Gender,Racial, and Ethnic Disclosure in NIH K-Award Funded Diabetes and Obesity Clinical Trials∗

In 1993, the National Institutes of Health (NIH) passed The Revitalization Act (Subtitle B) which mandated that all NIH funded clinical trials have “appropriate representation” of minority and women subjects. Our aim was to evaluate the impact of the mandate by examining the reporting and inclusion of minority and female subjects into NIH K-Award funded clinical trials, addressing the minority predominant diagnoses of diabetes and clinical obesity. Using the CRISP search engine and PUBMED, we selected publications published by the National Institute on Aging (NIA) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K-grant recipients during 1989–2004, associated with all the diabetes and obesity clinical trials. Studies were stratified into three timeline categories (1989–1993, pre-mandate; 1993–1996, post-mandate, and 1997–present, well past mandate) to evaluate trends in the recruiting of minorities and women before, during, and after the passing of the Revitalization Act. Of the 165 papers, only 37% disclosed race, a number that did not improve over time (p = .15), whereas 92% disclosed gender. Clinical trials that focused on females increased across the 3 timeframes (p < .001) for diabetes studies but not obesity studies. Overall, disclosure of race declined over the 3 timeframes whereas individually, the disclosure of African Americans improved.     

Insights and recommendations for recruitment and retention of low socio-economic parents with overweight children

Low socio-economic groups are typically difficult to recruit and retain in health research, which makes it difficult to investigate their health-related beliefs and behaviours. Low socio-economic parents with overweight or obese children took part in a longitudinal qualitative child obesity study over 12?months. These parents’ views of and recommendations for appropriate recruitment and retention strategies are reported. Their interpretations and suggestions are considered in the light of the difficulties that were experienced in designing the study to meet their needs and the approaches that were found to be more effective in achieving and maintaining a viable study cohort. Relevant aspects of recruitment included remuneration, recruitment locations and the use of appropriate weight-related terminology. Retention factors included protocol flexibility, ongoing remuneration and learning opportunities. Barriers to ongoing participation are also discussed. Suggestions are provided for future qualitative research with low socio-economic families.     

Testosterone deficiency and the metabolic syndrome

Evidence is presented to link components of the metabolic syndrome to testosterone deficiency and obesity. Testosterone deficiency in hypogonadism or testosterone deprivation in normo-gonadotropic men increases fat mass as well as fasting insulin levels. Testosterone supplementation (TS) in a dose dependent manner, increase lean body mass (LBM), reduces fat mass, body mass index (BMI) and waist hip ratio in both young and elderly hypogonadal men. A negative association between T and insulin resistance as well as impaired glucose intolerance has been demonstrated and in type 2 diabetic men TS improves metabolic parameters. TS improves most components of the metabolic syndrome and also reduces inflammatory cytokines.     

Bone mineral density in men with and without the metabolic syndrome

The objective of this study was to measure bone mineral density (BMD) in middle-aged men with and without the metabolic syndrome according to the International diabetes federation (IDF) definition from 2005. We studied 80 men (mean age: 51.9 ± 9.0 y, mean body mass index (BMI): 32.0 ± 1.7 kg/m²) with and 92 men without the metabolic syndrome (mean age: 52.6 ± 15.1 y, mean BMI: 24.9 ± 2.8 kg/m²). Height (cm), weight (kg), waist circumference (cm) and blood pressure were measured. Fasting plasma glucose (FPG) and blood lipids were determined. BMD at the lumbar spine and total hip was measured by dual X-ray absorptiometry on a Hologic QDR 4500 bone densitometer. In men around 59.3% had a waist circumference > 94 cm (abdominal obesity). Among them 58.7% showed abnormal BP values. Around 30.7% had FPG ≥ 5.6 mmol/L and 22.7% had low high density lipoprotein (HDL)-cholesterol and 36.6% had hypertriglyceridemia. In men with the metabolic syndrome, mean lumbar spine BMD was 0.986 ± 0.210 g/cm² and total hip BMD – 1.012 ± 0.209 g/cm². The corresponding values in men without this syndrome were 0.934 ± 0.179 g/cm² and 0.894 ± 0.189 g/cm², respectively. The inter-group BMD difference reached statistical significance only at the hip (p = 0.039). Respectively, the prevalence of osteoporosis at the central sites was significantly higher in men without the metabolic syndrome (MS) (13.2 versus 20.8%, p = 0.03). Our data confirmed the trend for higher BMD in the studied men with the metabolic syndrome.     

Fat government,thin populace? Is the growth of obesity prevalence lower in more generous welfare states?

In the last few decades, the prevalence of obesity has expanded rapidly and now constitutes a grave public health concern across the developed world. Obesity is negatively associated with, among other factors, education and healthcare quality, which are factors that governments can and do influence through welfare policies. This study investigated to what extent the change in the prevalence of obesity is lower in more generous welfare states. Based on pooled time series cross‐section regressions for 15 developed countries over 25 years, we found that the more generous are transfer payments, health policy and education policy, the lower is the increase of obesity prevalence. These findings have important implications for public policy formation and the public health and welfare state literatures.     

A Literature Review of the Experiences of African American and Caucasian TANF Women Transitioning from Welfare to Work

This study examined African American women's perceptions of their adolescent children's well-being since gaining employment. This study departed from other studies that focused on the entire Temporary Assistance to Needy Families (TANF) population and/or compared subgroups within the population. In this study, the sample population is composed of all African American mothers and all of the mothers receive Temporary Assistance to Needy Families benefits and have gained employment. The study explored the relationship between adult supervision of adolescent children that resided in distressed communities and adolescent overall well-being as measured by academic well-being, emotional well-being, and social well-being.     

Correlation between sex hormone levels and obesity in the elderly male

Objective: To investigate the levels of sex hormones and androgen receptor (AR) in elderly male patients and to explore a possible correlation with obesity. Methods: The cross-sectional study included 314 Elderly males (age ≥ 65 year). Of these subjects, 104 were healthy (age range 65–92 year; mean 71.38 ± 5.154 year), 74 were obese (65–87 year; 71.32 ± 4.74 year), and 111 were overweight (65–85 year; 71.43 ± 5.03 year). The following parameters were measured: total testosterone (TT), free testosterone, dehydroepiandrosterone sulfate, sex hormone-binding globulin (SHBG), estradiol (E2), luteinizing hormone, follicle-stimulating hormone and AR. Results: (i) The levels of TT and SHBG in the obesity group were significantly lower than those in non-obese subjects. (ii) Body mass index (BMI) negatively correlated with TT and SHBG. (iii) Multiple regression analysis revealed that TT (β: ?0.230; p = 0.045) and SHBG (β: ?0.163; p = 0.02) were statistically correlated with BMI. Conclusion: Testosterone levels in the obese population were significantly lower than in the non-obese population and there is a significant association between testosterone levels and the extent of obesity.     

Design of an educational strategy based on Intervention Mapping for nutritional health promotion in Child Care Centers

Early childhood is a critical period for instilling healthy habits to prevent overweight and obesity. This paper describes the development of an educational intervention for the promotion of healthy eating and physical activity among two-to-four-year-old children in public child care centers (CCCs) in Mexico City. Following the Intervention Mapping (IM) protocol, we developed the Bright Futures multidisciplinary intervention. First, a formative research process to identify the personal and environmental determinants of childhood overweight and obesity, behavioral outcomes and performance objectives was conducted. Then, a matrix of change objectives by intersecting the performance objectives with the determinants was integrated. Bright Futures lasted six months and included 24 weekly sessions, each composed of five phases: warm-up, theory, active movements, relaxation, and hydration. Ad hoc interactive teaching materials focused on recreational activities, and formulated plans for the adoption, implementation and process/impact evaluation of the intervention was developed. IM successfully guided the design of a theory-driven and evidence-based intervention for children in CCCs within a socio-ecological and participatory planning framework. This is one of the first studies in Mexico to use IM in the context of CCCs.     

The imbalance of sex-hormones related to depressive symptoms in obese men

Obese men may present hypogonadothrofic hypogonadism, mainly related to higher insulinemia and aromatase activity. Our objectives were to evaluate the relationship of sex-hormones profiles and frequency of depressive symptoms in 43 obese men, in a cross-sectional study. They had 19–60 years, and body mass index 30–50?kg/m². LH, total and free testosterone (TT and FT), estradiol (E₂), sex hormone binding globulin, estradiol/total testosterone ratio (E₂/T) were analyzed. Depressive symptoms were evaluated by “beck depression inventory” (BDI), and significant depression was considered if BDI?≥?16.Thirty-four (80%) presented low TT levels, but only 4 (14%) had low free testosterone and hypogonadism symptoms; 12 of 43 (28%) presented increased E₂. Forty five (56%) presented depressive symptoms, but 16 (28% of the 45) had significant depression. BDI correlated positively with E₂ (r?=?0.407; p?=?0.001) and E₂/T (r?=?0.473; p?=?0.001), but not TT or FT. Patients with significant depressive showed higher levels of estradiol (136?±?48 versus 103?±?48?pg/ml, p?=?0.02) and E₂/T (16.0?±?9.9 versus 9.8?±?4.6; p?=?0.002) (mean?±?SD).In conclusion, obese men may present relatively excess of estradiol and deficiency in testosterone, leading to an imbalance between these two hormones. The greater this imbalance, the more depressive symptoms had our patients.