Rationale and design of a pilot study to evaluate the acceptability and effectiveness of a revised protein sparing modified fast (rPSMF) for severe obesity in a pediatric tertiary care weight management clinic.

Aggressive dietary interventions may provide an accessible treatment option for children and adolescents with severe obesity who are not successful with traditional lifestyle behavioral interventions or do not want or qualify for weight loss surgery. One such intensive dietary option is the protein sparing modified fast (PSMF). The PSMF involves minimal carbohydrate intake to induce ketosis, while maintaining adequate or high protein intake to minimize catabolism. The PSMF, under medical supervision, can be an effective and safe intervention for children and adolescents, yet the PSMF diet is not regularly used in the treatment of pediatric severe obesity. This paper describes the rationale and design for a pilot study to evaluate the acceptability and effectiveness of a revised PSMF (rPSMF) implemented as a weight loss treatment option for children and adolescents with severe obesity in a pediatric tertiary care weight management clinic. The primary aim of the study is to evaluate the acceptability of the rPSMF as assessed by adherence, satisfaction with the intervention, and participation rate using quantitative and qualitative methods. The secondary aim is to investigate the effectiveness of the rPSMF on improving a) anthropometric measures (weight, body mass index [BMI], BMI z-score); b) metabolic measures (lipid profile, glycosylated hemoglobin, liver function tests); and c) quality of life. Results of this study will provide guidance for the standardization of a pediatric rPSMF protocol in a clinic setting, delineate which factors improve or hinder adherence and weight loss and provide preliminary data for a multicenter randomized controlled trial. CLINICALTRIALSGOV IDENTIFIER: NCT03899311.

Weight loss and asthma: a systematic review.

Epidemiological studies first demonstrated the association between obesity and asthma and they have begun to provide additional evidence to support causality: a dose-effect relationship, consistency across studies (especially among women) and the correct temporal order (ie, obesity before asthma). To date, relatively few studies have addressed reversibility, an important but less frequently demonstrated epidemiological criterion of causality. Reversibility suggests that if excessive weight is a risk factor for asthma, then reducing body weight should decrease the prevalence of asthma, or at least decrease asthma related symptoms or health care utilisation. We performed a systematic review on weight loss and asthma, based on searches between January 1966 and January 2007 of both PubMed and the Cochrane Clinical Trial Database. Of the 15 relevant studies, asthma was the primary outcome in only five. Only one study was conducted in children. Regardless of the type of intervention (surgical vs medical), all 15 studies noted an improvement in at least one asthma outcome after weight loss. The improvement was noted across studies that differed in sample age, gender or country of origin. The heterogeneity of the interventions and outcomes precluded quantitative synthesis. We briefly review the role of specific factors (eg, gastro-oesophageal reflux) in the weight loss-asthma association, and potential directions for future research.

Airway hyperresponsiveness and body mass index: the Child Health and Environment Cohort Study in Hesse, Germany.

Increased body mass index has been linked to wheezing, a diagnosis of asthma, and morbidity. We investigated the association between body mass index (BMI), breastfeeding, and airway hyperresponsiveness (AHR) in 536 German schoolchildren. We analyzed consecutive surveys in 1994-1995 and 1997, conducted as part of the Child Health and Environment Cohort Study in Hesse, Germany. The questionnaire included questions adapted from the German version of the International Study of Asthma and Allergy in Childhood (ISAAC). A bronchial challenge test using 4.5% hypertonic saline was conducted during the 1997 survey. AHR was defined as a fall in forced expiratory volume in 1 sec (FEV(1)) of > or = 15%. Of 536 children who participated in the 1997 survey (median age, 10.3 years), 82 (15%) tested positive for AHR. In a multivariate analysis, there was no association between AHR determined at age 10 years and the highest quintile of BMI compared to the lowest quintile at age 4 years (odds ratio (OR), 1.4; 95% confidence interval (CI), 0.5-3.6), 7-8 years (OR, 0.6; 95% CI, 0.1-2.5), or 10 years (OR, 1.1; 95% CI, 0.2-4.3). Breastfeeding for 12 weeks or longer protected against AHR (OR, 0.4; 95% CI, 0.2-0.9). However, when children in the highest quintile of BMI at age 4 years had been breastfed for 8 weeks or less, the prevalence of AHR at age 10 years was significantly increased (27.7%, P = 0.01). In conclusion, our results demonstrate a protective effect of breastfeeding against AHR, and reinforce the need to encourage breastfeeding. Although there was no association between BMI and AHR, our finding of an interactive effect of high BMI and short breastfeeding on AHR suggests a complex etiological pathway that needs to be further explored.

Diagnosis of attention-deficit/hyperactivity disorder and use of psychotropic medication in very young children.

CONTEXT: Increases in diagnosis and treatment of attention-deficit/hyperactivity disorder (ADHD) have elicited public and professional concern. Research suggests that this trend warrants the inclusion of previously underdiagnosed children and adults. It is not clear whether this trend includes young children. OBJECTIVE: To identify patterns of diagnosis and treatment of ADHD in very young children over time. DESIGN: Descriptive study of Michigan Medicaid claims data. PATIENTS: Inclusion criteria included recorded ADHD diagnosis, continuous Medicaid eligibility during a 15-month period, and age 3 years or younger at the first date of service. MAIN OUTCOME MEASURES: Diagnoses of ADHD, conditions commonly comorbid with ADHD, other chronic health conditions, and injuries; treatments such as psychological services and psychotropic medication; and the number of ambulatory visits. RESULTS: We identified 223 children aged 3 years or younger diagnosed with ADHD. Many had conditions commonly comorbid with ADHD (44%), other chronic health conditions (41%), and injuries (40%). More than half received psychotropic medication (57%); fewer received psychological services (27%). Twenty-two different psychotropic medications were used. Patterns included more than 1 psychotropic medication (46%) in 30 combinations of simultaneous use and 44 combinations of sequential use. The mean number of ambulatory visits was 18. CONCLUSIONS: Children aged 3 years or younger had ADHD diagnosed and received markedly variable psychotropic medication regimens. Little information is available to guide these practices. The presence of comorbid conditions and injuries attests to these children's vulnerability. Resources must be identified that will enable physicians to better respond to the compelling needs of these children and their families.