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Improving nutrition and physical activity environments of family child care homes: the rationale, design and study protocol of the 'Healthy Start/Comienzos Sanos' cluster randomized trial.

ABSTRACT: BACKGROUND:Early childhood is a crucial time to foster healthy eating and physical activity (PA) habits, which are critical for optimal child health, growth and development. Child care facilities are important settings to promote healthy eating and PA and prevent childhood obesity; however, almost all prior intervention studies have focused on child care centers and not family child care homes (FCCH), which care for over 1.6 million U.S. children. METHODS:This paper describes Healthy Start/Comienzos Sanos, a cluster-randomized trial evaluating the efficacy of a multicomponent intervention to improve nutrition and PA environments in English and Spanish-speaking FCCH. Eligible child care providers complete baseline surveys and receive a two-day FCCH observation of the home environment and provider practices. Parent-consented 2-5?year-old children are measured (height, weight, waist circumference), wear accelerometers and have their dietary intake observed during child care using validated protocols. FCCH providers are then randomly assigned to receive an 8-month intervention including written materials tailored to the FCCH providers' need and interest, videos, peer support coaching using brief motivational interviewing, and periodic group meetings focused on either nutrition and PA (Intervention) or reading readiness (Comparison). Intervention materials focus on evidence-based nutrition and physical activity best practices. The initial measures (surveys, two-day observation of the FCCH and provider practices, child diet observation, physical measures, and accelerometer) are assessed again 8 and 12?months after the intervention starts. Primary outcomes are children's diet quality (Healthy Eating Index), time in moderate and vigorous PA and sedentary PA during child care. Secondary outcomes include FCCH provider practices and foods served, and PA environments and practices. Possible mediators (provider attitudes, self-efficacy, barriers and facilitators) are also being explored. Process evaluation measures to assess reach, fidelity and dose, and their relationship with dietary and PA outcomes are included. DISCUSSION:Healthy Start/Comienzos Sanos fills an important gap in the field of childhood obesity prevention by rigorously evaluating an innovative multicomponent intervention to improve the nutrition and physical activity environments of FCCH. TRIAL REGISTRATION:(# NCT02452645 ) ClinicalTrials.gov Trial registered on May 22, 2015.

SUBMITTER: Risica PM

PROVIDER: S-EPMC6472069 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Improving nutrition and physical activity environments of family child care homes: the rationale, design and study protocol of the 'Healthy Start/Comienzos Sanos' cluster randomized trial.

Risica Patricia Markham PM Tovar Alison A Palomo Vanessa V Dionne Laura L Mena Noereem N Magid Kate K Ward Diane Stanton DS Gans Kim M KM

BMC public health 20190418 1

<h4>Background</h4>Early childhood is a crucial time to foster healthy eating and physical activity (PA) habits, which are critical for optimal child health, growth and development. Child care facilities are important settings to promote healthy eating and PA and prevent childhood obesity; however, almost all prior intervention studies have focused on child care centers and not family child care homes (FCCH), which care for over 1.6 million U.S. children.<h4>Methods</h4>This paper describes Heal ...[more]

PMID: 30999881

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Project description:BACKGROUND:Early childhood is a critical period of development. Caregivers, including providers of early care and education (ECE), have a substantial influence on the health of young children. Family child care homes (FCCHs), which are small, licensed ECE businesses operated out of the residences of providers, are important settings for promoting child health. However, to date, few interventions to promote the health of children have been developed for FCCHs. The purpose of this article is to describe the protocol for Happy Healthy Homes, a pilot interdisciplinary, community-based study to improve FCCH environments and the health of children in Oklahoma. We describe the development and evaluation of two interventions to be tested in a matched attention randomized controlled trial: 1) a nutrition intervention aimed at enhancing the nutritional quality of meals served to young children, incorporating the Child and Adult Care Food Program best practices, and improving nutritional self-efficacy of providers; and 2) an environmental intervention aimed at increasing providers' environmental health literacy, self-efficacy for integrated pest management (IPM), and awareness of less toxic cleaning practices and FCCH provider cleaning behaviors. METHODS:Both interventions are informed by common theoretical principles and are matched in attention (i.e., 6 h), format (i.e., two individual 90-min educational home visits and a 3-h small group class) and materials (i.e., tool kit of educational materials and supplies tailored to the allocated intervention). A randomized trial of both interventions is currently underway with 52 FCCH providers in the Oklahoma City metropolitan area who participate in the Child and Adult Care Food Program. Observed and self-reported measures will be collected at baseline, and 3 months and 12 months after baseline measurements. Randomization to one of the two interventions will occur after baseline data collection. DISCUSSION:This study aims to support FCCH providers in creating healthier FCCH environments for nutrition and environmental health. Successful completion will provide critical information about the nutritional quality and the environmental health of children in FCCHs, as well as much needed evidence about the efficacy of two community-based interventions to improve the nutrition and environmental health of children in home-based ECE settings. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03560050 . Retrospectively registered on 23 May 2018.

Project description:Early care and education (ECE) settings play an important role in shaping the nutrition and physical activity habits of young children. Increasing research attention is being directed toward family child care homes (FCCHs) specifically. However, existing measures of child care nutrition and physical activity environments are limited in that they have been created for use with center-based programs and require modification for studies involving FCCHs. This paper describes the modification of the Environment and Policy Assessment and Observation (EPAO) for use in FCCHs.The EPAO underwent a through modification process that incorporated an updated format for the data collection instrument, assessment of emerging best practices, tailoring to the FCCH environment, and creation of a new scoring rubric. The new instrument was implemented as part of a larger randomized control trial. To assess inter-rater reliability, observations on 61 different days were performed independently by two data collectors. To assess construct validity, associations between EPAO scores and measures of children's dietary intake (Healthy Eating Index (HEI) score) and physical activity (accelerometer-measured minutes per hour of moderate to vigorous physical activity, MVPA) were examined.The modified EPAO assesses 38 nutrition and 27 physical activity best practices, which can be summarized into 7 nutrition-related and 10 physical activity-related environmental sub- scores as well as overall nutrition and overall physical activity scores. There was generally good agreement between data collectors (ICC > 0.60). Reliability was slightly lower for feeding practices and physical activity education and professional development (ICC = 0.56 and 0.22, respectively). Child HEI was significantly correlated with the overall nutrition score (r = 0.23), foods provided (r = 0.28), beverages provided (r = 0.15), nutrition education and professional development (r = 0.21), and nutrition policy (r = 0.18). Child MVPA was significantly associated with overall time provided for activity (r = 0.18) and outdoor playtime (r = 0.20). There was also an unexpected negative association between child MVPA and screen time (-0.16) and screen time practices (r = -0.21).The EPAO for the FCCH instrument is a useful tool for researchers working with this unique type of ECE setting. It has undergone rigorous development and testing and appears to have good psychometric properties.NCT01814215 , March 15, 2013.

Project description:ObjectiveTo determine whether Rojiroti microfinance, for poor Indian women, improves child nutrition.DesignCluster randomised trial.SettingTolas (village communities) in Bihar State.ParticipantsWomen and children under 5 years.InterventionsWith Rojiroti microfinance, women form self-help groups and save their money to provide loans to group members. After 6 months, they receive larger external loans. Tolas were randomised to receive Rojiroti immediately or after 18 months.Outcome measuresThe primary analysis compared the mean weight for height Z score (WHZ) of children under 5 years in the intervention versus control tolas who attended for weight and height measurement 18 months after randomisation. Secondary outcomes were weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting.ResultsWe randomised 28 tolas to each arm and collected data from 2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up. At 18 months, mean WHZ was significantly higher for intervention (-1.02) versus controls (-1.37; regression coefficient adjusted for clustering β=0.38, 95% CI 0.16 to 0.61, p=0.001). Significantly fewer children were wasted in the intervention group (122, 18%) versus control (200, 29%; OR=0.46, 95% CI 0.28 to 0.74, p=0.002). Mean WAZ was better in the intervention group (-2.13 vs -2.37; β=0.27, 95% CI 0.11 to 0.43, p=0.001) as was MUAC (13.6 cm vs 13.4 cm; β=0.22, 95% CI 0.03 to 0.40, p=0.02). In an analysis adjusting for baseline nutritional measures (259 intervention children and 300 control), only WAZ and % underweight showed significant differences in favour of the intervention.ConclusionIn marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.Trial registration numberNCT01845545.

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:BackgroundAlthough the mandate of recreational facilities is to enhance well-being, many offer foods inconsistent with recommendations for healthy eating. Little is known regarding recreational facility food environments and how they might be improved, as few studies exist. The Alberta Nutrition Guidelines for Children and Youth (ANGCY) are intended to ensure access to healthy food choices in schools, childcare and recreational facilities. This study investigated awareness, adoption and implementation of the ANGCY among recreational facilities in Alberta, Canada, one year following their release.MethodsA cross-sectional telephone survey was conducted from June - December, 2009 (n = 151) with managers of publicly funded recreational facilities that served food. The questionnaire included 10 closed and 7 open ended questions to assess the organizational priority for healthy eating, awareness, adoption and implementation of the ANGCY. Chi-squared tests examined quantitative variables, while qualitative data were analysed using directed content analysis. Greenhalgh's model of diffusion of complex innovations within health service organizations constituted the theoretical framework for the study.ResultsOne half of respondents had heard of the ANGCY, however their knowledge of them was limited. Although 51% of facilities had made changes to improve the nutritional quality of foods offered in the past year, only a small fraction (11%) of these changes were motivated by the ANGCY. At the time of the survey, 14% of facilities had adopted the ANGCY and 6% had implemented them. Barriers to adoption and implementation were primarily related to perceived negative attributes of the ANGCY, the inner (organizational) context, and negative feedback received during the implementation process. Managers strongly perceived that implementing nutrition guidelines would limit their profit-making ability.ConclusionsIf fully adopted and implemented, the ANGCY have the potential to make a significant and sustained contribution to improving the recreational facility food environment, however one year following their release, awareness, adoption and implementation of the ANGCY remained low. A mandated policy approach could offer an efficacious, cost-effective means of improving the food environment within recreational facilities.

Project description:BACKGROUND:Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) study, a federally funded, randomized trial comparing two pharmacologic strategies against a control condition to manage SGA-related weight gain. METHODS:The design and methodology considerations of the IMPACT trial are described and embedded in a description of health risks associated with antipsychotic-related weight gain and the limitations of currently available research. RESULTS:The IMPACT study is a 4-site, six month, randomized, open-label, clinical trial of overweight/obese youth ages 8-19 years with pediatric schizophrenia-spectrum and bipolar-spectrum disorders, psychotic or non-psychotic major depressive disorder, or irritability associated with autistic disorder. Youth who have experienced clinically significant weight gain during antipsychotic treatment in the past 3 years are randomized to either (1) switch antipsychotic plus healthy lifestyle education (HLE); (2) add metformin plus HLE; or (3) HLE with no medication change. The primary aim is to compare weight change (body mass index z-scores) for each pharmacologic intervention with the control condition. Key secondary assessments include percentage body fat, insulin resistance, lipid profile, psychiatric symptom stability (monitored independently by the pharmacotherapist and a blinded evaluator), and all-cause and specific cause discontinuation. This study is ongoing, and the targeted sample size is 132 youth. CONCLUSION:Antipsychotic-related weight gain is an important public health issue for youth requiring ongoing antipsychotic treatment to maintain psychiatric stability. The IMPACT study provides a model for pediatric research on adverse event management using state-of-the art methods. The results of this study will provide needed data on risks and benefits of two pharmacologic interventions that are already being used in pediatric clinical settings but that have not yet been compared directly in randomized trials. TRIAL REGISTRATION:Clinical Trials.gov NCT00806234.

Dataset Information

Improving nutrition and physical activity environments of family child care homes: the rationale, design and study protocol of the 'Healthy Start/Comienzos Sanos' cluster randomized trial.

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Improving nutrition and physical activity environments of family child care homes: the rationale, design and study protocol of the 'Healthy Start/Comienzos Sanos' cluster randomized trial.

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