In this trial, overweight and obese adolescents were assigned to a 1-year intervention to decrease consumption of sugar-sweetened beverages or not; there was 1 year of additional follow-up without ...intervention. BMI increased less in the intervention group at 1 year but not at 2 years.
The consumption of sugar-sweetened beverages among adolescents
1
has increased in tandem with the prevalence of pediatric obesity in the United States,
2
suggesting a causal relationship. At present, a substantial proportion of high-school students habitually consume sugar-sweetened beverages, including carbonated soda, sports drinks, energy drinks, and highly sweetened coffees and teas.
3
Sugar-sweetened beverages are the leading source of added sugar in the diet of a wide range of racial and ethnic groups.
4
According to nationally representative data, overweight and obese adolescents obtain more than 300 kcal per day from these products, amounting to an average of 15% of their total daily . . .
The role of maternal immune responses in tolerance induction is poorly understood. To study whether maternal allergen sensitization affects offspring susceptibility to food allergy, we epicutaneously ...sensitized female mice with ovalbumin (OVA) followed by epicutaneous sensitization and oral challenge of their offspring with OVA. Maternal OVA sensitization prevented food anaphylaxis, OVA-specific IgE production, and intestinal mast cell expansion in offspring. This protection was mediated by neonatal crystallizable fragment receptor (FcRn)-dependent transfer of maternal IgG and OVA immune complexes (IgG-IC) via breast milk and induction of allergen-specific regulatory T (T reg) cells in offspring. Breastfeeding by OVA-sensitized mothers or maternal supplementation with IgG-IC was sufficient to induce neonatal tolerance. FcRn-dependent antigen presentation by CD11c
dendritic cells (DCs) in offspring was required for oral tolerance. Human breast milk containing OVA-IgG-IC induced tolerance in humanized FcRn mice. Collectively, we demonstrate that interactions of maternal IgG-IC and offspring FcRn are critical for induction of T reg cell responses and control of food-specific tolerance in neonates.
The role of sugar-sweetened beverages (SSBs) in promoting obesity is controversial. Observational data link SSB consumption with excessive weight gain; however, randomized, controlled trials are ...lacking and necessary to resolve the debate. We conducted a pilot study to examine the effect of decreasing SSB consumption on body weight.
We randomly assigned 103 adolescents aged 13 to 18 years who regularly consumed SSBs to intervention and control groups. The intervention, 25 weeks in duration, relied largely on home deliveries of noncaloric beverages to displace SSBs and thereby decrease consumption. Change in SSB consumption was the main process measure, and change in body mass index (BMI) was the primary end point.
All of the randomly assigned subjects completed the study. Consumption of SSBs decreased by 82% in the intervention group and did not change in the control group. Change in BMI, adjusted for gender and age, was 0.07 +/- 0.14 kg/m2 (mean +/- SE) for the intervention group and 0.21 +/- 0.15 kg/m2 for the control group. The net difference, -0.14 +/- 0.21 kg/m2, was not significant overall. However, baseline BMI was a significant effect modifier. Among the subjects in the upper baseline-BMI tertile, BMI change differed significantly between the intervention (-0.63 +/- 0.23 kg/m2) and control (+0.12 +/- 0.26 kg/m2) groups, a net effect of -0.75 +/- 0.34 kg/m2. The interaction between weight change and baseline BMI was not attributable to baseline consumption of SSBs.
A simple environmental intervention almost completely eliminated SSB consumption in a diverse group of adolescents. The beneficial effect on body weight of reducing SSB consumption increased with increasing baseline body weight, offering additional support for American Academy of Pediatrics guidelines to limit SSB consumption.
One of the most difficult aspects of conducting clinical research is the ability to successfully recruit participants. Pediatric clinical research presents unique recruitment challenges that relate ...to the need for parental consent on behalf of a minor, child assent, and school attendance. Yet, this has been less well studied. We conducted a survey of investigators performing human subjects research in a single large academic pediatric hospital to better understand characteristics of studies with successful recruitment.
We conducted a web-based survey from September 2011 to December 2011 of all principal investigators with an Institutional Review Board approved human subjects protocol at Boston Children's Hospital, a pediatric Academic Medical Center. The survey captured various characteristics of the protocols including study design, staffing, resources, and investigator experience and training as well as respondents' perceived barriers and facilitators to recruitment. We used chi square tests and Mantel-Haenszel test for linear trend to examine the relationship between selected predictor variables and the binary outcome of successful vs. unsuccessful recruitment and multivariable logistic regression analyses to examine the simultaneous influence of potential predictors on each outcome.
Among the 349 eligible investigators, 52% responded to the survey, and 181 with valid data were included in the analyses. Two-thirds of the 87 protocols closed to enrollment reached 80% or more of their target enrollment, whereas, only one-third of the 94 protocols actively recruiting were meeting 80% of their target. Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols. Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods. Other potentially modifiable factors such as number of study visits, study duration and investigator experience were suggestive of being meaningfully related to recruitment.
Recruiting in person may promote reaching an acceptable target enrollment in pediatric as well as adult clinical research. Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.
Adolescent severe obesity is a prevalent, chronic, and serious disease with few effective and safe treatment options. To address this issue, a National Institutes of Health-sponsored workshop ...entitled "Developing Precision Medicine Approaches to the Treatment of Severe Obesity in Adolescents," was convened, bringing together a multidisciplinary group of experts to review the current state of the science and identify (1) what is known regarding the epidemiology and biopsychosocial determinants of severe obesity in adolescents, (2) what is known regarding effectiveness of treatments for severe obesity in adolescents and predictors of response, and (3) gaps and opportunities for future research to develop more effective and targeted treatments for adolescents with severe obesity. Major topical areas discussed at the workshop included: appropriate BMI metrics, valid measures of phenotypes and predictors, mechanisms associated with the development of severe obesity, novel treatments informed by biologically and psychosocially plausible mechanisms, biopsychosocial phenotypes predicting treatment response, standardization of outcome measures and results reporting in research, and improving clinical care. Substantial gaps in knowledge were identified regarding the basic behavioral, psychosocial, and biological mechanisms driving the development of severe obesity and the influence of these factors on treatment response. Additional exploratory and observational studies are needed to better understand the heterogeneous etiology of severe obesity and explain the high degree of variability observed with interventions. Tailored treatment strategies that may be developed by achieving a better understanding of individual differences in genetic endowment, clinical, metabolic, psychological, and behavioral phenotypes, and response to environmental exposures need to be tested. It is anticipated that these recommendations for future research, including strategies to enhance methodological rigor, will advance precision medicine approaches to treat severe obesity in adolescents more effectively.
Preventing regain of lost weight is the most difficult challenge in the treatment of obesity. The National Institute of Diabetes and Digestive and Kidney Diseases convened a workshop, “The Physiology ...of the Weight‐Reduced State,” on June 3 to 4, 2019, in order to explore the physiologic mechanisms of appetitive and metabolic adaptation that take place in the weight‐reduced state and counter an individual’s efforts to maintain reduced weight following weight loss.
Psychological and behavioral correlates are considered important in the development and persistence of obesity in both adults and youth. This study aimed to identify such features in youth with ...severe obesity (BMI ≥ 120% of 95
percentile of sex-specific BMI-for-age) compared to those with overweight or non-severe obesity.
Youth with BMI ≥ 85
percentile were invited to participate in a prospective research registry where data was collected on attributes such as family characteristics, eating behaviors, dietary intake, physical activity, perception of health and mental well-being, and cardiometabolic parameters.
In a racially/ethnically diverse cohort of 105 youth (65% female, median age 16.1 years, range 4.62-25.5), 51% had severe obesity. The body fat percent increased with the higher levels of obesity. There were no differences in the self-reported frequency of intake of sugar sweetened beverages or fresh produce across the weight categories. However, the participants with severe obesity reported higher levels of emotional eating and eating when bored (p = 0.022), levels of stress (p = 0.013), engaged in fewer sports or organized activities (p = 0.044), and had suboptimal perception of health (p = 0.053). Asthma, depression and obstructive sleep apnea were more frequently reported in youth with severe obesity. The presence of abnormal HDL-C, HOMA-IR, hs-CRP and multiple cardiometabolic risk factors were more common among youth with severe obesity.
Youth with severe obesity have identifiable differences in psychosocial and behavioral attributes that can be used to develop targeted intervention strategies to improve their health.
Objectives
The use of mobile technology for smoking cessation holds promise for adolescents, who do not typically access traditional treatments, but most are not grounded in theory or mechanism. ...Operant conditioning theory suggests an addictive smoking loop is formed between nicotine use and affective states, leading to habitual cue-induced craving and automatic behavior; mindfulness training may bring automated smoking behavior into awareness, so smokers may work mindfully with cravings. Mindfulness training delivered via smartphone technology therefore has potential to help adolescent smokers break this addictive loop and quit smoking. This pair-matched cluster-randomized controlled school-based pilot study evaluated program feasibility and preliminary smoking outcomes in relation to intervention engagement.
Methods
Six high schools were pair-matched and randomly assigned to one of three interventions: (1) mindfulness training delivered via mobile smoking cessation application (Craving to Quit, C2Q), (2) NCI’s QuitSTART smoking cessation application (NCI), and (3) written cessation materials (Materials). Adolescents (
n
= 146) smoking 5 or more cigarettes per day were recruited. Interventions were implemented over 4 weeks and study assessments were collected at baseline and 3- and 6-month follow-up periods, including self-reported 7-day point prevalence abstinence, program usage, smoking-related measures, and psychosocial factors.
Results
Overall, cotinine-validated abstinence at 6 months was 15.8% and was similar between conditions. Odds of abstinence increased with each quartile increase in app/materials use with no significant differences between conditions (OR = 1.60 (C2Q), 1.66 (Materials), and 2.69 (NCI)). Of participants still smoking at 6 months, for each quartile increase in engagement, the number of cigarettes smoked in the previous 7 days showed a significantly greater decline in the C2Q condition (− 5.71) compared with the Materials (− 0.95) and NCI (+ 7.73) condition (
p
= 0.02 for differences between conditions).
Conclusions
Cotinine-validated abstinence was similar between intervention conditions and tended to increase with greater engagement in each condition. Greater C2Q app engagement among continuing smokers was associated with a significantly greater decline in number of cigarettes smoked compared with the other conditions. The Craving to Quit (C2Q) mobile smoking cessation application with mindfulness training was feasible to use and has promise in assisting adolescents to quit or decrease cigarette smoking.
Trial Registration
Developing a Smartphone App with Mindfulness Training for Teen Smoking Cessation:
ClinicalTrials.gov
Identifier: NCT02218281
Less than 45% of U.S. children meet the 60 min·d(-1) physical activity (PA) guideline. Structured after-school PA programing is one approach to help increase activity levels. This study aimed to ...evaluate the feasibility and short-term impact of a supervised after-school PA and nutrition education program on activity levels.
Forty-two 3rd-5th graders from an inner-city school in Boston, MA were randomly assigned to a 10-wk after-school program of either: 1) weekly nutrition education, or 2) weekly nutrition education plus supervised PA 3 d·wk(-1) at a community-based center. At baseline and follow-up, PA was measured using accelerometry and fitness (VO2max) was estimated using the PACER 15-m shuttle run. Additional measures obtained were non-fasting finger stick total cholesterol (TC) and glucose levels, waist circumference (WC), body mass index (BMI), percent body fat (%BF), and blood pressure (BP). Values are presented as mean±SE, unless noted otherwise.
Thirty-six participants completed the study (mean±SD; age 9.7±0.9 years). Participants attended >80% of the sessions. After adjusting for accelerometer wear time and other design factors, light and moderate-to-vigorous PA (MVPA) increased in the nutrition+PA group (+21.5±14.5 and +8.6±8.0 min·d(-1), respectively) and decreased in the nutrition only group (-35.2±16.3 and -16.0±9.0 min·d(-1), respectively); mean difference between groups of 56.8±21.7 min·d(-1) (light PA, p = 0.01) and 24.5±12.0 min·d(-1) (MVPA, p = 0.04). Time spent in sedentary behaviors declined in the nutrition+PA group (-14.8±20.7 min·d(-1)) and increased in the nutrition only group (+55.4±23.2 min·d(-1)); mean difference between groups of -70.2±30.9 min·d(-1) (p = 0.02). Neither group showed changes in TC, BP, WC, %BF, BMI percentile, or fitness (p>0.05).
The supervised afterschool community-based nutrition and PA program was well accepted and had high attendance. The changes in light PA and MVPA has potential to promote weight maintenance in inner-city elementary school children, however longer term studies with larger samples are needed.
ClinicalTrials.gov NCT01104038.