Improving Nutrition and Physical Activity Environments in Home-based Child Care

Study Overview
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Brief Summary
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Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual Principal Investigators for this project. The research team will first conduct formative research using focus groups and key-informant interviews of Family Child Care Home (FCCH) providers. This formative work will inform our adaptation of components of previous evidence-based interventions to create a new innovative intervention in both English and Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the effectiveness of the intervention with a Steering Committee and Community Advisory Board guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to inform the development and adaptation of the FCCH intervention. 2) Conduct a cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a) Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods will include survey data collection of the FCCH Providers; observation of children's' dietary intake and physical activity in FCCHs; recruitment of children within the FCCH for physical and survey measurement with permission from their parents.

Detailed Description
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Preschool years are critical times when dietary and PA behaviors are established and over 70% of U. S. children under the age of six attend out-of-home child care. Unhealthy food and PA behaviors contribute to the high prevalence rates of childhood obesity. Through this research study, our team will first conduct formative research using focus groups and key-informant interviews of Family Child Care Home (FCCH) providers. Partnering with Ready to Learn Providence the investigators will recruit FCCH providers to participate. The investigators will partner with Alison Tovar, PhD, (URI faculty) and her students to conduct interviews and discussion groups in English and Spanish. This formative work will inform our adaptation of components of previous evidence-based interventions to create a new innovative intervention in both English and Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys. A cluster-randomized trial with 132 FCCH and 396 children in their care will evaluate the effectiveness of the intervention with a Steering Committee and Community Advisory Board guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to inform the development and adaptation of the FCCH intervention. 2) Conduct a cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a) Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods will include survey data collection of the FCCH Providers; observation of children's' dietary intake and physical activity in FCCHs(Partnering with Diane Ward, PhD (UNC faculty) and her student/staff member team); recruitment of children within the FCCH for physical and survey measurement with permission from their parents. The investigators will also conduct extensive mixed-methods process evaluation to determine fidelity, dose, acceptability, context, and unintended consequences; explore the relationship between outcome measures and intervention dose as well as with mediating/moderating variables, and explore the intervention effect on child BMI. If proven effective, this intervention has the potential to be replicated and widely disseminated throughout RI and the US, where improvements in the childcare environment are a high priority.

Official Title
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Improving Nutrition and Physical Activity Environments in Home-based Child Care

Conditions
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Family Child Care Homes

Intervention / Treatment
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* Behavioral: Healthy Food and Physical Activity Environments
* Behavioral: Comparison Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: operator of a FCCH have at least 1 children in their care, provide at least 2 meals/snacks to the children ability to read and speak English or Spanish expect to be in operation in a year have a working phone have either a DVD player or internet access through computer or phone Exclusion Criteria: under 18 years of age has no children in their care between the ages of 2 and 5 years old child care will be closed for more than 1 month at a time in the forthcoming year. does not prepare the food served by the children (children bring it from home).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys to elicit changes to the nutrition and physical activity environments of family child care homes. | Behavioral: Healthy Food and Physical Activity Environments<br>* Tailored written materials, videos, telephone counseling, active toys<br>|
| Active Comparator: Comparison<br>The comparison intervention will provide print materials and videos on literacy and school readiness to children and books in both English and Spanish. Participants will also receive support from peer counselors with child care experience. | Behavioral: Comparison Group<br>* Written materials, videos, books, and telephone counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Observed Child Dietary Intake | Child food intake will be observed and recorded by trained research assistants on two days; data will be used to calculate mean daily intake of several nutrients for each child. | 8 Months | 
| Change in Measured Child Physical Activity in Child Care | Physical activity will be measured on two days using accelerometer devices attached onto waist bands; data will be used to calculate mean energy expenditure for each child. | 8 months | 
| Change in Observed Child Dietary Intake | Child food intake will be observed and recorded by trained research assistants on two days; data will be used to calculate mean daily intake of several nutrients for each child. | 12 Months | 
| Change in Measured Child Physical Activity in Child Care | Child food intake will be observed and recorded by trained research assistants on two days; data will be used to calculate mean daily intake of several nutrients for each child. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self Reported Provider Changes in motivators | These data will be collected via telephone survey of the providers. | 8 months | 
| Change in Self Reported Provider Changes in motivators | These data will be collected via telephone survey of the providers. | 12 months | 
| Change in Self Reported Provider Changes in self-efficacy | These data will be collected via telephone survey of the providers. | 8 months | 
| Change in Self Reported Provider Changes in self-efficacy | These data will be collected via telephone survey of the providers. | 12 months | 
| Change in Self Reported Provider Changes in barriers | These data will be collected via telephone survey of the providers. | 8 months | 
| Change in Self Reported Provider Changes in barriers | These data will be collected via telephone survey of the providers. | 12 months | 
| Change in Self Reported Provider Changes in social support | These data will be collected via telephone survey of the providers. | 8 months | 
| Change in Self Reported Provider Changes in social support | These data will be collected via telephone survey of the providers. | 12 months | 
| Change in Self Reported Provider Changes in attitudes | These data will be collected via telephone survey of the providers. | 8 months | 
| Change in Self Reported Provider Changes in attitudes | These data will be collected via telephone survey of the providers. | 12 months | 
| Change in Self Reported Provider Changes in practices | These data will be collected via telephone survey of the providers. | 8 months | 
| Change in Self Reported Provider Changes in practices | These data will be collected via telephone survey of the providers. | 12 months | 
| Change in Self Reported Provider Changes in beliefs | These data will be collected via telephone survey of the providers. | 8 months | 
| Change in Self Reported Provider Changes in beliefs | These data will be collected via telephone survey of the providers. | 12 months | 
| Change in measured food and physical activity environment of the family child care home as measured by the EPAO. | The EPAO estimates the food and activity environment using a questionnaire completed by the trained RA regarding observed environments and practices in the family child care home throughout one day. | 8 months | 
| Measured food and physical activity environment of the family child care home as measured by the EPAO. | The EPAO estimates the food and activity environment using a questionnaire completed by the trained RA regarding observed environments and practices in the family child care home throughout one day. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food, Nutrition, Physical Activity, Family, Child Care, Home, Environment