Implementing an evidence-based behavioral weight-loss program in community mental health centers: A randomized pilot study.

Background: Obesity is a leading cause of preventable death among individuals with serious mental illness (SMI). A prior randomized controlled trial demonstrated the efficacy of a lifestyle style intervention tailored to this population; however, such interventions need to be adapted and tested for real-world settings. Aims: This study evaluated implementation interventions to support community mental health program staff to deliver an evidence-based lifestyle intervention to clients with obesity and SMI. Materials & Methods: In this cluster-randomized pilot trial, the standard arm combined multimodal training with organizational strategy meetings and the enhanced arm included all standard strategies plus performance coaching. Staff-coaches delivered a 6-month group-based lifestyle intervention to clients with SMI. Primary outcomes were changes in staff knowledge, self-efficacy, and fidelity scores for lifestyle intervention delivery. Linear mixed-effects modeling was used to analyze outcomes, addressing within-site clustering and within-participant longitudinal correlation of outcomes. Results: Three sites were in the standard arm (7 staff-coaches); 5 sites in the enhanced arm (11 staff-coaches). All sites delivered all 26 modules of the lifestyle intervention. Staff-coaches highly rated the training strategy's acceptability, feasibility and appropriateness. Overall, mean knowledge score significantly increased pre-post by 5.5 (95% CI: 3.9, 7.1) and self-efficacy was unchanged; neither significantly differed between arms. Fidelity ratings remained stable over time and did not differ between arms. Clients with SMI achieved a mean 6-month weight loss of 3.8 kg (95% CI: 1.6, 6.1). Conclusions: Mental health staff delivering a lifestyle intervention was feasible using multicomponent implementation interventions, and preliminary results show weight reduction among clients with SMI. The addition of performance coaching did not significantly change outcomes. Future studies are needed to definitively determine the effect on client health outcomes.

Differences in weight-loss outcomes among race-gender subgroups by behavioural intervention delivery mode: An analysis of the POWER trial.

Prior in-person behavioural intervention studies have documented differential weight loss between men and women and by race, with Black women receiving the least benefit. Remotely delivered interventions are now commonplace, but few studies have compared outcomes by race-gender groups and delivery modality. We conducted a secondary analysis of POWER, a randomized trial (NCT00783315) designed to determine the effectiveness of 2 active, lifestyle-based, weight loss interventions (remote vs. in-person) compared to a control group. Participants with obesity and at least one cardiovascular disease risk factor (N = 415) were recruited in the Baltimore, MD area. Data from 233 white and 170 Black individuals were used for this analysis. Following an intention-to-treat approach, we compared the mean percent weight loss at 24 months by race-gender subgroups using repeated-measures, mixed-effects models. Everyone lost weight in the active interventions however, weight loss differed by race and gender. white and Black men had similar results for both interventions (white: in-person (-7.6%) remote (-7.4%); Black: in-person (-4.7%) remote (-4.4%)). In contrast, white women lost more weight with the in-person intervention (in-person (-7.2%) compared to the remote (-4.4%)), whereas Black women lost less weight in the in-person group compared to the remote intervention at 24 months (-2.0% vs. -3.0%, respectively; p for interaction <.001). We found differences between the effectiveness of the 2 weight loss interventions-in-person or remote-in white and Black women at 24 months. Future studies should consider intervention modality when designing weight loss interventions for women.

Association Between Maladaptive Eating Behaviors Among Black Women and Vicarious Racial Discrimination Following a High-Profile Event.

OBJECTIVE: Evidence suggests that racial discrimination causes stress among non-Hispanic Black women, and some Black women may cope with exposure to vicarious racial discrimination by engaging in maladaptive eating behaviors. METHODS: We examined eating behaviors among Black women (N = 254) before and after Freddie Gray's death while in police custody. Maladaptive eating behaviors were assessed using the three-factor eating questionnaire. Our independent variables included the following: (1) time period and (2) geographic proximity to the event. Three two-way analysis of covariance tests were conducted to assess potential effects of geographic proximity (close, distant), time period in relation to unrest (before, after unrest), and their interaction on emotional eating, uncontrolled eating, and cognitive restraint controlling for participant age. RESULTS: There was a statistically significant main effect of proximity to the unrest on emotional eating, F (1, 252) = 5.64, p = .018, and partial η2 = .022 such that women living in close geographic proximity to the unrest reported higher mean levels of emotional eating as compared to those living more distant to the unrest. There was also a borderline statistically significant interaction between geographic proximity and time period on cognitive restraint, F (1, 252) = 3.89, p = .050, and partial η2 = .015. CONCLUSION: Our study found a relationship between vicarious racial discrimination and maladaptive eating behaviors among Black women. Future work should examine stress related to vicarious racial discrimination and maladaptive eating behaviors longitudinally.

Study design and rationale for TEENS+REACH: Evaluating ripple effects of a family-based lifestyle intervention to untreated family members.

Background: Understanding the effects of family-based lifestyle intervention beyond the treated adolescent is important, given that obesity is a familial disease and there are likely bidirectional relations between an adolescent's treatment success and broader household changes. However, it is unknown if recommended household-wide changes are adopted or if untreated family members experience weight-related benefits. Methods: TEENS + REACH leverages our ongoing randomized clinical trial of TEENS+, a family-based lifestyle intervention for adolescents with obesity, to determine: 1) if household-wide changes to the shared home environment are implemented, 2) if ripple effects to untreated family members are observed, and 3) whether these changes are predictive of adolescents' weight management success. TEENS + REACH will expand trial assessments to include comprehensive assessments of the shared home feeding, weight, and physical activity environment of the target adolescents. Specifically, we will enroll untreated children (8-17yrs) and caregivers living in the same household as the target parent/adolescent dyad (N = 60 families). At 0, 2, 4 (primary endpoint), and 8-months, the target parent/adolescent dyad and other untreated children and caregivers in the home will complete anthropometric assessments. Discussion: Results will determine the familial reach of TEENS+ and reveal potential mediators of treatment response, which can inform future efforts to optimize family-based lifestyle interventions. Trial registration: TEENS + REACH was retrospectively registered in Clinicaltrials.gov March 22, 2023 (NCT05780970) as an observational study ancillary to the TEENS + clinical trial, registered February 22, 2019 (NCT03851796).

Comprehensive Diabetes Assessment Instrument for Patients With Type 2 Diabetes.

AIMS: There is a paucity of efficient processes for collecting information in a primary care setting to connect patients afflicted with type 2 diabetes to valuable resources. The objective of this research project was to develop a Comprehensive Diabetes Assessment (CDA) instrument which could be used to assess patients' barriers to best outcomes. METHODS: We reviewed published literature and online compilations for validated tools assessing threats to optimal diabetes self-management. We conducted focus groups with patients, clinicians, and service providers who provided feedback on the tools' appropriateness and feasibility. We aggregated the favored tools and did cognitive testing with patients to assess understanding and affective response to the instrument. RESULTS: Five focus groups involved varied stakeholders in Baltimore, MD and Honolulu, HI. We presented 2 tools assessing knowledge barriers, 3 tools assessing psychological barriers, 4 tools assessing literacy, and 1 numeracy. The final instrument included 6 multi-part items and takes 3 minutes to complete. Cognitive interviewing with 8 patients in Baltimore and 8 in Hawaii confirmed that the instrument is understandable, quick to complete, and is acceptable to patients. CONCLUSIONS: Because of the complexity of self-management of diabetes, we suggest that this CDA instrument, plus a social needs assessment, should be administered at least annually and at times of clinical deterioration. We anticipate the instrument will be proven valuable in connecting patients to services from which they will benefit.

Comparing Implementation Strategies for an Evidence-Based Weight Management Program Delivered in Community Mental Health Programs: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Among people with serious mental illness (SMI), obesity contributes to increased cardiovascular disease (CVD) risk. The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) randomized controlled trial (RCT) demonstrated that a behavioral intervention tailored to the needs of individuals with SMI results in clinically significant weight loss. While the research team delivered the ACHIEVE intervention in the trial, community mental health program staff are needed to deliver sessions to make scale-up feasible. Therefore, we adapted the ACHIEVE-Dissemination (ACHIEVE-D) curriculum to ease adoption and implementation in this setting. Designing and testing of implementation strategies is now needed to understand how to support ACHIEVE-D delivery by community mental health program staff coaches. OBJECTIVE: This study aims to conduct a pilot trial evaluating standard and enhanced implementation interventions to support the delivery of ACHIEVE-D in community mental health programs by examining effects on staff coaches' knowledge, self-efficacy, and delivery fidelity of the curriculum. We will also examine the effects on outcomes among individuals with SMI taking part in the curriculum. METHODS: The trial will be a cluster-randomized, 2-arm parallel pilot RCT comparing standard and enhanced implementation intervention at 6 months within community mental health programs. We will randomly assign programs to either the standard or enhanced implementation interventions. The standard intervention will combine multimodal training for coaches (real-time initial training via videoconference, ongoing virtual training, and web-based avatar-assisted motivational interviewing practice) with organizational strategy meetings to garner leadership support for implementation. The enhanced intervention will include all standard strategies, and the coaches will receive performance coaching. At each program, we will enroll staff to participate as coaches and clients with SMI to participate in the curriculum. Coaches will deliver the ACHIEVE-D curriculum to the clients with SMI. Primary outcomes will be coaches' knowledge, self-efficacy, and fidelity to the ACHIEVE-D curriculum. We will also examine the acceptability, feasibility, and appropriateness of ACHIEVE-D and the implementation strategies. Secondary outcomes among individuals with SMI will be weight and self-reported lifestyle behaviors. RESULTS: Data collection started in March 2021, with completion estimated in March 2023. We recruited 9 sites and a total of 20 staff coaches and 72 clients with SMI. The expected start of data analyses will occur in March 2023, with primary results submitted for publication in April 2023. CONCLUSIONS: Community mental health programs may be an ideal setting for implementing an evidence-based weight management curriculum for individuals with SMI. This pilot study will contribute knowledge about implementation strategies to support the community-based delivery of such programs, which may inform future research that definitively tests the implementation and dissemination of behavioral weight management programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03454997; https://clinicaltrials.gov/ct2/show/NCT03454997. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45802.

A Call to Reconceptualize Obesity Treatment in Service of Health Equity: Review of Evidence and Future Directions.

PURPOSE OF REVIEW: Rates of obesity and associated comorbidities are higher among Black and Latino adults compared to white adults. We sought to provide an overview of both structural and individual factors contributing to obesity inequities and synthesize available evidence regarding treatment outcomes in Black and Latino adults, with an eye towards informing future directions. RECENT FINDINGS: Obesity disparities are influenced by myriad systemic issues, yet the vast majority of interventions target individual-level factors only, and most behavioral treatments fail to target drivers beyond eating and physical activity. Extant treatments are not equally accessible, affordable, or effective among Black and Latino adults compared with white counterparts. Asset-based, culturally relevant interventions that target the root causes of obesity and address intersectional stress-designed in partnership with intended beneficiaries-are urgently needed. Treatment trials must improve enrollment of Black and Latino adults and report treatment outcomes by race and ethnicity.

Eating to cope: Advancing our understanding of the effects of exposure to racial discrimination on maladaptive eating behaviors.

OBJECTIVE: Racial discrimination is a stressor for young Black women that leads to poor health outcomes, including maladaptive eating. This study presents findings on racial discrimination and maladaptive eating behaviors (overeating, LOC eating) using ecological momentary assessment (EMA). METHODS: Black emerging adult women (N = 27) with overweight or obesity participated in a 14-day EMA study examining exposure to racial discrimination, eating behaviors, and racial identity. Frequencies and chi-square tests were used to characterize the type of racial discrimination experienced and frequency of overeating. Mixed effect ordinal logistic regression models were used to assess the relation between racial discrimination and maladaptive eating. Moderation analysis was conducted by creating interaction terms for discrimination and racial identity variables. RESULTS: 81.5% of participants reported experiencing racial discrimination. Young Black women reporting exposure to racial discrimination were more likely to endorse higher levels of both overeating and LOC eating compared to times when discrimination was not experienced (p < .0001). Racial identity moderated the link between racial discrimination and maladaptive eating (overeating, LOC) such that reporting greater levels of private regard buffered the deleterious effect of racial discrimination. Higher levels of public regard exacerbated the association between racial discrimination and both overeating, and LOC. Higher centrality worsened the relation between racial discrimination and LOC. CONCLUSION: Young Black women might use maladaptive eating to cope with exposure to racial discrimination, which underscores the importance of examining the link between racism and disordered eating, particularly among Black women submerged in a society that continuously exposes them to racial discrimination. PUBLIC SIGNIFICANCE: Emerging adult Black women are exposed to racial discrimination daily. In theory, exposure to racial discrimination could contribute to overeating and loss of control eating in this population. Using ecological momentary assessment, to capture experiences and eating behaviors in the moment they occur, this project quantified the magnitude of racial discrimination and how it was associated with maladaptive eating behaviors. Further, it examined ways in which racial identity was linked to this association.

Recruitment and retention of emerging adults in lifestyle interventions: Findings from the REACH trial.

OBJECTIVE: Emerging adulthood (EA) is a critical time to promote cardiometabolic health, but EAs are underrepresented in lifestyle intervention trials. Knowledge gaps exist regarding how best to recruit and retain sociodemographically diverse EAs. Our goal was to begin to address these gaps using data from the Richmond Emerging Adults Choosing Health (REACH) Trial. METHODS: REACH was a comparative efficacy trial for EAs, age 18-25, with a body mass index of 25-45 kg/m2. Enrollment goals were: N = 381, ≥40% underrepresented race/ethnicity, ≥30% men, ≥85% retention at 6 months. We translated formative work into a recruitment and retention plan, examined yield for recruitment and retention overall, and by gender and race/ethnicity, as well as cost data. Descriptive statistics and chi square tests were used. RESULTS: Enrollment benchmarks were met overall (N = 382) and for participants from underrepresented race/ethnic backgrounds (58.0%), but not men (17.3%). The most common recruitment sources were email (26.9%), radio (22.2%), and online radio (15.4%); this pattern largely held true across gender and race/ethnic groups, though word of mouth and participant referral together accounted for nearly a quarter of enrolled men. Costs averaged $155 per randomized participant. Retention was 89% at 3-months, 84% at 6-months (primary endpoint) and 80% at 12-months (follow-up), with no significant differences by gender or race/ethnicity (all p's > 0.05). Retention did not differ by recruitment method (p = .69). CONCLUSIONS: Grounding our approach in formative data and embracing participants as partners in research contributed to the recruitment and retention of sociodemographically diverse EAs. Additional efforts are needed to enroll EA men.

The Weight of Racial Discrimination: Examining the Association Between Racial Discrimination and Change in Adiposity Among Emerging Adult Women Enrolled in a Behavioral Weight Loss Program.

BACKGROUND: Non-Hispanic Black (NHB) emerging adult (EA) women are at disproportionate risk for obesity but experience limited benefit from behavioral weight loss (BWL) programs. Race-related stress could play a role; the goal of this study was to examine the association between racial discrimination (RD) and early (3 months) changes in adiposity, and to explore potential protective factors, among EA in an adapted BWL program. METHODS: This is an ancillary study of non-Hispanic White (NHW) and NHB EA women enrolled in an adapted BWL trial (N = 49; 55.1% NHB; Age 21.2 (2.1); BMI = 33.0 + 4.3 kg/m2). At baseline, group- and personal-level RD (RD-group and RD-personal), racial identity (NHB women only), vigilant coping, and social support were assessed via validated questionnaires. Weight and waist circumference were measured objectively at 0 and 3 months. RESULTS: NHW women manifested greater reductions in waist circumference relative to NHB women (p = .004). RD-personal did not predict change in waist circumference at 3 months (p = .402); however, the association between RD-group and change in waist circumference was statistically significant (p = .015), such that reporting greater group-level discrimination predicted a smaller decrease in waist circumference; the model explained 22% of the variance. Social support and vigilant coping were not statistically significant in the model. Among NHB women only, higher racial identity-centrality predicted greater reduction in waist circumference (p = .019). CONCLUSION: Findings suggest racial discrimination could contribute to greater cardiometabolic risk during this developmental period. Future research should examine how experiences of racial discrimination unfold in the daily lives of NHB women to inform mechanistic interventions to enhance health and well-being. TRIAL REGISTRATION: NCT02736981. Low Intensity Weight Loss for Young Adults.

The relationship between body mass index, binge eating disorder and suicidality.

BACKGROUND: While restrictive and compensatory eating disorders (e.g. anorexia and bulimia) are associated with elevated risk of suicide, less is known about binge eating disorder (BED). There is suggestive evidence of a U-shaped relationship between body mass index (BMI) and completed suicide, but fewer studies on suicidal ideation or attempts. This study examined the association between BED, BMI, and suicidality, and assessed whether these relationships varied by gender. METHODS: Data come from the Collaborative Psychiatric Epidemiologic Surveys (N = 14,497). Binge episodes and BED were assessed using the Composite International Diagnostic Inventory (CIDI). BMI was calculated from self-reported height and weight. Suicidal ideation/attempts were assessed using the CIDI. Weighted logistic regression was used to assess the association between binging/BED, BMI and suicidality. Interaction terms were used to assess whether the relationship between BMI and suicidality was moderated by binging/BED, and whether the relationships between binging/BED and BMI differed by gender. RESULTS: One-third of adults with BED had a history of suicidality, compared to 19% of those without. Both binging (OR: 1.95, 95% CI: 1.50-2.53) and BED (OR: 2.01, 95% CI: 1.41-2.86) were associated with suicidality in fully-adjusted models. BMI was associated with suicidality in a curvilinear manner, and this relationship was exacerbated by binging/BED (ORBinge eating x BMI: 1.04, 95% CI: 1.01-1.09, p < 0.05). The relationship between BMI and suicidality did not differ by gender (ORgender x BMI: 1.00, p < 0.770). However, the relationship between binge eating and suicidality was stronger for women relative to men (ORgender X binge: 1.87, p < 0.012). CONCLUSIONS: Binge eating, even below the threshold for BED, is associated with suicidality. BMI is associated with suicidality in a curvilinear manner, and the BMI-suicidality relationship is potentiated by binge eating/BED. Findings support the thoughtful integration of psychiatric care into weight loss programs for adults with a history of binging behavior.

The Transition into Young Adulthood: a Critical Period for Weight Control.

PURPOSE OF REVIEW: Emerging adulthood (age 18-25) represents a critical period for weight control: rate of weight gain is greatest during these years and the prevalence of overweight and obesity is estimated to be at least 40% among emerging adults. Unique behavioral, psychosocial, and cognitive risk factors among this population must be specifically addressed within weight management programs. We review extant treatment approaches, including lessons learned from the nascent literature specifically targeting this population. Lastly, we provide suggestions to inform future work in this area. RECENT FINDINGS: The EARLY consortium comprises seven clinical trials targeting weight control in young adults age 18-35. Though these studies encompass a broader age range, two of the trials enrolled large numbers of 18-25-year-olds. Results from these trials and other recent pilot trials provide a foundation for next steps with respect to developing weight management interventions for emerging adults. The design of targeted weight control approaches for emerging and young adults has contributed to improved outcomes for this high-risk population. However, suboptimal engagement and variability in response pose challenges. Identifying and intervening on individual-level behavioral and psychological variables may enhance the effects of these adapted treatments.

A pilot study of the effects of intranasal budesonide delivered by NasoNeb® on patients with perennial allergic rhinitis.

BACKGROUND: We investigated whether nebulization of budesonide via a NasoNeb® device would treat perennial allergic rhinitis. METHODS: We performed a parallel, randomized, double-blind, placebo-controlled, pilot study in subjects (n = 40) with perennial allergic rhinitis. After recording baseline symptoms, subjects were randomized to budesonide respules (0.25 mg) or an equivalent placebo for 26 days. Nasal peak inspiratory flow (NPIF) and nasal symptoms (graded on a 0­3 scale) were recorded by the subjects twice daily. Rhinoconjunctivitis quality of life (RQOL) as well as nasal volume, measured by acoustic rhinometry, was obtained at baseline, after 2 weeks, and at the end of treatment. RESULTS: The average change from baseline in symptoms over the treatment period was greater for the group on budesonide (−3.33) compared to placebo (−1.98) (p = 0.45). When the average change from baseline over the treatment period was compared between the groups, budesonide resulted in higher NPIF (36.4 L/min) than placebo (18.7 L/min), p = 0.094. QOL improved in both groups compared to baseline with no significant difference between the groups. Although acoustic rhinometry indicated a larger volume in the group treated with budesonide on the last trial visit, the differences between the groups were not significant when accounting for the baseline values. CONCLUSION: Compared to placebo, administration of nebulized budesonide in subjects with perennial allergic rhinitis resulted in improvements in symptoms and objective measures of nasal congestion which approached but did not achieve statistical significance. A higher dose of active agent, a less effective placebo and a larger number of subjects might have improved statistical significance.

Calcium montmorillonite clay reduces AFB1 and FB1 biomarkers in rats exposed to single and co-exposures of aflatoxin and fumonisin.

Aflatoxins (AFs) and fumonisins (FBs) can co-contaminate foodstuffs and have been associated with hepatocellular and esophageal carcinomas in humans at high risk for exposure. One strategy to reduce exposure (and toxicity) from contaminated foodstuffs is the dietary inclusion of a montmorillonite clay (UPSN) that binds AFs and FBs in the gastrointestinal tract. In this study, the binding capacity of UPSN was evaluated for AFB1, FB1 and a combination thereof in Fischer 344 rats. Rats were pre-treated with different dietary levels of UPSN (0.25% or 2%) for 1 week. Rats were gavaged with a single dose of either 0.125 mg AFB1 or 25 mg FB1 per kg body weight and a combination thereof in the presence and absence of an aqueous solution of UPSN. The kinetics of mycotoxin excretion were monitored by analyzing serum AFB1 -albumin, urinary AF (AFM1) and FB1 biomarkers over a period of 72 h. UPSN decreased AFM1 excretion by 88-97%, indicating highly effective binding. FB1 excretion was reduced, to a lesser extent, ranging from 45% to 85%. When in combination, both AFB1 and FB1 binding occurred, but capacity was decreased by almost half. In the absence of UPSN, the combined AFB1 and FB1 treatment decreased the urinary biomarkers by 67% and 45% respectively, but increased levels of AFB1 -albumin, presumably by modulating its cytochrome metabolism. UPSN significantly reduced bioavailability of both AFB1 and FB1 when in combination; suggesting that it can be utilized to reduce levels below their respective thresholds for affecting adverse biological effects.

Common African cooking processes do not affect the aflatoxin binding efficacy of refined calcium montmorillonite clay.

Aflatoxins are common contaminants of staple crops, such as corn and groundnuts, and a significant cause of concern for food safety and public health in developing countries. Aflatoxin B1 (AFB1) has been implicated in the etiology of acute and chronic disease in humans and animals, including growth stunting, liver cancer and death. Cost effective and culturally acceptable intervention strategies for the reduction of dietary AFB1 exposure are of critical need in populations at high risk for aflatoxicosis. Fermented gruels consisting of cornmeal are a common source for such exposure and are consumed by both children and adults in many countries with a history of frequent, high-level aflatoxin exposure. One proposed method to reduce aflatoxins in the diet is to include a selective enterosorbent, Uniform Particle Size NovaSil (UPSN), as a food additive in contaminated foods. For UPSN to be effective in this capacity, it must be stable in complex, acidic mixtures that are often exposed to heat during the process of fermented gruel preparation. Therefore, the objective of the present study was to test the ability of UPSN to sorb aflatoxin while common cooking conditions were applied. The influence of fermentation, heat treatment, acidity, and processing time were investigated with and without UPSN. Analyses were performed using the field-practical Vicam assay with HPLC verification of trends. Our findings demonstrated that UPSN significantly reduced aflatoxin levels (47-100%) in cornmeal, regardless of processing conditions. Upon comparison of each element tested, time appeared to be the primary factor influencing UPSN efficacy. The greatest decreases in AFB1 were reported in samples allowed to incubate (with or without fermentation) for 72 hrs. This data suggests that addition of UPSN to staple corn ingredients likely to contain aflatoxins would be a sustainable approach to reduce exposure.

Prenatal alcohol consumption and fetal growth restriction: potentiation effect by concomitant smoking.

INTRODUCTION: This study investigates whether maternal cigarette smoking modifies the association between alcohol use in pregnancy and the risk of small-for-gestational-age (SGA) delivery. METHOD: We employed linked vital statistics data of singleton births in the state of Missouri covering the period 1989 through 1997 (N = 655,758). Multivariate logistic regression was used to generate adjusted odds ratios (AORs) and 95% confidence intervals (CIs) for SGA associated with maternal alcohol intake. A subanalysis was conducted to assess the impact of the interaction of alcohol consumption and tobacco use on SGA. RESULTS: About 2% of mothers (n = 14,444) reported consuming alcohol during pregnancy, and approximately 4% of SGA births occurred among these mothers. Women who consumed alcohol during pregnancy had a 20% greater risk for delivering an SGA infant than mothers who abstained (AOR = 1.2; CI = 1.1-1.3). The relative risk for SGA birth rose as the reported number of drinks consumed per week increased (trend p < .0001). The relative risk of delivering an SGA infant was consistently higher among women who reported both drinking alcohol and using tobacco products in pregnancy as compared to women who were drinkers but nonsmokers. The greatest risk was among women who smoked and consumed five or more drinks per week (AOR = 4.8, CI = 4.2-5.5). DISCUSSION: Our findings suggest significant interaction between prenatal alcohol consumption and smoking on the risk of delivering an SGA infant and highlight the relevance of developing "dual message" health education programs that would stress the deleterious effect of joint exposure to alcohol and nicotine in pregnancy.