Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial.

BACKGROUND: Current treatments for generalized anxiety disorder (GAD) often yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (eg, avoidance reinforcement learning). Mindfulness training (MT) has shown efficacy for anxiety; yet, widespread adoption has been limited, partly because of the difficulty in scaling in-person-based delivery. Digital therapeutics are emerging as potentially viable treatments; however, very few have been empirically validated. OBJECTIVE: The aim of this study is to test the efficacy and mechanism of an app-delivered MT that was designed to target a potential mechanism of anxiety (reinforcement learning), based on which previous studies have shown concern regarding feedback and the perpetuation of anxiety through negative reinforcement. METHODS: Individuals with GAD were recruited using social media advertisements and randomized during an in-person visit to receive treatment as usual (n=33) or treatment as usual+app-delivered MT (Unwinding Anxiety; n=32). The latter was composed of 30 modules to be completed over a 2-month period. Associated changes in outcomes were assessed using self-report questionnaires 1 and 2 months after treatment initiation. RESULTS: We randomized 65 participants in this study, and a modified intent-to-treat approach was used for analysis. The median number of modules completed by the MT group was 25.5 (IQR 17) out of 30; 46% (13/28) of the participants completed the program. In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67% vs 14%; median change in GAD-7: -8.5 [IQR 6.5] vs -1.0 [IQR 5.0]; P<.001; 95% CI 6-10). Increases in mindfulness at 1 month (nonreactivity subscale) mediated decreases in worry at 2 months (Penn State Worry Questionnaire; P=.02) and decreases in worry at 1 month mediated reductions in anxiety at 2 months (P=.03). CONCLUSIONS: To our knowledge, this is the first report on the efficacy and mechanism of an app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT as a digital therapeutic for individuals with anxiety (number needed to treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways, resulting in tangible, clinically meaningful reductions in worry and anxiety. Evidence-based, mechanistically targeted digital therapeutics have the potential to improve health at a population level at a low cost. TRIAL REGISTRATION: ClinicalTrials.gov NCT03683472; https://clinicaltrials.gov/ct2/show/NCT03683472.

Source-space EEG neurofeedback links subjective experience with brain activity during effortless awareness meditation.

BACKGROUND: Meditation is increasingly showing beneficial effects for psychiatric disorders. However, learning to meditate is not straightforward as there are no easily discernible outward signs of performance and thus no direct feedback is possible. As meditation has been found to correlate with posterior cingulate cortex (PCC) activity, we tested whether source-space EEG neurofeedback from the PCC followed the subjective experience of effortless awareness (a major component of meditation), and whether participants could volitionally control the signal. METHODS: Sixteen novice meditators and sixteen experienced meditators participated in the study. Novice meditators were briefly trained to perform a basic meditation practice to induce the subjective experience of effortless awareness in a progressively more challenging neurofeedback test-battery. Experienced meditators performed a self-selected meditation practice to induce this state in the same test-battery. Neurofeedback was provided based on gamma-band (40-57Hz) PCC activity extracted using a beamformer algorithm. Associations between PCC activity and the subjective experience of effortless awareness were assessed by verbal probes. RESULTS: Both groups reported that decreased PCC activity corresponded with effortless awareness (P<0.0025 for each group), with high median confidence ratings (novices: 8 on a 0-10 Likert scale; experienced: 9). Both groups showed high moment-to-moment median correspondence ratings between PCC activity and subjective experience of effortless awareness (novices: 8, experienced: 9). Both groups were able to volitionally control the PCC signal in the direction associated with effortless awareness by practicing effortless awareness meditation (novices: median % of time=77.97, P=0.001; experienced: 89.83, P<0.0005). CONCLUSIONS: These findings support the feasibility of using EEG neurofeedback to link an objective measure of brain activity with the subjective experience of effortless awareness, and suggest potential utility of this paradigm as a tool for meditation training.

Knowledge, Attitudes and Provider Advice by Pre-Pregnancy Weight Status: A Qualitative Study of Pregnant Latinas With Excessive Gestational Weight Gain.

Latina women are at high risk of excessive gestational weight gain (GWG) during pregnancy; yet little is known about whether factors related to GWG differ by pre-pregnancy body mass index (BMI) within this population. We conducted in-depth interviews with 62 pregnant Latina women with pre-pregnancy BMIs in the healthy, overweight, and obese ranges, gestational age ≥22 weeks, and GWG for gestational age above Institute of Medicine (IOM) guidelines. Compared to healthy weight and obese women, overweight women least often reported viewing weight as important, making efforts to control their GWG, being aware of the role of diet on GWG, and receiving GWG advice from health-care providers. Among those who received GWG advice, overweight women more often recalled a target GWG above IOM guidelines. Obese women more often reported low acceptance of their GWG, concern about GWG, having received GWG advice from providers, difficulty following providers' dietary advice, and emotional eating as a challenge for controlling GWG. Participants welcomed practical advice to manage GWG. Future interventions to prevent excessive GWG among Latina women should consider differences among women of varying pre-pregnancy BMIs and include multi-level strategies to address psychosocial as well as provider factors.

Weight gain prevention in the school worksite setting: results of a multi-level cluster randomized trial.

OBJECTIVE: To describe the effectiveness, reach and implementation of a weight gain prevention intervention among public school employees. METHOD: A multi-level intervention was tested in a cluster randomized trial among 782 employees in 12 central Massachusetts public high schools from 2009 to 2012. The intervention targeted the nutrition and physical activity environment and policies, the social environment and individual knowledge, attitudes and skills. The intervention was compared to a materials only condition. The primary outcome measures were change in weight and body mass index (BMI) at 24-month follow-up. Implementation of physical environment, policy and social environment strategies at the school and interpersonal levels, and intervention participation at the individual level were assessed. RESULTS: At 24-month follow-up, there was a net change (difference of the difference) of -3.03 pounds (p=.04) and of -.48 BMI units (p=.05) between intervention and comparison conditions. The majority of intervention strategies were successfully implemented by all intervention schools, although establishing formal policies was challenging. Employee participation in programs targeting the physical and social environment was maintained over time. CONCLUSION: This study supports that a multi-level intervention integrated within the organizational culture can be successfully implemented and prevent weight gain in public high school employees.

Effect of mindfulness training on asthma quality of life and lung function: a randomised controlled trial.

BACKGROUND: This study evaluated the efficacy of a mindfulness training programme (mindfulness-based stress reduction (MBSR)) in improving asthma-related quality of life and lung function in patients with asthma. METHODS: A randomised controlled trial compared an 8-week MBSR group-based programme (n=42) with an educational control programme (n=41) in adults with mild, moderate or severe persistent asthma recruited at a university hospital outpatient primary care and pulmonary care clinic. Primary outcomes were quality of life (Asthma Quality of Life Questionnaire) and lung function (change from baseline in 2-week average morning peak expiratory flow (PEF)). Secondary outcomes were asthma control assessed by 2007 National Institutes of Health/National Heart Lung and Blood Institute guidelines, and stress (Perceived Stress Scale (PSS)). Follow-up assessments were conducted at 10 weeks, 6 and 12 months. RESULTS: At 12 months MBSR resulted in clinically significant improvements from baseline in quality of life (differential change in Asthma Quality of Life Questionnaire score for MBSR vs control: 0.66 (95% CI 0.30 to 1.03; p<0.001)) but not in lung function (morning PEF, PEF variability and forced expiratory volume in 1 s). MBSR also resulted in clinically significant improvements in perceived stress (differential change in PSS score for MBSR vs control: -4.5 (95% CI -7.1 to -1.9; p=0.001)). There was no significant difference (p=0.301) in percentage of patients in MBSR with well controlled asthma (7.3% at baseline to 19.4%) compared with the control condition (7.5% at baseline to 7.9%). CONCLUSIONS: MBSR produced lasting and clinically significant improvements in asthma-related quality of life and stress in patients with persistent asthma, without improvements in lung function. CLINICAL TRIAL REGISTRATION NUMBER: Asthma and Mindfulness-Based Reduction (MBSR) Identifier: NCT00682669. clinicaltrials.gov.

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial.

The aim of this study was determine the effectiveness of a mindfulness-based stress-reduction (MBSR) program on quality of life (QOL) and psychosocial outcomes in women with early-stage breast cancer, using a three-arm randomized controlled clinical trial (RCT). This RCT consisting of 172 women, aged 20-65 with stage I or II breast cancer consisted of the 8-week MBSR, which was compared to a nutrition education program (NEP) and usual supportive care (UC). Follow-up was performed at three post-intervention points: 4 months, 1, and 2 years. Standardized, validated self-administered questionnaires were adopted to assess psychosocial variables. Statistical analysis included descriptive and regression analyses incorporating both intention-to-treat and post hoc multivariable approaches of the 163 women with complete data at baseline, those who were randomized to MBSR experienced a significant improvement in the primary measures of QOL and coping outcomes compared to the NEP, UC, or both, including the spirituality subscale of the FACT-B as well as dealing with illness scale increases in active behavioral coping and active cognitive coping. Secondary outcome improvements resulting in significant between-group contrasts favoring the MBSR group at 4 months included meaningfulness, depression, paranoid ideation, hostility, anxiety, unhappiness, and emotional control. Results tended to decline at 12 months and even more at 24 months, though at all times, they were as robust in women with lower expectation of effect as in those with higher expectation. The MBSR intervention appears to benefit psychosocial adjustment in cancer patients, over and above the effects of usual care or a credible control condition. The universality of effects across levels of expectation indicates a potential to utilize this stress reduction approach as complementary therapy in oncologic practice.

Serum IGF-1 concentrations change with soy and seaweed supplements in healthy postmenopausal American women.

Insulin-like growth factor 1 (IGF-1) is an anabolic hormone important for growth and development. However, high-circulating serum concentrations in adults are associated with increased risk of postmenopausal breast cancer. Nutritional status and specific foods influence serum IGF-1 concentrations. Breast cancer incidence is typically low in Asian countries where soy is commonly consumed. Paradoxically, soy supplement trials in American women have reported significant increases in IGF-1. Seaweed also is consumed regularly in Asian countries where breast cancer risk is low. We investigated the possibility that seaweed could modify soy-associated increases in IGF-1 in American women. Thirty healthy postmenopausal women (mean age 58 yr) participated in this 14-wk double-blinded, randomized, placebo-controlled crossover clinical trial. Participants consumed 5 g/day placebo or seaweed (Alaria esculenta) in capsules for 7 wk. During the 7th wk, a high-soy protein isolate powder was added (2 mg/kg body weight aglycone equivalent isoflavones). Overnight fasting blood samples were collected after each intervention period. Soy significantly increased serum IGF-1 concentrations compared to the placebo (21.2 nmol/L for soy vs. 16.9 nmol/L for placebo; P = 0.0001). The combination of seaweed and soy significantly reduced this increase by about 40% (21.2 nmol/L for soy alone vs. 19.4 nmol/L; P = 0.01). Concurrent seaweed and soy consumption may be important in modifying the effect of soy on IGF-1 serum concentrations.

Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial.

BACKGROUND: Over a third of preadolescent children with overweight or obesity. The American Academy of Pediatrics (AAP) recommends pediatric providers help families make changes in eating and activity to improve body mass index (BMI). However, implementation is challenging given limited time and referral sources, and family burden to access in-person weight management programs. PURPOSE: To describe the design of a National Heart Blood and Lung Institute sponsored cluster randomized controlled pediatric-based trial evaluating the effectiveness of the Fitline pediatric practice-based referral program to reduce BMI and improve diet and physical activity in children with overweight or obesity. Comparison will be made between brief provider intervention plus referral to (1) eight weekly nutritionist-delivered coaching calls with workbook to help families make AAP-recommended lifestyle changes (Fitline-Coaching), vs. (2) the same workbook in eight mailings without coaching (Fitline-Workbook). METHODS: Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8-12 with a BMI of ≥85th percentile are being recruited. The primary outcome is child BMI; secondary outcomes are child's diet and physical activity at baseline and 6- and 12-months post-baseline. Cost-effectiveness of the two interventions also will be examined. CONCLUSION: This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes. If effective, the Fitline program will provide an innovative model for widespread dissemination, setting new standards for weight management care in pediatric practice. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT03143660.

Physician Anxiety and Burnout: Symptom Correlates and a Prospective Pilot Study of App-Delivered Mindfulness Training.

BACKGROUND: Physician burnout is on the rise, yet little is known about its relationship to anxiety. Mindfulness-based stress reduction has demonstrated decreases in anxiety, yet physicians have reported reluctance to engage in it due to significant time commitments. OBJECTIVE: The aims of this study are to assess whether app-based mindfulness training can reduce anxiety in physicians and to explore if anxiety and burnout are correlated, thus leading to a reduction in both anxiety and burnout. METHODS: This was a nonrandomized pilot study comprised of 34 physicians who worked in a large US health care network and reported having anxiety. The intervention was an app-based mindfulness program. The main outcome measure was anxiety, measured by the Generalized Anxiety Disorder-7 (GAD-7). The secondary outcome measures assessed burnout: cynicism and emotional exhaustion items from the Maslach Burnout Inventory. RESULTS: GAD-7 scores decreased significantly at posttreatment (1 month after treatment initiation, 48% reduction, P<.001) and at the 3-month follow-up (57% reduction, P<.001). There was a significant correlation between anxiety and burnout (cynicism: r=.43; P=.01; emotional exhaustion: r=.71; P<.001). There was also a significant decrease in cynicism (50% reduction, P=.003 at posttreatment; 50% reduction, P=.009 at follow-up) and emotional exhaustion at both time points (20% reduction, P<.001 at posttreatment; 20% reduction, P=.003 at follow-up). CONCLUSIONS: This pilot study is the first to test an app-based mindfulness training program targeted at reducing anxiety with physicians and to demonstrate that in physicians, anxiety is correlated with burnout. These findings suggest that this may be an effective tool to reduce anxiety and burnout in physicians. TRIAL REGISTRATION: ClinicalTrials.gov NCT04137081; https://www.clinicaltrials.gov/ct2/show/NCT04137081.

Women's Experiences with a Mindful Eating Program for Binge and Emotional Eating: A Qualitative Investigation into the Process of Change.

Objectives: Mindfulness-based interventions (MBIs) have been shown to reduce engagement in disordered eating behaviors, although how these interventions engender change remains unclear. The objective of this exploratory qualitative study was to describe the experiences and perceived attitudinal and behavioral changes of women participating in a mindful eating program. Design: Focus group discussions were held with women participating in a community-based mindful eating program for binge and emotional eating. A semistructured interview guide was used to explore participants' conceptualizations of mindfulness-based attitudinal and behavior change, as related to food, eating, and body image. The focus group discussions were audio-recorded, transcribed, and analyzed using thematic analysis to identify salient concepts. Settings/Location: Focus group discussions were held at the Center for Mindfulness at the University of Massachusetts Medical School (UMMS) (United States). Participants: A sample of nine women who were enrolled in the mindful eating program at UMMS for problems with self-reported binge and/or emotional eating participated in this study. Results: Four themes were constructed that described a process of mindfulness-based behavior change, including (1) Learning Through Self-Awareness, (2) Self-Empowerment, (3) Mindful Choice-Making, and (4) Resilient Self-Care. An overarching description of the participants' perceived attitudinal and behavior changes was developed: "unforced freedom of choice, emerging from embodied awareness." Conclusions: These findings suggest that MBIs reduce may disordered eating behaviors through empowering women to make positive choices about food, eating, and coping, without focusing on weight control. Future research is needed to examine whether these findings replicate in larger and more diverse samples, and how they can be used to optimize and implement eating-specific MBIs in community-based settings.

Feasibility of a Smartphone App with Mindfulness Training for Adolescent Smoking Cessation: Craving to Quit (C2Q)-Teen.

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 four weeks and study assessments were collected at baseline and 3- and 6- month follow-up, 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 to 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 to 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. CLINICAL TRIAL REGISTRATION: Developing a Smartphone App with Mindfulness Training for Teen Smoking Cessation: ClinicalTrials.gov Identifier: NCT02218281.

Beneficial Effects of School-based Mindfulness Training On Impulsivity in Healthy Adolescents: Results From a Pilot Randomized Controlled Trial.

BACKGROUND: Since impulsivity is associated with unhealthy behaviors in adolescents, interventions targeting impulsivity could positively affect such behaviors. Whether integrating mindfulness training (MT) into standard school-based health education could improve impulsivity is unknown. PURPOSE: To obtain preliminary estimates of effect of MT integrated in standard high school health education on impulsivity. METHODS: Two high schools in Massachusetts were randomized to school-based health education plus MT (HE-MT) or to health education plus attention control (HE-AC). The outcome was change in impulsivity at end of treatment (EOT) and 6 months after EOT. RESULTS: Students (n = 53; 30 HE-MT, 23 HE-AC) were on average 14.5 years old and 40% belonged to ethnic minorities. Compared to the control condition, HE-MT had significant effects on impulsivity at EOT (beta = -9.7; SE = 3.8, p = 0.01), while smaller, non-significant differences were seen 6 months after EOT. CONCLUSION: This rigorous pilot study suggests that MT could have a beneficial effect on impulsivity in adolescents. Improvements in impulsivity could have important implications should future larger studies show that such improvements result in healthier behaviors.

Quitting starts in the brain: a randomized controlled trial of app-based mindfulness shows decreases in neural responses to smoking cues that predict reductions in smoking.

Current treatments for smoking yield suboptimal outcomes, partly because of an inability to reduce cue-induced smoking. Mindfulness training (MT) has shown preliminary efficacy for smoking cessation, yet its neurobiological target remains unknown. Our prior work with nonsmokers indicates that MT reduces posterior cingulate cortex (PCC) activity. In individuals who smoke, the PCC, consistently a main hub of the "default mode network," activates in response to smoking cues. In this randomized controlled trial, we tested the effects of app-delivered MT on PCC reactivity to smoking cues and whether individual differences in MT-mediated PCC changes predicted smoking outcomes. Smoking cue-induced PCC reactivity was measured using functional magnetic resonance imaging at baseline and 1 month after receiving smartphone app-based MT (n = 33) vs. an active control (National Cancer Institute's QuitGuide, n = 34). Whether individual differences in treatment-related changes in PCC activity predicted smoking behavior was assessed. The MT group demonstrated a significant correlation between a reduction in PCC reactivity to smoking cues and a decline in cigarette consumption (r = 0.39, p = 0.02). No association was found in the control group (r = 0.08, p = 0.65). No effects of group alone were found in PCC or cigarette reduction. Post hoc analysis revealed this association is sex specific (women, r = 0.49, p = 0.03; men: r = -0.08, p = 0.79). This initial report indicates that MT specifically reduces smoking cue-induced PCC activity in a subject-specific manner, and the reduction in PCC activity predicts a concurrent decline in smoking. These findings link the hypothesized behavioral effects of MT for smoking to neural mechanisms particularly in women. This lays the groundwork for identifying individuals who may benefit from targeted digital therapeutic treatments such as smartphone-based MT, yielding improved clinical outcomes.

Integrating mindfulness training in school health education to promote healthy behaviors in adolescents: Feasibility and preliminary effects on exercise and dietary habits.

Whether mindfulness training (MT) could improve healthy behaviors is unknown. This study sought to determine feasibility and acceptability of integrating MT into school-based health education (primary outcomes) and to explore its possible effects on healthy behaviors (exploratory outcomes). Two high schools in Massachusetts (2014-2015) were randomized to health education plus MT (HE-MT) (one session/week for 8 weeks) or to health education plus attention control (HE-AC). Dietary habits (24-h dietary recalls) and moderate-to-vigorous physical activity (MVPA/7-day recalls) were assessed at baseline, end of treatment (EOT), and 6 months thereafter. Quantile regression and linear mixed models were used, respectively, to estimate effects on MVPA and dietary outcomes adjusting for confounders. We recruited 53 9th graders (30 HEM, 23 HEAC; average age 14.5, 60% white, 59% female). Retention was 100% (EOT) and 96% (6 months); attendance was 96% (both conditions), with moderate-to-high satisfaction ratings. Among students with higher MVPA at baseline, MVPA was higher in HE-MT vs. HE-AC at both EOT (median difference = 81 min/week, p = 0.005) and at 6 months (p = 0.004). Among males, median MVPA was higher (median difference = 99 min/week) in HE-MT vs. HEAC at both EOT (p = 0.056) and at 6 months (p = 0.04). No differences were noted in dietary habits. In sum, integrating school-based MT into health education was feasible and acceptable and had promising effects on MVPA among male and more active adolescents. These findings suggest that MT may improve healthy behaviors in adolescents and deserve to be reproduced in larger, rigorous studies.

A comparison of the psychometric properties of the hooked on nicotine checklist and the modified Fagerström tolerance questionnaire.

We compared the psychometric properties of the Hooked on Nicotine Checklist (HONC) and the Modified Fagerström Tolerance Questionnaire (MFTQ). Adolescent current smokers (n = 215) completed both instruments three times, at baseline and 6- and 12-month follow-up. Internal consistency of the HONC was high (alpha = 0.92), as was its stability over the follow-up interval (intraclass correlation (ICC) = 0.93 over 6 months and 0.91 over 1 year). Internal consistency of the MFTQ was acceptable (alpha = 0.83), and its stability over the follow-up interval was similar to that reported previously (ICC = 0.79 at 6 months and 0.76 at 1 year). The HONC predicted smoking at both follow-up points, while the MFTQ did so only at 6 months. The HONC compared favorably with the MFTQ in all respects. The most important advantage of the HONC is that it is measuring a clearly defined concept, diminished autonomy over tobacco, which begins when the sequelae of tobacco use present a barrier to quitting.

Use of a FITLINE to Support Families of Overweight and Obese Children in Pediatric Practices.

BACKGROUND: The American Academy of Pediatrics (AAP) recommends a staged approach to pediatric weight management, starting with helping families to make targeted dietary and activity changes. This pilot study evaluated the preliminary efficacy of a pediatric practice-based referral program to support parents in helping their overweight/obese children improve their weight-related behaviors and BMI. METHODS: A nonrandomized intervention study with contemporaneous control was used. Parents and their children ages 8-12 with BMI ≥85th percentile (N = 37) were recruited from a pediatric practice serving a low-income, multiethnic population. Providers delivered brief intervention and referred families to six weekly FITLINE telephone counseling sessions with a nutritionist who guided parents in helping their child make AAP-recommended changes. Child BMI and parent survey of child diet and physical activity were completed at baseline and 3 months. Medical record data from 44 children matched for age and BMI were collected. RESULTS: Mean change in BMI from baseline to 3-month follow-up was -0.49 BMI units (standard deviation [SD], 0.95; p = 0.007) for the FITLINE group and 0.35 BMI units (SD, 0.96; p = 0.02) for the control group. Adjusting for baseline BMI, age, and sex, children in the FITLINE condition reduced BMI significantly more than children in the control condition (mean difference = -0.89; p = 0.0003). Significant improvements in many dietary and sedentary behaviors also were noted. CONCLUSIONS: The FITLINE program reduced short-term BMI and improved dietary and sedentary behaviors. A randomized, controlled trial is warranted to assess the program's efficacy and potential to serve as a model for reducing obesity in pediatric practice.

A School-Based Program for Overweight and Obese Adolescents: A Randomized Controlled Trial.

BACKGROUND: Given the dramatic increase in adolescent overweight and obesity, models are needed for implementing weight management treatment through readily accessible venues. We evaluated the acceptability and efficacy of a school-based intervention consisting of school nurse-delivered counseling and an afterschool exercise program in improving diet, activity, and body mass index (BMI) among overweight and obese adolescents. METHODS: A pair-matched cluster-randomized controlled school-based trial was conducted in which 8 public high schools were randomized to either a 12-session school nurse-delivered cognitive-behavioral counseling intervention plus school-based after school exercise program, or 12-session nurse contact with weight management information (control). Overweight or obese adolescents (N = 126) completed anthropometric and behavioral assessments at baseline and 8-month follow-up. Main outcome measures included diet, activity, and BMI. Mixed effects regression models were conducted to examine differences at follow-up. RESULTS: At follow-up, students in intervention compared with control schools were not different in BMI, percent body fat, and waist circumference. Students reported eating breakfast (adjusted mean difference 0.81 days; 95% confidence interval [CI] 0.11-1.52) on more days/week; there were no differences in other behaviors targeted by the intervention. CONCLUSIONS: While a school-based intervention including counseling and access to an after-school exercise program is theoretically promising with public health potential, it was not effective in reducing BMI or key obesogenic behaviors. Our findings are important in highlighting that interventions targeted at the individual level are not likely to be sufficient in addressing the adolescent obesity epidemic without changes in social norms and the environment.

Perspectives in Implementing a Pragmatic Pediatric Primary Care-Based Intervention Trial.

The 2013 U.S. Preventive Services Task Force (USPSTF) concluded that behavioral interventions are effective in reducing initiation of smoking in youth, recommending primary care clinicians provide education or brief counseling to prevent initiation, and that there are promising trends toward behavioral interventions improving cessation in this population. Our primary care-based intervention RCT conducted between 2000 and 2004, Air It Out, informed these USPSTF recommendations. Our trial was designed to determine whether a pediatric primary care practice-based smoking prevention and cessation intervention would be effective in increasing abstinence rates among adolescents under usual clinic conditions, to inform clinical practice. Therefore, the trial was designed to be largely a pragmatic trial. In this paper, we describe where each of the Air It Out study components falls along the pragmatic-explanatory continuum regarding participant eligibility criteria, intervention and comparison condition design, follow-up and outcomes, compliance and adherence assessments, and analysis. Such an assessment assists researchers by providing a framework to guide decisions regarding study design and implementation. We then share a few principles and lessons learned in developing and implementing the primary care-based intervention trial, focusing on study setting selection, engaging providers who will be delivering the intervention and the target population who will be receiving it in designing the trial and interventions to be tested, and the need to carefully plan recruitment and retention procedures. The hope is to increase the number of well-designed studies that can be included in the evidence reviews to guide future USPSTF recommendation statements.

Systematic errors in middle-aged women's estimates of energy intake: comparing three self-report measures to total energy expenditure from doubly labeled water.

PURPOSE: To evaluate energy intake (EI) derived from a food frequency questionnaire (FFQ), seven-day dietary recall (7DDR), and seven 24-hour dietary recall interviews (24HR) for reporting errors associated with social desirability and social approval. METHODS: The FFQ and 7DDR were administered once before and once after a 14-day metabolic period during which total energy expenditure was determined using the doubly labeled water method (TEE(dlw)). Seven 24HR were conducted over the 14-day period. Data obtained from 80 healthy women (mean age = 49.1 years) were fit to linear regression models in which the EI estimates were the dependent variables and estimates of social desirability and social approval traits, body mass index [weight (kg)/ height (m)(2)], and TEE(dlw) were fit as independent variables. RESULTS: indicated that in college-educated women there was an underestimate associated with social desirability on the FFQ (-42.24 kcal/day/point on the social desirability scale; 95% CI:-75.48, -9.00). For college-educated women with an average social desirability score ( approximately 17 points) this would equal an underestimate of 507 kcal/day compared to women with the minimum score (4 points). The 7DDR was associated with a differential effect of social approval when comparing by education; i.e., there was a difference of 36.35 kcal/day/point between the two groups (-14.69 in women with >/=college and 21.66 in women with

Improving participation in Chlamydia screening programs: perspectives of high-risk youth.

BACKGROUND: Many young people at highest risk for chlamydial infection do not use chlamydia screening services. OBJECTIVES: To describe young people's beliefs and opinions about obstacles to and motivators for obtaining testing and to provide recommendations for how to improve youth participation in chlamydia screening programs. METHODS: Eight focus group interviews (4 male and 4 female groups) were conducted with young people using a semistructured interview guide. Thirty-two male and 23 female volunteers (mean age, 18.2 years; age range, 15-24 years) were recruited from Job Corps and Department of Youth Services sites. The main outcome measure was categorization of textual data using content analysis techniques. Data were coded by 2 investigators into categories of responses based on research questions and spontaneously offered comments. Satisfactory intercoder agreement was achieved. RESULTS: Participants described many obstacles to testing, including concern that someone will know they were tested or tested positive, fear about discovering they have a sexually transmitted disease, and fear of acquired immunodeficiency syndrome. Many participants were unsure what physical effects chlamydia produced or thought it was possible to die of a chlamydial infection. Participants recommended providing more information about the effects of chlamydia, availability of urine testing, and ease of treatment to motivate more young people to seek testing. They also emphasized the need to make sexually transmitted disease screening services more private and confidential. There was an overwhelming interest in using a home Chlamydia test (much like a home pregnancy test) if one were available. CONCLUSIONS: To increase youth participation in screening programs, it will be necessary to address their concerns, dispel misconceptions, and provide more information about chlamydia. A home Chlamydia test might be one way to increase screening.