The role of stress responses on engagement in dietary and physical activity behaviors among Latino adults living with prediabetes.

OBJECTIVES: Latinos are at a high risk of developing type 2 diabetes (T2D). Prediabetes is a major risk factor for T2D; however, progression to T2D can be slowed with engagement in healthy behaviors. Stress can hinder engagement with health behaviors. Qualitative methods were used to understand how Latinos with prediabetes attempted to modify their diet and physical activity behaviors to slow T2D progression and how stress affected their engagement in these behaviors. DESIGN: Semi-structured interviews were conducted with 20 Latinos with prediabetes in North Carolina. Participants were asked questions about types of stress they experienced and how stress affected their health. We generated codes on stress and stress responses and used content analysis to organize codes between and within participants. RESULTS: Behaviors changed after prediabetes diagnosis. Few participants reported changing their physical activity, however, all participants attempted to change their eating patterns by changing food types consumed and reducing portion sizes. The stress participants experienced impacted their ability to self-regulate their diet. They reported overeating or appetite suppression during stressful periods. Stress also affected cognitive responses by compromising healthy decision-making and instigating negative emotional reactions. Overall, stress complicated participants' ability to properly engage in recommended behaviors by negatively impacting participants' behavioral self-regulation and cognitive processes. CONCLUSIONS: Stress affects behavioral and cognitive progresses that adversely alters primarily dietary behaviors. Tailored plans acknowledging the impact of stress and providing coping and supportive help for dealing with stress may enhance engagement in healthy behaviors for Latinos with prediabetes.

College student motivations for and perceived impacts of volunteering with a nutrition and cooking education program for children.

To assess among college students their motivations for and perceived impacts of volunteering with Cooking Matters for Kids as part of No Kid Hungry NC. Seventeen college student volunteers responded to an online survey questionnaire assessing their motivations for volunteering and how they were impacted by their experiences. Motivational functions for volunteering (values, understanding, social, career, protective, enhancement) were assessed using the Volunteer Functions Inventory. The strongest motivational functions for volunteering were values and understanding. Students were also strongly motivated to volunteer related to the areas specifically addressed by the program (i.e., nutrition, public health, working with children). Perceived impacts of volunteering included being more comfortable working with children, improving knowledge/skills, gaining experience related to their future career, and having fun. Volunteering with Cooking Matters for Kids benefited college students. Issues addressed by the program and the desire to gain experience motivated students to volunteer.

Is late bedtime an overlooked sleep behaviour? Investigating associations between sleep timing, sleep duration and eating behaviours in adolescence and adulthood.

OBJECTIVE: To examine whether bedtime is associated with usual sleep duration and eating behaviour among adolescents, emerging adults and young adults. DESIGN: Cross-sectional multivariable regression models, stratified by developmental stage, to examine: (1) association between bedtime and sleep duration and (2) associations between bedtime and specific eating behaviours at each developmental period, controlling for sleep duration. All models adjusted for sociodemographic characteristics, depressive symptoms and screen time behaviours. SETTING: National Longitudinal Study of Adolescent to Adult Health, waves I-IV, USA. PARTICIPANTS: A national probability sample surveyed in adolescence (aged 12-18 years, wave I: 1994-1995, n 13 048 and wave II: 1996, n 9438), emerging adulthood (aged 18-24 years, wave III: 2001-2002, n 9424) and young adulthood (aged 24-34 years, wave IV: 2008, n 10 410). RESULTS: Later bedtime was associated with shorter sleep duration in all developmental stages, such that a 1-h delay in bedtime was associated with 14-33 fewer minutes of sleep per night (Ps < 0·001). Later bedtime was also associated with lower odds of consuming healthier foods (i.e. fruits, vegetables; range of adjusted OR (AOR), 0·82-0·93, Ps < 0·05) and higher odds of consuming less healthy foods and beverages (i.e. soda, pizza, desserts and sweets; range of AOR, 1·07-1·09, Ps < 0·05). Later bedtime was also associated with more frequent fast-food consumption and higher sugar-sweetened beverage consumption (Ps < 0·05). CONCLUSIONS: Later bedtime was associated with shorter sleep duration and less healthy eating behaviours. Bedtime may be a novel behaviour to address in interventions aiming to improve sleep duration and dietary intake.

Sleep duration and body mass: direction of the associations from adolescence to young adulthood.

Research suggests that sleep duration and obesity are related, but the direction of this association remains uncertain. We applied autoregressive cross-lag models to evaluate the directionality of the relationship between sleep duration and BMI from adolescence through emerging and young adulthood, life stages where the risk for developing obesity are particularly high. Using data from the National Longitudinal Study of Adolescent to Adult Health (Add Health), we examined sex-stratified associations between sleep duration and BMI in this cohort from adolescence (ages 12-18, year 1996), to emerging adulthood (ages 18-24, 2001-2002), to young adulthood (ages 24-32, 2008), controlling for key confounders. For both males and females, higher BMI during an earlier developmental stage was associated with shorter sleep duration in the subsequent stage (both Bs = -0.02, ps < 0.01). However, sleep duration at an earlier developmental stage was not associated with BMI at the subsequent stage. Findings suggest that researchers should be cautious when interpreting cross-sectional relationships between sleep and BMI, as higher BMI may precede shorter sleep during adolescence to young adulthood. Researchers may also wish to account for potential bi-directional associations when modeling sleep and BMI using longitudinal data.

Nurturing Children's Healthy Eating: Position statement.

The relationship between eating a healthy diet and positive health outcomes is well known; nurturing healthy eating among children therefore has the potential to improve public health. A healthy diet occurs when one's usual eating patterns include adequate nutrient intake and sufficient, but not excessive, energy intake to meet the energy needs of the individual. However, many parents struggle to establish healthy eating patterns in their children due to the pressures of modern life. Moreover, healthcare providers often do not have the time or the guidance they need to empower parents to establish healthy eating practices in their children. Based on existing evidence from epidemiologic and intervention research, the Nurturing Children's Healthy Eating collaboration, established by Danone Institute International, has identified four key themes that encourage and support healthy eating practices among children in the modern Western world. The first - positive parental feeding - explores how parenting practices and styles, such as avoiding food restriction, allowing children to make their own food choices, and encouraging children to self-limit their portion sizes, can influence children's dietary intake. The second - eating together - highlights the link between eating socialization through regular family meals and healthful diet among children. The third - a healthy home food environment - explores the impact on eating practices of family resources, food availability/accessibility, parental modeling, and cues for eating. The fourth - the pleasure of eating - associates children's healthy eating with pleasure through repeated exposure to healthful foods, enjoyable social meals, and enhancement of the cognitive qualities (e.g. thoughts or ideas) of healthful foods. This paper reviews the evidence leading to the characterization of these nurturing themes, and ways in which recommendations might be implemented in the home.

State-Level Point-of-Sale Tobacco News Coverage and Policy Progression Over a 2-Year Period.

BACKGROUND: Mass media content may play an important role in policy change. However, the empirical relationship between media advocacy efforts and tobacco control policy success has rarely been studied. We examined the extent to which newspaper content characteristics (volume, slant, frame, source, use of evidence, and degree of localization) that have been identified as important in past descriptive studies were associated with policy progression over a 2-year period in the context of point-of-sale (POS) tobacco control. METHOD: We used regression analyses to test the relationships between newspaper content and policy progression from 2012 to 2014. The dependent variable was the level of implementation of state-level POS tobacco control policies at Time 2. Independent variables were newspaper article characteristics (volume, slant, frame, source, use of evidence, and degree of localization) and were collected via content analysis of the articles. State-level policy environment contextual variables were examined as confounders. RESULTS: Positive, significant bivariate relationships exist between characteristics of news content (e.g., high overall volume, public health source present, local quote and local angle present, and pro-tobacco control slant present) and Time 2 POS score. However, in a multivariate model controlling for other factors, significant relationships did not hold. DISCUSSION: Newspaper coverage can be a marker of POS policy progression. Whether media can influence policy implementation remains an important question. Future work should continue to tease out and confirm the unique characteristics of media content that are most associated with subsequent policy progression, in order to inform media advocacy efforts.

Setting the agenda for a healthy retail environment: content analysis of US newspaper coverage of tobacco control policies affecting the point of sale, 2007-2014.

BACKGROUND: Tobacco control policies affecting the point of sale (POS) are an emerging intervention, yet POS-related news media content has not been studied. PURPOSE: We describe news coverage of POS tobacco control efforts and assess relationships between article characteristics, including policy domains, frames, sources, localisation and evidence present, and slant towards tobacco control efforts. METHODS: High circulation state (n=268) and national (n=5) newspapers comprised the sampling frame. We retrieved 917 relevant POS-focused articles in newspapers from 1 January 2007 to 31 December 2014. 5 raters screened and coded articles, 10% of articles were double coded, and mean inter-rater reliability (IRR) was 0.74. RESULTS: POS coverage emphasised tobacco retailer licensing (49.1% of articles) and the most common frame present was regulation (71.3%). Government officials (52.3%), followed by tobacco retailers (39.6%), were the most frequent sources. Half of articles (51.3%) had a mixed, neutral or antitobacco control slant. Articles presenting a health frame, a greater number of protobacco control sources, and statistical evidence were significantly more likely to also have a protobacco control slant. Articles presenting a political/rights or regulation frame, a greater number of antitobacco control sources, or government, tobacco industry, tobacco retailers, or tobacco users as sources were significantly less likely to also have a protobacco control slant. CONCLUSIONS: Stories that feature procontrol sources, research evidence and a health frame also tend to support tobacco control objectives. Future research should investigate how to use data, stories and localisation to encourage a protobacco control slant, and should test relationships between content characteristics and policy progression.

Small Food Store Retailers' Willingness to Implement Healthy Store Strategies in Rural North Carolina.

Access to supermarkets is lacking in many rural areas. Small food stores are often available, but typically lack healthy food items such as fresh produce. We assessed small food store retailer willingness to implement 11 healthy store strategies to increase the availability, display, and promotion of healthy foods and decrease the availability, display, and promotion of tobacco products. Interviews were conducted with 55 small food store retailers in three rural North Carolina counties concurrently with store observations assessing current practices related to the strategies. All stores sold low-calorie beverages, sugar-sweetened beverages, candy and cigarettes. Nearly all sold smokeless tobacco and cigars/cigarillos, and 72 % sold e-cigarettes. Fresh fruits were sold at 30.2 % of stores; only 9.4 % sold fresh vegetables. Retailers reported being most willing to stock skim/low-fat milk, display healthy snacks near the register, and stock whole wheat bread. About 50 % were willing to stock at least three fresh fruits and three fresh vegetables, however only 2 % of stores currently stocked these foods. Nearly all retailers expressed unwillingness to reduce the availability of tobacco products or marketing. Our results show promise for working with retailers in rural settings to increase healthy food availability in small food stores. However, restrictions on retail tobacco sales and marketing may be more feasible through local tobacco control ordinances, or could be included with healthy foods ordinances that require stores to stock a minimum amount of healthy foods.

Sociodemographic Disparities in Proximity of Schools to Tobacco Outlets and Fast-Food Restaurants.

OBJECTIVES: To examine the association of school sociodemographic characteristics with tobacco outlet and fast-food restaurant availability near schools in a national study. METHODS: Business lists and data from the National Center for Education Statistics were used to calculate the numbers of tobacco outlets and fast-food restaurants within 800 meters of public schools in 97 US counties. RESULTS: More than 50% of schools with a majority of Hispanic students had both a fast-food restaurant and tobacco outlet nearby, compared with 21% of schools with a majority of White students. In adjusted models, each 10% increase in the number of low-income and Hispanic students enrolled in a school led to a 3% to 5% increase in the odds of the school having both a fast-food restaurant and a tobacco outlet nearby. CONCLUSIONS: Low-income and Hispanic students are disproportionately exposed to both tobacco outlets and fast-food restaurants near their schools. Easy access to tobacco products and fast food may influence youth smoking initiation and contribute to poor dietary intake.

Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population.

Excess weight gain tends to occur in young adulthood. However, research examining effective weight-related interventions for this age group has been limited. As one of seven trials in the EARLY Trials consortium (Early Adult Reduction of weight through LifestYle intervention), the CHOICES Study (Choosing Healthy Options in College Environments and Settings) tested effects of a technology-integrated, young adult weight gain prevention intervention. It was a randomized controlled trial with assessments at baseline (2011) and 4-, 12- and 24-months post-intervention initiation and included 441 participants (ages 18-35) who were students at three Minnesota community colleges. The 24-month intervention included a 1-credit academic course and social networking and support online intervention. This analysis examined effects on 12 secondary behavioral outcomes across three domains: diet (fast food, sugary beverages, breakfast, at-home meal preparation), physical activity/screen time (minutes and energy expenditure in leisure time physical activity, television viewing, leisure time computer use) and sleep (hours of sleep, time required to fall asleep, days not getting enough rest, difficulty staying awake). The intervention resulted in significant reductions in fast food (p=0.007) but increases in difficulty staying awake (p=0.015). There was limited evidence of other behavior changes at 4months (0.05

Recruiting and retaining young adults in a weight gain prevention trial: Lessons learned from the CHOICES study.

BACKGROUND/AIMS: Young adults are at risk of weight gain, but little is known about designing effective weight control trials for young adults or how to recruit and retain participants in these programs. The Choosing Healthy Options in College Environments and Settings (CHOICES) study evaluated the effectiveness of a weight gain prevention intervention for 2-year college students. We describe the methods used to recruit and retain the colleges and their students, describe the sample and discuss recommendations for future studies. METHODS: Students were recruited into a 24-month trial of a weight control intervention with assessment periods at baseline, 4-, 12- and 24-month follow-up. RESULTS: We successfully recruited 441 students through partnerships with three 2-year colleges through a variety of campus-based methods. Ultimately, 83.4% of the randomized cohort participated in the 24-month assessment period. Those retained more often were White (p = 0.03) compared to those who dropped out or were lost to follow-up; no other socio-demographic factor (e.g. gender, ethnicity and education), body mass index, body fat, waist circumference or weight status was observed to differ between randomly assigned groups. CONCLUSION: Two-year colleges and their students are interested in participating in weight-related trials and partnering with universities for research. Researchers must work closely with administrators to identify benefits to their institutions and to resolve student-level barriers to recruitment and retention. Our experiences from the Choosing Healthy Options in College Environments and Settings study should be useful in identifying effective recruitment and retention methods for weight gain prevention trials among young adults.

A randomized trial to reduce sugar-sweetened beverage and juice intake in preschool-aged children: description of the Smart Moms intervention trial.

BACKGROUND: Obesity in young children remains a public health concern, and maternal weight is one of the strongest predictors of obesity in early childhood. However, parental adherence in interventions for young children is often low and existing programs have had mixed success. An innovative approach to treatment is needed that increases adherence among mothers and improves weight-related behaviors simultaneously in mothers and children. The objective of the Smart Moms randomized controlled trial (RCT) is to test the efficacy of a 6-month primarily smartphone-delivered program to reduce sugar-sweetened beverage and juice consumption among children ages 3-5 whose mothers are overweight or obese. This paper describes the study design and intervention. METHODS/DESIGN: Mother-child dyads were eligible if the mother was overweight or obese, owned a smartphone, and if the child was between the ages of 3-5 and consumed 12 oz or more per day of sugar-sweetened beverages (SSBs) and 100 % fruit juice. Participants were randomly assigned to the Smart Moms intervention or a waitlist control group. The intervention consisted of theoretically grounded and evidence-based behavioral strategies delivered through one group session, lessons on a mobile-optimized website, and text messages. Mothers submitted self-monitoring information via text message and received regular tailored feedback emails from interventionists. The primary outcome is change in child SSB and juice consumption and a secondary outcome is change in maternal weight. DISCUSSION: This Smart Moms study was designed to determine if a low-burden intervention delivered using mobile methods and targeted towards mothers could be effective at changing child sugar-sweetened beverage intake. Results will indicate if mobile-based methods can be a feasible way to engage mothers in family-based studies and will inform successful strategies to prevent childhood obesity through parent-targeted approaches. TRIAL REGISTRATION: Clinicaltrials.gov NCT02098902 (Registered March 25, 2014).

A 2-year young adult obesity prevention trial in the US: Process evaluation results.

Our objective was to conduct a process evaluation of the CHOICES (Choosing Healthy Options in College Environments and Settings) study, a large, randomized, controlled trial designed to prevent unhealthy weight gain in young adults (aged 18-35) attending 2-year community colleges in the USA. The 24-month intervention consisted of participation in an academic course and a social networking and support website. Among intervention participants, completion rates for most course activities were >80%, reflecting a high level of dose received. Course retention and participant satisfaction were also high. Engagement results, however, were mixed with less than half of participants in the online and hybrid sections of the course reporting that they interacted with course materials ≥3 h/week, but 50-75% reporting that they completed required lessons 'all/very thoroughly'. Engagement in the website activities was also mixed with more than half of intervention participants logging onto the website during the first month, but then declining to 25-40% during the following 23 months of the intervention. Intervention engagement is a challenge of online interventions and a challenge of working with the young adult age group in general. Additional research is needed to explore strategies to support engagement among this population, particularly for relatively long intervention durations.

[Prevention of overweight and obesity in children and adolescents : Critical appraisal of the evidence base]. / Prävention von Übergewicht und Adipositas bei Kindern und Jugendlichen : Kritische Bewertung der Evidenzbasierung.

BACKGROUND: Despite careful planning and implementation, overweight/obesity prevention interventions in children and adolescents typically show no, inconsistent or merely weak effects. Such programs usually aim at behavior changes, rarely also at environmental changes, that draw upon conventional wisdom regarding the commonly accepted determinants of childhood overweight/obesity. OBJECTIVE: This paper evaluates the evidence base of the apparently overweight-/obesity-related determinants diet, physical activity and stress. The results of international intervention studies are discussed against this background. METHODS AND MATERIALS: Based on the mediating-moderating variable model, we investigate the effect of theory specified mediating variables and how potential moderating variables may impact these relationships. RESULTS: Contrary to common beliefs, recent research has revealed inconsistent evidence regarding associations between potentially obesogenic behaviors and overweight/obesity in youth. Moreover, the evidence for strong and causal relationships between mediating variables and targeted behaviors seems to be inconsistent. In addition, inadequate attention is paid to moderating effects. DISCUSSION: The etiology of overweight/obesity in youth is likely the result of a complex interplay of multi-causal influences. Future prevention interventions would benefit from a more thorough understanding of the complex relationships that have been hypothesized and of the mechanisms of suspected behaviors for affecting overweight/obesity. Only if substantial change can be demonstrated in mediators with reasonable effort under real world circumstances, it will make sense to progress to community behavior change trials.

Socioeconomic inequalities in children's diet: the role of the home food environment.

BACKGROUND: It is well documented in the literature that low socioeconomic status (SES) is associated with lower consumption of healthy foods and that these differences in consumption patterns are influenced by neighborhood food environments. Less understood is the role that SES differences in physical and social aspects of the home food environment play in consumption patterns. METHODS: Using data on 4th grade children from the 2009-2011 Texas School Physical Activity and Nutrition (SPAN) study, we used mixed-effects regression models to test the magnitude of differences in the SPAN Health Eating Index (SHEI) by parental education as an indicator of SES, and the extent to which adjusting for measures of the home food environment, and measures of the neighborhood environment accounted for these SES differences. RESULTS: Small but significant differences in children's SHEI by SES strata exist (-1.33 between highest and lowest SES categories, p<0.01). However, incorporating home food environment and neighborhood environment measures in this model eliminates these differences (-0.7, p=0.145). Home food environment explains a greater portion of the difference. Both social (mealtime structure) and physical aspects (food availability) of the home food environment are strongly associated with consumption of healthy and unhealthy foods. CONCLUSIONS: Our findings suggest that modifiable parent behaviors at home can improve children's eating habits and that the neighborhood may impact diet in ways other than through access to healthy food.

How we eat what we eat: identifying meal routines and practices most strongly associated with healthy and unhealthy dietary factors among young adults.

OBJECTIVE: (i) To examine associations between young adults' meal routines and practices (e.g. food preparation, meal skipping, eating on the run) and key dietary indicators (fruit/vegetable, fast-food and sugar-sweetened beverage intakes) and (ii) to develop indices of protective and risky meal practices most strongly associated with diet. DESIGN: Cross-sectional survey. SETTING: Minneapolis/St. Paul metropolitan area, Minnesota (USA). SUBJECTS: A diverse sample of community college and public university students (n 1013). RESULTS: Meal routines and practices most strongly associated with healthy dietary patterns were related to home food preparation (i.e. preparing meals at home, preparing meals with vegetables) and meal regularity (i.e. routine consumption of evening meals and breakfast). In contrast, factors most strongly associated with poor dietary patterns included eating on the run, using media while eating and purchasing foods/beverages on campus. A Protective Factors Index, summing selected protective meal routines and practices, was positively associated with fruit/vegetable consumption and negatively associated with fast-food and sugar-sweetened beverage consumption (P<0·001). A Risky Factors Index yielded significant, positive associations with fast-food and sugar-sweetened beverage consumption (P<0·001). The probability test for the association between the Risky Factors Index and fruit/vegetable intake was P=0·05. CONCLUSIONS: Meal routines and practices were significantly associated with young adults' dietary patterns, suggesting that ways in which individuals structure mealtimes and contextual characteristics of eating likely influence food choice. Thus, in addition to considering specific food choices, it also may be important to consider the context of mealtimes in developing dietary messaging and guidelines.

A healthy trend: less food used in fundraising and as rewards and incentives in Minnesota middle and high schools.

OBJECTIVE: To assess change in the 4-year prevalence (2006-2009) of the use of food in school fundraising and as rewards and incentives for students, following implementation of federal legislation in the USA in 2006. DESIGN: Serial cross-sectional design using trend analysis to assess school-level data collected over four consecutive years from 2006/2007 to 2009/2010. SETTING: Minneapolis/St. Paul, MN. SUBJECTS: Convenience sample of middle and high schools participating in two longitudinal, aetiological studies that examined youth, their environment and obesity-related factors. RESULTS: A significant and sustained decrease was demonstrated in the use of low-nutrient, energy-dense foods in school fundraising activities and the use of food and food coupons as rewards and incentives by teachers and school staff. CONCLUSIONS: Results support the utility of policy and legislative action as a tool for creating healthy, sustainable environmental change.

The relationship of area-level sociodemographic characteristics, household composition and individual-level socioeconomic status on walking behavior among adults.

Understanding the contextual factors associated with why adults walk is important for those interested in increasing walking as a mode of transportation and leisure. This paper investigates the relationships between neighborhood-level sociodemographic context, individual level sociodemographic characteristics and walking for leisure and transport. Data from two community-based studies of adults (n=550) were used to determine the association between the area-sociodemographic environment (ASDE), calculated from U.S. Census variables, and individual-level SES as potential correlates of walking behavior. Descriptive statistics, mean comparisons and Pearson's correlations coefficients were used to assess bivariate relationships. Generalized estimating equations were used to model the relationship between ASDE, as quartiles, and walking behavior. Adjusted models suggest adults engage in more minutes of walking for transportation and less walking for leisure in the most disadvantaged compared to the least disadvantaged neighborhoods but adding individual level demographics and SES eliminated the significant results. However, when models were stratified for free or reduced cost lunch, of those with children who qualified for free or reduced lunch, those who lived in the wealthiest neighborhoods engaged in 10.7 minutes less of total walking per day compared to those living in the most challenged neighborhoods (p<0.001). Strategies to increase walking for transportation or leisure need to take account of individual level socioeconomic factors in addition to area-level measures.

Identifying the behavior change techniques used in obesity interventions: An example from the EARLY trials.

Objective: The dissemination of effective obesity interventions requires the documentation of key elements of the intervention. But outcome papers and other published manuscripts often lack detail that allow the replication of the intervention. The Behavior Change Technique (BCT) Taxonomy (BCTTv1) is a widely used approach to identify key elements of an intervention study. This study compares the extent to which BCTs and domains identified in studies' intervention protocol are concordant with detail from corresponding intervention design and study outcome papers. Methods: Data come from four obesity interventions with complete intervention protocols as well as published intervention design and outcome papers. The number of domains and BCTs was calculated for each treatment arm and stratified by coding source. Emphasis of domains and BCTs was determined using an Analytical Hierarchy Process (AHP). Results: A review of each study's intervention protocol showed the mean number of domains and BCTs used in treatment arms as 11.8 and 26.7, respectively. Primary outcome papers had a mean loss of 34% of the reported domains and 43% of BCTS as compared with intervention protocl. Design papers showed a loss of 11% and 21% of domains and BCTs, respectively. Conclusions: The results confirm the limitations of using the BCTTv1 coding of outcome papers to describe obesity-related interventions. The results also highlight the need for mechanisms that allow for a full description of intervention content such as inclusion in a supplemental section of an online journal or the use of intervention-focused consort guidelines.

Implementation Research at NHLBI: Methodological and Design Challenges and Lessons Learned from the DECIPHeR Initiative.

NHLBI funded seven projects as part of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Initiative. They were expected to collaborate with community partners to (1) employ validated theoretical or conceptual implementation research frameworks, (2) include implementation research study designs, (3) include implementation measures as primary outcomes, and (4) inform our understanding of mediators and mechanisms of action of the implementation strategy. Several projects focused on late-stage implementation strategies that optimally and sustainably delivered two or more evidence-based multilevel interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and to improve population health in high-burden communities. Projects that were successful in the three-year planning phase transitioned to a 4-year execution phase. NHLBI formed a Technical Assistance Workgroup during the planning phase to help awardees refine study aims, strengthen research designs, detail analytic plans, and to use valid sample size methods. This paper highlights methodological and study design challenges encountered during this process. Important lessons learned included (1) the need for greater emphasis on implementation outcomes, (2) the need to clearly distinguish between intervention and implementation strategies in the protocol, (3) the need to address clustering due to randomization of groups or clusters, (4) the need to address the cross-classification that results when intervention agents work across multiple units of randomization in the same arm, (5) the need to accommodate time-varying intervention effects in stepped-wedge designs, and (6) the need for data-based estimates of the parameters required for sample size estimation.