Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes.

BACKGROUND: One-third of US adults, 86 million people, have prediabetes. Two-thirds of adults are overweight or obese and at risk for diabetes. Effective and affordable interventions are needed that can reach these 86 million, and others at high risk, to reduce their progression to diagnosed diabetes. OBJECTIVE: The aim was to evaluate the effectiveness of a fully automated algorithm-driven behavioral intervention for diabetes prevention, Alive-PD, delivered via the Web, Internet, mobile phone, and automated phone calls. METHODS: Alive-PD provided tailored behavioral support for improvements in physical activity, eating habits, and factors such as weight loss, stress, and sleep. Weekly emails suggested small-step goals and linked to an individual Web page with tools for tracking, coaching, social support through virtual teams, competition, and health information. A mobile phone app and automated phone calls provided further support. The trial randomly assigned 339 persons to the Alive-PD intervention (n=163) or a 6-month wait-list usual-care control group (n=176). Participants were eligible if either fasting glucose or glycated hemoglobin A1c (HbA1c) was in the prediabetic range. Primary outcome measures were changes in fasting glucose and HbA1c at 6 months. Secondary outcome measures included clinic-measured changes in body weight, body mass index (BMI), waist circumference, triglyceride/high-density lipoprotein cholesterol (TG/HDL) ratio, and Framingham diabetes risk score. Analysis was by intention-to-treat. RESULTS: Participants' mean age was 55 (SD 8.9) years, mean BMI was 31.2 (SD 4.4) kg/m(2), and 68.7% (233/339) were male. Mean fasting glucose was in the prediabetic range (mean 109.9, SD 8.4 mg/dL), whereas the mean HbA1c was 5.6% (SD 0.3), in the normal range. In intention-to-treat analyses, Alive-PD participants achieved significantly greater reductions than controls in fasting glucose (mean -7.36 mg/dL, 95% CI -7.85 to -6.87 vs mean -2.19, 95% CI -2.64 to -1.73, P<.001), HbA1c (mean -0.26%, 95% CI -0.27 to -0.24 vs mean -0.18%, 95% CI -0.19 to -0.16, P<.001), and body weight (mean -3.26 kg, 95% CI -3.26 to -3.25 vs mean -1.26 kg, 95% CI -1.27 to -1.26, P<.001). Reductions in BMI, waist circumference, and TG/HDL were also significantly greater in Alive-PD participants than in the control group. At 6 months, the Alive-PD group reduced their Framingham 8-year diabetes risk from 16% to 11%, significantly more than the control group (P<.001). Participation and retention was good; intervention participants interacted with the program a median of 17 (IQR 14) of 24 weeks and 71.1% (116/163) were still interacting with the program in month 6. CONCLUSIONS: Alive-PD improved glycemic control, body weight, BMI, waist circumference, TG/HDL ratio, and diabetes risk. As a fully automated system, the program has high potential for scalability and could potentially reach many of the 86 million US adults who have prediabetes as well as other at-risk groups. TRIAL REGISTRATION: Clinicaltrials.gov NCT01479062; https://clinicaltrials.gov/ct2/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6bt4V20NR).

Accuracy of multisensor activity monitors in normal versus high BMI African American children.

BACKGROUND: Overweight children show different movement patterns during walking than normal-weight children, suggesting the accuracy of multisensory activity monitors may differ in these groups. METHODS: Eleven normal and 15 high BMI African American children walked at 2, 4, 5, and 6 km/h on a treadmill wearing the Intelligent Device for Energy Expenditure and Activity (IDEEA) and SenseWear (SW). Accuracy was determined using indirect calorimetry and manually counted steps as references. RESULTS: For IDEEA, no significant differences in accuracy were observed between BMI groups for energy expenditure (EE), but differences were significant by speed (+15% at 2 km/h to -10% at 6 km/h). For SW, EE accuracy was significantly different for high (+21%) versus normal BMI girls (-13%) at 2 km/h. For high BMI girls, EE was overestimated at low speed and underestimated at higher speeds. Underestimations in steps did not differ by BMI group at 4 to 6 km/h, but were significantly larger at 2 km/h than at the other speeds for all groups with IDEEA, and for normal BMI children with SW. CONCLUSIONS: Similar accuracies during walking may be expected in normal and overweight children using IDEEA and SW. Both monitors showed small errors for steps provided speed exceeded 2 km/h.

Relationship of insulin resistance to psychobehavioral characteristics of overweight and obese African American children.

OBJECTIVES: The objective of this study was to evaluate the relationships of insulin resistance to positive as well as negative dimensions of the child's emotions, behavior and personality (hereafter referred to as "psychobehavioral characteristics") in a convenience sample of inner-city, overweight and obese, African American children. METHODS: A secondary analysis was performed on a sample of 127 children ages 9-12 yr old who were participating in a community-based, Type 2 diabetes prevention program. Psychobehavioral characteristics of children were assessed using both child and parent ratings derived from the Behavioral Assessment for Children, 2nd edition (BASC-2). Body fatness was evaluated using anthropometric techniques, and insulin resistance (HOMA-IR) was calculated from fasting glucose and insulin concentrations. Hierarchical multiple linear regression models were employed with BASC scales as dependent variables and HOMA-IR as the independent variable of interest. RESULTS: After adjusting for child age, pubertal stage, gender, family socioeconomic index, and intervention group assignment, child HOMA-IR was related at p<0.05 to less favorable scores for parent-report of behavioral symptoms and externalizing problems composites, and to content scales for bullying and negative emotionality. Additionally, child HOMA-IR was related at p<0.01 to less favorable scores for child-report inattention/hyperactivity composite. Body fatness suppressed the unfavorable relationship between HOMA-IR and these and other psychobehavioral characteristics as the degree of significance was higher following adjustment for body fatness in this cohort. CONCLUSION: More than one psychobehavioral characteristic were associated with body fatness and insulin resistance in the overweight children of this study. Whether the associations are due to several, or only one, of these psychobehavioral characteristics could not be determined. A much larger and future study will be needed to determine which, if any, of these psychobehavioral characteristics are independently associated with insulin resistance in overweight children.

Accelerometer response to physical activity intensity in normal-weight versus overweight African American children.

BACKGROUND: Different movement efficiency in overweight children may affect accelerometer output data. The purpose was to investigate the ability of accelerometers to assess physical activity intensity and number of steps in normal-weight compared with overweight children. METHODS: Eleven normal-weight and 14 overweight African American children walked at 2, 4, 5, and 6 km/h on a treadmill wearing Lifecorder, ActiGraph, RT3, and Biotrainer. Oxygen uptake was measured and steps manually counted. Fat free mass (FFM) was assessed from bioelectrical impedance analysis. Accelerometer counts and the individual linear regression lines of accelerometer counts versus VO(2)/FFM were evaluated, together with steps recorded by Lifecorder and Actigraph. RESULTS: Correlations between accelerometer counts and VO(2)/FFM for all monitors were r ≥ .95 (P < .01). The accelerometer counts and their relationship to VO(2)/FFM did not generally differ significantly by body weight status. Lifecorder and Actigraph underestimated steps at 4, 5, and 6 km/h by less than 9%, but the error was up to -95% at 2 km/h. CONCLUSIONS: All 4 accelerometers show high ability to assess physical activity intensity, and can be used to compare physical activity between normal-weight and overweight children. The Lifecorder and the ActiGraph showed high accuracy in assessing steps, providing speed of movement exceeded 2 km/h.

Insulin resistance and self-perceived scholastic competence in inner-city, overweight and obese, African American children.

PURPOSE: scholastic competence is a predictor of future achievement, yet there is little research about health factors that influence the development of self-perceived scholastic competence (SPSC). This study examined the relationship of insulin resistance and body fatness with SPSC in low-income, overweight and obese, African American children. METHODS: data were analyzed from a convenience sample of 9-10years old African American children (89 boys and 113 girls) enrolled in a type 2 diabetes prevention study. Health variables analyzed for their influence on SPSC (Harter scale) included insulin resistance (Homeostatic model-derived insulin sensitivity, HOMA-IR) and body fatness (% body fat). Adjustments were made for self-esteem (Global Self Worth). RESULTS: there was a significant gender by insulin resistance interaction effect on the child's SPSC, so separate regression models were developed for each gender. In boys, neither insulin resistance nor body fatness was related to SPSC. In girls, however, insulin resistance was negatively related to SPSC scores, and the significance of the relationship increased further after adjusting for body fatness. Body fatness alone was not significantly related to SPSC in girls, but after adjusting for insulin resistance, body fatness was positively related to SPSC. Thus, insulin resistance and body fatness mutually suppressed SPSC in girls. CONCLUSION: high SPSC was associated with lower insulin resistance and, with insulin resistance held constant, with higher body fatness in girls but not in boys. These relationships were not influenced by self-esteem in these children.

Insulin resistance is improved in overweight African American boys but not in girls following a one-year multidisciplinary community intervention program.

AIM: To assess potential for effectiveness, in a non-randomized pilot study, of a community-based lifestyle intervention program to reduce the risk for type 2 diabetes mellitus in overweight African American (AA) children. RESEARCH DESIGN: Sample of 165 9-11 year-old AA children with body mass index (BMI) >85th percentile were recruited from local recreational sites, schools and churches. Participants self-selected to attend one of two study sites, blinded to the specifics of the intervention administered at each site. The intervention group received a programmatically focused 2-week summer camp with once-a-week community-based exercise, nutrition, and behavioral modification sessions, and their families were invited to monthly nutrition educational sessions. Control group participants received a 2-week conventional YMCA summer camp and their families received nutrition and physical activity education material through the mail. Baseline assessment and 1-year follow-up were conducted in collaboration with the YMCA of the East Bay and Children's Hospital Oakland, CA, with 109 participants (66%) having pre/post data. RESULTS: After one-year of intervention, treatment boys showed a drop in homeostasis model assessment of insulin-resistance (HOMA-IR) (-0.58 vs +0.17; p = 0.003), fasting glucose (Gf, mg/dL) (mean change: -2.9 vs +0.4; p = 0.126) and fasting insulin (If, microU/mL) (-2.2 vs +0.7; p = 0.009) compared to control boys, after accounting for baseline differences and pubertal stage of the child. Treatment girls had similar changes to the control girls in HOMA-IR (-0.02 vs -0.17; p = 0.66), Gr (-0.3 vs +1.4; p = 0.29) and If (+0.03 vs +0.17; p = 0.57). CONCLUSION: After one year, this community-based intervention program effectively improved insulin resistance and thus reduced risk for type 2 diabetes mellitus in overweight AA boys but did not change the risk in girls compared to control children.

Taking Action Together: a YMCA-based protocol to prevent type-2 diabetes in high-BMI inner-city African American children.

BACKGROUND: Associated with a tripling in obesity since 1970, type 2 diabetes mellitus (T2DM) in children has risen 9-10 fold. There is a critical need of protocols for trials to prevent T2DM in children. METHODS/DESIGN: This protocol includes the theory, development, evaluation components and lessons learned from a novel YMCA-based T2DM prevention intervention designed specifically for high-BMI African American children from disadvantaged, inner-city neighborhoods of Oakland, California. The intervention was developed on the basis of: review of epidemiological and intervention studies of pediatric T2DM; a conceptual theory (social cognitive); a comprehensive examination of health promotion curricula designed for children; consultation with research, clinical experts and practitioners and; input from community partners. The intervention, Taking Action Together, included culturally sensitive and age-appropriate programming on: healthy eating; increasing physical activity and, improving self esteem. DISCUSSION: Evaluations completed to date suggest that Taking Action Together may be an effective intervention, and results warrant an expanded evaluation effort. This protocol could be used in other community settings to reduce the risk of children developing T2DM and related health consequences. TRIAL REGISTRATION: ClinicalTrials.gov NCT01039116.

Macronutrient intakes and cardio metabolic risk factors in high BMI African American children.

BACKGROUND: The aim of this study was to evaluate the relationship between intakes of energy-providing macronutrients, and markers of cardio metabolic risk factors in high BMI African American (AA) children. METHODS: A cross sectional analysis of a sample of 9-11 year old children (n = 80) with BMI greater then the 85th percentile. Fasting hematological and biochemical measurements, and blood pressure were measured as selected markers of cardio metabolic risk factors and their relationships to dietary intakes determined. RESULTS: After adjusting for gender, pubertal stage and waist circumference (WC), multivariate regression analysis showed that higher total energy intakes (when unadjusted for source of energy) were associated with higher plasma concentrations of intermediate density lipoprotein cholesterol (IDL-C) and very low density lipoprotein cholesterol (VLDL-C). Higher intakes of carbohydrate energy (fat and protein held constant) were associated with higher IDL-C, VLDL-C, triglycerides (TG) and homeostasis model assessment of insulin resistance (HOMA-IR). Higher intakes of fat (carbohydrate and protein held constant), however, were associated with lower IDL-C; and higher protein intakes (fat and carbohydrate held constant) were associated with lower HOMA-IR. CONCLUSION: The specific macronutrients that contribute energy are significantly associated with a wide range of cardio metabolic risk factors in high BMI AA children. Increases in carbohydrate energy were associated with undesirable effects including increases in several classes of plasma lipids and HOMA-IR. Increases in protein energy were associated with the desirable effect of reduced HOMA-IR, and fat energy intakes were associated with the desirable effect of reduced IDL-C. This analysis suggests that the effect of increased energy on risk of developing cardio metabolic risk factors is influenced by the source of that energy.

Maternal diet and risk of childhood acute lymphoblastic leukemia.

OBJECTIVE: Intrauterine environmental factors, including maternal diet, may play an etiologic role in acute lymphoblastic leukemia (ALL), a common childhood cancer. Expanding on previous findings from phase 1 of the Northern California Childhood Leukemia Study (NCCLS), a population-based case-control study, we sought to further elucidate and replicate the relationships between maternal diet and ALL risk. METHODS: We matched 282 case-control sets of children (205 pairs and 77 triplets) from phases 1 and 2 of the NCCLS on sex, date of birth, mother's race, Hispanic racial/ethnic status, and county of residence at birth. We used an interviewer-administered food frequency questionnaire to obtain information on maternal dietary intake in the 12 months prior to pregnancy. RESULTS: Risk of ALL was inversely associated with maternal consumption of vegetable (adjusted odds ratio [AOR] = 0.65, 95% confidence interval [CI] 0.50, 0.84); protein sources (AOR = 0.55, 95% CI 0.32, 0.96); fruit (AOR = 0.81, 95% CI 0.65, 1.00); and legume food groups (AOR = 0.75, 95% CI 0.59, 0.95). The risk reduction was strongest for consumption of the protein sources and vegetable food groups, independent of the child's diet up to age 2 years, and consistent across phases 1 and 2 of data collection for vegetable consumption. CONCLUSIONS: These data suggest that it may be prudent for women to consume a diet rich in vegetables and adequate in protein prior to and during pregnancy as a possible means of reducing childhood ALL risk in their offspring.

Unusual clustering of coefficients of variation in published articles from a medical biochemistry department in India.

A simple statistical method is described to test whether data are consistent with minimum statistical variability expected in a biological experiment. The method is applied to data presented in data tables in a subset of 84 articles among more than 200 published by 3 investigators in a small medical biochemistry department at a major university in India and to 29 "control" articles selected by key word PubMed searches. Major conclusions include: 1) unusual clustering of coefficients of variation (CVs) was observed for data from the majority of articles analyzed that were published by the 3 investigators from 2000-2007; unusual clustering was not observed for data from any of their articles examined that were published between 1992 and 1999; and 2) among a group of 29 control articles retrieved by PubMed key word, title, or title/abstract searches, unusually clustered CVs were observed in 3 articles. Two of these articles were coauthored by 1 of the 3 investigators, and 1 was from the same university but a different department. We are unable to offer a statistical or biological explanation for the unusual clustering observed.

Baseline correlates of insulin resistance in inner city high-BMI African-American children.

To characterize the influence of diet-, physical activity-, and self-esteem-related factors on insulin resistance in 8- 10-year-old African-American (AA) children with BMI greater than the 85th percentile who were screened to participate in a community-based type 2 diabetes mellitus (T2DM) prevention trial. In 165 subjects, fasting glucose- and insulin-derived values for homeostasis model assessment of insulin resistance (HOMA-IR) assessed insulin resistance. Body fatness was calculated following bioelectrical impedance analysis, and fitness was measured using laps from a 20-m shuttle run. Child questionnaires assessed physical activity, dietary habits, and self-esteem. Pubertal staging was assessed using serum levels of sex hormones. Parent questionnaires assessed family demographics, family health, and family food and physical activity habits. Girls had significantly higher percent body fat but similar anthropometric measures compared with boys, whereas boys spent more time in high-intensity activities than girls. Scores for self-perceived behavior were higher for girls than for boys; and girls desired a more slender body. Girls had significantly higher insulin resistance (HOMA-IR), compared with boys (P < 0.01). Adjusting for age, sex, pubertal stage, socioeconomic index (SE index), and family history of diabetes, multivariate regression analysis showed that children with higher waist circumference (WC) (P < 0.001) and lower Harter's scholastic competence (SC) scale (P = 0.044) had higher insulin resistance. WC and selected self-esteem parameters predicted insulin resistance in high-BMI AA children. The risk of T2DM may be reduced in these children by targeting these factors.

Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study.

BACKGROUND: Dietary supplement use in the United States is prevalent and represents an important source of nutrition. However, little is known about individuals who routinely consume multiple dietary supplements. This study describes the dietary supplement usage patterns, health, and nutritional status of long-term multiple dietary supplement users, and where possible makes comparisons to non-users and multivitamin/mineral supplement users. METHODS: Using a cross-sectional study design, information was obtained by online questionnaires and physical examination (fasting blood, blood pressure, body weight) from a convenience sample of long-term users of multiple dietary supplements manufactured by Shaklee Corporation (Multiple Supp users, n = 278). Data for non-users (No Supp users, n = 602) and multivitamin/mineral supplement users (Single Supp users, n = 176) were obtained from the National Health and Nutrition Examination Survey (NHANES) 2001-2002 and NHANES III 1988-1994. Logistic regression methods were used to estimate odds ratios with 95% confidence intervals. RESULTS: Dietary supplements consumed on a daily basis by more than 50% of Multiple Supp users included a multivitamin/mineral, B-complex, vitamin C, carotenoids, vitamin E, calcium with vitamin D, omega-3 fatty acids, flavonoids, lecithin, alfalfa, coenzyme Q10 with resveratrol, glucosamine, and a herbal immune supplement. The majority of women also consumed gamma linolenic acid and a probiotic supplement, whereas men also consumed zinc, garlic, saw palmetto, and a soy protein supplement. Serum nutrient concentrations generally increased with increasing dietary supplement use. After adjustment for age, gender, income, education and body mass index, greater degree of supplement use was associated with more favorable concentrations of serum homocysteine, C-reactive protein, high-density lipoprotein cholesterol, and triglycerides, as well as lower risk of prevalent elevated blood pressure and diabetes. CONCLUSION: This group of long-term multiple dietary supplement users consumed a broad array of vitamin/mineral, herbal, and condition-specific dietary supplements on a daily basis. They were more likely to have optimal concentrations of chronic disease-related biomarkers, and less likely to have suboptimal blood nutrient concentrations, elevated blood pressure, and diabetes compared to non-users and multivitamin/mineral users. These findings should be confirmed by studying the dietary supplement usage patterns, health, and nutritional status of other groups of heavy users of dietary supplements.

Ethnic differences in bone mass of young women vary with method of assessment.

To examine ethnic differences in bone mass measured by calcaneus ultrasound (CUS) and dual energy X-ray absorptiometry (DXA), and to compare the two methodologies, CUS was performed in 904 healthy Asian, African American, Latina, and Caucasian women 20-26 yr old using the Lunar Achilles Plus ultrasonometer. CUS measurements (broadband ultrasound attenuation [BUA] and speed of sound [SOS]) were made following standard methodology (standard CUS) and repeated adjusting for foot size using shims (with-shim CUS). Areal bone mineral density (BMD) and estimated volumetric bone density (BMAD) at the spine, femoral neck, and whole body were determined using the Lunar DPX-IQ. African Americans had greater height- and weight-adjusted BUA than Caucasians, while Asians and African Americans had greater SOS than Caucasians and Latinas. Additionally, African Americans had greater height- and weight-adjusted BMD and BMAD than all other groups. CUS and DXA measurements correlated moderately (r = 0.2-0.5). With-shim CUS values were 0.9-7.8% lower than standard CUS values. In conclusion, African American women had greater DXA measurements than all others and greater CUS measurements than Caucasians. In contrast to DXA, CUS measurements in Asians and Latinas were not significantly lower than those in African Americans. Most notably, Asians had greater values for SOS than Caucasians and Latinas. Discrepancies in ethnic comparisons and modest correlations suggest that CUS and DXA methods may capture different bone qualities.