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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

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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

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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:Background:Connect 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. Methods:We 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. Results:We 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. Conclusions:To 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 registration:NCT04042493.

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.

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