Improving Nutrition and Physical Activity Environments in Home-based Child Care
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 19, 2017
July 1, 2017
3.1 years
March 30, 2015
July 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (16)
Change in Self Reported Provider Changes in motivators
8 months
Change in Self Reported Provider Changes in motivators
12 months
Change in Self Reported Provider Changes in self-efficacy
8 months
Change in Self Reported Provider Changes in self-efficacy
12 months
Change in Self Reported Provider Changes in barriers
8 months
- +11 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALThe 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.
Comparison
ACTIVE COMPARATORThe 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.
Interventions
Tailored written materials, videos, telephone counseling, active toys
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- University of Connecticutcollaborator
- University of Rhode Islandcollaborator
- University of North Carolinacollaborator
Study Sites (1)
Ready 2 Learn
Providence, Rhode Island, 02903, United States
Related Publications (4)
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.
PMID: 35428298DERIVEDGans 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.
PMID: 34851731DERIVEDRisica 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.
PMID: 30999881DERIVEDGans 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.
PMID: 30707598DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor (Research) of Epidemiology
Study Record Dates
First Submitted
March 30, 2015
First Posted
May 22, 2015
Study Start
December 1, 2015
Primary Completion
January 1, 2019
Study Completion
May 1, 2019
Last Updated
July 19, 2017
Record last verified: 2017-07