Giving adolescents with cystic fibrosis a voice: Predicting cystic fibrosis nutritional adherence from their decision-making involvement.

OBJECTIVE: Suboptimal nutritional adherence in adolescents with cystic fibrosis (awCF) has been associated with lower lung function. AwCF often have more independence in dietary decisions than younger children, yet little research has examined how adolescent decision-making relates to nutritional adherence. This study explored whether components of adolescent decision-making involvement facilitate enzyme and caloric adherence in awCF. METHODS: 37 families participated and completed study procedures. AwCF and caregivers completed electronic surveys, including the Decision-Making Involvement Scale (DMIS). The DMIS evaluated awCF behaviors during nutrition-related decision-making/discussions with caregivers using DMIS subscales: Child Seek (asking for help/advice from caregivers), Child Express (awCF stating opinions) and Joint/Options (awCF participating in joint decision-making or caregiver providing options). AwCF completed 2, 24-hr diet recalls via videoconferencing/phone to estimate adherence. Chart reviews collected medical information. DMIS subscales were regressed onto enzyme and caloric adherence. RESULTS: 43% of awCF met calorie recommendations; 48.6% took all enzymes as prescribed. Caloric adherence was positively correlated with adolescent- and parent-reported Child Seek (r = 0.53; r = 0.36) and adolescent-reported Joint/Options (r = 0.41). Per adolescent-report, the caloric adherence regression model was significant, with Child Seek contributing unique variance in caloric adherence (ß = .62, p = .03). Parent-reported adolescent-decision-making involvement significantly predicted caloric adherence, but none of the subscales contributed unique variance. No other regressions were significant. CONCLUSIONS: When awCF participated in nutrition-related discussions with a caregiver, especially with questions, caloric adherence was better. Future research should examine whether family factors influence these results. AwCF are encouraged to ask questions in nutrition discussions.

Education-related needs for children with cystic fibrosis: Perspectives of US pediatric care teams.

OBJECTIVE: Patients with cystic fibrosis (CF) often bring education-related concerns to their medical teams. Concerns around the ability for CF care teams to identify and address these concerns exist. We sought to describe CF care team perceptions of (1) patient and family education-related needs, (2) how these needs are identified, documented and addressed, and (3) education-related resource gaps. METHODS: A survey was emailed to pediatric care teams in the CF Foundation Care Center Network in April 2022. Individuals or care teams could complete the survey. Responses were aggregated for descriptive analysis. RESULTS: Sixty-seven programs responded representing 52% of United States pediatric CF centers. Most centers (88%) indicated social workers primarily address school concerns. Care teams often complete school forms (99%), coach families to communicate with schools (96%), communicate with schools directly (90%), and develop educational plans (76%). Formal education risk assessment and support programs are relatively uncommon (19%). Common student-specific needs include carrying medications (75%) and leaving class for gastrointestinal issues (54%). Needs reported are informational materials for families and schools (94%), staff education about school concerns and how to address them (91%), additional staff for education-related issues (65%), and expertise in education plan development (62%). CONCLUSION: CF care teams often lack comprehensive resources to identify and address education-related concerns. Systematically performing needs assessments, improving training for providers, and evaluating the benefits of education specialists on care teams may better identify and address education-related needs. Supporting educational progression will foster continued independence and well-being in adulthood.

Longitudinal mental health trends in cystic fibrosis.

BACKGROUND: Mental health screening in accordance with consensus guidelines became routine clinical practice in our cystic fibrosis (CF) Center in 2015. We hypothesized improvement in anxiety and depression symptoms over time and associations between elevated screening scores and disease severity. We aimed to observe the impact of the COVID-19 pandemic and modulator use on mental health symptoms. METHODS: Retrospective chart reviews were conducted for people 12 years and older with at least one Generalized Anxiety Disorder-7 (GAD-7) or Patient Health Questionnaire-9 (PHQ-9) screening for six years. Descriptive statistics were used to summarize demographic variables and logistic regression and linear mixed models were used to evaluate the relationship between screening scores and clinical variables. RESULTS: Analyses included 150 participants (ages 12-22 years). The percentage of minimal to no symptom scores increased over time for anxiety and depression. Increased mental health visits and CFRD were associated with higher PHQ-9 and GAD-7 scores. Higher FEV1pp was associated with lower GAD-7 and PHQ-9 scores. More effective modulator use was associated with lower PHQ-9 scores. Mean PHQ-9 and GAD-7 scores were not significantly different when comparing pre-pandemic and pandemic scores. CONCLUSION: Disruptions in screening during the pandemic were minimal and symptom scores remained stable. Individuals with higher mental health screening scores were more likely to have CFRD and utilization of mental health services. Consistent mental health monitoring and support is needed so individuals with CF can endure anticipated and unanticipated stressors including changes in physical health, healthcare, and societal stressors such as COVID-19 pandemic.

Longitudinal Assessment of Educational Risk for K-12 Students with Cystic Fibrosis.

OBJECTIVES: To assess the use of services provided by a cystic fibrosis (CF) center school specialist and evaluate relationships among student educational risk scores, family concerns for school engagement and performance, and disease severity. STUDY DESIGN: This was a retrospective review of medical records for 126 children with CF in grades K-12 who were screened for educational risk or used school intervention services during the 2017- 020 school years. Regression analyses were performed to identify and quantify predictors of educational risk, family concern for school performance and ability to advocate, and use of school specialist services. RESULTS: Most children with CF (62%-82%) were at moderate-to-high educational risk. Sixteen or more school absences, family concerns for their child's school performance or inability to advocate for their school needs, child mental health visits, and greater frequency of hospitalization predicted greater educational risk scores and more encounters with the school specialist. Better lung function and lower grade level were associated with lower educational risk. Number of encounters with the School Specialist remained high across three pre-coronavirus disease 2019 school years. CONCLUSIONS: Our experience illustrates a need to identify educational risk and support school experiences of children and youth with CF as a component of the care model. Tailored support, based on identification of risk predictors, has potential to improve educational outcomes.

Management of Mental Health in Cystic Fibrosis.

This article is intended for use among all cystic fibrosis care team members. It covers common mental health concerns and their unique presentations in persons with cystic fibrosis (pwCF) in areas such as depression, anxiety, trauma, behavioral disorders emerging in childhood, sleep, problematic eating patterns, and the impact of substance use. Furthermore, the authors address ways to manage these mental health symptoms through risk assessment, psychological interventions, and/or psychotropic medications. Quick reference tables are provided for evidence-based psychological interventions and medications often used for mental health conditions in pwCF.

Assessment of treatment burden and complexity in cystic fibrosis: A quality improvement project.

BACKGROUND: Treatment regimens for cystic fibrosis (CF) continue to evolve and grow in complexity. Treatment regimen burden, and associated sequelae, are incompletely understood. OBJECTIVE: Quality improvement (QI) methods were used to investigate treatment burden of CF care, family and care team partnerships, and potential interventions to reduce burden. METHODS: Patients 6-24 years with CF and caregivers of patients 6-13 years were surveyed. Portions of validated tools and existing surveys measured burden and family-care team partnership. An automated report calculated treatment complexity. Plan-do-study-act cycles tested survey administration during CF visits and run charts tracked progress. Interventions to reduce burden were tracked, and bidirectional assessments explored partnerships among patients, families and clinicians. RESULTS: Over 6 months, 110 patients and 62 caregivers completed assessments. Caregivers reported lower burden/higher quality of life (74.0, range 22.2-100) than patients (66.5, range 16.7-100). The mean treatment complexity score was 17.2 (range 6-34). Treatment complexity and burden increased with patient age (p < .05 and p < .01 respectively). Lower lung function correlated with higher patient-reported burden (p < .01) and higher treatment complexity (p < .0001). As burden increased, providers more often performed select interventions (discussed combining treatments, simplified regimens, or involved other team members (p < .05 for each)). Families reported high partnership (mean scores 4.7-4.8, 5 = high), and providers reported high utilization of partnership tools (tool used in 77% of encounters). CONCLUSION: We assessed, quantified, and responded to treatment burden and complexity in real-time during outpatient CF visits. Systematic and individualized assessments of treatment complexity and burden may enhance treatment adherence while preserving quality of life.

Promoting emotional wellness in children with cystic fibrosis, Part I: Child and family resilience.

Attention should be given to individual and family well-being from a child's first interaction with the medical team and continuing throughout development, especially for families who experience chronic illnesses, such as cystic fibrosis (CF). While much attention has been given to the mental health of people with CF 12 years and older, this paper explores various areas for CF teams to assess and provide additional resources during the first 12 years of a child's life to promote child and family wellness. In this paper, we discuss parental mental health, social determinants of health, adherence/self-care, nutrition, attention to family lifestyle factors, engagement with school and peers, and modulator therapy for this age group of people with CF. This is the first of two companion papers which examines emotional wellness of children during the early years. The second paper examines mental health assessment and intervention for children under 12. Both encourage teams to strive to promote optimal child and family emotional health and wellness, emphasizing holistic health promotion and prevention, early identification, and intervention.

Promoting emotional wellness in children with CF, part II: Mental health assessment and intervention.

This is the second of two companion papers that examine the emotional wellness of children with cystic fibrosis (CF) during the early years of life, defined here as the period between birth and age 12. Both papers promote optimal mental health and well-being, with an emphasis on early identification and intervention. The first paper explores child and family resilience. Here, we discuss strategies for pediatric CF teams to provide routine, systematic mental health assessment, anticipatory guidance, brief intervention, and triage to evidence-based treatment when needed, while addressing barriers to accessing care. Many mental health conditions emerge before the age of 12, with the potential for lifelong effects on individuals, their families, and society. Living with a chronic illness such as CF can further increase the risk of mental health concerns and, in a bidirectional manner, their consequences for the quality of life, sustaining daily care, and health outcomes. There has been a significant focus in recent years on the mental health and wellness of adolescents and adults with CF, but less attention to specifics of depression and anxiety in younger children, or to other common pediatric comorbidities including trauma, developmental disorders such as attention-deficit/hyperactivity disorder or autism spectrum disorder, and oppositional behavior. Given the availability of psychometrically sound screening instruments and effective interventions, routinely addressing the mental health of children with CF and their families is feasible to integrate within multidisciplinary CF care, allowing for a personalized approach respecting individual needs, values, and goals.

Introduction to Cystic Fibrosis for Mental Health Care Coordinators and Providers: Collaborating to Promote Wellness.

To maximize health, individuals with cystic fibrosis (CF) follow a complex, burdensome daily care regimen. Managing CF is associated with a range of significant biopsychosocial challenges and places individuals with CF, and their caregivers, at greater risk for developing anxiety and depression. To promote wellness and address the potential barriers that affect management of this complex chronic illness, many individuals would benefit from treatment from a behavioral health provider. Social workers within multidisciplinary CF care teams are well positioned to respond to this need, and an expanding number of social workers serving as behavioral health providers in the community will be sought as a resource to provide treatment to this population. This article serves as a primer for social workers to maximize knowledge of the psychosocial and potential behavioral health needs of individuals with CF across the life span. To best support individuals with CF, authors describe the disease-specific manifestations and outline the numerous potential clinical targets for social work to promote wellness. The article concludes by highlighting the importance of communication with the medical team and considerations for effective collaborative care.

A Pilot Study of Mindfulness-Based Cognitive Therapy to Improve Well-Being for Health Professionals Providing Chronic Disease Care.

OBJECTIVE: To assess the efficacy of mindfulness-based cognitive therapy delivered onsite during work hours in reducing stress and improving well-being in an interdisciplinary chronic care health care team. STUDY DESIGN: A longitudinal, mixed methods, observational pilot study using a survey created from validated assessment tools to measure effectiveness of training. Surveys were completed before training, and 1 and 15 months after training. Twenty-four professionals in the cystic fibrosis Centers at Cincinnati Children's Hospital and the University of Cincinnati participated in 6 mindfulness-based cognitive therapy training sessions. Sessions incorporated mindfulness, cognitive therapy, and experiential exercises for processing feelings related to stress and burnout. RESULTS: The presurvey and 1-month postsurvey responses revealed statistically significant improvements for empathy, perceived stress, depersonalization, anxiety, perspective taking, resilience, and negative affect. Sustained effects were seen at 15 months for empathy, perspective taking, and depressive symptoms. The 1-month post-training surveys reported a quarter of respondents (25%) practiced skills at least 5 times in between sessions; at 15 months, 35% reported practicing at the same frequency. Participants reported using mindfulness skills for personal stressful events (74%), work-related general stress (65%), patient-related stress (30%), sleep or general relaxation (22%), and wellness (13%). CONCLUSIONS: Group mindfulness-based cognitive therapy training was feasible and effective in decreasing stress for interdisciplinary cystic fibrosis care team members who elected to participate. Further investigation is needed to determine optimal dose of training, durability of perceived benefits, and generalizability to health care professionals working with other chronic disorders.

Assessing and responding to stress related to pulmonary function testing in cystic fibrosis through quality improvement.

BACKGROUND: Pulmonary function tests (PFTs) are performed routinely to evaluate lung function in patients with cystic fibrosis (CF). Staff at the Cincinnati Children's Hospital Medical Center CF Center observed stress in patients before PFTs. An interdisciplinary quality improvement (QI) team was assembled to address this clinical issue. METHODS: The Plan-Do-Study-Act method of QI was used to investigate feasibility of assessing stress and offering brief interventions to reduce stress before PFTs. Interventions included listening to music, covering the PFT screen, or doing breathing meditation before PFTs. Patients rated stress levels on a 1 to 5 Likert scale before and after testing. RESULTS: Of 75 patient encounters, interventions were trialed in 20. Fifteen patients who tried an intervention reported wanting to use the intervention again (five encounters had missing data); patients reported that the intervention benefited performance on PFTs in eight encounters (40%). The average pre-PFT stress rating for encounters that trialed an intervention was 2.1 and post-PFT rating was 2.0. Average stress pre-PFT and post-PFT ratings were 1.7 and 1.6 respectively, for encounters that did not trial an intervention. Median length of PFT encounter was 15 minutes regardless of whether intervention was trialed. CONCLUSION: Some patients with CF utilized interventions, while many opted out. This QI effort identified feasible outpatient clinic interventions that did not negatively impact clinic flow. Finding ways to reduce stress associated with PFTs could have a meaningful impact on patient performance and emotional well-being for a subset of patients.

Executive functioning in pediatric cystic fibrosis: A preliminary study and conceptual model.

BACKGROUND: Research has shown that broad cognitive functioning in individuals with CF is intact. Specific executive functioning (EF) deficits have been identified, however, and adults with CF report more symptoms of ADHD than the general population. EF skills are critical to the management of a complex disease like CF although studies have not adequately examined EF mechanisms in CF. This manuscript (a) described EF in a small sample of children with CF, (b) summarized relations found between EF and psychosocial variables, and (c) presented a conceptual model by which to understand EF's impact on adherence in CF. METHODS: Data for this preliminary study were collected from 19 children with CF and their caregivers (ages, 6-18). Caregivers completed questionnaires assessing their child's physical and mental health, their own functioning, and overall family functioning. EF was measured using a parent-report rating scale. Patient health data were collected from the electronic medical record. RESULTS: This sample did not demonstrate elevated levels of EF impairment. Worse EF was related to poor family communication/cohesion, as well as higher treatment burden, worse lung function, poorer adherence, and older age. From these findings, a preliminary model was developed describing EF in the context of CF and adherence. CONCLUSIONS: Findings from this preliminary study suggest that the CF regimen and associated symptoms may overload otherwise adequate EF skills. Reducing disease burden and preventing burnout should be a focus of treatment. A better understanding of EF in CF and the impact on adherence would allow for better clinical management and effective design of interventions.

Psychological predictors of nutritional adherence in adolescents with cystic fibrosis.

BACKGROUND & AIMS: The CF medical regimen is notoriously burdensome, comprised of respiratory treatments, oral medications, and nutritional demands. Adequate caloric intake has been identified as a challenge over the lifespan; however, we lack detailed information about nutritional adherence in teens, and the contextual drivers of these behaviors. Adolescence is a time of increased responsibility, reduced parental monitoring, and growing peer connections. There is no literature examining the impact of familial attitudes (e.g., privacy, disease disclosure) and the social milieu (e.g., friendships) on teen nutritional adherence behavior. We hypothesized that better teen nutritional adherence behaviors would be predicted by more favorable familial privacy attitudes, better relationship quality, and greater comfort in disease disclosure. METHODS: Assessment included questionnaires of caregiver privacy attitudes, relationship quality, and disease disclosure. Teens tracked PERT adherence for 1 month and logged daily caloric intake for 2 weeks. This produced detailed information on daily enzyme adherence, caloric intake, and eating frequency. RESULTS: Average PERT adherence, caloric intake, and eating frequency were suboptimal in this sample. More comfort in disease disclosure and less teen/mother discord predicted better PERT adherence. Higher caregiver privacy and lower teen closeness with friends predicted greater caloric intake and eating frequency. CONCLUSIONS: Results suggest that comfort in disease disclosure supports consistent PERT adherence across environments. Adolescents with close friendships may have less time for self-management (e.g., eating). Future research should collect more detailed information about friendships of teens with CF. Results suggest that daily structure and positive, appropriately supportive relationships should be encouraged by care teams.

Assessing psychosocial risk in pediatric cystic fibrosis.

BACKGROUND: Psychosocial risk factors are known to impact quality of life, treatment adherence, and health outcomes. No standardized comprehensive psychosocial risk screener is routinely utilized in cystic fibrosis (CF) care. The objectives of the study were to describe the range and severity of psychosocial risk within this CF population, investigate the reliability of a comprehensive psychosocial screener in pediatric CF clinical care, and explore relationships between psychosocial risk and key factors affecting health outcomes. It was hypothesized that the PAT-CF total and subscale α coefficients would be similar to those found in other pediatric medical populations. METHOD: Parents of 154 children with CF completed a CF-specific version of the Psychosocial Assessment Tool_All-lit (PAT-CF), an empirically-based psychosocial risk assessment, during routine CF clinical care. RESULTS: The internal consistency of the PAT-CF Total score was 0.71. Total score and subscale reliabilities reflect findings in other pediatric populations. Total risk scores fell in the following categories: 7% (Clinical-highest risk), 41% (Targeted), and 52% (Universal-lowest risk), respectively. Increased psychosocial risk was associated with Medicaid status and lower parent education, whereas having private insurance was associated with decreased psychosocial risk. CONCLUSIONS: The PAT-CF can feasibly be used as an empirically-based comprehensive psychosocial risk tool in routine CF care and is acceptable by parents. In addition to providing universal anticipatory guidance regarding child and family wellness, early identification of risk factors allows care teams to proactively provide targeted support and intervention for specific psychosocial risk factors to promote improved quality of life and ability to sustain daily care.

Maintenance Following a Randomized Trial of a Clinic and Home-based Behavioral Intervention of Obesity in Preschoolers.

OBJECTIVE: To assess maintenance of improved weight outcomes in preschoolers with obesity 6 and 12 months following a randomized clinical trial comparing a home- and clinic-based behavioral intervention (Learning about Activity and Understanding Nutrition for Child Health [LAUNCH]) to motivational interviewing and standard care. STUDY DESIGN: Randomized controlled trial with children between the ages of 2 and 5 years above the 95th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012, and June 8, 2015, were followed 6 and 12 months post-treatment. Child and caregiver weight, height, and caloric intake, child physical activity, and home environment were assessed. The primary outcome was maintenance of greater reduction of percent over the 50th percentile body mass index (BMI%50th) by LAUNCH compared with motivational interviewing and standard care at the 6- and 12-month follow-up. RESULTS: Significantly lower child BMI%50th was maintained for LAUNCH compared with motivational interviewing at 12-month follow-up and to standard care at the 6-month follow-up; however, the effect sizes were maintained for comparison with standard care at 12-month follow-up. LAUNCH had significantly lower daily caloric intake compared with motivational interviewing and standard care at both follow-ups and maintained significantly fewer high-calorie foods in the home compared with standard care at 6 and 12 months and compared with motivational interviewing at 12 months. However, caloric intake increased by 12% from post-treatment. LAUNCH caregivers did not maintain improved BMI at follow-up. CONCLUSIONS: LAUNCH showed success in reducing weight in preschoolers. However, maintaining treatment gains post-treatment is more difficult. Treatment may need to last longer than 6 months to achieve optimal results. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01546727.

Are Preschoolers Meeting the Mark? Comparing the Dietary, Activity, and Sleep Behaviors of Preschoolers With Obesity to National Recommendations.

Objective: National health organizations and expert committees have issued recommendations for health behaviors related to obesity risk. Behavioral and family-based weight management interventions for preschoolers often target improving adherence to these recommendations, but it is unknown how the health behaviors of preschoolers with obesity enrolled in weight control treatments (WCTs) compare with these guidelines. In this study, the dietary intake, activity, and sleep behaviors of preschoolers with obesity enrolled in a family-based behavioral WCT are described and compared with national health behavior recommendations. Methods: Health behaviors of 151 preschoolers with obesity (M age = 4.60, SD = 0.93) enrolled in a clinical trial of a weight management program were measured at baseline through caregiver-report questionnaires, three 24-hr dietary recalls, and accelerometers. Results: In total, 70% of the sample exceeded daily caloric recommendations, only 10 and 5% met recommendations for fruit and vegetable intake, respectively, and only 30% met the recommendation of consuming no sugar-sweetened beverages. The majority of the sample met the daily recommendations for 60 min of moderate-to-vigorous activity (80%), < 2 hr of screen time (68%), and sleep duration (70%). Conclusions: Behavioral weight management interventions for preschoolers with obesity should target the health behaviors where children are not meeting recommendations.

Clinic and Home-Based Behavioral Intervention for Obesity in Preschoolers: A Randomized Trial.

OBJECTIVE: To test the hypotheses that an innovative skills-based behavioral family clinic and home-based intervention (LAUNCH) would reduce body mass index z score (BMIz) compared with motivational interviewing and to standard care in preschool-aged children with obesity. STUDY DESIGN: Randomized controlled trial with children between the ages of 2 and 5 years above the 95th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012 and June 8, 2015. Children were randomized to LAUNCH (an 18-session clinic and home-based behavioral intervention), motivational interviewing (delivered at the same frequency as LAUNCH), or standard care (no formal intervention). Weight and height were measured by assessors blinded to participant assignment. The primary outcome, BMIz at month 6 after adjusting for baseline BMIz, was tested separately comparing LAUNCH with motivational interviewing and LAUNCH with standard care using regression-based analysis of covariance models. RESULTS: A total of 151 of the 167 children randomized met intent-to-treat criteria and 92% completed the study. Children were 76% White and 57% female, with an average age of 55 months and BMI percentile of 98.57, with no demographic differences between the groups. LAUNCH participants demonstrated a significantly greater decrease in BMIz (mean = -0.32, SD = ±0.33) compared with motivational interviewing (mean = -0.05, SD = ±0.27), P < .001, ω2 = 0.74 and compared with standard care (mean = -0.13, SD = ±0.31), P < .004, ω2 = 0.75. CONCLUSIONS: In preschool-age children, an intensive 6-month behavioral skills-based intervention is necessary to reduce obesity. TRIAL REGISTRATION: Clinicaltrials.gov NCT01546727.

Macronutrient intake in preschoolers with cystic fibrosis and the relationship between macronutrients and growth.

BACKGROUND: Adequate nutrition is essential for growth in children with cystic fibrosis (CF). The new CF Foundation Clinical Practice Guidelines bring attention to monitoring macronutrient intake as well as total energy. METHODS: Dietary intake of 75 preschool children with CF and pancreatic insufficiency was examined and compared to the Clinical Practice Guidelines. Regression analyses examined relationships between macronutrient intake and growth. RESULTS: Approximately 45% of children met the 110% minimum recommended dietary allowance (RDA) recommendation. Children consumed 35.3% (6.1) of total daily energy intake from fat, 12.7% (1.7) from protein, and 52.0% (6.1) from carbohydrates. Percent energy from protein was associated with height growth. CONCLUSIONS: Many preschoolers with CF are not meeting nutrition benchmarks for total energy and fat. To optimize nutrition early, dietary monitoring with frequent individualized feedback is needed. Optimizing intake of macronutrients that promote growth, especially fat and protein, should be a primary clinical target.

Learning about Activity and Understanding Nutrition for Child Health (LAUNCH): Rationale, design, and implementation of a randomized clinical trial of a family-based pediatric weight management program for preschoolers.

Obesity affects nearly 2 million preschool age children in the United States and is not abating. However, research on interventions for already obese preschoolers is limited. To address this significant gap in the literature, we developed an intervention targeting obesity reduction in 2 to 5year olds, Learning about Activity and Understanding Nutrition for Child Health (LAUNCH). This paper describes the rationale, design, participant enrollment, and implementation of a 3-arm randomized, parallel-group clinical trial comparing LAUNCH to a motivational-interviewing intervention (MI) and standard care (STC), respectively. Whereas LAUNCH was designed as a skills based intervention, MI focused on addressing the guardian's motivation to make changes in diet and activity and providing tools to do so at the guardian's level of readiness to implement changes. Child body mass index z-score was the primary outcome, assessed at pretreatment, posttreatment (Month 6), and 6 and 12month follow-ups (Months 12 and 18). Mechanisms of weight change (e.g., dietary intake, physical activity) and environmental factors associated with weight (e.g., foods available in the home, caregiver diet) were also assessed. This study is unique because it is one of the few randomized controlled trials to examine a developmentally informed, clinic and home skills based behavioral family intervention for preschoolers who are already obese. Being obese during the preschool years increases the likelihood of remaining obese as an adult and is associated with serious health conditions; if this intervention is successful, it has the potential to change the health trajectories for young children with obesity.