Psychosocial factors related to Cardiovascular Disease Risk in Young African American Women: a systematic review.

OBJECTIVE: African American women are exposed to multiple adverse psychosocial factors, including racism, discrimination, poverty, neighborhood stress, anxiety, and depression. The impact of these psychosocial factors on cardiovascular disease (CVD) risk in women during early adulthood is limited. This review aims to summarize and synthesize the recent literature on psychosocial factors related to CVD risk in young African American women. METHODS: We conducted a comprehensive search of the literature in PubMed, APA PsycINFO, and CINAHL. We systematically reviewed the literature for studies examining associations between psychosocial factors (e.g. racism, discrimination, neighborhood stress, anxiety) and CVD risk factors (e.g. body mass index [BMI], blood pressure, diabetes) in African American women age 19-24 years. Eligible studies measured at least one psychosocial factor, a CVD risk factor, and included young adult African American women (age 19-24) or reported sex-stratified analyses. RESULTS: We identified nine studies that met our inclusion criteria: six cross-sectional and three longitudinal studies. Of these, eight studies reported that psychosocial factors (i.e. perceived stress, racial discrimination, internalized racism, depression) are related to higher BMI and blood pressure. The majority of studies were conducted among college students or had a small sample size (<200). The quality of six studies was rated as excellent; the remainder were good and fair. CONCLUSIONS: Findings from this review suggest that exposure to adverse psychosocial factors may be related to increased CVD risk in early adulthood (age 19-24) in African American women. However, larger prospective analyses are necessary to examine these associations.

Methodological Considerations in Scale Refinement with Diverse Populations: A Case Example Using the CES-D with a Community Sample of American Indian Women.

Although many psychometric assessments are used extensively in population-based research to determine psychopathology, these tools have not been thoroughly validated or appropriately adapted for use in diverse populations. Indeed, depression measurement studies among American Indian and female populations are scarce, omitting key opportunities to tailor psychological measurement for this population. To build psychometric evidence of measures in this population, we used a procedural method to examine a standard psychological instrument-the Center for Epidemiological Studies Depression Scale (CES-D)-with a community sample of southeast American Indian women. Our results showed strong psychometric reliability of the 20-item CES-D. The "effort" item presented diminished validity, as demonstrated by a negative counter-intuitive item-to-total correlation (ITC) value. Dropping the "effort" item resulted in a 19-item scale with a better fit in the within-group examination of community-based American Indian women. Compared to the 20-item CES-D scale, the revised 19-item measure ("effort" item removed) resulted in minimal changes to women's depression categories. However, we did detect patterns in shifts such that the 19-item scale generally underestimated (i.e., placed women in a lower category) depressive symptoms compared to the 20-item scale. Depending on their study goals, researchers engaging in population-based research should carefully weigh the use of original scales that allow for consistency in reporting with refined scales that fit psychometrically. We present the outlined method as a tool that expands on current approaches in scale refinement, and aids researchers in making more informed decisions regarding refined scales with diverse populations.

Family Influence on Children's Nutrition and Physical Activity Patterns in Oman.

PURPOSE: The objective of this study is to expand the understanding of the family influence on children's nutrition and physical activity patterns in Oman. DESIGN AND METHODS: A cross-sectional research design was used in this study. We recruited 204 dyads (a mother with a child) conveniently. Research data were collected in public cycle one schools, nongovernmental community centers, and home visits from five provinces in Oman. Study measures included a general information survey, anthropometric measurements, electronic children and family nutrition and physical activity questionnaires, and a single-day dietary recall for children. Univariate, bivariate, and multivariate analyses were used. RESULTS: Children's nutrition intake was significantly associated with parental education level, family income, and family nutrition and physical activity patterns, while children's physical activity patterns were significantly associated with maternal BMI and parental education level. CONCLUSIONS: Children's nutrition and physical activity patterns are associated with maternal BMI, family's sociodemographic characteristics, and family's nutrition and physical activity pattern. PRACTICE IMPLICATIONS: Family is a key element in shaping and influencing children's lifestyle-related behaviors. School-health programs that actively involve the families hold promise in promoting children's nutrition and physical activity pattern. Future research should be directed toward understanding the moderating and mediating factors.

A community-engaged approach to investigate cardiovascular-associated inflammation among American Indian women: A research protocol.

American Indian women are more likely to die from cardiovascular disease (CVD) than White or African American women. Inflammatory processes may underlie CVD disparities by gender and race and may be critical to understanding population-specific drivers and potential buffers. Exposure to environmental air pollutants, especially particulate matter (PM), is known to be an important catalyst in CVD-associated inflammation. Positive psychological states, associated with low levels of inflammatory gene expression, could serve to moderate the inflammatory response to environmental air pollutants and ultimately lead to better cardiovascular health outcomes. The aim of the ongoing community-engaged and NIH-funded study described in this study protocol is to address the racial and gender gaps in CVD mortality by investigating the contextually relevant and culturally important determinants of health among American Indian women. In this paper we describe the procedures used to examine the relationship between environmental air pollutant exposures (PM10-2.5 and PM 2.5 ), psychological factors (e.g., depressive symptoms, posttraumatic stress symptoms, eudemonic well-being, and positive emotions), and cardiovascular-associated inflammation (hs-CRP, IL-6, Amyloid A, CBCs with differentials) in a sample of 150 women 18-50 years of age from the Lumbee Tribe in southeastern North Carolina. We describe lessons learned and strategies used in developing a community-engaged approach to enhance recruitment of American Indian women in biomedical research. The empirical data and community infrastructure resulting from this study will be foundational in designing and testing future interventions to reduce CVD-associated morbidity and mortality in American Indian women.

The Process of Integrating an Evidence-Based Intervention into a Public Health Department to Improve Nutrition and Physical Activity Behaviors in Parents and Children.

The purpose of this manuscript is to describe a mutually beneficial collaboration with a Public Health Department and a University to implement an evidence-based program to teach nutrition and physical activity to improve adult and child outcomes. We first assessed the needs of the Public Health Department to build sustainable capacity. Next, all collaborators were invited to work together to focus on success. We invested in the leadership structure and strategically planned together. Finally, all of the collaborators worked together to practice cultural awareness. The process of implementing evidence-based programs allows all collaborators to emerge from the interaction stronger as a result of respectful dialogue and team building.

A Nurse-Led and Teacher-Assisted Adolescent Healthy Weight Program to Improve Health Behaviors in the School Setting.

Adolescents with overweight and obesity are at risk for future health problems. The purpose of this study was to examine the feasibility and initial efficacy of a weight management intervention to help adolescents develop healthy nutrition and physical activity behaviors and improve their anthropometrics. This study used a single-group repeated measures design in a small school in Durham, North Carolina (NC). The intervention consisted of a nurse-led and teacher-assisted nutrition and physical activity education and exercise classes that met twice each week for 45-60 minutes for 7 weeks. Data were collected at Time 1 (baseline), Time 2 (after intervention completion), and Time 3 (after 3 months on their own). Interview feedback, low cost, and successful completion of all planned activities indicated that all stakeholders found the project beneficial and suitable for their school. This study suggests that a weight management intervention for adolescents was feasible in the school setting.

Rationale, design, and methods for the Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD) study.

BACKGROUND: Annually in the US, over 100,000 pregnant women with overt type 2 diabetes give birth. Strict maternal glycemic control is the key to optimizing infant outcomes. Medical treatment of type 2 diabetes in pregnancy is generally restricted to insulin, as data on the safety and efficacy of oral hypoglycemic agents in pregnancy are limited. However, over one-third of infants born to women with type 2 diabetes experience an adverse outcome, such as premature delivery, large-for-gestational age, hypoglycemia, hyperbilirubinemia, or birth trauma, suggesting that current treatment regimens fall short of optimizing outcomes. Metformin is the pharmacologic treatment of choice for type 2 diabetes outside of pregnancy. Metformin is favored over insulin because it results in less weight gain, fewer hypoglycemic episodes, and is administered orally rather than injected. However, metformin is not typically used for treatment of type 2 diabetes complicating pregnancy, mainly because no large clinical studies have been conducted to examine its use in this context. METHODS/DESIGN: This is a randomized double-blind multi-center clinical trial of insulin plus metformin versus insulin plus placebo for the treatment of type 2 diabetes complicating pregnancy. A total of 1200 women with type 2 diabetes will be randomized between 10 weeks 0 days' and 20 weeks 6 days' gestation and followed until 30 days after delivery. Neonate outcomes will be followed until 30 days of age. The primary aim is to compare the effect of insulin and metformin versus insulin and placebo on composite adverse neonatal outcomes, comprising perinatal mortality, preterm delivery, neonatal hypoglycemia, hyperbilirubinemia, large-for-gestational age small for gestational age, low birth weight, and/or birth trauma. Key secondary aims are to compare treatment groups for neonatal fat mass and rate of maternal hypoglycemia. Additional aims are to assess the side effects and safety of insulin and metformin among pregnant women with overt type 2 diabetes and to compare gestational weight gain among women treated with metformin plus insulin versus insulin alone. DISCUSSION: Successful completion of this study will result in high-quality, contemporary evidence for management of overt type 2 diabetes complicating pregnancy to improve neonatal outcomes. TRIAL REGISTRATION: NCT02932475 (05/17/2016).

Benefits for African American and white low-income 7-10-year-old children and their parents taught together in a community-based weight management program in the rural southeastern United States.

BACKGROUND: Low-income children and parents are at increased risk for developing overweight and obesity. Therefore, the purpose of this exploratory study was to compare whether African American and white children and parents benefitted equally from a community-based weight management intervention delivered in two rural counties in southeastern North Carolina (N.C.). METHODS: We compared the efficacy of the Family Partners for Health intervention for African American and white children and their parents by testing the three-way interaction of the intervention group according to visit and race. RESULTS: African American children in the intervention group weighed significantly (P = 0.027) less than those in the control group, while white children in the intervention group weighed less than those in the control group, but the difference did not reach statistical significance. African American and white parents in the intervention group weighed less than their respective control groups across all three data collections, but the difference was only significant in the group of white parents (P = 0.010) at the completion of the study. At the completion of the study, African American children in the intervention group received significantly (P = 0.003) more support for physical activity than African American children in the control group. At both time points, white children in the intervention group were not significantly different from those in the control group. African American parents in the intervention group scored slightly worse in the stress management assessment compared to those in the control group, while white parents in the intervention group showed a significantly (P = 0.041) better level of stress management than those in the control group. At the completion of the study, African American parents in the intervention group scored somewhat worse in emotional eating self-efficacy compared to the scores of the African American parents in the control group, while white parents in the intervention group scored significantly (P < 0.001) better than those in the control group. CONCLUSIONS: We were successful in affecting some outcomes in both African American and white children and parents using the same intervention. TRIAL REGISTRATION: NCT01378806 Registered June 22, 2011.

The Association of Metabolic Dysfunction with Breastfeeding Outcomes in Gestational Diabetes.

OBJECTIVE: To evaluate the relationship between prenatal metabolic markers and breastfeeding outcomes in women with gestational diabetes mellitus (GDM). STUDY DESIGN: Secondary analysis of a cluster-randomized trial of a lifestyle intervention to improve metabolic health among women with GDM. Women were enrolled between 22 and 36 weeks' gestation and followed through 10 months postpartum. Metabolic markers were measured at enrollment. Women reported when they stopped breastfeeding, whether they breastfed as long as desired, and when they introduced formula. We evaluated the association of tertiles of metabolic markers with undesired weaning and time to breastfeeding cessation using Cox proportional hazards models and Mantel-Haenszel chi-square tests, respectively. RESULTS: Eighty-two women were eligible for analysis. There was a statistically significant difference in time to breastfeeding cessation among tertiles of fasting glucose, hemoglobin A1c (A1c), body mass index (BMI), and skinfolds (all p < 0.05). Women with higher fasting glucose, BMI, or skinfolds were also more likely to report undesired weaning; women with higher fasting glucose introduced formula earlier. CONCLUSION: Higher fasting glucose, A1c, BMI, and subscapular skinfolds were associated with earlier breastfeeding cessation in women with GDM. These markers may identify mothers in need of enhanced postpartum support to achieve their breastfeeding goals.

Impact of weight stigma on physiological and psychological health outcomes for overweight and obese adults: A systematic review.

AIM: To summarize the associations between weight stigma and physiological and psychological health for individuals who are overweight or obese. BACKGROUND: Weight stigma can be defined as individuals experiencing verbal or physical abuse secondary to being overweight or obese. Weight stigma has negative consequences for both physiological and psychological health. DESIGN: A quantitative systematic review. DATA SOURCES: PubMed, PsycINFO, CINAHL and MEDLINE from 1 January 2008 - 30 July 2016. REVIEW METHODS: A systematic review was conducted using the Cochrane Collaboration guidelines, the PRISMA statement guidelines and the quality assessment from the National Heart, Lung and Blood Institute. Inclusion criteria consisted of quantitative studies that examined the associations between weight stigma and physiological and psychological health outcomes in adults who were overweight or obese. Exclusion criteria consisted of qualitative studies, literature reviews, expert opinions, editorials and reports on weight stigma without health outcomes or with behavioural outcomes and intervention studies that reduced weight stigma. A quality appraisal of the selected studies was conducted. RESULTS: A total of 33 studies met the eligibility criteria. Weight stigma was positively associated with obesity, diabetes risk, cortisol level, oxidative stress level, C-reactive protein level, eating disturbances, depression, anxiety, body image dissatisfaction and negatively associated with self-esteem among overweight and obese adults. CONCLUSION: Weight stigma is associated with adverse physiological and psychological outcomes. This conclusion highlights the need to increase public and professional awareness about the issue of weight stigma and the importance of the further development of assessment and prevention strategies of weight stigma.

The effectiveness of multimedia education for patients with type 2 diabetes mellitus.

AIMS: The aim of this study was to explore the effectiveness of two types of health education on improving knowledge concerning diabetes and insulin injection, insulin injection skills and self-efficacy, satisfaction with health education and glycated haemoglobin (HbA1c) and creatinine levels among patients with type 2 diabetes who began insulin therapy using a pen injector. BACKGROUND: Insulin therapy is recommended to facilitate the regulation of plasma glucose; however, patient's acceptance of insulin therapy is generally low. Healthcare providers should help them improve their knowledge of diabetes and insulin injection, as well as their insulin injection skills. DESIGN: A randomized repeated measures experimental study design. METHODS: The experimental (n = 21) and control (n = 21) groups received multimedia and regular health education programmes, respectively from October 2013-August 2014. Four structured questionnaires were used and videotapes were applied to demonstrate injection skills. RESULTS: Generalized estimating equations showed that the experimental group's scores were significantly higher than those of the control group for diabetes and insulin injection knowledge, insulin injection skills, self-efficacy in insulin injection and satisfaction with health education. On the other hand, an analysis of covariance revealed glycated hemoglobin (HbA1c) and creatinine levels did not differ significantly between the two groups. CONCLUSIONS: Implementation of a multimedia diabetes education programme could improve patients' diabetes and insulin injection knowledge, insulin injection skills, self-efficacy in insulin injection and satisfaction with health education. Healthcare providers should improve quality of patient care by providing multimedia diabetes health education.

Diabetes affects everything: Type 2 diabetes self-management among Spanish-speaking hispanic immigrants.

This article is a report of qualitative findings of a mixed-methods study of the relationships among knowledge, self-efficacy, health promoting behaviors, and type 2 diabetes mellitus (T2DM) self-management among limited-english-proficient recent Hispanic immigrants, a population with increased incidence of T2DM and barriers to successful T2DM management. Semi-structured interviews were conducted with 30 participants, and physiological and demographic data also were collected. The participants generally attributed developing the disease to strong emotions and viewed T2DM as a serious disease. Although a majority understood the importance of exercise and diet in T2DM self-management, other aspects such as medication adherence were not well-understood. Obstacles to effective T2DM self-management were negative interactions and communications with health care providers and other personnel, cultural stigma related to the disease, financial constraints, immigration status, and the complexity of the disease. Suggested interventions to improve the care and self-management of this at-risk population are discussed.

Management of Pregnant Women with Type 2 Diabetes Mellitus and the Consequences of Fetal Programming in Their Offspring.

The obesity epidemic has fueled an epidemic of prediabetes and type 2 diabetes mellitus in women of childbearing age. This paper examines the state of the science on preconception and pregnancy management of women with type 2 diabetes to optimize outcomes for the women and their infants. In addition, the consequence of fetal programming as a result of suboptimal maternal glycemic control is discussed. The paper focuses on type 2 diabetes, not type 1 diabetes or gestational diabetes. Management of women with type 2 diabetes includes preconception counseling, preconception weight management and weight loss, proper weight gain during pregnancy, self-monitoring of blood glucose levels, medication, medical nutrition therapy, and exercise.

Relationships of physical activity and sedentary time in obese parent-child dyads: a cross-sectional study.

BACKGROUND: Research suggests physical activity is linked to obesity. Further, the physical activity of healthy parents and their children is associated with each other. However, this relationship has not been examined in obese parents and their obese children. METHODS: The purpose of this study was to compare the physical activity and sedentary time of obese, low-income, ethnic minority parents and their children on weekdays and weekend days using accelerometry. Data were obtained from eight rural sites in the middle and eastern part of North Carolina (N.C.), United States (U.S.) from 2007-2010 using a rolling enrollment. One hundred and ninety-nine obese parents (94 % female) and their obese children (54 % female) wore accelerometers simultaneously for three weekdays and one weekend day. Total physical activity, moderate-to-vigorous physical activity (MVPA) and sedentary time and proportions were determined. RESULTS: Parents' and children's total physical activity and MVPA levels were lower on weekend days than weekdays. Total counts per minute for children on weekdays and weekend days were greater than for parents (p < 0.001). Total counts per minute were more highly correlated on weekend days than weekdays (r = 0.352, p < 0.0002 versus r = 0.165, p < 0.025). Parents' performed MVPA for 14 (SD = ±25) and 9 (SD = ±16) minutes/day on weekdays and weekend days, respectively; children performed MVPA for 37 (SD = ±25) and 31(SD = ±38) minutes/day for weekdays and weekend days, respectively. Correlations between parents and children for MVPA were higher on weekend days versus weekdays (r = 0.253 and 0.177, respectively; p < 0.015). Associations for sedentary time followed a similar trend, with r = 0.33 (p < 0.0002) for weekend days and r = 0.016 (p < 0.026) for weekdays. Associations between obese parent-child dyads on sedentary time were stronger for girls, while associations between dyads on MVPA were stronger for boys. However, formal interaction analyses were not significant (p > 0.13). DISCUSSION: Since physical activity levels of obese parents and their obese child are somewhat related, especially on weekend days, combined parent-child obesity programs focused on reducing sedentary time could be beneficial, particularly for the child. CONCLUSION: In conclusion, this study of the physical activity levels of obese parents and their obese children found some relationships between the parents' and children's physical activity and sedentary behavior patterns, especially on weekend days. TRIAL REGISTRATION: NCT01378806 .

Results of the Optimizing Outcomes in Women with Gestational Diabetes Mellitus and Their Infants, a Cluster Randomized, Controlled Pilot Study: Lessons Learned.

The purpose of this pilot study was as follows: Aim I was to determine the feasibility of the intervention, including its acceptability, and tofurther refine intervention materials and study procedures including recruitment, enrollment, intervention, retention, and data collection. Aim 2 was to test the initial effects of the intervention on the primary outcome of fasting blood glucose and secondary outcomes including metabolic, clinical, adiposity, health behavior, and self-efficacy outcomes in women. Aim 3 examined infant feeding. Infant weight and adiposity growth are discussed in this manuscript. The intervention group received the Phase I intervention, which included 14 classes, each lasting 60 minutes, with the first class delivered during pregnancy on the benefits of breastfeeding for maternal metabolic control andfor infant health. The classes resumed 6 weeks postpartum and were delivered weekly. The Phase II intervention included 3 monthly classes, each lasting 60 minutes, during which the interventionist facilitated a group discussion and assisted the women with problems related to breastfeeding, nutrition, or exercise. Results demonstrated that 100 women were enrolled in the study; however, secondary to the majority of women returning to work part-time or full-time, the retention for the intervention and data collection was poor. In addition, statistical significancefor the primary outcomes was not achieved. However, women made some changes in adiposity and health behaviors, and infants made changes in adiposity growth. Both lessons learned and future research are discussed.

A Qualitative Study: African-American Girls' Perceptions of Why Physical Activity Declines in High School.

African-American adolescent girls are less physically active than any other U.S. racial/ethnic group. The school environment may contribute to physical inactivity in this group. The purpose of this study was to explore African-American girls' perceptions offactors that contribute to girls being less physically active in high school. Interpretative Phenomenological Analysis (IPA) was used to identify individual perceptions of girls regarding physical activity. This resulted in four themes: personal appearances, scheduling/timing of classes, environmental/facilities issues, and lack of variety of activities in PE classes. Thefindings from this study indicated that African-American adolescent girls did not feel the physical or social school environment encouraged or supported them to be physically active.

Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

BACKGROUND: Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. METHODS/DESIGN: Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. DISCUSSION: Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations. TRIAL REGISTRATION: NCT01809431.

Recruitment and retention strategies for a community-based weight management study for multi-ethnic elementary school children and their parents.

This article describes successful recruitment and retention strategies for a community-based weight management study in two school districts in North Carolina. Recruitment and retention on both district and school levels and child and parent levels are discussed. A total of 358 children and 358 parents from eight schools in rural North Carolina participated in a randomized controlled trial to test the effectiveness of a nutrition and exercise education, coping skills training, and exercise intervention. Recruitment and retention at the district and school level included meeting with superintendents and receiving a proper introduction to school principals and consistently clear communication throughout the study. At the school level, relationships were developed with the principal and other key personnel to keep lines of communication open during the study. Recruitment and retention strategies at the child and parent level included allowing adequate time for questions during consent and assent and providing a free nutrition and exercise program, a light meal, homework assistance, child care for other children who came to the program, and transportation vouchers if needed. Successful recruitment and retention strategies at the district and school levels and child and parent levels are important for conducting longitudinal community-based studies.

Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study.

BACKGROUND: Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. METHODS/DESIGN: The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy.A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m² have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I), 9 months of continued monthly contact (Phase II) and then 6 months (follow-up) on their own. Safety endpoints include adverse event reporting. Intention-to-treat analysis will be applied to all data. DISCUSSION: Findings from this trial may lead to an effective intervention to assist children and parents to work together to improve nutrition and exercise patterns by making small lifestyle pattern changes. TRIAL REGISTRATION: NCT01378806.