Key Findings and Implications of a Recent Systematic Review of the Potential Adverse Effects of Caffeine Consumption in Healthy Adults, Pregnant Women, Adolescents, and Children.

In 2016⁻2017, we conducted and published a systematic review on caffeine safety that set out to determine whether conclusions that were presented in the heavily cited Health Canada assessment, remain supported by more recent data. To that end, we reviewed data from 380 studies published between June 2001 and June 2015, which were identified from an initial batch of over 5000 articles through a stringent search and evaluation process. In the current paper, we use plain language to summarize our process and findings, with the intent of sharing additional context for broader reach to the general public. We addressed whether caffeine doses previously determined not to be associated with adverse effects by Health Canada (400 mg/day for healthy adults, 300 mg/day for pregnant women, 2.5 mg/kg body weight/day for adolescents and children, and 10 g/day for acute effects) remain appropriate for five outcome areas (acute toxicity, cardiovascular toxicity, bone & calcium effects, behavior, and development and reproduction) in healthy adults, pregnant women, adolescents, and children. We used a weight-of-evidence approach to draw conclusions for each of the five outcomes, as well as more specific endpoints within those outcomes, which considered study quality, consistency, level of adversity, and magnitude of response. In general, updated evidence confirms the levels of intake that were put forth by Health Canada in 2003 as not being associated with any adverse health effects, and our results support a shift in caffeine research from healthy to sensitive populations.

Scientific rigor and credibility in the nutrition research landscape.

Scientific progress depends on the quality and credibility of research methods. As discourse on rigor, transparency, and reproducibility joins the cacophony of nutrition information and misinformation in mass media, buttressing the real and perceived reliability of nutrition science is more important than ever. This broad topic was the focus of a 2016 plenary session, "Scientific Rigor and Competing Interests in the Nutrition Research Landscape." This article summarizes and expands on this session in an effort to increase understanding and dialogue with regard to factors that limit the real and perceived reliability of nutrition science and steps that can be taken to mitigate those factors. The end goal is to both earn and merit greater trust in nutrition science by both the scientific community and the general public. The authors offer suggestions in each of the domains of education and training, communications, research conduct, and procedures and policies to help achieve this goal. The authors emphasize the need for adequate funding to support these efforts toward greater rigor and transparency, which will be resource demanding and may require either increased research funding or the recognition that a greater proportion of research funding may need to be allocated to these tasks.

Implementing Evidence-Based Nutrition Practice Guidelines for Type 2 Diabetes Mellitus in Lebanon.

Lebanon is a Middle Eastern country experiencing a surge in the prevalence of type 2 diabetes mellitus among adults. This pilot study evaluated the feasibility and outcomes of implementing the Academy of Nutrition and Dietetics Evidence-Based Nutrition Practice Guidelines (EBNPGs) as part of medical care for patients newly diagnosed with type 2 diabetes mellitus. Seventy-five patients were recruited from 3 Lebanese hospitals, received nutrition care according to EBNPGs, and were followed up for 12 months. Patients achieved significant improvement in clinical outcomes between baseline and 3, 6, and 12 months. Further research is recommended to confirm the benefits of using EBNPGs.

Systematic review of the potential adverse effects of caffeine consumption in healthy adults, pregnant women, adolescents, and children.

To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al. (2003). Thus, as an update to this foundational publication, we conducted a systematic review of data on potential adverse effects of caffeine published from 2001 to June 2015. Subject matter experts and research team participants developed five PECO (population, exposure, comparator, and outcome) questions to address five types of outcomes (acute toxicity, cardiovascular toxicity, bone and calcium effects, behavior, and development and reproduction) in four healthy populations (adults, pregnant women, adolescents, and children) relative to caffeine intake doses determined not to be associated with adverse effects by Health Canada (comparators: 400 mg/day for adults [10 g for lethality], 300 mg/day for pregnant women, and 2.5 mg/kg/day for children and adolescents). The a priori search strategy identified >5000 articles that were screened, with 381 meeting inclusion/exclusion criteria for the five outcomes (pharmacokinetics was addressed contextually, adding 46 more studies). Data were extracted by the research team and rated for risk of bias and indirectness (internal and external validity). Selected no- and low-effect intakes were assessed relative to the population-specific comparator. Conclusions were drawn for the body of evidence for each outcome, as well as endpoints within an outcome, using a weight of evidence approach. When the total body of evidence was evaluated and when study quality, consistency, level of adversity, and magnitude of response were considered, the evidence generally supports that consumption of up to 400 mg caffeine/day in healthy adults is not associated with overt, adverse cardiovascular effects, behavioral effects, reproductive and developmental effects, acute effects, or bone status. Evidence also supports consumption of up to 300 mg caffeine/day in healthy pregnant women as an intake that is generally not associated with adverse reproductive and developmental effects. Limited data were identified for child and adolescent populations; the available evidence suggests that 2.5 mg caffeine/kg body weight/day remains an appropriate recommendation. The results of this systematic review support a shift in caffeine research to focus on characterizing effects in sensitive populations and establishing better quantitative characterization of interindividual variability (e.g., epigenetic trends), subpopulations (e.g., unhealthy populations, individuals with preexisting conditions), conditions (e.g., coexposures), and outcomes (e.g., exacerbation of risk-taking behavior) that could render individuals to be at greater risk relative to healthy adults and healthy pregnant women. This review, being one of the first to apply systematic review methodologies to toxicological assessments, also highlights the need for refined guidance and frameworks unique to the conduct of systematic review in this field.

Insights From the Diabetes in India Nutrition Guidelines Study: Adopting Innovations Using a Knowledge Transfer Model.

This 12-month prospective randomized cluster trial of 20 dietitians in India compared usual care (UC) and evidence-based nutrition practice guideline (EBNPG) care for patients with type 2 diabetes mellitus. Baseline, 6-month, and 12-month data from 238 patients were analyzed. EBNPG implementation was evaluated using the Ottawa Model for Knowledge Transfer. EBNPG and UC groups achieved significant hemoglobin A1C improvements. EBNPG-treated participants were significantly more likely to meet low-density lipoprotein, high-density lipoprotein, and triglyceride goals at 6 or 12 months. Dietitian dropout, implementation barriers, and undetermined EBNPG intervention fidelity are limitations. Future research should assess barriers/supports and degree of EBNPG use.

Limited Agreement on Etiologies and Signs/Symptoms among Registered Dietitian Nutritionists in Clinical Practice.

BACKGROUND: Clinical studies that establish the reliability and validity of nutrition diagnoses are absent from the literature. OBJECTIVE: The purpose of this study was to assess the reliability and validity of the diagnoses, etiologies, and signs/symptoms within the clinical practice of registered dietitian nutritionists (RDNs). DESIGN: Nine pairs of RDNs randomly selected adult patients to diagnose. The two RDNs in each pair independently assessed nutritional data from the same patient. Each RDN chose one nutrition diagnosis and rated the presence or absence of the etiologies and signs/symptoms. Clinical reliability was determined with percentage of agreement for the diagnoses, and percentage agreement, kappa coefficient, and the proportions of positive agreement (p(pos)) and negative agreement (p(neg)) for the etiologies and signs/symptoms. Clinical validity was calculated according to a clinical diagnostic validity score for etiologies and signs/symptoms. RESULTS: These RDNs practiced either in an acute-care facility (n=10; 58.8%), ambulatory/outpatient facility (n=3; 17.6%), or both (n=4; 23.5%). Nutrition diagnoses were selected for 316 patients. Two raters selected the same diagnosis for 121 patients (38% agreement). Agreement was moderate (κ=0.54) for etiologies and at the lower end of substantial (κ=0.63) for signs/symptoms. For etiologies p(pos)=0.71 and p(neg)=0.78 and for signs/symptoms p(pos)=0.82 and p(neg)=0.79, indicating that the raters agreed on the presence of each as well as the absence. The overall clinical diagnostic validity score for etiologies was 0.33 and for signs/symptoms was 0.44, signifying they were not characteristic of the diagnoses. CONCLUSIONS: Although RDNs knew a nutrition problem was present, they were in poor agreement as to the most important diagnosis, etiologies, and signs/symptoms. The lack of agreement indicated inconsistencies in determining a primary diagnosis among these RDNs.

Energy Balance 4 Kids with Play: Results from a Two-Year Cluster-Randomized Trial.

BACKGROUND: Identifying sustainable approaches to improving the physical activity (PA) and nutrition environments in schools is an important public health goal. This study examined the impact of Energy Balance for Kids with Play (EB4K with Play), a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks, on students' PA, dietary habits and knowledge, and weight status over 2 years. METHODS: This cluster-randomized, controlled trial took place in four intervention and two control schools over 2 years (n=879; third- to fifth-grade students). PA (fourth and fifth grades only), dietary knowledge and behaviors, school policies, and BMI z-score were assessed at baseline (fall 2011), midpoint (spring 2012), and endpoint (fall 2012 for accelerometers; spring 2013 for all other outcomes). RESULTS: At endpoint, there were no group differences in change in PA or dietary behaviors, although BMI z-score decreased overall by -0.07 (p=0.05). Students' dietary knowledge significantly increased, as did the amount of vegetables schools served. Post-hoc analyses stratified by grade revealed that, relative to control students, fourth-grade intervention students reduced school-day sedentary time by 15 minutes (p=0.023) and third-grade intervention students reduced BMI z-score by -0.2 (0.05; p<0.05). There were no significant differences for older students. CONCLUSIONS: EB4K with Play, which leverages the existing infrastructure of two national programs, increases children's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children. Future iterations should examine programming specific for different age groups.

Energy Balance 4 Kids with Play: Results from a Two-Year Cluster-Randomized Trial.

BACKGROUND: Identifying sustainable approaches to improving the physical activity (PA) and nutrition environments in schools is an important public health goal. This study examined the impact of Energy Balance for Kids with Play (EB4K with Play), a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks, on students' PA, dietary habits and knowledge, and weight status over 2 years. METHODS: This cluster-randomized, controlled trial took place in four intervention and two control schools over 2 years (n=879; third- to fifth-grade students). PA (fourth and fifth grades only), dietary knowledge and behaviors, school policies, and BMI z-score were assessed at baseline (fall 2011), midpoint (spring 2012), and endpoint (fall 2012 for accelerometers; spring 2013 for all other outcomes). RESULTS: At endpoint, there were no group differences in change in PA or dietary behaviors, although BMI z-score decreased overall by -0.07 (p=0.05). Students' dietary knowledge significantly increased, as did the amount of vegetables schools served. Post-hoc analyses stratified by grade revealed that, relative to control students, fourth-grade intervention students reduced school-day sedentary time by 15 minutes (p=0.023) and third-grade intervention students reduced BMI z-score by -0.2 (0.05; p<0.05). There were no signicifant differences for older students. CONCLUSIONS: EB4K with Play, which leverages the existing infrastructure of two national programs, increases children's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children. Future iterations should examine programming specific for different age groups.

Motivational interviewing and dietary counseling for obesity in primary care: an RCT.

BACKGROUND AND OBJECTIVE: Few studies have tested the impact of motivational interviewing (MI) delivered by primary care providers on pediatric obesity. This study tested the efficacy of MI delivered by providers and registered dietitians (RDs) to parents of overweight children aged 2 through 8. METHODS: Forty-two practices from the Pediatric Research in Office Settings Network of the American Academy of Pediatrics were randomly assigned to 1 of 3 groups. Group 1 (usual care) measured BMI percentile at baseline and 1- and 2-year follow-up. Group 2 (provider only) delivered 4 MI counseling sessions to parents of the index child over 2 years. Group 3 (provider + RD) delivered 4 provider MI sessions plus 6 MI sessions from a RD. The primary outcome was child BMI percentile at 2-year follow up. RESULTS: At 2-year follow-up, the adjusted BMI percentile was 90.3, 88.1, and 87.1 for groups 1, 2, and 3, respectively. The group 3 mean was significantly (P = .02) lower than group 1. Mean changes from baseline in BMI percentile were 1.8, 3.8, and 4.9 across groups 1, 2, and 3. CONCLUSIONS: MI delivered by providers and RDs (group 3) resulted in statistically significant reductions in BMI percentile. Research is needed to determine the clinical significance and persistence of the BMI effects observed. How the intervention can be brought to scale (in particular, how to train physicians to use MI effectively and how best to train RDs and integrate them into primary care settings) also merits future research.

Do sugar-sweetened beverages cause adverse health outcomes in adults? A systematic review protocol.

BACKGROUND: Chronic diseases, such as cardiovascular disease and type 2 diabetes, impose significant burden to public health. Most chronic diseases are associated with underlying preventable risk factors, such as elevated blood pressure, blood glucose, and lipids, physical inactivity, excessive sedentary behaviours, overweight and obesity, and tobacco usage. Sugar-sweetened beverages are known to be significant sources of additional caloric intake, and given recent attention to their contribution in the development of chronic diseases, a systematic review is warranted. We will assess whether the consumption of sugar-sweetened beverages in adults is associated with adverse health outcomes and what the potential moderating factors are. METHODS/DESIGN: Of interest are studies addressing sugar-sweetened beverage consumption, taking a broad perspective. Both direct consumption studies as well as those evaluating interventions that influence consumption (e.g. school policy, educational) will be relevant. Non-specific or multi-faceted behavioural, educational, or policy interventions may also be included subject to the level of evidence that exists for the other interventions/exposures. Comparisons of interest and endpoints of interest are pre-specified. We will include randomized controlled trials, controlled clinical trials, interrupted time series studies, controlled before-after studies, prospective and retrospective comparative cohort studies, case-control studies, and nested case-control designs. The MEDLINE, Embase, The Cochrane Library, CINAHL, ERIC, and PsycINFO databases and grey literature sources will be searched. The processes for selecting studies, abstracting data, and resolving conflicts are described. We will assess risk of bias using design-specific tools. To determine sets of confounding variables that should be adjusted for, we have developed causal directed acyclic graphs and will use those to inform our risk of bias assessments. Meta-analysis will be conducted where appropriate; parameters for exploring statistical heterogeneity and effect modifiers are pre-specified. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used for determining the quality of evidence for outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009638.

Do sugar-sweetened beverages cause adverse health outcomes in children? A systematic review protocol.

BACKGROUND: Cardiovascular disease and type 2 diabetes are examples of chronic diseases that impose significant morbidity and mortality in the general population worldwide. Most chronic diseases are associated with underlying preventable risk factors, such as elevated blood pressure, high blood glucose or glucose intolerance, high lipid levels, physical inactivity, excessive sedentary behaviours, and overweight/obesity. The occurrence of intermediate outcomes during childhood increases the risk of disease in adulthood. Sugar-sweetened beverages are known to be significant sources of additional caloric intake, and given recent attention to their contribution in the development of chronic diseases, a systematic review is warranted. We will assess whether the consumption of sugar-sweetened beverages in children is associated with adverse health outcomes and what the potential moderating factors are. METHODS/DESIGN: Of interest are studies addressing sugar-sweetened beverage consumption, taking a broad perspective. Both direct consumption studies as well as those evaluating interventions that influence consumption (e.g. school policy, educational) will be relevant. Non-specific or multi-faceted behavioural, educational, or policy interventions may also be included subject to the level of evidence that exists for the other interventions/exposures. Comparisons of interest and endpoints of interest are pre-specified. We will include randomized controlled trials, controlled clinical trials, interrupted time series studies, controlled before-after studies, prospective and retrospective comparative cohort studies, case-control studies, and nested case-control designs. The MEDLINE®, Embase, The Cochrane Library, CINAHL, ERIC, and PsycINFO® databases and grey literature sources will be searched. The processes for selecting studies, abstracting data, and resolving conflicts are described. We will assess risk of bias using design-specific tools. To determine sets of confounding variables that should be adjusted for, we have developed causal directed acyclic graphs and will use those to inform our risk of bias assessments. Meta-analysis will be conducted where appropriate; parameters for exploring statistical heterogeneity and effect modifiers are pre-specified. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used to determine the quality of evidence for outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009641.

Energy balance for kids with play: design and implementation of a multi-component school-based obesity prevention program.

BACKGROUND: Improving nutrition and physical activity behaviors associated with childhood obesity are significant national public health goals. Energy Balance for Kids with Play (EB4K with Play), developed through a partnership between the Academy of Nutrition and Dietetics Foundation and Playworks, is a multi-component school-based intervention designed to address youth's nutrition and physical activity behaviors. This article describes the EB4K with Play intervention and evaluation study and presents the baseline data. METHODS: The evaluation is a 2-year cluster-randomized design targeting third- to fifth-grade students enrolled in a low-income, urban school district in northern California. Six schools were recruited to participate. Four were randomized to the intervention group and two into a control group. Baseline student-level data pertaining to nutrition, physical activity, fitness, and BMI were collected in the fall of 2011. The EB4K with Play program, which includes direct-to-student nutrition and physical activity interventions, a school wellness component, and parent/community partner outreach components, began immediately after baseline data collection. RESULTS: An ethnically diverse sample of students (n=844) was recruited to participate in the study. Baseline data showed a higher percent of eligibility for free and reduced-price school lunch and higher rates of obesity/overweight than the California state averages. Fitness levels and levels of moderate-to-vigorous physical activity were comparable to state averages. CONCLUSIONS: End-point data will be collected after 2 years of the intervention. The findings from this study should help guide future efforts to design effective intervention programs to support the prevention of pediatric obesity.

Self-reported health parameters compared with clinician measurements: methods in practice-based research.

CONTEXT: Self-reported health data are used by health insurance companies to assess risk. Most studies show underreporting compared with clinical measurements. OBJECTIVE: To compare self-reported height, weight, blood pressure, waist circumference, and dietary intake with registered dietitian's (RD's) measures of the same parameters. DESIGN: This is a secondary analysis of data collected in a larger study on the benefits of Medical Nutrition Therapy from an RD for overweight and obese patients when provided free of charge through an insurance benefit. SETTING: Participants completed a health risk assessment survey at home, from which the self-reported measures were extracted. The clinical measurements were taken by an RD in the office during a visit for Medical Nutrition Therapy. PARTICIPANTS: Participants were 81.4% female, with a mean body mass index of 35.0. All were insured and had a least 1 visit with an RD. MAIN OUTCOME MEASURE(S): Main outcomes were correlation between self-reported and RD-measured height, weight, body mass index, blood pressure, and waist circumference. Blood pressure was categorized as normal or high and the κ statistic was used to examine category agreement between the 2 measures. Servings of food groups were compared between the 2 measures by examining cumulative percent within 0, 1, or 2 servings of the RD-measured value. RESULTS: The 2 measures of height and weight were highly correlated (0.974 and 0.986, respectively). Blood pressure was more weakly correlated and when categorized had low κ scores, as did servings of food groups. CONCLUSIONS: Height and weight were more closely correlated than in previous studies. In an insured population enrolled in a weight management program, self-reported measures may be accurate for determining program impact. Blood pressure may be better collected categorically than continuously. The necessity of food intake assessment on a risk assessment should be reconsidered.

A critical assessment of research needs identified by the dietary guidelines committees from 1980 to 2010.

The Dietary Goals for the United States were introduced in 1977 and have been followed by the Dietary Guidelines for Americans (DGA) every 5 years from 1980 to 2010. The DGA provide science-based advice to promote health and reduce risk for major chronic diseases through diet and physical activity. The Dietary Guidelines Advisory Committees are charged to provide updates of the DGA topics using the best available science. The Dietary Guidelines Advisory Committees' reports also identified 169 research gaps. To date, these gaps have not been compiled and assessed. We evaluated trends in number, topics, and specificity of research gaps by year by placing them in the following topic categories: general, chronic diseases/conditions, diet/diet pattern, food/ingredient, and nutrient-specific research gaps. Some research topics (eg, sodium and hypertension and appropriate uses of DGA) have been identified consistently across the years, some emerged in later years (eg, increasingly specific research gaps between dietary fatty acids and cardiovascular disease), and others appeared intermittently (eg, relationships between dietary components and cancer). These results are a call to action for all DGA stakeholders to have an immediate dialogue about how the research enterprise can best address critical research needs in a timely way to support public policy.

The incremental value of medical nutrition therapy in weight management.

OBJECTIVE: To evaluate the incremental cost of and health benefits attributable to medical nutrition therapy (MNT) for managed care members participating in an obesity-related health management program. DESIGN: Retrospective case-control. METHODOLOGY: Overweight or obese adult managed care members who utilized the MNT benefit (n = 291) were matched, using propensity score matching, with similar individuals (n = 1,104) who did not utilize the MNT benefit. Health outcomes data on weight, body mass index (BMI), waist circumference, and physical exercise were collected via surveys administered at baseline and approximately 2 years later. PRINCIPAL FINDINGS: Both groups experienced statistically significant reductions in weight, BMI, and waist circumference and increases in exercise frequency. Compared with matched controls, individuals who received MNT were about twice as likely to achieve a clinically significant reduction in weight, with an adjusted odds ratio of 2.2 (95% confidence interval, -1.7-2.9; P < .001). They also experienced greater average reductions in weight (3.1 vs. 1.4 kg; beta = -1.75; t[1314] = -2.21; P = .028) and were more likely to exercise more frequently after participating in the program (F[1,1358] = 4.07, P = .044). There was no difference between the groups in waist circumference. The MNT benefit was used by 5% of eligible members and cost $0.03 per member per month. CONCLUSION: MNT is a valuable adjunct to health management programs that can be implemented for a relatively low cost. MNT warrants serious consideration as a standard inclusion in health benefit plans.