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.

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.

Study protocol: effects of the THAO-child health intervention program on the prevention of childhood obesity - the POIBC study.

BACKGROUND: The speeding increase and the high prevalence of childhood obesity is a serious problem for Public Health. Community Based Interventions has been developed to combat against the childhood obesity epidemic. However little is known on the efficacy of these programs. Therefore, there is an urgent need to determine the effect of community based intervention on changes in lifestyle and surrogate measures of adiposity. METHODS/DESIGN: Parallel intervention study including two thousand 2249 children aged 8 to 10 years ( 4th and 5th grade of elementary school) from 4 Spanish towns. The THAO-Child Health Program, a community based intervention, were implemented in 2 towns. Body weight, height, and waist circumferences were measured. Children recorded their dietary intake on a computer-based 24h recall. All children also completed validated computer based questionnaires to estimate physical activity, diet quality, eating behaviors, and quality of life and sleep. Additionally, parental diet quality and physical activity were assessed by validated questionnaires. DISCUSSION: This study will provide insight in the efficacy of the THAO-Child Health Program to promote a healthy lifestyle. Additionally it will evaluate if lifestyle changes are accompanied by favorable weight management. TRIAL REGISTRATION: Trial Registration Number ISRCTN68403446.

A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men. OBJECTIVE: To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables. METHODS: Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization. RESULTS: This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing. CONCLUSIONS: We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23690.

Nutrition-Related Practices of Family Child Care Providers and Differences by Ethnicity.

BACKGROUND: Child care settings play an important role in shaping children's eating behaviors; yet few studies have included family child care homes (FCCHs). We examined provider-reported nutrition-related practices in FCCHs and observed adherence to nutrition guidelines from the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC), exploring differences by provider ethnicity. METHODS: We assessed baseline data from a cluster-randomized trial, including surveys with FCCH providers and observational data collected at the FCCH. We examined provider-reported nutrition-related practices and if providers met NAP SACC guidelines using observational data. Differences by ethnicity were assessed using chi-square and multivariate log-linear analysis adjusting for education. RESULTS: Providers completed a telephone survey (n = 166, 100% female and 72% Hispanic) and participated in 2 full-day observations (n = 119). Many providers reported engaging in positive nutrition-related practices. Significant differences by ethnicity included the following: Hispanic providers less likely to report feeding practices that were responsive to children's self-regulation, but also less likely to report eating and drinking unhealthy foods/beverages in front of children and having screens on during meals and more likely to report seeking nutrition trainings. Using observational data, only 10 of 26 NAP SACC practices were met by >60% of providers. Few ethnic differences in meeting guidelines were found (7 of 26 practices). CONCLUSIONS: While providers engage in some positive nutrition practices, improvement is needed to ensure that all providers actually meet evidence-based guidelines. Ethnic differences in certain practices underscore the need for culturally relevant trainings. TRIAL REGISTRATION NUMBER: NCT02452645.