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Study protocol for a cluster randomized controlled trial to test "¡Miranos! Look at Us, We Are Healthy!" - an early childhood obesity prevention program.

ABSTRACT: BACKGROUND:One in three Head Start children is either overweight or obese. We will test the efficacy of an early childhood obesity prevention program, "¡Míranos! Look at Us, We Are Healthy!" (¡Míranos!), which promotes healthy growth and targets multiple energy balance-related behaviors in predominantly Latino children in Head Start. The ¡Míranos! intervention includes center-based (policy changes, staff development, gross motor program, and nutrition education) and home-based (parent engagement/education and home visits) interventions to address key enablers and barriers in obesity prevention in childcare. In partnership with Head Start, we have demonstrated the feasibility and acceptability of the proposed interventions to influence energy balance-related behaviors favorably in Head Start children. METHODS:Using a three-arm cluster randomized controlled design, 12 Head Start centers will be randomly assigned in equal number to one of three conditions: 1) a combined center- and home-based intervention, 2) center-based intervention only, or 3) comparison. The interventions will be delivered by trained Head Start staff during the academic year. A total of 444 3-year-old children (52% females; n?=?37 per center at baseline) in two cohorts will be enrolled in the study and followed prospectively 1?year post-intervention. Data collection will be conducted at baseline, immediately post-intervention, and at the one-year follow-up and will include height, weight, physical activity (PA) and sedentary behaviors, sleep duration and screen time, gross motor development, dietary intake and food and activity preferences. Information on family background, parental weight, PA- and nutrition-related practices and behaviors, PA and nutrition policy and environment at center and home, intervention program costs, and treatment fidelity will also be collected. DISCUSSION:With endorsement and collaboration of two local Head Start administrators, ¡Míranos!, as a culturally tailored obesity prevention program, is poised to provide evidence of efficacy and cost-effectiveness of a policy and environmental approach to prevent early onset of obesity in low-income Latino preschool children. ¡Míranos! can be disseminated to various organized childcare settings, as it is built on the Head Start program and its infrastructure, which set a gold standard for early childhood education, as well as current PA and nutrition recommendations for preschool children. TRIAL REGISTRATION:ClinicalTrials.Gov ( NCT03590834 ) July 18, 2018.

SUBMITTER: Yin Z

PROVIDER: S-EPMC6556954 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Study protocol for a cluster randomized controlled trial to test "¡Míranos! Look at Us, We Are Healthy!" - an early childhood obesity prevention program.

Yin Zenong Z Ullevig Sarah L SL Sosa Erica E Liang Yuanyuan Y Olmstead Todd T Howard Jeffrey T JT Errisuriz Vanessa L VL Estrada Vanessa M VM Martinez Cristina E CE He Meizi M Small Sharon S Schoenmakers Cindy C Parra-Medina Deborah D

BMC pediatrics 20190610 1

<h4>Background</h4>One in three Head Start children is either overweight or obese. We will test the efficacy of an early childhood obesity prevention program, "¡Míranos! Look at Us, We Are Healthy!" (¡Míranos!), which promotes healthy growth and targets multiple energy balance-related behaviors in predominantly Latino children in Head Start. The ¡Míranos! intervention includes center-based (policy changes, staff development, gross motor program, and nutrition education) and home-based (parent en ...[more]

PMID: 31179916

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Project description:Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention randomized trial in the child care setting.A randomized, controlled obesity prevention trial is currently being conducted over a three year period (2010-present). The sample consists of 28 low-income, ethnically diverse child care centers with 1105 children (sample is 60% Hispanic, 15% Haitian, 12% Black, 2% non-Hispanic White and 71% of caregivers were born outside of the US). The purpose is to test the efficacy of a parent and teacher role-modeling intervention on children's nutrition and physical activity behaviors. . The Healthy Caregivers-Healthy Children (HC2) intervention arm schools received a combination of (1) implementing a daily curricula for teachers/parents (the nutritional gatekeepers); (2) implementing a daily curricula for children; (3) technical assistance with meal and snack menu modifications such as including more fresh and less canned produce; and (4) creation of a center policy for dietary requirements for meals and snacks, physical activity and screen time. Control arm schools received an attention control safety curriculum. Major outcome measures include pre-post changes in child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, amount of physical activity, and parental nutrition and physical activity knowledge, attitudes, and beliefs, defined by intentions and behaviors. All measures were administered at the beginning and end of the school year for year one and year two of the study for a total of 4 longitudinal time points for assessment.Although few attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation will inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting.NCT01722032.

Project description:BackgroundThe INFANT Program is an efficacious, group-based program for first-time parents, delivered at three-monthly intervals when INFANT are aged 3-18 months through an existing universal care service in Victoria, Australia. Many lessons have been learnt from its origins as a cluster randomized control trial to its small-scale, community-level implementation. This study aimed to describe factors contributing to its sustained implementation to inform large-scale implementation across Australia.MethodsThis study used a multi-site qualitative exploratory approach. INFANT facilitators trained between 2013 and 2017 were sent an online survey, with optional telephone interviews. The Consolidated Framework for Implementation Research (CFIR) was selected as the underpinning theoretical framework as it offered the opportunity to explore a breadth of possible barriers and enablers across patterns of implementation (never, discontinued, ongoing).ResultsAll participants were female (n = 31), the majority were Maternal and Child Health Nurses (48%), representing five regional and nine metro local government areas (LGAs), across all patterns of implementation (never implemented n = 4; discontinued implementation n = 5; ongoing implementation n = 5). All consenting participants were interviewed (n = 11) representing four regional and seven metro LGAs, across all patterns of implementation (never implemented n = 3; discontinued implementation n = 4; ongoing implementation n = 4). The main reason for attending INFANT Program training was to become skilled to implement the program. Mapping identified barriers and enablers to the CFIR revealed the inner and outer settings and implementation process to be of greatest influence. Main differences between LGAs with ongoing and discontinued implementation related to funding availability, organizational management support and endorsement, organizational resourcing and capacity, integration into routine practice and establishing role clarity with partner organizations, and planning for sustained implementation from the start.ConclusionThis study provides important insights into the barriers and enablers to the sustained implementation of an evidence-based intervention (the INFANT Program) during small scale community-level implementation. The authors therefore contend that the pre-requisite for scale-up of a population health intervention is not just proof of effectiveness but also proof of sustained implementation at the local/organizational level. Study findings have broad transferability given their similarity to those identified for health promotion interventions implemented globally, in healthcare, education and community settings.

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Project description:IntroductionHealthy Beginnings is an established nurse-led early childhood obesity prevention program that promotes healthy infant feeding practices and active play in the early years of life. To improve engagement with culturally and linguistically diverse populations, the Healthy Beginnings program delivered by telephone was culturally adapted and implemented with Arabic- and Chinese-speaking mothers in Sydney, Australia. The cultural adaptation process has been published separately. In this article, we aimed to evaluate the feasibility of the culturally adapted program.MethodsIn 2018-2019, the culturally adapted Healthy Beginnings program was implemented with Arabic- and Chinese-speaking women recruited from antenatal clinics in Sydney. At four staged timepoints (from third trimester until 6 months of age), mothers were sent culturally adapted health promotion booklets and text messages and offered four support calls from bi-cultural child and family health nurses in Arabic and Chinese. A mixed methods evaluation included a) baseline and 6-month telephone surveys, followed by b) semi-structured follow-up interviews with a subset of participating mothers and program delivery staff. Main outcomes of this feasibility study were reach (recruitment and retention), intervention dose delivered (number of nurse support calls completed) and acceptability (appropriateness based on cognitive and emotional responses).ResultsAt recruitment, 176 mothers were eligible and consented to participate. Of 163 mothers who completed the baseline survey, 95% completed the program (n = 8 withdrew) and 83% completed the 6-month survey (n = 70 Arabic- and n = 65 Chinese-speaking mothers). Most mothers (n = 127, 78%) completed at least one nurse support call. The qualitative analysis of follow-up interviews with 42 mothers (22 Arabic- and 20 Chinese-speaking mothers) and 10 program delivery staff highlighted the perceived value of the program and the positive role of bi-cultural nurses and in-language resources. Mothers who completed more nurse support calls generally expressed greater acceptability.ConclusionsThe culturally adapted Healthy Beginnings program was feasible to deliver and acceptable to Arabic- and Chinese-speaking mothers. Our results highlight the importance of in-language resources and individualised bi-cultural nurse support by telephone for supporting culturally and linguistically diverse migrant families with infant feeding and active play. These findings support the potential for program refinements and progression to an effectiveness trial.

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Study protocol for a cluster randomized controlled trial to test "¡Miranos! Look at Us, We Are Healthy!" - an early childhood obesity prevention program.

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Study protocol for a cluster randomized controlled trial to test "¡Míranos! Look at Us, We Are Healthy!" - an early childhood obesity prevention program.

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