Outcome of BMI2+: Motivational Interviewing to Reduce BMI Through Primary Care AAP PROS Practices.

BACKGROUND: Pediatric obesity rates in the United States remain at an all-time high. Pediatric primary care clinicians and registered dietitians can help treat childhood obesity, and motivational interviewing (MI) has shown promising effects in prior trials. METHODS: We randomized 18 pediatric primary care practices to receive the Brief Motivational Interviewing to Reduce BMI or BMI2+ intervention or continue with usual care (UC). Practices were recruited through the American Academy of Pediatrics Pediatric Research in Office Settings network. The intervention comprised 4 components1: in-person and telehealth MI counseling by pediatric clinicians; 4 recommended sessions,2 6 telephone MI counseling sessions from a registered dietitian,3 text message reminders and tailored motivational messages, and4 parent educational materials. The main outcome was the change in the percentage of the 95th percentile of BMI. The study was conducted 2017 through 2021. RESULTS: There was a significant treatment x time interaction (b = 0.017, 95% confidence interval: [0.0066-0.027]) for the main outcome, favoring the UC group, with youth in the intervention arm showing a greater relative increase in their percent of the 95th percentile. CONCLUSIONS: There was no overall benefit of the intervention and, contrary to expectations, youth in the intervention arm gained more weight, based on percent of the distance from the 95th percentile than matched youth from UC practices. The absolute excess weight gain among intervention relative to UC youth was small, approximately 0.5 BMI units and 1 kg over 2 years. We offer several potential explanations for these unexpected findings.

HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine.

OBJECTIVES: A single dose of human papillomavirus (HPV) vaccine would simplify logistics and reduce costs of vaccination programs worldwide. We conducted a phase IIa trial to determine the stability of HPV type-specific antibody responses after a single dose of the nonavalent HPV vaccine, Gardasil9. METHODS: Two hundred-and-one healthy 9 to 11-year-old girls and boys were enrolled at 2 centers in the United States to receive a prime dose of the nonavalent vaccine at baseline, a delayed dose at month 24, and an optional third dose at month 30. Blood samples were collected to measure HPV type-specific antibodies at baseline and at 6, 12, 18, 24, and 30 months after the prime dose. The primary outcomes were serum HPV16 and HPV18 antibody responses. RESULTS: In both girls and boys, geometric mean concentrations of HPV16 and HPV18 antibodies increased at 6 months, declined between months 6 to 12, and then remained stable and high (at 20- and 10-times those at baseline for HPV16 and HPV18, respectively) throughout months 12, 18, and 24 (prebooster) visits. Both HPV16 and HPV18 antibody responses demonstrated anamnestic boosting effect at 30-months after the delayed (24-month) booster dose. CONCLUSIONS: A single dose of the nonavalent HPV vaccine induced persistent and stable HPV16 and HPV18 antibody responses up to 24 months. This study contributes important immunogenicity data to inform feasibility of the single dose HPV vaccination paradigm. Further research is needed to assess the long-term antibody stability and individual clinical and public health benefit of the single dose schedule.

Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network.

INTRODUCTION: Primary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI. METHODS AND ANALYSIS: This cluster randomised effectiveness trial includes 24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings (PROS) practice-based research network. To date, practices have been randomised (nine to intervention and nine to usual care). Intervention Ped/NPs have been trained in MI, behavioural therapy, billing/coding for weight management and study procedures. Usual care Ped/NPs received training in billing/coding and study procedures only. Children 3- 11 years old with BMI >the 85th percentile were identified via electronic health records (EHRs). Parents from intervention practices have been recruited and enrolled. Over about 2 years, these parents are offered approximately 10 MI-based counselling sessions (about four in person sessions with their child's Ped/NP and up to six telephonic sessions with a trained RD). The primary outcome is change in child BMI (defined as per cent from median BMI for age and sex) over the study period. The primary comparison is between eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices. Data sources will include EHRs, billing records, surveys and counselling call notes. ETHICS AND DISSEMINATION: Institutional Review Board approval was obtained from the AAP. All Ped/NPs provided written informed consent, and intervention group parents provided consent and Health Insurance Portability and Accountability Act (HIPAA) authorisation. Findings will be disseminated through peer-reviewed publications, conference presentations and appropriate AAP channels. TRIAL REGISTRATION NUMBER: NCT03177148; Pre-results.

A prospective, single-arm, open-label, non-randomized, phase IIa trial of a nonavalent prophylactic HPV vaccine to assess immunogenicity of a prime and deferred-booster dosing schedule among 9-11 year-old girls and boys - clinical protocol.

BACKGROUND: Human papillomavirus (HPV) vaccines are indicated for the prevention of cancers and genital warts caused by vaccine-covered HPV types. Although the standard regimen requires a two or three-dose vaccine series, there is emerging data suggesting that a single dose of the bivalent or quadrivalent HPV vaccine generates persistently positive antibody titers. No similar data is yet available for the nonavalent HPV vaccine, currently the only HPV vaccine available in the United States. The overall objective of our study is to assess the stability and kinetics of antibody titers for 24 months following a single dose of the nonavalent HPV vaccine among preteen girls and boys. METHODS: This is a prospective, single-arm, open-label, non-randomized, Phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (GARDASIL® 9) over 24 months, with a deferred booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provide blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point. The primary objective is to determine the stability of type-specific serologic GMT of HPV16 and HPV18 between the 6- vs. 12-month, 12- vs. 18-month, and 18- vs. 24-month visits. Secondary objectives are to determine the stability of type-specific serologic GMT of the other HPV types (HPV 6/11/31/33/45/52/58) between the visits and to assess safety and reactogenicity after each vaccine dose. DISCUSSION: Single dose HPV vaccination could simplify the logistics and reduce costs of HPV vaccination in the US and across the world. This study will contribute important immunogenicity data on the stability and kinetics of type-specific antibody titers and inform feasibility of the single dose HPV vaccination paradigm. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02568566 . Registered on October 6, 2015.

Special article: 2014 Pediatric Clinical Trials Forum.

In November 2014, the American Academy of Pediatrics convened key stakeholders to discuss the feasibility of accelerating children's medical advances by creating an independent global Pediatric Clinical Trials Network. The Forum identified challenges posed by the U.S. and global clinical trial systems regarding testing and disseminating drugs and devices for pediatric patients. Stakeholders mapped a vision to improve the safety and efficacy of pediatric drugs, biological products, and medical devices by creating a global Pediatric Clinical Trials Network. Such a Network would act as a central infrastructure for pediatric subspecialties and enable dedicated staff to provide clinical research sites with scientific, medical, and operational support. A Network would facilitate development and availability of innovative, high-quality therapies to extend and enhance the lives of neonates, infants, children, adolescents, and young adults. Participants expressed strong interest in forming such a Network, since drugs and devices still come to market without adequate pediatric indications-particularly in neonatology and rare diseases. Participants developed a Consensus Statement expressing their shared vision for a Network: Attendees of the Pediatric Clinical Trials Stakeholder Forum resolved to establish a Global Pediatric Clinical Trials Network and are committed to engage in the work to create and sustain it.

Black versus white differences in rates of addressing parental tobacco use in the pediatric setting.

OBJECTIVE: To examine racial differences in rates of screening parents for cigarette smoking during pediatric outpatient visits and to determine if a parental tobacco control intervention mitigates racial variation in whether cigarette smoking is addressed. METHODS: As part of the Clinical Effort Against Secondhand Smoke Exposure (CEASE) randomized controlled trial, exit interviews were conducted with parents at 10 control and 10 intervention pediatric practices nationally. Parents were asked to report if during the visit did anyone ask if they smoke cigarettes. A generalized linear mixed model was used to estimate the effect of black vs white race on asking parents about cigarette smoking. RESULTS: Among 17,692 parents screened at the exit interview, the proportion of black parents who were current smokers (16%) was lower than the proportion of white parents who smoked (20%) (P < .001). In control group practices, black parents were more likely to be asked (adjusted risk ratio 1.23; 95% confidence interval 1.08, 1.40) about cigarette smoking by pediatricians than whites. In intervention group practices both black and white parents were more likely to be asked about smoking than those in control practices and there was no significant difference between black and white parents in the likelihood of being asked (adjusted risk ratio 1.01; 95% confidence interval 0.93, 1.09). CONCLUSIONS: Although a smaller proportion of black parents in control practices smoked than white, black parents were more likely to be asked by pediatricians about smoking. The CEASE intervention was associated with higher levels of screening for smoking for both black and white parents.

Sustainability of a parental tobacco control intervention in pediatric practice.

OBJECTIVE: To determine whether an evidence-based pediatric outpatient intervention for parents who smoke persisted after initial implementation. METHODS: A cluster randomized controlled trial of 20 pediatric practices in 16 states that received either Clinical and Community Effort Against Secondhand Smoke Exposure (CEASE) intervention or usual care. The intervention provided practices with training to provide evidence-based assistance to parents who smoke. The primary outcome, assessed by the 12-month follow-up telephone survey with parents, was provision of meaningful tobacco control assistance, defined as discussing various strategies to quit smoking, discussing smoking cessation medication, or recommending the use of the state quitline after initial enrollment visit. We also assessed parental quit rates at 12 months, determined by self-report and biochemical verification. RESULTS: Practices' rates of providing any meaningful tobacco control assistance (55% vs 19%), discussing various strategies to quit smoking (25% vs 10%), discussing cessation medication (41% vs 11%), and recommending the use of the quitline (37% vs 9%) were all significantly higher in the intervention than in the control groups, respectively (P < .0001 for each), during the 12-month postintervention implementation. Receiving any assistance was associated with a cotinine-confirmed quitting adjusted odds ratio of 1.89 (95% confidence interval: 1.13-3.19). After controlling for demographic and behavioral factors, the adjusted odds ratio for cotinine-confirmed quitting in intervention versus control practices was 1.07 (95% confidence interval: 0.64-1.78). CONCLUSIONS: Intervention practices had higher rates of delivering tobacco control assistance than usual care practices over the 1-year follow-up period. Parents who received any assistance were more likely to quit smoking; however, parents' likelihood of quitting smoking was not statistically different between the intervention and control groups. Maximizing parental quit rates will require more complete systems-level integration and adjunctive cessation strategies.

The parent-child dyad and risk perceptions among parents who quit smoking.

BACKGROUND: Most parental smokers are deeply invested in their child's health, but it is unknown what factors influence parent risk perceptions of the effects of smoking on their child's health and benefits to the child of cessation. PURPOSE: To explore differences in former versus current smokers' beliefs about harm of continuing to smoke, benefits of quitting, and how much smoking interferes with their parenting. METHODS: As part of a cluster RCT to increase tobacco control in the pediatric setting, we analyzed data collected at the ten control arm practices for 24 months starting in May 2010; a cross-sectional secondary data analysis was conducted in 2013. Parents were asked about smoking status and perceived harm, benefit, and well-being related to smoking behaviors. RESULTS: Of the 981 enrolled smoking parents, 710 (72.4%) were contacted at 12 months. The odds of having successfully quit at 12 months was 4.12 times more likely (95% CI=1.57, 10.8) for parents who believed that quitting will benefit their children; 1.68 times more likely (95% CI=1.13, 2.51) for parents with more than a high school education; and 1.74 times greater (95% CI=1.13, 2.68) for parents with children under age 3 years. Another factor associated with having successfully quit was a prior quit attempt. CONCLUSIONS: Providers' smoking-cessation advice and support should begin early and underscore how cessation will benefit the health and well-being of patients' children. Additionally, parents who have recently attempted to quit may be particularly primed for another attempt.

Thirdhand smoke beliefs of parents.

OBJECTIVE: To determine if the belief that thirdhand smoke is harmful to children is associated with smoking parents' attitudes, home or car smoking policies, and quitting behaviors. METHODS: Data from a national randomized controlled trial, Clinical Effort Against Secondhand Smoke Exposure, assessed thirdhand smoke beliefs of 1947 smoking parents in an exit survey after a pediatric office visit in 10 intervention and 10 control practices. Twelve-month follow-up data were collected from 1355 parents. Multivariable logistic regression determined whether belief that thirdhand smoke harms the health of children is independently associated with parental behaviors and attitudes 12 months later. A χ(2) test assessed whether parents who disagreed that thirdhand smoke is harmful were more likely to make a quit attempt if they later believed that thirdhand smoke is harmful. RESULTS: Belief at the exit survey that thirdhand smoke is harmful was independently associated with having a strictly enforced smoke-free home policy (adjusted odds ratio: 2.05; 95% CI: 1.37-3.05) and car policy (adjusted odds ratio: 1.69; 95% CI: 1.04-2.74) at the 12-month follow-up. A significantly higher percentage (71% vs 50%) of parents who did not hold the thirdhand smoke harm belief at baseline made at least 1 quit attempt if they agreed that thirdhand smoke is harmful at the 12-month follow-up (P = .02). CONCLUSIONS: Thirdhand smoke harm belief was associated with a strictly enforced smoke-free home and car and attempts to quit smoking. Sensitizing parents to thirdhand smoke risk could facilitate beneficial tobacco control outcomes.

Implementation of a parental tobacco control intervention in pediatric practice.

OBJECTIVE: To test whether routine pediatric outpatient practice can be transformed to assist parents in quitting smoking. METHODS: Cluster RCT of 20 pediatric practices in 16 states that received either CEASE intervention or usual care. The intervention gave practices training and materials to change their care delivery systems to provide evidence-based assistance to parents who smoke. This assistance included motivational messaging; proactive referral to quitlines; and pharmacologic treatment of tobacco dependence. The primary outcome, assessed at an exit interview after an office visit,was provision of meaningful tobacco control assistance, defined as counseling beyond simple advice (discussing various strategies to quit smoking), prescription of medication, or referral to the state quitline, at that office visit. RESULTS: Among 18 607 parents screened after their child's office visit between June 2009 and March 2011, 3228 were eligible smokers and 1980 enrolled (999 in 10 intervention practices and 981 in 10 control practices). Practices' mean rate of delivering meaningful assistance for parental cigarette smoking was 42.5% (range 34%­66%) in the intervention group and 3.5% (range 0%­8%) in the control group (P < .0001).Rates of enrollment in the quitline (10% vs 0%); provision of smoking cessation medication (12% vs 0%); and counseling for smoking cessation(24% vs 2%) were all higher in the intervention group compared with the control group (P < .0001 for each). CONCLUSIONS: A system-level intervention implemented in 20 outpatient pediatric practices led to 12-fold higher rates of delivering tobacco control assistance to parents in the context of the pediatric office visit.

Parent smoker role conflict and planning to quit smoking: a cross-sectional study.

BACKGROUND: Role conflict can motivate behavior change. No prior studies have explored the association between parent/smoker role conflict and readiness to quit. The objective of the study is to assess the association of a measure of parent/smoker role conflict with other parent and child characteristics and to test the hypothesis that parent/smoker role conflict is associated with a parent's intention to quit smoking in the next 30 days. As part of a cluster randomized controlled trial to address parental smoking (Clinical Effort Against Secondhand Smoke Exposure-CEASE), research assistants completed exit interviews with 1980 parents whose children had been seen in 20 Pediatric Research in Office Settings (PROS) practices and asked a novel identity-conflict question about "how strongly you agree or disagree" with the statement, "My being a smoker gets in the way of my being a parent." Response choices were dichotomized as "Strongly Agree" or "Agree" versus "Disagree" or "Strongly Disagree" for the analysis. Parents were also asked whether they were "seriously planning to quit smoking in 30 days." Chi-square and logistic regression were performed to assess the association between role conflict and other parent/children characteristics. A similar strategy was used to determine whether role conflict was independently associated with intention to quit in the next 30 days. METHODS: As part of a RTC in 20 pediatric practices, exit interviews were held with smoking parents after their child's exam. Parents who smoked were asked questions about smoking behavior, smoke-free home and car rules, and role conflict. Role conflict was assessed with the question, "Please tell me how strongly you agree or disagree with the statement: 'My being a smoker gets in the way of my being a parent.' (Answer choices were: "Strongly agree, Agree, Disagree, Strongly Disagree.") RESULTS: Of 1980 eligible smokers identified, 1935 (97%) responded to the role-conflict question, and of those, 563 (29%) reported experiencing conflict. Factors that were significantly associated with parent/smoker role conflict in the multivariable model included: being non-Hispanic white, allowing home smoking, the child being seen that day for a sick visit, parents receiving any assistance for their smoking, and planning to quit in the next 30 days. In a separate multivariable logistic regression model, parent/smoker role conflict was independently associated with intention to quit in the next 30 days [AOR 2.25 (95% CI 1.80-2.18)]. CONCLUSION: This study demonstrated an association between parent/smoker role conflict and readiness to quit. Interventions that increase parent/smoker role conflict might act to increase readiness to quit among parents who smoke.

Pediatrician interventions and thirdhand smoke beliefs of parents.

BACKGROUND: Thirdhand smoke is residual tobacco smoke contamination that remains after a cigarette is extinguished. A national study indicates that adults' belief that thirdhand smoke (THS) harms children is associated with strict household no-smoking policies. The question of whether pediatricians can influence THS beliefs has not been assessed. PURPOSE: To identify prevalence of THS beliefs and associated factors among smoking parents, and the association of pediatrician intervention on parent belief that THS is harmful to their children. METHODS: Exit interview data were collected from 1980 parents following a pediatric office visit. Parents' level of agreement or disagreement that THS can harm the health of babies and children was assessed. A multivariate logistic regression model was constructed to identify whether pediatricians' actions were independently associated with parental belief that THS can harm the health of babies and children. Data were collected from 2009 to 2011, and analyses were conducted in 2012. RESULTS: Ninety-one percent of parents believed that THS can harm the health of babies and children. Fathers (AOR=0.59, 95% CI=0.42, 0.84) and parents who smoked more than ten cigarettes per day (AOR=0.63, 95% CI=0.45, 0.88) were less likely to agree with this statement. In contrast, parents who received advice (AOR=1.60, 95% CI=1.04, 2.45) to have a smokefree home or car or to quit smoking and parents who were referred (AOR=3.42, 95% CI=1.18, 9.94) to a "quitline" or other cessation program were more likely to agree that THS can be harmful. CONCLUSIONS: Fathers and heavier smokers were less likely to believe that THS is harmful. However, pediatricians' actions to encourage smoking parents to quit or adopt smokefree home or car policies were associated with parental beliefs that THS harms children. TRIAL REGISTRATION: This study is registered at NCT00664261.

Parental compliance with after hours telephone triage advice: nurse advice service versus on-call pediatricians.

To compare parental compliance with after-hours triage advice provided by telephone advice nurses and on-call pediatricians, a randomized controlled trial was undertaken at a university general pediatrics practice that enrolled parents or guardians calling for after-hours advice. Advice calls were randomized to a call center advice nurse or the on-call pediatrician. Parental compliance with the triage advice and agreement of the parental report of advice with the pediatrician/nurse report of advice given was evaluated. There were 566 participants in the pediatrician and 616 in the nurse group. Compliance with advice (pediatrician v. nurse) was not significantly different for emergent/urgent care (75.8% v. 72.6%) and self care (74.3% v. 77.2%) but was significantly higher in the pediatrician group for office care (51.5% v. 29.6%; 95% CI of difference, 8.9%-34.2%). Overall agreement between the caller reported and physician or nurse advice was 84.5% for emergent/ urgent, 42.7% for office care, and 93.7% for self-care.

Does telephone triage delay significant medical treatment?: Advice nurse service vs on-call pediatricians.

BACKGROUND: Advice nurse call centers are used to ensure access to medical advice, thereby potentially reducing the costs of health services. OBJECTIVE: To determine if medical advice from advice nurses and on-call physicians delays significant medical treatment in a general pediatrics population. DESIGN: Randomized controlled trial. SETTING: A university general pediatrics faculty practice. PARTICIPANTS: Parents or guardians calling for after-hours advice regarding their children.Intervention After-hours medical advice calls were randomized at the time of the call to an advice nurse or an on-call pediatrician. MAIN OUTCOME MEASURES: The proportion of callers who sought medical care not advised by the advice nurse or on-call pediatrician and the proportion who received unadvised significant care. RESULTS: There were 1182 advice calls: 566 in the pediatrician group and 616 in the advice nurse group. There were no significant differences in the types of telephone triage advice in the physician and advice nurse groups. There was no significant difference in the proportion of callers who sought unadvised care (108 [19.9%] in the physician group vs 110 [19.0%] in the advice nurse group) or in the proportion of callers who received unadvised significant care (23 [4.2%] in the physician group vs 25 [4.3%] in the advice nurse group). CONCLUSIONS: The proportions of callers who sought unadvised medical care and who received unadvised significant care were not significantly different in the advice nurse and pediatrician groups. This suggests that advice nurses do not delay significant medical treatment when compared with pediatricians.

Caller satisfaction with after-hours telephone advice: nurse advice service versus on-call pediatricians.

OBJECTIVE: To compare caller satisfaction with after-hours medical advice provided by a for-profit nurse advice service with advice provided by on-call pediatricians. METHODS: The study setting was the general pediatrics faculty practice of an urban university medical center. Participants were parents or guardians of a population of approximately 6000 children calling for after-hours medical advice over a 10-month period from January 18 to November 20, 2000. After-hours medical advice calls were randomized to either a nurse advice service or the on-call pediatrician. Caller satisfaction and subsequent health care utilization were measured by a telephone survey of callers and review of all health care visits within 3 days of the initial telephone advice call. RESULTS: Five hundred sixty-six (48%) callers were enrolled in the on-call pediatrician group, and 616 (52%) were enrolled in the advice nurse group. Caller satisfaction was rated as very good or excellent significantly more often for the on-call pediatrician than for the nurse advice service as follows: telephone call overall (68.5% vs 55.0%; 95% confidence interval [CI] of difference: 8.0%-19.0%), thoroughness and competence of the person they spoke with (74.0% vs 59.1%; 95% CI of difference: 9.6%-20.2%), courtesy and friendliness of the person they spoke with (77.4% vs 73.9%; 95% CI of difference: -1.4%-8.4%), length of time spent waiting (70.8% vs 60.1%; 95% CI of difference: 5.4%-16.2%), time spent talking with the on-call pediatrician or advice nurse (68.2% vs 52.4%; 95% CI of difference: 10.2%-21.3%), and the medical advice given (68.6% vs 53.9%; 95% CI of difference: 9.2%-20.1%). Compliance with the advice given was significantly higher for office care in the on-call pediatrician group (51.5% vs 29.6%; 95% CI of difference: 8.9%-34.2%). Repeat calls for advice were significantly more frequent for the nurse advice service, both within 4 hours (13.0% vs 4.8%; 95% CI of difference: 5.0%-11.4%), and within 72 hours (23.4% vs 13.3%; 95% CI of difference: 5.8%-14.5%). CONCLUSION: Callers were less satisfied with medical advice provided by a nurse advice service compared with the traditional on-call pediatrician. The lower satisfaction was associated with somewhat poorer compliance with recommended triage dispositions and more frequent repeat calls for medical advice.