CI: -0.80, -0.08)]. At six-months, Hispanic [ß: -0.96 h (-1.28, -0.63)] and Black [ß: -0.60 h (-1.07, -0.12)] infants had shorter nighttime sleep than white infants. The near 1-h differential in night sleep among Hispanics resulted in shorter total sleep [ß: -0.66 h (-1.16, -0.15)]. Associations across all racial/ethnic groups were attenuated after adjustment for SES at one- and six months. Sleep continuity attenuated associations with nighttime and total sleep duration by 20-60% for Hispanic infants at six-months. CONCLUSIONS: Differences in sleep duration emerge early in life among racial/ethnic groups and are in part explained by SES and sleep continuity.

Prosthetic replacement of the ocular surface ecosystem: impact at 5†years.

BACKGROUND/AIMS: To determine the impact of prosthetic replacement of the ocular surface ecosystem (PROSE) treatment at 5 years. METHODS: Retrospective review of clinical, manufacturing and quality databases at the Boston Foundation for Sight. RESULTS: 121 patients who completed treatment and had 5-year follow-up data were identified from a cohort of patients (n=199) seen in consultation for PROSE treatment from January 2008 to June 2008. Mean age was 52 years, M:F=56:65. The primary indication for treatment was ocular surface disease (OSD) in 64 patients and distorted corneal surface in 57 patients. At 5 years, continued device wear was confirmed in 89/121 (73.6%) patients. Discontinuation of wear was confirmed in 32/121 (26.4%). There was an increased likelihood of continued device wear at 5 years in patients with distorted cornea (84%) compared with those with OSD (64%), (p=0.0121, χ(2)). National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score increased for patients wearing PROSE devices at 6 months (Δ=+23 points, mean=82, p<0.001, two-tailed t test) with no significant decline among those still wearing a device at 5 years (Δ=-4 points, mean=78, p=0.22, two-tailed t test). At 5 years, those wearing (mean=78) had a higher NEI VFQ-25 than those not wearing (mean=70, p=0.029, two-tailed t test). CONCLUSIONS: PROSE treatment offers continued benefit, as defined by improved visual function and continued device wear at 5 years, in patients with complex corneal disease. Patients with distorted cornea have a higher rate of continued wear at 5 years than patients with OSD, although this is not true among all subgroups within OSD.

Dietary Approaches to Stop Hypertension: Lessons Learned From a Case Study on the Development of an mHealth Behavior Change System.

BACKGROUND: Evidence-based solutions for changing health behaviors exist but problems with feasibility, sustainability, and dissemination limit their impact on population-based behavior change and maintenance. OBJECTIVE: Our goal was to overcome the limitations of an established behavior change program by using the inherent capabilities of smartphones and wireless sensors to develop a next generation mobile health (mHealth) intervention that has the potential to be more feasible. METHODS: In response to the clinical need and the growing capabilities of smartphones, our study team decided to develop a behavioral hypertension reduction mHealth system inspired by Dietary Approaches to Stop Hypertension (DASH), a lifestyle modification program. We outline the key design and development decisions that molded the project including decisions about behavior change best practices, coaching features, platform, multimedia content, wireless devices, data security, integration of systems, rapid prototyping, usability, funding mechanisms, and how all of these issues intersect with clinical research and behavioral trials. RESULTS: Over the 12 months, our study team faced many challenges to developing our prototype intervention. We describe 10 lessons learned that will ultimately stimulate more effective and sustainable approaches. CONCLUSIONS: The experiences presented in this case study can be used as a reference for others developing mHealth behavioral intervention development projects by highlighting the benefits and challenges facing mHealth research.

Usability testing of Avoiding Diabetes Thru Action Plan Targeting (ADAPT) decision support for integrating care-based counseling of pre-diabetes in an electronic health record.

PURPOSE: Usability testing can be used to evaluate human-computer interaction (HCI) and communication in shared decision making (SDM) for patient-provider behavioral change and behavioral contracting. Traditional evaluations of usability using scripted or mock patient scenarios with think-aloud protocol analysis provide a way to identify HCI issues. In this paper we describe the application of these methods in the evaluation of the Avoiding Diabetes Thru Action Plan Targeting (ADAPT) tool, and test the usability of the tool to support the ADAPT framework for integrated care counseling of pre-diabetes. The think-aloud protocol analysis typically does not provide an assessment of how patient-provider interactions are effected in "live" clinical workflow or whether a tool is successful. Therefore, "Near-live" clinical simulations involving applied simulation methods were used to compliment the think-aloud results. This complementary usability technique was used to test the end-user HCI and tool performance by more closely mimicking the clinical workflow and capturing interaction sequences along with assessing the functionality of computer module prototypes on clinician workflow. We expected this method to further complement and provide different usability findings as compared to think-aloud analysis. Together, this mixed method evaluation provided comprehensive and realistic feedback for iterative refinement of the ADAPT system prior to implementation. METHODS: The study employed two phases of testing of a new interactive ADAPT tool that embedded an evidence-based shared goal setting component into primary care workflow for dealing with pre-diabetes counseling within a commercial physician office electronic health record (EHR). Phase I applied usability testing that involved "think-aloud" protocol analysis of eight primary care providers interacting with several scripted clinical scenarios. Phase II used "near-live" clinical simulations of five providers interacting with standardized trained patient actors enacting the clinical scenario of counseling for pre-diabetes, each of whom had a pedometer that recorded the number of steps taken over a week. In both phases, all sessions were audio-taped and motion screen-capture software was activated for onscreen recordings. Transcripts were coded using iterative qualitative content analysis methods. RESULTS: In Phase I, the impact of the components and layout of ADAPT on user's Navigation, Understandability, and Workflow were associated with the largest volume of negative comments (i.e. approximately 80% of end-user commentary), while Usability and Content of ADAPT were representative of more positive than negative user commentary. The heuristic category of Usability had a positive-to-negative comment ratio of 2.1, reflecting positive perception of the usability of the tool, its functionality, and overall co-productive utilization of ADAPT. However, there were mixed perceptions about content (i.e., how the information was displayed, organized and described in the tool). In Phase II, the duration of patient encounters was approximately 10 min with all of the Patient Instructions (prescriptions) and behavioral contracting being activated at the end of each visit. Upon activation, providers accepted the pathway prescribed by the tool 100% of the time and completed all the fields in the tool in the simulation cases. Only 14% of encounter time was spent using the functionality of the ADAPT tool in terms of keystrokes and entering relevant data. The rest of the time was spent on communication and dialog to populate the patient instructions. In all cases, the interaction sequence of reviewing and discussing exercise and diet of the patient was linked to the functionality of the ADAPT tool in terms of monitoring, response-efficacy, self-efficacy, and negotiation in the patient-provider dialog. There was a change from one-way dialog to two-way dialog and negotiation that ended in a behavioral contract. This change demonstrated the tool's sequence, which supported recording current exercise and diet followed by a diet and exercise goal setting procedure to reduce the risk of diabetes onset. CONCLUSIONS: This study demonstrated that "think-aloud" protocol analysis with "near-live" clinical simulations provided a successful usability evaluation of a new primary care pre-diabetes shared goal setting tool. Each phase of the study provided complementary observations on problems with the new onscreen tool and was used to show the influence of the ADAPT framework on the usability, workflow integration, and communication between the patient and provider. The think-aloud tests with the provider showed the tool can be used according to the ADAPT framework (exercise-to-diet behavior change and tool utilization), while the clinical simulations revealed the ADAPT framework to realistically support patient-provider communication to obtain behavioral change contract. SDM interactions and mechanisms affecting protocol-based care can be more completely captured by combining "near-live" clinical simulations with traditional "think-aloud analysis" which augments clinician utilization. More analysis is required to verify if the rich communication actions found in Phase II compliment clinical workflows.

Practice Patterns in Screening for Metabolic Disease in Women with PCOS of Diverse Race-Ethnic Backgrounds.

OBJECTIVES: Women with polycystic ovary syndrome (PCOS) are at high risk for metabolic disorders, which prompted the American Association of Clinical Endocrinologists (AACE) to publish a 2005 position statement recommending screening for metabolic disease.The purposes of the present study were to 1) to examine changes in screening rates for obesity, type 2 diabetes (T2D), metabolic syndrome (MetS), hyperlipidemia (HL), nonalcoholic fatty liver disease (NAFLD), and hypertension (HTN) in women with PCOS after publication of the 2005 AACE position statement and 2) to determine if screening rates and metabolic disorders vary by race-ethnicity. METHODS: PCOS cases in 2006 (n = 547) and 2011 (n = 1,159) and metabolic disorders were identified by International Classification of Diseases, 9th revision (ICD9) code. Screening rates for metabolic disorders were determined by the presence of blood tests (hemoglobin A1c [HbA1c], lipid profile, alanine aminotransferase/aspartate aminotransferase [ALT/AST]). RESULTS: In 2006, ≤25% of PCOS patients underwent recommended screening tests: HbA1c 18%; lipid profile <20%; ALT/AST ≤25%. By 2011, only HbA1c testing had increased (18% to 21%). Obesity increased from 35% to 40%, while other metabolic disorders remained stable. Black women had the highest rates of obesity and HTN in 2011 (Obesity: Black 48%, Hispanic 44%, White 33%, Other 31%, P<.0001; HTN: Black 18%, Hispanic 9%, White 10%, Other 7%, P<.0001). Blacks and Hispanics were screened more often with ALT/AST testing (Black 27/27%, Hispanic 28/27%, White 23/22%, Other 17/18%, P = .02/.03). Screening rates were higher in the endocrine clinic for all metabolic disorders than in other clinics (P<.05). CONCLUSION: Despite the publication of recommendations in 2005, screening rates for metabolic disease in women with PCOS remained low across all race-ethnicities in 2011.

What do primary care prediabetes patients need? A baseline assessment of patients engaging in a technology-enhanced lifestyle intervention.

OBJECTIVE: This study assessed the baseline knowledge, perceptions, attitudes and behaviors of prediabetes patients in order to tailor a new technology-enhanced primary care-based lifestyle modification intervention. METHODS: Patients with a diagnosis of prediabetes were enrolled in a randomized, controlled pilot study, Avoiding Diabetes Thru Action Plan Targeting (ADAPT), a technology-based intervention to promote action plan discussions around patient-selected behavior change goals. RESULTS: A total of 54 adults (82% female) were enrolled in the pilot study. Most (89%) had comorbid conditions and mean BMI was 36. Participants exhibited high risk of diabetes knowledge (knowledge score 20 on a 32 point scale) and high levels of willingness to make changes to decrease diabetes risk. Number of daily steps was inversely correlated with perceived physical activity (r=-0.35082, p<0.001). Poorer scores on diet quality were inversely correlated with BMI. CONCLUSION: Participants in this sample demonstrated requisite levels of knowledge, self-efficacy, motivation and risk perception for effective behavior change. These data suggest that primary care-based prediabetes interventions can move beyond educational goals and focus on enhancing patients' ability to select, plan and enact action plans.

Family, peer, and media predictors of becoming eating disordered.

OBJECTIVE: To identify predictors of becoming eating disordered among adolescents. DESIGN: Prospective cohort study. SETTING: Self-report questionnaires. SUBJECTS: Girls (n = 6916) and boys (n = 5618), aged 9 to 15 years at baseline, in the ongoing Growing Up Today Study (GUTS). Main Exposures Parent, peer, and media influences. MAIN OUTCOME MEASURES: Onset of starting to binge eat or purge (ie, vomiting or using laxatives) at least weekly. RESULTS: During 7 years of follow-up, 4.3% of female subjects and 2.3% of male subjects (hereafter referred to as "females" and "males") started to binge eat and 5.3% of females and 0.8% of males started to purge to control their weight. Few participants started to both binge eat and purge. Rates and risk factors varied by sex and age group (<14 vs > or =14 years). Females younger than 14 years whose mothers had a history of an eating disorder were nearly 3 times more likely than their peers to start purging at least weekly (odds ratio, 2.8; 95% confidence interval, 1.3-5.9); however, maternal history of an eating disorder was unrelated to risk of starting to binge eat or purge in older adolescent females. Frequent dieting and trying to look like persons in the media were independent predictors of binge eating in females of all ages. In males, negative comments about weight by fathers was predictive of starting to binge at least weekly. CONCLUSIONS: Risk factors for the development of binge eating and purging differ by sex and by age group in females. Maternal history of an eating disorder is a risk factor only in younger adolescent females.