A genetic disorder reveals a hematopoietic stem cell regulatory network co-opted in leukemia.

The molecular regulation of human hematopoietic stem cell (HSC) maintenance is therapeutically important, but limitations in experimental systems and interspecies variation have constrained our knowledge of this process. Here, we have studied a rare genetic disorder due to MECOM haploinsufficiency, characterized by an early-onset absence of HSCs in vivo. By generating a faithful model of this disorder in primary human HSCs and coupling functional studies with integrative single-cell genomic analyses, we uncover a key transcriptional network involving hundreds of genes that is required for HSC maintenance. Through our analyses, we nominate cooperating transcriptional regulators and identify how MECOM prevents the CTCF-dependent genome reorganization that occurs as HSCs differentiate. We show that this transcriptional network is co-opted in high-risk leukemias, thereby enabling these cancers to acquire stem cell properties. Collectively, we illuminate a regulatory network necessary for HSC self-renewal through the study of a rare experiment of nature.

Incidence of Hypertriglyceridemia in Patients on Propofol, Clevidipine, or Both.

BACKGROUND: Propofol and clevidipine (PC) are commonly used in the treatment of critically ill patients. While both medications are lipid emulsions, there is limited evidence concerning the incidence of hypertriglyceridemia (HTG) when these agents are used individually or concurrently. OBJECTIVE: The objective of this study is to determine the effects of propofol, clevidipine, or concurrent PC on triglycerides (TGs) and related outcomes in critically ill adults. METHODS: This was a retrospective cohort study conducted at an academic medical center. Patients were included if they received ≥24 hours of continuous propofol and/or clevidipine. Excluded were those without TG levels after ≥24 hours of infusion, baseline HTG, acute pancreatitis at admission, or receiving total parenteral nutrition with lipids. The primary outcome was incidence of HTG (defined as a TG level >400 mg/dL). Secondary outcomes included median and peak TG levels, hospital length of stay, intensive care unit length of stay, total lipid infused, time to peak TG level, peak lipase level, and development of pancreatitis. RESULTS: In total, 190 patients were studied: 109 in the propofol group, 50 in the clevidipine group, and 31 in the PC group. Incidence of HTG was similar (19 [17.4%] vs 6 [12%] vs 4 [12.9%] patients, P = 0.6246). Peak and median TG levels were similar for propofol, clevidipine, and PC groups (216 mg/dL vs 189.5 mg/dL vs 205 mg/dL, P = 0.7069; 177 mg/dL vs 185.5 mg/dL vs 177 mg/dL, P = 0.6791). CONCLUSIONS AND RELEVANCE: There was a similar incidence of HTG in all groups. The results of this study suggest that the concurrent use of PC should not modify the frequency of TG level monitoring.

Food Security is Associated with Higher Diet Quality Among Children of the US-Affiliated Pacific Region.

BACKGROUND: The prevalence of food insecurity and its relationship to diet quality are factors impacting the health of persons living across the United States-affiliated Pacific region (USAP). OBJECTIVES: The aim of this study was to describe characterize the relationship between household food security status and diet quality of 2- to 8-y-old children across jurisdictions in the USAP. METHODS: Baseline data from 2- to 8-y-olds (n = 3099) enrolled in the Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific region, an obesity prevention study conducted in communities across Alaska, American Samoa, Commonwealth of the Northern Mariana Islands (CNMI), Guam, and Hawaii, and a concomitant prevalence study in communities across the Freely Associated States (FAS) (the Federated States of Micronesia: Kosrae, Pohnpei, Chuuk, Yap; Republic of Marshall Islands; Republic of Palau) were collected in 2012. Caregivers self-reported sociodemographic data and food insecurity. Assisted by their caregiver, children completed two dietary records on nonconsecutive, randomly assigned days. The Healthy Eating Index 2005 (HEI-2005) was used to assess the diet quality. Data were summarized overall and by jurisdiction. Differences in HEI-2005 and HEI component scores among jurisdictions and by household food security status were tested using 1-factor ANOVA. RESULTS: Half or more of participants from American Samoa, Guam, CNMI, and FAS reported household food insecurity (n = 295, 59.7%; n = 292, 49.9%; n = 267, 54.6%; n = 572, 69.0%, respectively). HEI-2005 scores varied by jurisdiction (P < 0.001) and were significantly lower among FAS participants (54.7 ± 1.2) than among all other jurisdictions (P < 0.05). Total diet quality scores did not differ by food security status (59.9 ± 0.8 food secure compared with 58.3 ± 1.1 food insecure, P = 0.07); however, most diet quality adequacy component scores were significantly higher and moderation component scores significantly lower among participants in food secure households than those in food insecure households. CONCLUSIONS: Significant differences in children's diet quality and household food security existed across USAP jurisdictions.

Food Group, Macronutrient Intake, and Metabolic Status in the US-Affiliated Pacific's Children's Healthy Living (CHL) Program.

BACKGROUND: The Children's Healthy Living study provided dietary intake information for understudied Native Hawaiian and Other Pacific Islander (NHOPI) young children. OBJECTIVES: Our objective was to describe food group and macronutrient intakes of NHOPI children in the US-Affiliated Pacific region (USAP), overall and by jurisdiction, income level, and metabolic status. METHODS: We evaluated 2-8-y-olds (n = 3520) in a cross-sectional cluster sampled study using 2 d of dietary records completed by caregivers using provided tools, quantified by a specially developed food composition table and compared with US dietary recommendations. Overweight and obesity (OWOB) and acanthosis nigricans (AN) assessment (metabolic status) was completed by trained evaluators using standard tools. Demographic data were collected by questionnaire. Regression analysis identified differences in dietary component means by jurisdiction, World Bank income groups (WBIGs), and metabolic status, adjusted for age and sex. RESULTS: Few children met US recommendations for vegetable (2.4%) and milk (4.1%) food groups. US macronutrient recommendations were generally met. Food group and macronutrient intakes were significantly different by jurisdiction and WBIG. Means for food groups, except meats, and macronutrients, except protein, were higher in overweight/obese (OWOB) compared with healthy-weight children. Grain intake of 7.25 (SE: 0.08) oz was higher (P < 0.05) and milk intake of 0.90 (SE: 0.05) cups was lower (P < 0.05) in children with OWOB compared with those without OWOB [grains: 7.17 (SE: 0.07) oz; and milk: 0.96 (SE: 0.04) cups]. Monounsaturated fat intake of 11.68 (SE: 0.10) % energy was higher in those with OWOB, compared with healthy-weight children [11.56 (SE: 0.08) % energy, P < 0.05]. CONCLUSIONS: Young children's diets in the USAP did not meet milk, vegetable, or fruit intake recommendations. There was variability in dietary patterns across the USAP and by WBIG. Grain intake and monounsaturated fat intake were lower and milk intake was higher in children with better metabolic status.

CRISPR/Cas9 mutagenesis reveals a role for ABCB1 in gut immune responses to Vibrio diazotrophicus in sea urchin larvae.

The ABC transporter ABCB1 plays an important role in the disposition of xenobiotics. Embryos of most species express high levels of this transporter in early development as a protective mechanism, but its native substrates are not known. Here, we used larvae of the sea urchin Strongylocentrotus purpuratus to characterize the early life expression and role of Sp-ABCB1a, a homolog of ABCB1. The results indicate that while Sp-ABCB1a is initially expressed ubiquitously, it becomes enriched in the developing gut. Using optimized CRISPR/Cas9 gene editing methods to achieve high editing efficiency in the F0 generation, we generated ABCB1a crispant embryos with significantly reduced transporter efflux activity. When infected with the opportunistic pathogen Vibrio diazotrophicus, Sp-ABCB1a crispant larvae demonstrated significantly stronger gut inflammation, immunocyte migration and cytokine Sp-IL-17 induction, as compared with infected control larvae. The results suggest an ancestral function of ABCB1 in host-microbial interactions, with implications for the survival of invertebrate larvae in the marine microbial environment.

Evaluation of the Hemodynamic Effects of Intravenous Amiodarone Formulations During the Maintenance Phase Infusion.

BACKGROUND: Two of the excipients in intravenous formulations of amiodarone, polysorbate 80 and benzyl alcohol, have been shown to cause hypotension. A newer formulation of amiodarone, which contains cyclodextrin, is devoid of these excipients. OBJECTIVE: To evaluate the change in mean arterial pressure when utilizing 2 intravenous amiodarone formulations. METHODS: This was a retrospective cohort analysis conducted at an academic medical center. Patients received intravenous amiodarone containing either polysorbate 80/benzyl alcohol (control) or cyclodextrin (cyclodextrin). Patients received these formulations based on a standard institutional protocol of 1 mg/min for 6 hours, followed by 0.5 mg/min for at least 18 hours or until discontinued by the provider. All data were collected from the medical record and included changes in blood pressures, time to lowest systolic blood pressure, concurrent antihypertensive use, and number of patients requiring treatment for hypotension. RESULTS: A total of 160 patients (120 control, 40 cyclodextrin) were included. There was a statistically significant difference in mean arterial pressure between the groups receiving the control formulation of amiodarone compared with the cyclodextrin formulation across the 24-hour maintenance phase infusion (P < 0.001). There was a significant difference between formulations with regard to the change in mean arterial pressure during the 0- to 6-hour and 12- to 18-hour time blocks. There was a statistically significant difference in the number of patients receiving fluid boluses for treatment of hypotension (P = 0.001). CONCLUSIONS: The excipients in the formulation of intravenous amiodarone may have a significant role in the hypotensive effects seen throughout the duration the maintenance phase infusion.

Acculturation and Health Status in the Children's Healthy Living Program in the Pacific Region.

Acculturation/enculturation has been found to impact childhood health and obesity status. The objective of this study is to use cross-sectional data to examine the association between proxies of adult/caregiver acculturation/enculturation and child health status (Body Mass Index [BMI], waist circumference [WC], and acanthosis nigricans [AN]) in the U.S.-Affiliated Pacific Islands (USAPI), Alaska, and Hawai'i. Study participants were from the Children's Healthy Living (CHL) Program, an environmental intervention trial and obesity prevalence survey. Anthropometric data from 2-8 year olds and parent/caregiver questionnaires were used in this analysis. The results of this study (n = 4121) saw that those parents/caregivers who identified as traditional had children who were protected against overweight/obesity (OWOB) status and WC > 75th percentile (compared to the integrated culture identity) when adjusted for significant variables from the descriptive analysis. AN did not have a significant association with cultural classification. Future interventions in the USAPI, Alaska, and Hawai'i may want to focus efforts on parents/caregivers who associated with an integrated cultural group as an opportunity to improve health and reduce child OWOB prevalence.

Diet and Acanthosis Nigricans over a Two-Year Period in Children of the Pacific Region.

BACKGROUND: The impact that dietary carbohydrates have on children developing type 2 diabetes remains controversial. Furthermore, there are limited pediatric longitudinal studies on changes in body mass index (BMI) and diet related to the development of acanthosis nigricans (AN), a risk factor associated with type 2 diabetes. METHODS: Two 24 h dietary records were collected for 558 children, 2-8 years of age, at baseline and at a 2-year follow-up. Data on age, sex, BMI, and the presence of AN were also collected at each time point from the Children's Healthy Living Program. Logistic regression was used to determine factors associated with the presence of AN at follow-up. Multinominal regression was used to determine factors associated with changes in AN status. Linear regression was used to measure the associations between changes in dietary intake and in the Burke Score for AN. RESULTS: AN was present in 28 children at baseline and 34 children at follow-up. Adjusting for the presence of AN at baseline, age, sex, study group, baseline BMI, change in BMI z-score, time between assessments, and baseline intake, an increase from baseline for each teaspoon of sugar and serving of carbohydrate-rich food increased the risk for having AN at follow-up by 9% and 8%, respectively (p ≤ 0.05). An increased intake of added sugar (teaspoons) increased the risk of developing AN by 13% (p ≤ 0.01) and an increase in servings of foods rich in starch increased the risk of developing AN by 12% (p ≤ 0.01) compared to children who never had AN. Increasing the intake of fruit was also associated with decreased Burke Scores using multiple regression. However, the intake of energy and macronutrients were not associated with AN. CONCLUSIONS: Added sugar and foods rich in starch were independently associated with the occurrence of AN, suggesting the type of carbohydrates consumed is a factor in AN occurrence.

Diet Quality of Young Children in the US-Affiliated Pacific's Children's Healthy Living (CHL) Program.

BACKGROUND: Childhood diet can impact health outcomes over the life course. Few studies have assessed dietary quality among infants and children in the US-Affiliated Pacific (USAP) region. OBJECTIVE: The aim of this study was to examine the differences in diet quality among Pacific children in the Children's Healthy Living (CHL) program by Pacific jurisdiction and by their World Bank Income Group (WBIG) level. DESIGN: This cross-sectional study used dietary records collected from 2012 to 2015. PARTICIPANTS/SETTING: Data were collected on 2- to 8-year-old children (n = 3,529) enrolled in the Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific region, conducted in the USAP jurisdictions of Alaska, Hawai'i, American Samoa, Commonwealth of the Northern Mariana Islands (CNMI), Guam, Federated States of Micronesia (FSM islands include Chuuk, Kosrae, Pohnpei, Yap), Republic of the Marshall Islands (RMI), and Republic of Palau. MAIN OUTCOME MEASURE: Diet quality was assessed using the Healthy Eating Index-2005 (HEI-2005). This HEI version was commensurate with the time of dietary data collection for the CHL project and previous studies, thus allowing cross-study comparisons. STATISTICAL ANALYSIS PERFORMED: Means of total HEI-2005 scores between jurisdictions and their WBIG level were compared using linear models, with and without adjustment for age, sex, and dietary energy. RESULTS: Differences in mean HEI-2005 scores among children were found between jurisdictions and their WBIG level. Alaska had the highest adjusted mean score (63.3). RMI had the lowest adjusted mean score (50.1). By WBIG, lower-middle income jurisdictions had the lowest adjusted mean HEI-2005 score (56.0), whereas high income jurisdictions had the highest adjusted mean HEI-2005 score (60.5). CONCLUSIONS: Variation in children's diet quality was found between USAP jurisdictions, notably between jurisdictions of different WBIG levels. Future research is needed to deepen understanding of these differences in diet quality by WBIG level, such as whether differences may be attributable to the jurisdictions' varying food systems, and possibly explained by the nutrition transition. Understanding childhood diet quality in this region can inform approaches for nutrition programs in the Pacific region.

Children's Dietary Intake by Early Care and Education Setting in the US Affiliated Pacific.

OBJECTIVE: Examine differences in dietary intake of children aged 2-5 years in early care and education (ECE) setting in the US Affiliated Pacific (USAP). DESIGN: Secondary analysis of cross-sectional data collected by the Children's Healthy Living program. PARTICIPANTS: Children (n = 1,423) with complete dietary records and information on the ECE setting. MAIN OUTCOME MEASURES: Dietary intake by ECE setting; Head Start (HS), other ECE (OE), and no ECE. ANALYSIS: Comparison of mean dietary intake across ECE settings and multivariate logistic regression to evaluate ECE setting and likelihood for meeting dietary reference intake (DRI). RESULTS: Children in HS and OE settings had a significantly higher intake of several food groups and nutrients, compared with no ECE; vegetables (0.4 cup-equivalents per thousand kcals [CETK] vs 0.3 CETK; P < 0.001), fruits (0.8 CETK vs 0.6 CETK; P = 0.001), milk (0.9 CETK for HS and 1.0 CETK for OE vs 0.8 CETK; P < 0.001). Sixty-five percent of the HS group met DRI and had greater odds of meeting calcium DRI (odds ratio, 1.8; 95% confidence interval, 1.2-2.7) compared with other groups. The OE group had the lowest proportion of children meeting recommended intakes for 19 out of 25 nutrients. CONCLUSIONS AND IMPLICATIONS: Mean intakes of foods and nutrients for children across the USAP meet some, but not all, recommendations and intakes vary across children attending various ECE setting types. Additional research on the clinical importance of these differences and the impact of the complex food systems in the USAP may identify systematic strategies for improving diet among children.

Maintenance Outcomes of the Children's Healthy Living Program on Overweight, Obesity, and Acanthosis Nigricans Among Young Children in the US-Affiliated Pacific Region: A Randomized Clinical Trial.

Importance: Few obesity prevention trials among children have demonstrated sustainable outcomes in the long term. Objectives: To sustain a community-wide decrease in the prevalence of overweight and obesity among young children in the US-affiliated Pacific region. Design, Setting, and Participants: In the Children's Healthy Living community-randomized clinical trial, hierarchical modeling comparing the change in intervention and control communities accounted for community randomization (community clustering with jurisdictions), and adjusted for the age and sex distribution of the assessed children in a cross-sectional design. The outcome measures were repeated in communities rather than among individual children. A total of 27 communities in 5 jurisdictions (Hawai'i, Alaska, Commonwealth of the Northern Mariana Islands, American Samoa, and Guam) of the US-affiliated Pacific region were included. Participants included children aged 2 to 8 years in the 27 selected communities from October 1, 2012 (4329 in time 1 [baseline]) to August 31, 2015 (4043 in time 2 [intervention end]) and from January 1, 2019, to April 30, 2020 (1469 in time 3 [maintenance period]). Study analysis was completed March 25, 2022. Interventions: Nineteen activities addressed training, policies, systems, and environments of communities and 6 target behaviors of children (consumption of fruit and vegetables, water, and sugar-sweetened beverages; sleep; physical activity; and screen time) during a 2-year intervention period. Continued partnership with community coalitions, ongoing academic training of community partners, and use of trial data during a 6-year maintenance period. Main Outcomes and Measures: The primary outcome was measured anthropometry; secondary outcomes were the presence of acanthosis nigricans, dietary intake derived from 2 days of food records, and survey questions on screen time and sleep disturbance. Results: Among the 9840 children included in the analysis (4866 girls [49.5%] and 4974 boys [50.5%]; 6334 [64.4%] aged 2-5 years), the intervention group showed significant improvements compared with the control group from times 1 to 3 in prevalence of overweight plus obesity (d = -12.60% [95% CI, -20.92% to -4.28%]), waist circumference (d = -1.64 [95% CI, -2.87 to -0.41] cm), and acanthosis nigricans prevalence (d = -3.55% [95% CI, -6.17% to -0.92%]). Significant improvements were also observed from times 2 to 3 in prevalence of overweight plus obesity (d = -8.73% [95% CI, -15.86% to -1.60%]) but not in waist circumference (d = -0.81 [95% CI, -1.85 to 0.23] cm). Conclusions and Relevance: This randomized clinical trial found that the outcomes of the Children's Healthy Living intervention were maintained and enhanced 6 years after the intervention among young children in the US-affiliated Pacific region. The prevalence of overweight, obesity, and acanthosis nigricans was further reduced in communities, suggesting that multilevel multicomponent interventions may help reduce child overweight and obesity in this region. Trial Registration: ClinicalTrials.gov Identifier: NCT01881373.

Estimating intervention dose of the multilevel multisite children's healthy living program intervention.

Increased community collective efficacy (CE), defined as social cohesion among neighbors and their willingness to intervene for common good, is associated with improved community health outcomes. However, processes to increase CE and estimate its dose within an intervention are not well understood. The 2 year Children's Healthy Living (CHL) intervention aimed to improve child behaviors known to affect obesity. We used data from CHL to estimate CE dose and examine its association with a successful outcome from CHL-reduction in children's recreational screen time. Monthly reports from nine intervention communities were quantified, and CE dose was calculated for each community overall, at 4 time intervals (6, 12, 18, and 24 months), and for each CE building block-social bonding, social bridging, social leveraging, empowerment, and civic engagement. CE dose at each time interval and change in screen time was correlated using Spearman's rho. Next, communities were categorized as having a high CE dose or a low CE dose, and differences between four high-dose and five low-dose communities were compared using a two-tailed t-test. The correlation between change in screen time and CE dose was significant (rs = 0.83, p = .003). Significantly more activities facilitating empowerment and civic engagement were conducted in high-dose communities, which were more likely to show improvements in screen time, than in low-dose communities. This method of estimating an intervention's CE dose and examining change over time and effect of CE and its building blocks on intervention outcomes shows promise.

The Affordability of a Thrifty Food Plan-based Market Basket in the United States-affiliated Pacific Region.

In an effort to characterize food costs in the United States (US)-affiliated Pacific Region, a first-time food cost survey was conducted in March 2014. A market basket survey was developed using an adaptation of the US Department of Agriculture Thrifty Food Plan. Surveys were conducted in the states of Alaska and Hawai'i; Portland, Oregon; the US-affiliated Pacific Islands of American Samoa (American Samoa); Commonwealth of the Northern Mariana Islands; the island of Pohnpei within the Federated States of Micronesia; Guam; Republic of the Marshall Islands; and Republic of Palau. Urban and rural communities were included. Multiple stores in multiple communities were surveyed in each jurisdiction. Food retailers (N = 74) ranged from convenience markets to supermarkets. Not all foods in the market basket survey were available in each of the communities. Inspection of available income data also showed that food costs represented a higher percentage of household income for American Samoa than those of Alaska, Hawai'i, and Portland. Thrifty Food Plan weighted weekly totals for the region ranged from $181.90 to $264.30. Weighting was based on the amount of the item converted to grams required for the Thrifty Food Plan menu. These food costs are significantly higher than those of Portland ($142.00) for the survey period. Protein foods, grains, vegetables, fruit, and dairy were the 5 most costly components, in descending order. Food affordability was assessed by comparing food costs across jurisdictions and examining estimated food costs to reported average jurisdiction incomes. The survey is intended to help inform public health policy and educational programs in the region. A locally adapted food survey would benefit future analyses, regional policy, and educational efforts.

Surface attached manganese-oxo clusters as potential contrast agents.

Surface attachment of the manganese-oxo cluster known as Mn-12 provided aqueous solution stabilization that allowed investigation of the use of the cluster as an MRI contrast agent.

The painted sea urchin, Lytechinus pictus, as a genetically-enabled developmental model.

Although sea urchins are one of the oldest and most widely used marine model systems, few species have been routinely kept in culture through multiple generations. The workhorse of the field is the purple urchin Strongylocentrotus purpuratus. However, one disadvantage of S. purpuratus is its long generation time, making it impractical as a model for generating and maintaining transgenic lines. In an effort to develop a sea urchin that is suitable for transgenerational experiments and the generation of transgenic lines, we have focused on development of updated culturing methods and genomic resources for the painted sea urchin, Lytechinus pictus. Compared to S. purpuratus, L. pictus have relatively large eggs, develop into optically clear embryos, and the smaller adults can become gravid in under a year. Fifty years ago, Hinegardner developed culturing methods for raising L. pictus through metamorphosis. Here, we provide an updated protocol for establishing and maintaining L. pictus in the laboratory, and describe a new genome resource for this urchin. In our hands, L. pictus reach the 4-armed pluteus stage at 4 days; become competent to metamorphosis at 24 days; and are gravid by 6 months. Plutei and juveniles are fed on a diet of algae and diatoms, and adults are fed on kelp. We also make available a L. pictus transcriptome generated from developmental stages (eggs to 2-day-old plutei) to support the annotation of our genome sequencing project, and to enhance the utility of this species for molecular studies and transgenesis.

Effect of the Children's Healthy Living Program on Young Child Overweight, Obesity, and Acanthosis Nigricans in the US-Affiliated Pacific Region: A Randomized Clinical Trial.

Importance: Pacific Islanders have among the highest rates of obesity and type 2 diabetes in the world. Targeting children is critical for primary prevention. Objectives: To prevent young child overweight and obesity and to improve health in the US-Affiliated Pacific region via the Children's Healthy Living Program. Design, Setting, and Participants: In this multijurisdictional, multilevel, multicomponent community randomized clinical trial, where all evaluable children were analyzed according to the random assignment of their community, hierarchical difference-in-difference models accounted for the community randomization, community clustering with jurisdictions, and these models were adjusted for the age and sex distribution of the community. The setting was 27 communities in 5 jurisdictions (Alaska, American Samoa, Commonwealth of the Northern Mariana Islands, Guam, and Hawaii). Participants were 4329 children (time 1) and 4042 children (time 2) aged 2 to 8 years in 27 selected communities from October 7, 2012, to October 25, 2015. Data analysis was completed in June 2018. Interventions: Nineteen activities addressed policy, environment, messaging, training, and 6 target behaviors (sleep time, screen time, physical activity, fruits and vegetables, water, and sugar-sweetened beverages). Main Outcomes and Measures: Primary outcomes were body size measurements. Secondary outcomes were acanthosis nigricans, sleep quality and duration, dietary intake, physical activity, and other questionnaire reponses. Results: The study included 27 communities and 8371 evaluable children (mean [SD] age, 5.4 [1.8] years; 50.9% male [n = 4264]). Data analysis included 952 children in the intervention group and 930 children in the control group aged 2 to 5 years at time 1; 825 children in the intervention group and 735 children in the control group aged 2 to 5 years at time 2; 565 children in the intervention group and 561 children in the control group aged 6 to 8 years at time 1; and 517 children in the intervention group and 560 children in the control group aged 6 to 8 years at time 2. The intervention communities showed significant improvement compared with control communities in overweight and obesity prevalence (effect size [d] = -3.95%; 95% CI, -7.47% to -0.43%), waist circumference (d = -0.71 cm; 95% CI, -1.37 to -0.05 cm), and acanthosis nigricans prevalence (d = -2.28%; 95% CI, -2.77% to -1.57%). Age and sex subgroup analysis revealed greater difference among the intervention communities in acanthosis nigricans prevalence in the group aged 2 to 5 years (-3.99%) vs the group aged 6 to 8 years (-3.40%), and the interaction was significant (d = 0.59%, P < .001), as well as the smaller difference in the group aged 2 to 5 years (-0.10%) vs the group aged 6 to 8 years (-1.07%) in screen time (d = -0.97 hour per day, P = .01). Conclusions and Relevance: The intervention reduced the prevalence of young child overweight and obesity and acanthosis nigricans. Comprehensive, effective, and sustainable interventions are needed to improve child health in the US-Affiliated Pacific region. Trial Registration: ClinicalTrials.gov Identifier: NCT01881373.

Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

BACKGROUND: Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. METHODS: Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. RESULTS: Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. CONCLUSIONS: Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. TRIAL REGISTRATION: NIH clinical trial #NCT01881373.

Recruitment Strategies and Lessons Learned from the Children's Healthy Living Program Prevalence Survey.

The US Affiliated Pacific region's childhood obesity prevalence has reached epidemic proportions. To guide program and policy development, a multi-site study was initiated, in collaboration with partners from across the region, to gather comprehensive information on the regional childhood obesity prevalence. The environmental and cultural diversity of the region presented challenges to recruiting for and implementing a shared community-based, public health research program. This paper presents the strategies used to recruit families with young children (n = 5775 for children 2 - 8 years old) for obesity-related measurement across eleven jurisdictions in the US Affiliated Pacific Region. Data were generated by site teams that provided summaries of their recruitment strategies and lessons learned. Conducting this large multi-site prevalence study required considerable coordination, time and flexibility. In every location, local staff knowledgeable of the community was hired to lead recruitment, and participant compensation reflected jurisdictional appropriateness (e.g., gift cards, vouchers, or cash). Although recruitment approaches were site-specific, they were predominantly school-based or a combination of school- and community-based. Lessons learned included the importance of organization buy-in; communication, and advance planning; local travel and site peculiarities; and flexibility. Future monitoring of childhood obesity prevalence in the region should consider ways to integrate measurement activities into existing organizational infrastructures for sustainability and cost-effectiveness, while meeting programmatic (e.g. study) goals.

Assessing intervention fidelity in a multi-level, multi-component, multi-site program: the Children's Healthy Living (CHL) program.

Addressing complex chronic disease prevention, like childhood obesity, requires a multi-level, multi-component culturally relevant approach with broad reach. Models are lacking to guide fidelity monitoring across multiple levels, components, and sites engaged in such interventions. The aim of this study is to describe the fidelity-monitoring approach of The Children's Healthy Living (CHL) Program, a multi-level multi-component intervention in five Pacific jurisdictions. A fidelity-monitoring rubric was developed. About halfway during the intervention, community partners were randomly selected and interviewed independently by local CHL staff and by Coordinating Center representatives to assess treatment fidelity. Ratings were compared and discussed by local and Coordinating Center staff. There was good agreement between the teams (Kappa = 0.50, p < 0.001), and intervention improvement opportunities were identified through data review and group discussion. Fidelity for the multi-level, multi-component, multi-site CHL intervention was successfully assessed, identifying adaptations as well as ways to improve intervention delivery prior to the end of the intervention.