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We discuss the evolution and composition of breast milk and briefly describe how mammalian evolution resulted in lactation, which played a crucial role in infant growth and development. We focus on three teleological factors that significantly contribute to breast milk composition: (1) biological sex at birth, (2) gestational age, and (3) circadian rhythms. We also explain how these factors lead to variability in human milk composition. We emphasize the importance of standardizing the definitions of "preterm" and "term" to accurately study the effects of gestational age on milk composition. Finally, we discuss the role of the circadian clock in regulating lactation and the impact of breast milk on fetal and infant sleep. Investigators may integrate these critical factors when designing a research study that involves the collection of breast milk samples. Teleological factors greatly influence milk composition, and these factors may be considered when designing a study that requires breast milk. We provide both the rationale and application of solutions to address these factors.
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Background: Maternal depression is considered a major contributor to morbidity and mortality in pregnancy. A population at risk are U.S. born or immigrant Hispanic women, and few prenatal depression or immune studies have focused on this population. Objective: The research questions for the study were 1) What are the occurrences, risk factors and outcomes associated with depression in Hispanic pregnant women in the United States and 2) What are the associations of plasma immune cytokines and prenatal depression in this population. Study design: Women of self-reported Hispanic ethnicity were born in the continental United States or foreign-born. Screening of potential participants (n = 690) at a first prenatal clinic visit consisted of antibody testing for Toxoplasma gondii antibodies in a larger grant, and only the women with antibody levels below the cutoff for T. gondii positivity (N = 536) were included in the present study. All participants completed a health and demographic questionnaire, the Edinburgh Postpartum Depression (EPDS) scale, the Perceived Stress Scale (PSS), and the Medical Outcomes Study Social Support (MOS) scale. We surveyed electronic health records (EHR) for risk factors and adverse pregnancy outcomes in the sample. We further measured physical and mental health and seven plasma immune cytokines at four study visits during pregnancy in a longitudinal subsample (N = 128). Results: The frequency of EPDS scores of 10 (depression risk) or above was 18.6 % at the time of enrollment. Socioeconomic factors such as less education, greater unemployment, and U.S. born nativity were associated with greater depression risk, but these relationships became insignificant when we corrected for false discovery rate. Depression scores were not associated with adverse birth and pregnancy outcomes. The inflammatory cytokine TNF-α was significantly higher across pregnancy in women with depression risk (p < 0.03). Other inflammatory cytokines were higher in depressed women, but only at one time point in mid-pregnancy. Conclusions: Prenatal depression occurs in early pregnancy and then declines in Hispanic women. The frequency of depression and stress were higher in U.S. born compared to immigrant Hispanic women. There was an elevation in plasma levels of TNF-α through the pregnancy in depressed women, and elevations in other cytokines, at midpregnancy. The adverse pregnancy outcomes, including preterm delivery, known to be associated with prenatal depression were not present in this cohort.
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BACKGROUND: Neonates with critical congenital heart defects (CCHD neonates) experience high rates of feeding intolerance, necrotizing enterocolitis (NEC), and malnutrition. The benefits of human milk and direct chest/breastfeeding are well known, but research is limited in CCHD neonates. Therefore, the purpose of this study is to examine the impact of neonatal diet and feeding modality on the incidence of feeding intolerance, NEC, and malnutrition among a cohort of CCHD neonates. METHODS: A single-center retrospective study was conducted using electronic health record data of CCHD neonates admitted to a cardiac intensive care unit between April 2016 and April 2020. Regression models were fit to analyze associations between neonatal diet, feed modality, and adverse feeding outcomes. RESULTS: Seventy-four CCHD neonates were included. Increased days of direct chest/breastfeeding were associated with fewer signs of gastrointestinal distress ( P = .047) and bloody stools ( P = .021). Enteral feeding days of "all human milk" were associated with higher growth trajectory ( P < .001). CONCLUSIONS: Human milk and direct chest/breastfeeding may be protective against some adverse feeding outcomes for CCHD neonates. Larger, multicenter cohort studies are needed to continue investigating the effects of neonatal diet type and feeding modality on the development of adverse feeding outcomes in this unique population.
Subject(s)
Enterocolitis, Necrotizing , Heart Defects, Congenital , Malnutrition , Infant, Newborn , Humans , Retrospective Studies , Enterocolitis, Necrotizing/epidemiology , Enterocolitis, Necrotizing/etiology , Milk, Human , Malnutrition/complicationsABSTRACT
BACKGROUND: There has been a concerning surge in maternal mortality among Hispanic women in recent years. Compromised mental health is present in nearly half of all maternal deaths, and risk factors include poor social support and depression. OBJECTIVE: Among Hispanic women who were born in the USA versus those not born in the USA, we sought to describe and compare social determinants of health and maternal psychological outcomes. METHODS: Hispanic pregnant women (n = 579) were recruited from two clinics in Tampa, FL, and completed various questionnaires related to social determinants of health, depression, stress, and social support. STATISTICAL ANALYSIS: Descriptive statistics, t-tests, and chi-square analyses were used to compare relationships between maternal nativity and subsequent psychosocial outcomes. Pearson correlations were used to explore associations between variables. RESULTS: Hispanic pregnant women who were not born in the USA had lower incomes (χ2 = 5.68, p = 0.018, df = 1), were more likely to be unemployed (χ2 = 8.12, p = 0.004, df = 1), and were more likely to be married (χ2 = 4.79, p = 0.029, df = 1) when compared with those born in the USA. Those not born in the USA reported lower social support (t = 3.92, p<0.001), specifically the tangible (t = 4.18, p < 0.001) and emotional support subscales (t = 4.4, p<0.001). When compared with those born in the USA, foreign-born Hispanic women reported less stress (t = 3.23, p = 0.001) and depression (t = 3.3, p = 0.002). CONCLUSION: Pregnant Hispanic women not born in the USA are at increased risk for suboptimal social determinants of health, including less social support. US-born women were more stressed and depressed and had higher BMIs.
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BACKGROUND: Sleep is essential for optimal health, and disturbed postpartum sleep is associated with compromised infant attachment. The postpartum experience of mothers with preterm infants is unlike the biological norm, as they are separated from their infants and often express breast milk. PURPOSE: The purpose of this study was to examine the feasibility of conducting a clinical research study among women with hospitalized preterm infants. We also explored for associations between maternal sleep patterns and sleep-related psychological states and subsequent breast milk volume. METHODS: Participants were recruited from Magee-Womens Hospital, located in Pittsburgh, Pennsylvania New mothers completed daily sleep and pumping logs and scales to measure stress, trauma, depression, fatigue, and sleep quality. RESULTS: A total of 78 women were screened, 18 women consented, and a total of 8 participants completed the study. Screening from the postpartum unit increased recruitment. The participants experience worsening sleep quality over time, moderate stress, and fatigue. Stress, postnatal depression, and fatigue are negatively associated with milk volume. IMPLICATIONS FOR PRACTICE AND RESEARCH: Postpartum recruitment with frequent follow-ups improved recruitment and retention. We present a preliminary association between maternal stress, fatigue, and depression, and subsequent breast milk volume. Sleep-related psychological states may negatively influence milk volume.
Subject(s)
Infant, Premature , Milk, Human , Infant , Infant, Newborn , Female , Humans , Feasibility Studies , Mothers/psychology , Sleep , Fatigue/etiology , Fatigue/psychology , Breast Feeding/psychologyABSTRACT
PROBLEM: Pregnancy markedly modifies women's metabolism and immune functions. We hypothesized that pregnancy might alter the immune and metabolic responses to chronic Toxoplasma gondii infection in pregnancy. METHOD OF STUDY: A population of 690 pregnant Hispanic women were screened for antibodies to T. gondii and 158 women were positive (23% positivity) with 83% showing high avidity indices. These seropositive women were followed through their pregnancies with four data collection time points and a postpartum collection at two clinics in Tampa, Florida. A T. gondii seronegative group (N = 128) was randomly selected to serve as a control group and measured along pregnancy in the same way. Serum levels of tryptophan, kynurenine, and their ratio, phenylalanine, tyrosine and their ratio, neopterin, and nitrite were measured through pregnancy and the postpartum. A plasma cytokine panel (IFN-γ, TNFα, IL-2, IL-10, IL-12, IL-6, IL-17) was analyzed in parallel. RESULTS: The major findings suggest that indoleamine 2,3-dioxygenase (IDO-1) was less activated in T. gondii seropositive pregnant Hispanic women with chronic infection. Evidence for IDO-1 suppression was that tryptophan catabolism was less pronounced and there were lower levels of multiple inflammatory cytokines including IFN-γ, which is the major inducer of IDO-1, and higher nitrite concentration, a surrogate marker for nitric oxide, an inhibitor of IDO. CONCLUSIONS: Latent T. gondii infection was associated with higher plasma tryptophan levels, and lower inflammatory cytokines across pregnancy, suggesting suppression of the IDO-1 enzyme, and possible T cell exhaustion during pregnancy.
Subject(s)
Nitrites , Toxoplasmosis , Tryptophan , Female , Humans , Pregnancy , Antibodies , Cytokines , Hispanic or Latino , Tryptophan/metabolism , Toxoplasma , Toxoplasmosis/immunology , Toxoplasmosis/metabolismABSTRACT
BACKGROUND: Human milk is a complex source of nutrition and other bioactives that protects infants from disease, holding a lifetime of beneficial effects. The field of metabolomics provides a robust platform through which we can better understand human milk at a level rarely examined. RESEARCH AIM: To Identify, describe, synthesize, and critically analyze the literature within the past 5 years related to the human milk metabolome. METHODS: We conducted a scoping literature review and quality analysis of the recent science reflecting untargeted metabolomic approaches to examining human milk. We searched six databases using the terms "breast milk," "metabolome," "metabolite," and "human milk," Out of more than 1,069 abstracts, we screened and identified 22 articles that met our inclusion criteria. RESULTS: We extracted data related to the study author, geographic location, research design, analyses, platform used, and results. We also extracted data related to human milk research activities, including collection protocol, infant/maternal considerations, and time. Selected studies focused on a variety of phenotypes, including maternal and infant disease. Investigators used varying approaches to evaluate the metabolome, and differing milk collection protocols were observed. CONCLUSION: The human milk metabolome is informed by many factors-which may contribute to infant health outcomes-that have resulted in disparate milk metabolomic profiles. Standardized milk collection and storage procedures should be implemented to minimize degradation. Investigators may use our findings to develop research questions that test a targeted metabolomic approach.
Subject(s)
Breast Feeding , Milk, Human , Infant , Female , Humans , Milk, Human/metabolism , MetabolomeABSTRACT
BACKGROUND: Necrotizing enterocolitis is associated with a high incidence of morbidity and mortality in premature infants. Human milk minimizes necrotizing enterocolitis risk, although the mechanism of protection is not thoroughly understood. Increasingly, dysbiosis of the infant gut microbiome, which is affected by infant diet, is hypothesized to play a role in necrotizing enterocolitis pathophysiology. RESEARCH AIM: The aim of this scoping review was to summarize the state of the science regarding the hypothesis that the gut microbiome composition is a mediator of the relationship between human milk and decreased incidence of necrotizing enterocolitis within a sample of human infants. METHODS: Electronic databases and reference lists were searched for peer-reviewed primary research articles addressing the link between human milk, gut microbiome composition, and subsequent incidence of necrotizing enterocolitis among human infants. RESULTS: A total of four studies met criteria for inclusion in this review. Of these, evidence supporting the link between human milk, gut microbiome composition, and necrotizing enterocolitis was found in two (50%) studies. CONCLUSION: Some evidence linking all three variables is provided in this review. Given the small number of available studies, and the limitations of those studies, more research is urgently needed to thoroughly understand the protection against necrotizing enterocolitis gained through the provision of human milk.
Subject(s)
Enterocolitis, Necrotizing/drug therapy , Gastrointestinal Microbiome/physiology , Milk, Human/microbiology , Enterocolitis, Necrotizing/physiopathology , Gastrointestinal Microbiome/drug effects , Humans , Infant , Infant Nutritional Physiological Phenomena/physiology , Infant, Newborn , Milk, Human/chemistry , Milk, Human/metabolismABSTRACT
INTRODUCTION: The human microbiome, the microorganisms living in and on the body, plays a vital role in brain physiology and pathophysiology. The gut microbiome (GMB) has been identified as a link in the gut-brain axis moderating cognitive development and health. OBJECTIVES: The objectives of this scoping review are to discuss mechanisms of the microbiome-gut-brain axis in cognition, review the existing literature on the GMB and cognition, and discuss implications for nursing research. METHODS: We searched Pubmed using the terms "gut microbiome," "brain," and "cognition" and the terms "gut brain axis," "microbiome," and "cognition"; removed duplicates, studies not published in English, and unrelated publications; and added additional articles identified through references. We retained the 85 most relevant publications for this review. RESULTS: Common themes in the current literature include GMB components; interactions on cognitive development; effects of GMB-gut-brain interactions on cognition, mild cognitive impairment and Alzheimer's disease; effects of GMB interactions with physiologic stress on cognition in critical care; and GMB modification for improved cognition. Review of the literature on each of these topics reveals multiple theoretical mechanisms of action for GMB-gut-brain interaction that modify cognitive development and function across the lifespan. DISCUSSION: GMB components and dysbiosis have been implicated in many cognitive states, and specific microbiota constituents contribute to cognitive development, stability, and impairment. The study of these interactions is relevant to nursing research as it addresses the holistic human experience and microbiome constituents are modifiable, facilitating translation into the clinical setting.
Subject(s)
Brain/physiology , Cognition/physiology , Cognitive Dysfunction/physiopathology , Gastrointestinal Microbiome/physiology , Dysbiosis/physiopathology , Humans , Nursing ResearchABSTRACT
OBJECTIVE: To determine what is known about the sleep experiences of mothers of hospitalized preterm infants. DATA SOURCES: A literature search of PubMed and CINAHL was performed in February 2018. Additional articles were identified from reference lists. STUDY SELECTION: Whittemore's integrative review methodology was used to synthesize existing literature; 17 articles met eligibility criteria. DATA EXTRACTION: Data were reported in tabular format, including subjects, purpose, setting, interventions, sleep measurements, psychometric instruments, analyses, and results. DATA SYNTHESIS: Overall, sleep is disrupted and of poor quality, and many mothers report insomnia with less total sleep time. Potential beneficial interventions include bright light therapy, relaxation guided imagery, and progressive muscle relaxation. CONCLUSION: Although some interventions show promise, there are significant limitations. Future research should consider maternal/infant separation and milk expression.
Subject(s)
Infant, Premature , Mothers/psychology , Sleep , Female , Humans , Infant, Newborn , Intensive Care Units, NeonatalABSTRACT
BACKGROUND: Maternal interleukin (IL) single nucleotide polymorphisms (SNPs) are associated with obstetrical outcomes. Conversely, infant SNPs are associated with subsequent neonatal intensive care unit (NICU) outcomes. Little is known about relationships between maternal SNPs and neonatal outcomes. PURPOSE: To examine the relationships between maternal IL genotypes and neonatal outcomes. METHODS: An ancillary study was conducted among mothers ( N = 63) who delivered very low-birth-weight infants ( N = 74). Maternal DNA was extracted from breast milk and genotyped. Outcomes included fecal calprotectin, length of stay, scores for neonatal acute physiology with perinatal extension (SNAPPE-II), weight gain, oxygen needs, necrotizing enterocolitis, intraventricular hemorrhage, sepsis, retinopathy of prematurity, blood transfusions, and feeding intolerance. Multivariate analyses examined the relationships between maternal IL SNPs and outcomes, controlling for gestational age and the ratio of maternal milk to total milk. RESULTS: Absence of a minor allele in 2 IL6 SNPs was associated with fecal calprotectin ( p = .0222, p = .0429), length of stay ( p = .0158), SNAPPE-II ( p = .0497), weight gain ( p = .0272), and days on oxygen ( p = .0316). IL6 genotype GG (rs1800795) was associated with length of stay ( p = .0034) and calprotectin ( p = .0213). Minor-allele absence in 2 IL10 SNPs was associated with days on oxygen ( p = .0320). There were associations between IL10 genotype TT (rs1800871) and calprotectin ( p = .0270) and between IL10 genotypes AA (rs1800872 and rs1800896) and calprotectin ( p = .0158, p = .0045). CONCLUSION: Maternal IL SNPs are associated with NICU outcomes. A potential clinical application includes an antenatal risk profile to identify neonatal needs.
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BACKGROUND: Breast milk concentrations of immune components are variable between women and interleukin (IL) differences may be associated with infant outcomes. Molecular mechanisms for milk variability remain unknown. OBJECTIVE: The aims were to (1) examine the relationship between maternal IL genotypes and milk concentrations of IL4, IL6, and IL10, (2) describe the trajectories of milk IL change, (3) examine whether maternal IL genotypes predict IL trajectories and/or average weekly IL concentration, and (4) examine if weekly IL levels and/or IL trajectories are associated with infant outcomes. METHODS: Milk aliquots were collected from each feeding of mother's own milk and pooled weekly. DNA was extracted from 1 sample of each mother's breast milk whey (n = 64), and single nucleotide polymorphisms (SNPs) of IL genes were genotyped. Milk IL concentrations were measured and trajectory analysis examined IL milk change over time. Multivariate breast milk IL concentration analyses controlled for gestational age and prepregnancy body mass index. Multivariate infant outcome (n = 73) analyses controlled for gestational age and the ratio of human milk to total milk. RESULTS: Trajectory analysis resulted in linear group shapes, with 2 distinct subgroups in IL6 and 3 subgroups in IL4 and IL10. Trajectory groups trended toward significance with calprotectin, intraventricular hemorrhage, and blood transfusions. Multivariate analyses resulted in trending associations between maternal SNPs and subsequent IL6 and IL10 milk levels. There was a trending relationship between IL milk levels and both fecal calprotectin and intraventricular hemorrhage. CONCLUSION: Maternal IL SNPs may affect IL breast milk levels and IL milk levels may be associated with infant outcomes.
Subject(s)
Infant, Premature , Interleukins/genetics , Interleukins/metabolism , Milk, Human/immunology , Polymorphism, Single Nucleotide , Promoter Regions, Genetic , Adult , Biomarkers/metabolism , Cross-Sectional Studies , Female , Genotype , Humans , Infant, Newborn , Male , Milk, Human/chemistry , Multivariate Analysis , Postpartum Period , Prospective StudiesABSTRACT
Wet-nursing was an essential practice that allowed for infant survival after many mothers died in childbirth. The story of wet-nursing is complicated by both religious pressures and cultural expectations of women. It is likely that these historical practices have shaped our current social, political and legislative environments regarding breastfeeding. The aim of this article is to provide a historical perspective on the practice of wet-nursing, with a focus on: 1) social views of wet nurses, 2) breastmilk evaluation and 3) the ideal wet nurse. Historical perspectives from Ancient Egypt, Ancient Greece and Rome, 19th and 20th century America and current practices are examined. An appreciation for the evolution of breastmilk sharing provides clinicians and lactation advocates with the historical origins which provided the template for current practice as it relates to donor milk, breastfeeding culture and relevant legislation.
Subject(s)
Breast Feeding/history , Infant Care/history , Infant Welfare/history , Milk Banks/history , Milk, Human , Female , History, 15th Century , History, 16th Century , History, 17th Century , History, 18th Century , History, 19th Century , History, 20th Century , History, 21st Century , History, Ancient , History, Medieval , Humans , Infant Food/history , Infant, NewbornABSTRACT
The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provides foods, education, and referrals to participants who are considered to be at nutritional risk. The outreach of the program is impressive, and nearly 9.17 million people participated in the program in 2010. WIC participation is associated with many positive outcomes, including improved birthweights and childhood dietary practices. Despite these benefits, WIC mothers experience lower breastfeeding rates when compared with demographically similar women who do not participate in the WIC program. According to WIC, "A breastfeeding mother and her infant shall be placed in the highest priority level." Despite this statement and others that support breastfeeding, WIC allocates only 0.6% of its budget toward breastfeeding initiatives. Formula expenses accounted for 11.6% ($850 million) of WIC's 2009 expenses. The inconsistency between WIC's policies that encourage breastfeeding vs. practices that favor formula begs further examination. Research shows consistent success with peer counseling programs among WIC participants; however, little money is budgeted for these programs. Rebates included, WIC spends 25 times more on formula than on breastfeeding initiatives. The American Academy of Nursing Expert Panel on Breastfeeding is calling for a re-evaluation of how these taxpayer dollars are spent. Additionally, the American Academy of Nursing recommends a shift from formula bargaining to an investment in structured peer counseling programs. All WIC programs should offer peer counseling support services that encourage breastfeeding and meet the needs of the families they serve.
Subject(s)
Breast Feeding/statistics & numerical data , Health Promotion/organization & administration , Organizational Policy , Counseling/organization & administration , Female , Health Promotion/economics , Humans , Infant , Infant Formula/economics , Peer Group , Program Evaluation , Societies, Nursing , United StatesABSTRACT
BACKGROUND: The Epworth Sleepiness Scale (ESS) was initially developed to measure daytime sleep propensity in patients affected by a variety of sleep disorders. Obstetrical research has measured sleepiness in pregnant women with the ESS, although psychometric analyses and dimensionality evaluations have never been conducted with this population. OBJECTIVE: The objective was to perform a psychometric evaluation of the ESS in an obstetric population. The design was a secondary data analysis of the subjects enrolled in the Prenatal Exposures and Preeclampsia Prevention III (PEPP) study. The setting for the subjects who received prenatal care was at Magee-Women's Hospital UPMC in Pittsburgh, Pennsylvania and included 337 pregnant women in their first trimester that completed the ESS. METHODS: Principal components analysis and confirmatory factor analysis were performed using SPSS and M-Plus. Additionally, reliability was assessed and construct validity was measured using the Life Orientation Test (LOT). Lastly, a relationship between daytime sleepiness and snoring was investigated using item 5e from the Pittsburgh Sleep Quality Index (PSQI). RESULTS: PCA with varimax rotation yielded two factors that explained approximately 50% of the variance and CFA results verified this two-factor solution. An overall Cronbach's alpha (0.751) revealed moderate reliability (Factor 1α=.754; Factor 2α=.524). Both convergent and discriminant validity were established. CONCLUSION: The ESS is appropriate for use in an obstetric population to measure daytime sleepiness. Future work should include additional evaluations of the ESS in a diverse group of pregnant women.
Subject(s)
Pregnancy Complications/diagnosis , Sleep Wake Disorders/diagnosis , Factor Analysis, Statistical , Female , Humans , Pregnancy , Pregnancy Complications/physiopathology , Pregnancy Complications/psychology , Pregnancy Trimester, First/physiology , Pregnancy Trimester, First/psychology , Principal Component Analysis , Psychological Tests , Psychometrics , Reproducibility of Results , Sleep Wake Disorders/physiopathology , Sleep Wake Disorders/psychology , Surveys and Questionnaires , Wakefulness/physiology , Young AdultABSTRACT
This study synthesized scientific literature that applies genetic or genomic approaches to breastmilk. A literature search of PubMed was conducted in March 2012 using the key words "breast milk," "lactation," "genetic," "gene expression," and "epigenetic." Additional articles were identified/selected for evaluation with MeSH term searches, and a review of article reference lists was obtained from the search. The initial 657 abstracts retrieved from the literature search were reviewed, and 16 studies were selected for evaluation. Studies that examined the transmission of viruses/bacteria into breastmilk and/or measured concentration of specific proteins without examination of genetic material from milk were excluded. Data related to subjects, tissue, purpose, setting, gene/protein, approach (candidate versus genome-wide), platform, statistical analysis, and results were extracted. Gene expression and epigenetic/epigenomic study designs have been successfully implemented using breastmilk. A major weakness of both gene expression studies and epigenetic studies that examine breastmilk is the omission of maternal information known to influence milk composition. This review article is the first to synthesize evidence related to the application of breastmilk to evaluate RNA and epigenetic modifications. Additional research is needed that applies epigenetic analyses to human breastmilk samples. Findings from this review can be used for future research designs that use breastmilk for genetic analyses.
Subject(s)
Breast Neoplasms/genetics , Kallikreins/genetics , Lactation/genetics , Milk, Human , Breast Feeding , Breast Neoplasms/metabolism , Epigenomics , Female , Gene Expression , Genes, Tumor Suppressor , Humans , Infant, Newborn , Kallikreins/metabolism , Lactation/metabolism , Life Style , Mass Screening/trends , Milk, Human/metabolism , Pregnancy , Premature Birth , Promoter Regions, GeneticABSTRACT
Genetic and genomic research approaches have the capability to expand our understanding of the complex pathophysiology of disease susceptibility, susceptibility to complications related to disease, trajectory of recovery from acquired injuries and infections, patient response to interventions and therapeutics, as well as informing diagnoses and prognoses. Nurse scientists are actively involved in all of these fields of inquiry, and the goal of this chapter is to assist with incorporation of genetic and genomic trajectories into their research and facilitate the design and execution of these studies. New studies that are going to embark on recruitment, phenotyping, and sample collection will benefit from forethought about research design to ensure that it addresses the research questions or hypotheses being tested. Studies that will use existing data or samples will also benefit from forethought about research design for the same reason but will also address the fact that some designs may not be feasible with the available data or samples. This chapter discusses candidate gene association, genome-wide association, candidate gene expression, global gene expression, and epigenetic/epigenomic study designs. Information provided includes rationale for selecting an appropriate study design, important methodology considerations for each design, key technologies available to accomplish each type of study, and online resources available to assist in executing each type of study design.