Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Stark LJ

PROVIDER: S-EPMC6309338 | biostudies-other | 2017 Jan

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

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.

Stark Lori J LJ Filigno Stephanie Spear SS Bolling Christopher C Ratcliff Megan B MB Kichler Jessica C JC Robson Shannon L SL Simon Stacey L SL McCullough Mary Beth MB Clifford Lisa M LM Stough Cathleen O CO Zion Cynthia C Ittenbach Richard F RF

Contemporary clinical trials 20161021

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 ...[more]

PMID: 27777128

Similar Datasets

Project description:BackgroundUnderstanding the cost and/or cost-effectiveness of implementation strategies is crucial for organizations to make informed decisions about the resources needed to implement and sustain evidence-based interventions (EBIs). This economic evaluation protocol describes the methods and processes that will be used to assess costs and cost-effectiveness across implementation strategies used to improve the reach, adoption, implementation, and organizational maintenance of an evidence-based pediatric weight management intervention- Building Health Families (BHF).MethodsA within-trial cost and cost-effectiveness analysis (CEA) will be completed as part of a hybrid type III effectiveness-implementation trial (HEI) designed to examine the impact of an action Learning Collaborative (LC) strategy consisting of network weaving, consultee-centered training, goal-setting and feedback, and sustainability action planning to improve the adoption, implementation, organizational maintenance, and program reach of BHF in micropolitan and surrounding rural communities in the USA, over a 12-month period. We discuss key features of implementation strategy components and the associated cost collection and outcome measures and present brief examples on what will be included in the CEA for each discrete implementation strategy and how the results will be interpreted. The cost data will be collected by identifying implementation activities associated with each strategy and using a digital-based time tracking tool to capture the time associated with each activity. Costs will be assessed relative to the BHF program implementation and the multicomponent implementation strategy, included within and external to a LC designed to improve reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of BHF. The CEA results will be reported by RE-AIM outcomes, using the average cost-effectiveness ratio or incremental cost-effectiveness ratio. All the CEAs will be performed from the community perspective.DiscussionThe proposed costing approach and economic evaluation framework for dissemination and implementation strategies and EBI implementation will contribute to the evolving but still scant literature on economic evaluation of implementation and strategies used and facilitate the comparative economic analysis.Trial registrationClinicalTrials.gov NCT04719442 . Registered on January 22, 2021.

Project description:BACKGROUND:North Carolina Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) resources improve child body mass index (BMI) when the resources are introduced by nurses to child care providers, and offered with workshops and incentives. In San Francisco, public health and child care agencies partnered to adapt NAP SACC resources into an annual "Healthy Apple" quality improvement program (HAP). METHODS:This cluster randomized controlled trial pilot-tested integration of the HAP with bi-annual public health screenings by nurses. All child care centers that participated in Child Care Health Program (CCHP) screenings in San Francisco in 2011-2012 were offered routine services plus HAP in 2012-2013 (CCHP?+?HAP, n?=?19) or routine services with delayed HAP in 2014-2015 (CCHP?+?HAP Delayed, n?=?24). Intention-to-treat analyses (robust SE or mixed models) used 4 years of screening data from 12 to 17 CCHP?+?HAP and 17 to 20 CCHP?+?HAP Delayed centers, regarding 791 to 945 children ages 2 to 5y, annually. Year-specific, child level models tested if children in CCHP?+?HAP centers had greater relative odds of exposure to 3 index best practices and smaller Autumn-to-Spring changes in BMI percentile and z-score than children in CCHP?+?HAP Delayed centers, controlling for age, sex, and Autumn status. Multi-year, child care center level models tested if HAP support modified year-to-year changes (2013-2014 and 2014-2015 vs 2011-2012) in child care center annual mean Autumn-to-Spring BMI changes. RESULTS:In 2011-2012, the CCHP?+?HAP and CCHP?+?HAP Delayed centers had similar index practices (<15% of children were exposed to a physical activity curriculum, staff joining in active play, and drinking water pitchers) and annual BMI changes. In 2013-2014: 60% of children in CCHP?+?HAP centers were exposed to the 3 index practices vs 19% in CCHP?+?HAP Delayed centers; Mean (SE) child BMI percentile (-2.6 (0.9), p?=?0.003) and z-score (-0.08 (0.03), p?=?0.007) decreased more in CCHP?+?HAP vs CCHP?+?HAP Delayed centers. In 2014-2015, after all centers were offered HAP, the index practices and BMI changes were improved for all centers vs 2011-2012. CONCLUSIONS:Integration of the HAP with existing public health nursing services was associated with significantly more children exposed to best practices and improvement in child BMI change. The results warrant continued integration of HAP into local public health infrastructure. TRIAL REGISTRATION:ISRCTN18857356 (24/04/2015) Retrospectively registered.

Project description:BackgroundMulticomponent family-based behavioral treatment (FBT) program for pediatric obesity includes nutrition and physical activity education, as well as behavior therapy techniques. Studies suggest that parent weight loss is the best predictor of child weight loss in FBT. However, given the important role that parents play in the implementation of FBT for their child, isolating the effects of specific FBT treatment component requires consideration of parent influences over time.MethodsThe following treatment components were assessed: stimulus control (high/low-fat food items in home), nutrition knowledge, energy intake, physical activity, and parental monitoring, as well as weekly anthropometric measures. Adjusted models of interest using inverse probability weights were used to evaluate the effect of specific FBT components on time-varying child weight loss rate, adjusting for time-varying influence of parent weight loss.ResultsOne hundred thirty-seven parent-child dyads (CHILD: mean BMI = 26.4 (3.7) and BMIz = 2.0 (0.3); mean age = 10.4 (1.3); 64.1% female; ADULT: mean BMI = 31.9 (6.3); mean age = 42.9 (6.5); 30.1% Hispanic parents; 87.1% female) participated in an FBT program. In traditional model, adult BMI change (b = 0.08; p < 0.01) was the most significant predictor of child weight loss rates and no other treatment components were significant (p's > 0.1). In models that accounted for potential influences from parental weight loss and differential attendance during treatment period, lower availability of high-fat items (b = 1.10, p < 0.02), higher availability of low-fat items (b = 3.73; p < 0.01), and higher scores on parental monitoring practices (b = 1.10, p < 0.01) were associated with greater rates of weight loss, respectively.ConclusionResults suggest that outside of parent weight change, changes in stimulus control strategies at home and improved parental-monitoring practices are important FBT components for child weight loss.

Project description:BackgroundConnect for Health is an evidence-based weight management program with clinical- and family-facing components for delivery in pediatric primary care for families of children ages 2 to 12 years. We used the Consolidated Framework for Implementation Research (CFIR) to guide formative work prior to national implementation. The purpose of this study was to describe the process and results of stakeholder engagement and program adaptation.MethodsWe used mixed qualitative and quantitative methods to iteratively adapt and optimize the program by assessing needs and perspectives of clinicians and parents, as well as contextual barriers, facilitators, and organizational readiness for the uptake of the proposed program tools and implementation strategies. We conducted interviews with primary care clinicians from four health care organizations in Boston, MA; Denver, CO; and Greenville, SC, and used principles of immersion-crystallization for qualitative analyses. We also conducted surveys of parents of children with a body mass index ≥ 85th percentile.ResultsWe reached thematic saturation after 52 clinician interviews. Emergent themes representing the CFIR domains of intervention characteristics, outer and inner setting, and process included (1) importance of evidence-based clinical decision support tools that integrate into the workflow and do not extend visit time, (2) developing resources that respond to family's needs, (3) using multimodal delivery options for family resources, (4) addressing childhood obesity while balancing competing demands, (5) emphasizing patient care rather than documentation and establishing sustainability plans, and (6) offering multiple training methods that incorporate performance feedback. Of the parents surveyed (n = 400), approximately 50% were Spanish-speaking and over 75% reported an annual income < $50,000. Parents affirmed the importance of addressing weight management during well-child visits, being provided with referrals and resources, and offering multiple methods for resource delivery. Decisions about program modifications were made at the program and healthcare-system level and based on stakeholder engagement findings. Modifications included cultural, geographic, and target audience adaptations, as well as varied resource delivery options.ConclusionsTo ensure the fit between the Connect for Health program and national implementation settings, adaptations were systematically made through engagement of clinician and parent stakeholders to support adoption, sustainability, and health outcomes.Trial registrationNCT04042493.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets