Is economic hardship associated with young children's cortisol levels?

Economic hardship during childhood has been linked to poor physical and mental health. This study examines cross-sectional and longitudinal associations of a summed economic hardship score of poverty, food insecurity, and financial hardship with hair cortisol in young children. Data from 24-month (Time 1, mean age 5 years) and 36-month (Time 2, mean age 6 years) follow-up from the NET-Works obesity prevention trial (NET-Works, NCT0166891) were used. Hair cortisol measures obtained at each time point were log-transformed and regressed on economic hardship at Time 1 and a cumulative economic hardship from Time 1 to Time 2, using generalized linear regressions. All models were adjusted for child age, sex, race/ethnicity, and intervention (prevention vs. control) arm. The final analytic sample sizes ranged from 248 to 287. Longitudinal analyses indicated that for every 1-unit higher economic hardship score at Time 1, hair cortisol at Time 2 follow-up was on average 0.07 log-picograms per milligram (pg/mg) higher (95% confidence interval [CI]: 0.01, 0.13). For every 1-unit increase in the cumulative economic hardship score between Time 1 and 2, there was a 0.04 log-pg/mg (95% CI: 0.00, 0.07) average higher level of hair cortisol at Time 2 follow-up. Results show suggestive but limited evidence for an association between economic hardship and cortisol in young children.

Using targeting to recruit men and women of color into a behavioral weight loss trial.

BACKGROUND: The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach. METHODS: Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit. RESULTS: Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger (p = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means (p = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study. CONCLUSIONS: Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02368002. Registered on 20 February 2015.

Beyond the dinner table: who's having breakfast, lunch and dinner family meals and which meals are associated with better diet quality and BMI in pre-school children?

OBJECTIVE: Having frequent family dinners is associated with better diet quality in children; however, it is unknown whether the frequency of certain family meal types (i.e. dinner) is more strongly associated with better child weight and diet quality compared with other meal types (i.e. breakfast, lunch). Thus, the current study examined the frequency of eating breakfast, lunch or dinner family meals and associations with pre-school children's overall diet quality (HEI-2010) and BMI percentile. DESIGN: Cross-sectional baseline data (2012-2014) from two randomized controlled childhood obesity prevention trials, NET-Works and GROW, were analysed together. SETTING: Studies were carried out in community and in-home settings in urban areas of Minnesota and Tennessee, USA. SUBJECTS: Parent-child (ages 2-5 years) pairs from Minnesota (n 222 non-Hispanics; n 312 Hispanics) and Tennessee (n 545 Hispanics; n 55 non-Hispanics) participated in the study. RESULTS: Over 80 % of families ate breakfast or lunch family meals at least once per week. Over 65 % of families ate dinner family meals ≥5 times/week. Frequency of breakfast family meals and total weekly family meals were significantly associated with healthier diet quality for non-Hispanic pre-school children (P<0·05), but not for Hispanic children. Family meal frequency by meal type was not associated with BMI percentile for non-Hispanic or Hispanic pre-school children. CONCLUSIONS: Breakfast family meal frequency and total weekly family meal frequency were associated with healthier diet quality in non-Hispanic pre-school children but not in Hispanic children. Longitudinal research is needed to clarify the association between family meal type and child diet quality and BMI percentile.

Recruitment and retention in obesity prevention and treatment trials targeting minority or low-income children: a review of the clinical trials registration database.

BACKGROUND: Efforts to recruit and retain participants in clinical trials are challenging, especially in studies that include minority or low-income children. To date, no studies have systematically examined recruitment and retention strategies and their effectiveness in working successfully with this population. We examined strategies employed to recruit or retain minority or low-income children in trials that included an obesity-related behavior modification component. METHODS: First, completed home-, community-, and school-based trials involving minority or low-income children aged 2-17 years were identified in a search of the ClinicalTrials.gov registry. Second, a PubMed search of identified trials was conducted to locate publications pertinent to identified trials. Recruitment and retention rates were calculated for studies that included relevant information. RESULTS: Our final analytic sample included 43 studies. Of these, 25 studies reported recruitment or retention strategies, with the amount of information varying from a single comment to several pages; 4 published no specific information on recruitment or retention; and 14 had no publications listed in PubMed. The vast majority (92 %) of the 25 studies reported retention rates of, on average, 86 %. Retention rates were lower in studies that: targeted solely Hispanics or African Americans (vs. mixed races of African Americans, whites, and others); involved children and parents (vs. children only); focused on overweight or obese children (vs. general children), lasted ≥1 year (vs. <1 year), were home or community-based (vs. school-based), included nutrition and physical activity intervention (vs. either intervention alone), had body mass index or other anthropometrics as primary outcome measures (vs. obesity-related behavior, insulin sensitivity, etc.). Retention rates did not vary based on child age, number of intervention sessions, or sample size. CONCLUSIONS: Variable amounts of information were provided on recruitment and retention strategies in obesity-related trials involving minority or low-income children. Although reported retention rates were fairly high, a lack of reporting limited the available information. More and consistent reporting and systematic cataloging of recruitment and retention methods are needed. In addition, qualitative and quantitative studies to inform evidence-based decisions in the selection of effective recruitment and retention strategies for trials including minority or low-income children are warranted.

Factors Associated With Adherence to Blood Pressure Measurement Recommendations at Pediatric Primary Care Visits, Minnesota and Colorado, 2007-2010.

INTRODUCTION: Elevated blood pressure in childhood may predict increased cardiovascular risk in young adulthood. The Task Force on the Diagnosis, Evaluation and Treatment of High Blood pressure in Children and Adolescents recommends that blood pressure be measured in children aged 3 years or older at all health care visits. Guidelines from both Bright Futures and the Expert Panel of Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents recommend annual blood pressure screening. Adherence to these guidelines is unknown. METHODS: We conducted a cross-sectional study to assess compliance with blood pressure screening recommendations in 2 integrated health care delivery systems. We analyzed electronic health records of 103,693 subjects aged 3 to 17 years. Probability of blood pressure measurement documented in the electronic health record was modeled as a function of visit type (well-child vs nonwell-child); patient age, sex, race/ethnicity, and body mass index; health care use; insurance type; and type of office practice or clinic department (family practice or pediatrics). RESULTS: Blood pressure was measured at 95% of well-child visits and 69% of nonwell-child outpatient visits. After adjusting for potential confounders, the percentage of nonwell-child visits with measurements increased linearly with patient age (P < .001). Overall, the proportion of children with annual blood pressure measurements was high and increased with age. Family practice clinics were more likely to adhere to blood pressure measurement guidelines compared with pediatric clinics (P < .001). CONCLUSION: These results show good compliance with recommendations for routine blood pressure measurement in children and adolescents. Findings can inform the development of EHR-based clinical decision support tools to augment blood pressure screening and recognition of prehypertension and hypertension in pediatric patients.

Impact of hypertension on healthcare costs among children.

OBJECTIVES: Despite the significant prevalence of elevated blood pressure (BP) and body mass index (BMI) in children, few studies have assessed their combined impact on healthcare costs. This study estimates healthcare costs related to BP and BMI in children and adolescents. STUDY DESIGN: Prospective dynamic cohort study of 71,617 children aged 3 to 17 years with 208,800 child years of enrollment in integrated health systems in Colorado or Minnesota between January 1, 2007, and December 31, 2011. METHODS: Generalized linear models were used to calculate standardized annual estimates of total, inpatient, outpatient, and pharmacy costs, outpatient utilization, and receipt of diagnostic and evaluation tests associated with BP status and BMI status. Results: Total annual costs were significantly lower in children with normal BP ($736, SE = $15) and prehypertension ($945, SE = $10) than children with hypertension ($1972, SE = $74) (P <.001, each comparison), adjusting for BMI. Total annual cost for children below the 85th percentile of BMI ($822, SE = $8) was significantly lower than for children between the 85th and 95th percentiles ($954, SE = $45) and for children at or above the 95th percentile ($937, SE = $13) (P <.001, each), adjusting for HT. CONCLUSIONS: This study shows strong associations of prehypertension and hypertension, independent of BMI, with healthcare costs in children. Although BMI status was also statistically significantly associated with costs, the major influence on cost in this large cohort of children and adolescents was BP status. Costs related to elevated BMI may be systematically overestimated in studies that do not adjust for BP status.

Automating assessment of lifestyle counseling in electronic health records.

BACKGROUND: Numerous population-based surveys indicate that overweight and obese patients can benefit from lifestyle counseling during routine clinical care. PURPOSE: To determine if natural language processing (NLP) could be applied to information in the electronic health record (EHR) to automatically assess delivery of weight management-related counseling in clinical healthcare encounters. METHODS: The MediClass system with NLP capabilities was used to identify weight-management counseling in EHRs. Knowledge for the NLP application was derived from the 5As framework for behavior counseling: Ask (evaluate weight and related disease), Advise at-risk patients to lose weight, Assess patients' readiness to change behavior, Assist through discussion of weight-loss methods and programs, and Arrange follow-up efforts including referral. Using samples of EHR data between January 1, 2007, and March 31, 2011, from two health systems, the accuracy of the MediClass processor for identifying these counseling elements was evaluated in postpartum visits of 600 women with gestational diabetes mellitus (GDM) compared to manual chart review as the gold standard. Data were analyzed in 2013. RESULTS: Mean sensitivity and specificity for each of the 5As compared to the gold standard was at or above 85%, with the exception of sensitivity for Assist, which was 40% and 60% for each of the two health systems. The automated method identified many valid Assist cases not identified in the gold standard. CONCLUSIONS: The MediClass processor has performance capability sufficiently similar to human abstractors to permit automated assessment of counseling for weight loss in postpartum encounter records.

Healthy Homes/Healthy Kids: a randomized trial of a pediatric primary care-based obesity prevention intervention for at-risk 5-10 year olds.

Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a Contact Control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The Contact Control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial.

Health and healing: traditional medicine and the Karen experience.

OBJECTIVE: To examine the beliefs, attitudes and health-seeking behavior surrounding the use of traditional medicine among the Karen (refugees from Burma). METHODS: Three focus groups and two key-informant interviews were conducted with the Karen along with observations by researchers. RESULTS: The Karen continue to use elements of their traditional healthcare system after resettling in the U.S. Accessibility and perceived efficacy of treatments influence their health-seeking behavior. The participants discussed beliefs about health and healing, spirituality, and their experience as refugees. Implications for improving the quality of healthcare for the Karen and recommendations for further research are discussed.

Body mass index measurement and obesity prevalence in ten U.S. health plans.

OBJECTIVE: The objective of this study was to examine the frequency of body mass index (BMI) measurement before the implementation of two new Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity that require U.S. health plans to annually report the frequency of BMI and BMI percentile measurement among all adults and children who had at least one outpatient visit during the past two years. DESIGN: Cross-sectional study. SETTING: A consortium of ten U.S. health plans and care delivery systems from the Health Maintenance Organization Research Network, which together provide care to more than 6.5 million adults and children. PARTICIPANTS: Children and adults, age 2 years and older, who were continuously enrolled in one of ten U.S. health plans for at least one full year from 2005 to 2006. METHODS: We extracted available anthropometric data for 3.7 million adults and 1.2 million children with at least one visit captured from ten electronic medical record databases from 2005 to 2006. RESULTS: We found that the availability of BMI measurements for adults ranged widely across health plans from 28% to 88%, and availability of BMI percentiles for children ranged from 21% to 81%. Among adults and children with BMI measures in these ten health plans, the overall prevalence of overweight and obesity were very similar to those reported in the 2005 to 2006 U.S. national surveys that used measured heights and weights. CONCLUSION: The newly approved HEDIS performance measures likely represent an important step in addressing the quality of obesity care in the United States. The current study demonstrates that these HEDIS measures are achievable, especially among health plans that have implemented electronic medical records. Future research should assess the relationship between BMI assessment, provider counseling and treatment practices, and long-term changes in obesity rates among different population groups.

The drop it at last study: six-month results of a phone-based weight loss trial.

PURPOSE: To address the translational research question regarding the optimal intervention "dose" to produce the most cost-effective rate of weight loss, we conducted the Drop It At Last (DIAL) study. DESIGN: DIAL is a 6-month pilot randomized trial to examine the efficacy of phone-based weight loss programs with varying levels of treatment contact (10 vs. 20 sessions) in comparison to self-directed treatment. SETTING: Participants were recruited from the community via mailings and advertisement. SUBJECTS: Participants were 63 adults with a body mass index between 30 and 39 kg/m(2). INTERVENTION: Participants received a standard set of print materials and were randomized to either: (1) self-directed treatment; (2) 10 phone coaching sessions; or (3) 20 phone coaching sessions. MEASURES: Measured height, weight, and psychosocial and weight-related self-monitoring measures were collected at baseline and follow-up. ANALYSIS: General linear models were used to examine 6-month treatment group differences in weight loss and in psychosocial and behavioral measures. RESULTS: Weight losses were -2.3, -3.2, and -4.9 kg in the self-directed, 10-session, and 20-session groups, respectively (p < .21). Participants who completed 10 or more sessions lost more weight (-5.1 kg) compared to those completed four or fewer sessions (-.3 kg, p < .04). CONCLUSION: Phone-based weight loss program participation is associated with modest weight loss. The optimal dose and timing of intervention warrant further study.

The long and winding road to physical activity maintenance.

OBJECTIVES: To build upon state-of-the-art theory and empirical data to estimate the strength of multiple mediators of the efficacious Keep Active Minnesota (KAM) physical activity (PA) maintenance intervention. METHODS: The total, direct, and indirect effects through which KAM helped randomized participants (KAM n = 523; UC n = 526) maintain moderate or vigorous PA (MVPA) for up to 2 years were estimated using structural equation modeling. RESULTS: Multiple mediators explained half (beta = .052, P = .13) of the effect of KAM on MVPA (beta = .105, P = .004). Self-efficacy was the upstream variable in 2 endogenously mediated effects, and the self-concept mediator emerged as the strongest predictor of MVPA. CONCLUSIONS: KAM positively impacted self-efficacy, which was associated with PA enjoyment, integration into the self-concept, and PA maintenance. Successful long-term PA maintenance appears to be influenced by multiple small interrelated mediational pathways. Future research evaluating maintenance models should specify recursive relationships among mediators and outcomes.

Maintaining physical activity among older adults: 24-month outcomes of the Keep Active Minnesota randomized controlled trial.

OBJECTIVE: To evaluate the efficacy at 6-, 12-, and 24-month follow-up of Keep Active Minnesota (KAM), a telephone and mail-based intervention designed to promote physical activity (PA) maintenance among currently active adults age 50 to 70. METHOD: Participants who reported having recently increased their MVPA to a minimum of 2d/wk, 30 min/bout, (N=1049) were recruited in 2004 and 2005 from one large managed care organization in Minnesota, and randomly assigned to either treatment (KAM; N=523), or Usual Care (UC; N=526) with PA assessed using the CHAMPS questionnaire, and expressed as kcal/wk energy expenditure. RESULTS: We find a sustained, significant benefit of the intervention at 6, 12 and 24 months. kcal/wk expenditure in moderate or vigorous activities was higher at 6 (p<.03, Cohen's d(6m)=.16), 12 (p<.04, d(12 m)=.13) and 24 months (p<.01, d(24 m)=.16) for KAM participants, compared to UC participants. CONCLUSIONS: The KAM telephone- and mail-based PA maintenance intervention was effective at maintaining PA in both the short-term (6 months) and longer-term (12 and 24 months) relative to usual care.

Population reach and recruitment bias in a maintenance RCT in physically active older adults.

OBJECTIVE: To assess the representativeness of older adults recruited to a physical activity maintenance RCT by conducting sequential comparisons to characterize study sample composition changes occurring between sampling frame construction and study enrollment. METHOD: Study subjects (N = 1049) were 50 to 70 year old men and women who had increased physical activity within the past year recruited from a Midwestern managed care organization. RESULTS: Those responding to an initial mailed screener differed on demographic, behavioral, and SES characteristics from those not responding. Compared with ineligibles, eligible individuals were significantly younger, more highly educated, and more likely to report improved health in the prior year. Compared with eligible individuals who did not enroll, enrollees had generally higher education and income. CONCLUSIONS: Physical activity promotion programs in older adults may have limited reach and substantial volunteer bias. Additional strategies to increase the reach of physical activity interventions into the target population are needed.

A new approach to physical activity maintenance: rationale, design, and baseline data from the Keep Active Minnesota Trial.

BACKGROUND: Since many individuals who initiate physical activity programs are highly likely to return to a sedentary lifestyle, innovative strategies to efforts to increase the number of physically active older adults who successfully maintain beneficial levels of PA for a substantial length of time are needed. METHODS/DESIGN: The Keep Active Minnesota Trial is a randomized controlled trial of an interactive phone- and mail-based intervention to help 50-70 year old adults who have recently increased their physical activity level, maintain that activity level over a 24-month period in comparison to usual care. Baseline, 6, 12, and 24 month measurement occurred via phone surveys with kilocalories expended per week in total and moderate-to-vigorous physical activity (CHAMPS Questionnaire) as the primary outcome measures. Secondary outcomes include hypothesized mediators of physical activity change (e.g., physical activity enjoyment, self-efficacy, physical activity self-concept), body mass index, and depression. Seven day accelerometry data were collected on a sub-sample of participants at baseline and 24-month follow-up. DISCUSSION: The Keep Active Minnesota study offers an innovative approach to the perennial problem of physical activity relapse; by focusing explicitly on physical activity maintenance, the intervention holds considerable promise for modifying the typical relapse curve. Moreover, if shown to be efficacious, the use of phone- and mail-based intervention delivery offers potential for widespread dissemination.

Maintaining physical activity among older adults: six-month outcomes of the Keep Active Minnesota randomized controlled trial.

OBJECTIVE: We evaluate the 6-month efficacy of Keep Active Minnesota, a phone- and mail-based physical activity maintenance intervention designed for use with adults age 50 to 70 years who have increased their physical activity within the past year. METHOD: Participants (N=1049) recruited in 2004 and 2005 from one large managed-care organization in Minnesota were randomly assigned to either treatment (N=523) or usual care (N=526) with physical activity assessed using the Community Healthy Activities Model Program for Seniors questionnaire, and expressed as kcal/week expenditures. RESULTS: Total physical activity at baseline was similar for treatment and usual care participants (p<0.44) as was moderate/vigorous physical activity (p<0.21). Maintenance of physical activity was higher among treatment participants whose mean 6-month change in total kcal/week energy expenditure was -91, compared to -683 for usual care participants (p<0.002). Mean 6-month change in kcal/week expenditure in moderate or vigorous activities was -49 for treatment participants, compared to -612 for usual care participants (p<0.001). CONCLUSIONS: This phone- and mail-based physical activity maintenance intervention is efficacious at maintaining physical activity at 6 months.

Evaluating strategies and costs to recruit smokeless tobacco users.

We recruited smokeless tobacco users throughout Minnesota to participate in a trial testing telephone counseling versus a written self-help manual for cessation. This paper describes the recruitment strategies applied on a state-wide basis. We established a recruitment tracking system to monitor weekly rates of screened callers and returned consents, allowing us to adjust future recruitment efforts. Screening was completed with 783 callers, with 406 subjects enrolled. Overall 44% of initial contacts and 52% of those screened enrolled in the study. The overall average cost per consented subject was $99. Sports talk radio, small print ads, and newspaper articles based on press releases were consistently effective channels for recruitment. The overall cost was expensive but reflected the geographic diversity of recruitment and the prevalence of oral snuff use.

Anthropometric, parental, and psychosocial correlates of dietary intake of African-American girls.

OBJECTIVE: This paper identifies the anthropometric, parental, and psychosocial characteristics and meal practices (e.g., breakfast skipping and number of meals and snacks consumed) associated with consumption of total energy, percent energy from fat, fruit, 100% fruit juice, vegetables, sweetened beverages, and water among 8- to 10-year-old African-American girls. RESEARCH METHODS AND PROCEDURES: This study included 114 8- to 10-year-old African-American girls and a parent or primary caregiver. Girls and a parent or primary caregiver completed several dietary questionnaires. Two 24-hour dietary recalls were conducted with each girl. Height and weight were measured. Separate hierarchical regression analyses were conducted for each dependent dietary variable; potential field center differences were examined. RESULTS: The number of meals and snacks consumed was correlated with energy intake. Lower BMI was related to higher vegetable consumption, and the number of snacks consumed was positively related to sweetened beverage consumption. Greater low-fat food preparation practices reported by parents were related to lower consumption of fat as a percentage of total energy. DISCUSSION: Dietary behavior differed across geographic areas. Low-fat food preparation practices in the home seemed to be an important influence on the percentage of energy consumed from fat. Greater vegetable consumption was associated with lower BMI. Interventions to prevent excessive weight gain in African-American girls should encourage low-fat food preparation in the home and greater consumption of vegetables.

Depressive symptoms and adolescent eating and health behaviors: a multifaceted view in a population-based sample.

BACKGROUND: Previous research has shown significant associations between depression and substance use and eating disordered behaviors. However, no research to date has described associations between depressive symptoms and nutritional intake or physical activity among adolescents in a nonclinical, population-based sample. METHODS: Classroom surveys were completed by 4,734 ethnically diverse, middle- and high school students. Based on their depressive symptom scores, males and females were categorized with low-, moderate-, or high-depressive symptom status. Linear models were used to examine eating and health behavior variables by depressive symptom groups. RESULTS: Depressive symptoms were positively associated with health-compromising attitudes such as perceived barriers to healthy eating and weight concerns, and health-compromising behaviors such as unhealthy weight-control behaviors and substance use, including caffeine. Depressive symptoms were negatively associated with health-promoting behaviors such as eating breakfast, lunch, and dinner. However, most associations between depressive symptoms and dietary micronutrients were not statistically significant. Health-promoting moderate-to-vigorous physical activity was negatively associated with depressive symptoms among males. CONCLUSIONS: Adolescents who report depressive symptoms are at risk for other health-compromising attitudes and behaviors and are also less likely to engage in health-promoting behaviors. Depressive symptoms may be an underlying trait in the expression of health behaviors among adolescents.

Collaborative planning for formative assessment and cultural appropriateness in the Girls health Enrichment Multi-site Studies (GEMS): a retrospection.

OBJECTIVE: The Girls health Enrichment Multi-site Studies (GEMS), Phase 1, developed and pilot-tested interventions to prevent obesity in African-American preadolescent girls. This article describes the collaborative planning process undertaken to take full advantage of formative assessment activities for improving contextual relevance and cultural appropriateness. DESIGN: Working group activities were designed to stimulate awareness and reflection among group members and, through them, among other field center investigators and staff about developmental, cultural, and contextual issues for formative assessment. SETTING: Telephone, Internet, and face-to-face interactions across GEMS field centers in Houston, Texas; Memphis, Tennessee; Minneapolis, Minnesota; and Palo Alto, California. PARTICIPANTS: Investigators and staff involved in intervention development. MAIN OUTCOME MEASURES: The utility of the process was judged from feedback by participants and field center principal investigators about the contribution of the collaborative effort to improving the perceived relevance and cultural appropriateness of formative assessment data collection and interpretation. RESULTS: A working bibliography was compiled. A detailed matrix of programmatic, child, family, and contextual issues related to ethnicity, socioeconomic status, general health and lifestyle, food, physical activity, and body image/weight control was completed. Additional guidance was derived from a workshop that involved scholars with expertise in aspects of African-American culture, child development, and family processes. CONCLUSIONS: This process improved the breadth and depth of GEMS formative assessment activities by increasing the appreciation of the complex structural, contextual, and personal forces at play. A similar process may be useful to other investigators when attempting to develop culturally appropriate interventions.