Clinical trial NCT02452645: Improving Nutrition and Physical Activity Environments in Home-based Child Care
Official title: Improving Nutrition and Physical Activity Environments in Home-based Child Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Family Child Care Homes
Keywords: Food
Nutrition
Physical Activity
Family
Child Care
Home
Environment
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: University of Rhode Island
name: University of North Carolina
First posted: 2015-05-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Observed Child Dietary Intake
timeFrame: 8 Months
measure: Change in Measured Child Physical Activity in Child Care
timeFrame: 8 months
measure: Change in Observed Child Dietary Intake
timeFrame: 12 Months
measure: Change in Measured Child Physical Activity in Child Care
timeFrame: 12 Months
Secondary outcomes:
measure: Change in Self Reported Provider Changes in motivators
timeFrame: 8 months
measure: Change in Self Reported Provider Changes in motivators
timeFrame: 12 months
measure: Change in Self Reported Provider Changes in self-efficacy
timeFrame: 8 months
measure: Change in Self Reported Provider Changes in self-efficacy
timeFrame: 12 months
measure: Change in Self Reported Provider Changes in barriers
timeFrame: 8 months
measure: Change in Self Reported Provider Changes in barriers
timeFrame: 12 months
measure: Change in Self Reported Provider Changes in social support
timeFrame: 8 months
measure: Change in Self Reported Provider Changes in social support
timeFrame: 12 months
measure: Change in Self Reported Provider Changes in attitudes
timeFrame: 8 months
measure: Change in Self Reported Provider Changes in attitudes
timeFrame: 12 months
measure: Change in Self Reported Provider Changes in practices
timeFrame: 8 months
measure: Change in Self Reported Provider Changes in practices
timeFrame: 12 months
measure: Change in Self Reported Provider Changes in beliefs
timeFrame: 8 months
measure: Change in Self Reported Provider Changes in beliefs
timeFrame: 12 months
measure: Change in measured food and physical activity environment of the family child care home as measured by the EPAO.
timeFrame: 8 months
measure: Measured food and physical activity environment of the family child care home as measured by the EPAO.
timeFrame: 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Ready 2 Learn
state: Rhode Island
Study officials:
References:
citation: Gans KM, Tovar A, Kang A, Ward DS, Stowers KC, von Ash T, Dionne L, Papandonatos GD, Mena N, Jiang Q, Risica PM. A multi-component tailored intervention in family childcare homes improves diet quality and sedentary behavior of preschool children compared to an attention control: results from the Healthy Start-Comienzos Sanos cluster randomized trial. Int J Behav Nutr Phys Act. 2022 Apr 15;19(1):45. doi: 10.1186/s12966-022-01272-6.
citation: Gans KM, Jiang Q, Tovar A, Kang A, McCardle M, Risica PM. Physical Activity and Screen Time Practices of Family Child Care Providers: Do They Meet Best Practice Guidelines? Child Obes. 2022 Jun;18(4):281-290. doi: 10.1089/chi.2021.0094. Epub 2021 Dec 1.
citation: Risica PM, Tovar A, Palomo V, Dionne L, Mena N, Magid K, Ward DS, Gans KM. 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. BMC Public Health. 2019 Apr 18;19(1):419. doi: 10.1186/s12889-019-6704-6.
citation: Gans KM, Tovar A, Jiang Q, Mello J, Dionne L, Kang A, Mena NZ, Palomo V, Risica PM. Nutrition-Related Practices of Family Child Care Providers and Differences by Ethnicity. Child Obes. 2019 Apr;15(3):167-184. doi: 10.1089/chi.2018.0083. Epub 2019 Feb 1.