Family Child Care HomesNCT02452645
Improving Nutrition and Physical Activity Environments in Home-based Child Care
A study testing Healthy Food and Physical Activity Environments and Comparison Group in people with Family Child Care Homes, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Child Care Homes
- What is being tested?
- Healthy Food and Physical Activity Environments and Comparison Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ready 2 Learn
Providence, Rhode Island, 02903
Leslie Gell
About this study
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.
Read the 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.
- Conditions
- Family Child Care Homes
- Being tested
- Healthy Food and Physical Activity Environments, Comparison Group
- Keywords
- Food, Nutrition, Physical Activity, Family, Child Care, Home, Environment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Food and Physical Activity EnvironmentsBehavioural
Tailored written materials, videos, telephone counseling, active toys
Comparison GroupBehavioural
Written materials, videos, books, and telephone counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Healthy Food and Physical Activity Environments |
| Comparison | Active comparator | 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. Receives: Behavioral: Comparison Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Secondary outcomes (16)
Change in Self Reported Provider Changes in motivators
These data will be collected via telephone survey of the providers.
Measured: 8 months
Change in Self Reported Provider Changes in motivators
These data will be collected via telephone survey of the providers.
Measured: 12 months
Change in Self Reported Provider Changes in self-efficacy
These data will be collected via telephone survey of the providers.
Measured: 8 months
Change in Self Reported Provider Changes in self-efficacy
These data will be collected via telephone survey of the providers.
Measured: 12 months
Change in Self Reported Provider Changes in barriers
These data will be collected via telephone survey of the providers.
Measured: 8 months
Change in Self Reported Provider Changes in barriers
These data will be collected via telephone survey of the providers.
Measured: 12 months
Change in Self Reported Provider Changes in social support
These data will be collected via telephone survey of the providers.
Measured: 8 months
Change in Self Reported Provider Changes in social support
These data will be collected via telephone survey of the providers.
Measured: 12 months
Change in Self Reported Provider Changes in attitudes
These data will be collected via telephone survey of the providers.
Measured: 8 months
Change in Self Reported Provider Changes in attitudes
These data will be collected via telephone survey of the providers.
Measured: 12 months
Change in Self Reported Provider Changes in practices
These data will be collected via telephone survey of the providers.
Measured: 8 months
Change in Self Reported Provider Changes in practices
These data will be collected via telephone survey of the providers.
Measured: 12 months
Change in Self Reported Provider Changes in beliefs
These data will be collected via telephone survey of the providers.
Measured: 8 months
Change in Self Reported Provider Changes in beliefs
These data will be collected via telephone survey of the providers.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Family Child Care HomesStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, University of Rhode Island, University of North Carolina
- Responsible party
- Principal investigator, Patricia M. Risica, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452645
- Sponsor's protocol ID
- BrownMC
- Status last verified
- Jul 2017
- First submitted
- 30 Mar 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35428298Gans 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.
PubMed 34851731Risica 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.
PubMed 30999881Gans 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.
PubMed 30707598
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Nutrition and Physical Activity Environments in Home-based Child Care
- ClinicalTrials.gov ID
- NCT02452645
- Acronym / sponsor ID
- BrownMC
- Conditions
- Family Child Care Homes
- Keywords
- Food, Nutrition, Physical Activity, Family, Child Care, Home, Environment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut, University of Rhode Island, University of North Carolina
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Healthy Food and Physical Activity EnvironmentsThe 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 comparator | Behavioral: Comparison GroupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Food and Physical Activity EnvironmentsTailored written materials, videos, telephone counseling, active toys | Behavioural | Intervention |
| Comparison GroupWritten materials, videos, books, and telephone counseling. | Behavioural | Comparison |
Primary outcome
Change in Observed Child Dietary Intake
Time frame: 8 Months
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.
Change in Measured Child Physical Activity in Child Care
Time frame: 8 months
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.
Change in Observed Child Dietary Intake
Time frame: 12 Months
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.
Change in Measured Child Physical Activity in Child Care
Time frame: 12 Months
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.
16 secondary outcomes
Change in Self Reported Provider Changes in motivators
Time frame: 8 months
Change in Self Reported Provider Changes in motivators
Time frame: 12 months
Change in Self Reported Provider Changes in self-efficacy
Time frame: 8 months
Change in Self Reported Provider Changes in self-efficacy
Time frame: 12 months
Change in Self Reported Provider Changes in barriers
Time frame: 8 months
Change in Self Reported Provider Changes in barriers
Time frame: 12 months
Change in Self Reported Provider Changes in social support
Time frame: 8 months
Change in Self Reported Provider Changes in social support
Time frame: 12 months
Change in Self Reported Provider Changes in attitudes
Time frame: 8 months
Change in Self Reported Provider Changes in attitudes
Time frame: 12 months
Change in Self Reported Provider Changes in practices
Time frame: 8 months
Change in Self Reported Provider Changes in practices
Time frame: 12 months
Change in Self Reported Provider Changes in beliefs
Time frame: 8 months
Change in Self Reported Provider Changes in beliefs
Time frame: 12 months
Change in measured food and physical activity environment of the family child care home as measured by the EPAO.
Time frame: 8 months
Measured food and physical activity environment of the family child care home as measured by the EPAO.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Derived from this study: PubMed 35428298Gans 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.
- Derived from this study: PubMed 34851731Gans 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.
- Derived from this study: PubMed 30999881Risica 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.
- Derived from this study: PubMed 30707598Gans 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.
Related trials for Family Child Care Homes
Recruiting
Healthy Children, Healthy Communities: Effectiveness of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes
Childhood Obesity Pevention, Diet Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Food and Physical Activity Environments and Comparison Group in people with Family Child Care Homes, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia M Risica, DrPH (401-863-6553, patricia_risica@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Observed Child Dietary Intake (time frame: 8 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02452645, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.