Child ObesityNCT06978270
Healthy Start: Family Childcare Providers and Parents
A study testing Healthy Eating: Provider and Parent Components and Healthy Start: Reading Readiness Childcare Proiver and Parent Materials in people with Child Obesity and Nutrition, Healthy, run by Brown University at 1 site in United States.
Trial summary
The preschool years are a critical time for shaping food preferences and eating behaviors, which affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease, and other chronic conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Obesity, Nutrition, Healthy
- What is being tested?
- Healthy Eating: Provider and Parent Components and Healthy Start: Reading Readiness Childcare Proiver and Parent Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 31 Mar 2026
- 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
- English and/or Spanish-speaking and reading
- State licensed family childcare providers (FCCP)
- FCCP that care for 18-54 month-old children,
- Plan for FCCH to be in operation for the next year
- Willing to be randomized to either study arm,
- Have at least 2 eligible children in their care with at least 1 parent-child dyad consenting to participate
Show all 16Show fewer
- English and/or Spanish-speaking and reading
- Legal guardian of child(ren) who receive care in a participating FCCH
- Child(ren) must be 18-54 months-old
- Care must be for at least 15 hrs./wk
- Plan to continue childcare with their current FCCP for the next 9 months
- Be the caregiver mainly responsible for the child's eating at home
- Willing to be randomized (with the FCCP) to either study arm
- Children 18-54 months-old who receive care in a participating FCCH
- Care must be for at least 15 hours per week
- Agree to be measured (All other evaluation is observation that does not require assent).
Who cannot join
- Participation in the prior Healthy Start Project
- Parents:
- Not meeting above criteria.
- Children:
- Not meeting above criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Start: An Innovative, Multi-level Intervention With Family Childcare Providers and Families to Improve the Dietary Behaviors of Pre-school Children
The preschool years are a critical time for shaping food preferences and eating behaviors, which affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease, and other chronic conditions. Unfortunately, many US children, especially low-income and ethnic minorities, have dietary patterns associated with obesity and increased morbidity. Thus, to improve child diet quality, it is essential to develop effective targeted interventions in settings where children (especially higher-risk children) spend time. The investigators build upon our efficacious Healthy Start intervention with family childcare home (FCCH) providers (FCCP) to pilot a novel, 8-month multilevel tailored intervention to reach families through FCCH. This would be the first study to incorporate family-based intervention components into FCCH. The 8-month intervention will include an adapted version of the Healthy Start intervention as well as FCCP training to deliver nutrition messages to parents using an existing childcare App, complemented with FCCH environmental cues and tailored print and videos for parents. In sum, feasible and effective interventions to improve young children's diets are urgently needed. The FCCH is a novel and untapped setting to intervene with both FCCP and parents simultaneously to affect children's diets in both childcare and home settings, which has the potential to more fully impact the child's overall diet and weight status.
Read the detailed description
The preschool years are a critical time for shaping food preferences and eating behaviors which, in turn, affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease and other chronic conditions. Unfortunately, many US children, especially low-income and ethnic minorities, have dietary patterns associated with obesity and increased morbidity. Thus, to improve child diet quality, it is essential to develop effective targeted interventions in settings where children (especially higher risk children) spend time. There is a national call for dietary interventions that span multiple settings including the childcare and home environments. In response to PAS-20-160, the investigators build upon our efficacious Healthy Start intervention with family childcare home (FCCH) providers (FCCP) to pilot a novel, multilevel tailored intervention to reach families through FCCH. This would be the first study to incorporate family-based intervention components into FCCH. FCCH are a promising intervention setting as parents trust FCCPs as extended family members and FCCP feel comfortable talking to parents about children's diet, but want more training to do so effectively. The intervention will include an adapted version of the Healthy Start intervention for English and Spanish-speaking FCCP as well as FCCP training to deliver nutrition messages to parents using an existing childcare App, complemented with FCCH environmental cues and tailored print and videos for parents. Specific Aims are to: SA.1. Conduct formative research with FCCP and parents to inform refinement of the multi-level intervention. SA.2. Conduct a pilot trial with 40 FCCP and 80 parents with 18-54-month-old children to evaluate feasibility and acceptability of intervention and study protocols, and preliminary efficacy of the nutrition intervention compared to an attention-matched control on: a). children's dietary quality at FCCH and home, b). social/physical FCCH and home food environments, c). children's dermal carotenoid levels and z-BMI scores. SA3. Conduct post qualitative interviews with parents, FCCP, coaches, staff \& partners to assess the intervention's acceptability and suggestions for improvement. In sum, feasible and effective interventions to improve young children's diets are urgently needed. The FCCH is a novel and untapped setting to intervene with both FCCP and parents simultaneously to affect children's diets in both the childcare and home settings, which has the potential to more fully impact the child's overall diet and weight status. This pilot feasibility research of a novel, multi-level intervention will inform a future full-scale cluster RCT, which will fill important research gaps and move the frontier of nutrition research forward.
- Conditions
- Child Obesity, Nutrition, Healthy
- Being tested
- Healthy Eating: Provider and Parent Components, Healthy Start: Reading Readiness Childcare Proiver and Parent Materials
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating: Provider and Parent ComponentsBehavioural
Healthy Eating intervention for child care providers: Peer coaching using brief MI online, tailored materials, coach-led online support groups for FCCP and children's tableware and food toys; 2) Brief training on using and scheduling messages within the Classtag App; 3) Posters for the FCCH. Also for parents, healthy eating encoragement and communication from childcare providers including via the Classtag App, newsletters, videos and tableware/food toys focused on child diet at home.
Healthy Start: Reading Readiness Childcare Proiver and Parent MaterialsBehavioural
Reading readiness intervention for child care providers: Peer coaching using brief MI online, tailored materials, coach-led online support groups for FCCP and children's books; 2) Brief training on using and scheduling messages within the Classtag App; 3) Posters for the FCCH. Also for parents, reading readiness encoragement and communication from childcare providers including via the Classtag App, newsletters, books focused for use at home.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Start: Healthy Eating in Childcare and Home Settings | Experimental | 1) Adapted version of Healthy Start nutrition intervention (peer coach using brief MI online, tailored materials, coach-led online support groups for FCCP and children's tableware and food toys for the FCCH); 2) Brief training from coach on using and scheduling healthy eating messages within the Classtag App; 3) Posters for the FCCH; 4) Tailored health eating packets (newsletters, videos and tableware/food toys) for parents. Receives: Behavioral: Healthy Eating: Provider and Parent Components |
| Healthy Start: Reading Readiness in Childcare and at Home | Active comparator | An attention-matched intervention re. reading readiness and literacy promotion based on the dialogic reading technique to be delivered with a similar dose and intensity including reading readiness-focused Tailored feedback reports, monthly support coach calls, Classtag App, and tailored packets (with FCCP and parent materials) distributed monthly and online peer support groups. The FCCP will select which of the reading readiness-related and early literacy skills topics they want to work on monthly. FCCP and parents in this group will receive a set of books. Receives: Behavioral: Healthy Start: Reading Readiness Childcare Proiver and Parent Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Score
Feasibility Score Recruitment and retention success will be measured and scored. Higher scores will indicate higher recruitment and retention.
Measured: 9 Months
Acceptability Score
Acceptability Score Participant providers and parents rate the intervention as acceptable, which will be coded as a score. Higher score will indicate higher acceptability of the intervention.
Measured: 9 months
Child diet at home
HEI Score - Diet Quality at Home Parents will be called on two randomly selected days (at least one weekend day) and asked to recall child's food intake in previous 24-hours using gold standard multiple-pass method. Parents will report child's foods and beverage intake on the previous day (excluding child intake while outside their care) using established methods as in our Healthy Start diversity supplement. Data will be entered into the NDSR program, which will be used to average data across both days and then calculate HEI-2015 score using same methods as for childcare.
Measured: Baseline and 9 months
Dietary Observation in Child Care
HEI Score - Diet Quality in Childcare Dietary Observation for Childcare (DOCC) is a validated visual observation technique that minimizes observer intrusion, so children don't know intake is being observed. Observers visually estimate and record amount /type of foods/beverages served to children in meals/snacks. Foods not easily discerned will be clarified with FCCP (e.g. food prep, brand names). Amount of food wasted (e.g. dropped, spilled, traded) and remaining will be recorded and amount of food consumed will be estimated as amount served - amount remaining. -Both days of observation data will be entered into NDSR, and averaged to estimate daily nutrient and food data. -Nutrient content, HEI-2015 total and component scores will be derived
Measured: Baseline and 9 months
Secondary outcomes (7)
Veggie Meter
Carotenoid Score Provides an objective measure of F\&V intake using reflection spectroscopy to detect non-invasively, the level of carotenoids in the child's skin.
Measured: Baseline and 9 months
Environment and Policy Assessment and Observation Tool
EPAO Score Measures childcare nutrition environments and practices over a full-day.
Measured: Baseline and 9 months
Child Weight
Weight (kg) Investigators will use standard techniques for measuring child weight in kilograms
Measured: Baseline and 9 months
Child Height
Height (cm) Investigators will use standard techniques for measuring child height in cm.
Measured: Baseline and 9 months
Feeding Practices
CFPQ Score Parents will be surveyed about their feeding practices of their own children at home. 32 questions from the Comprehensive Feeding Practices Questionnaire (CFPQ) will be used.
Measured: Baseline and 9 months
Beverage Intake Questionnaire (BEVQ-PS)
BEVQ-PS is a valid instrument used to assess SSB, water, and whole-milk intake.
Measured: Baseline and 9 months
Rapid Prime Diet Quality Score (rPDQS)
rPDQS Score The rPDQS is a valid, brief diet quality screener that identifies clinically relevant patterns of food intake.
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start11 Sep 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Child ObesityStudies 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
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Sponsor
- Investigators
- Patricia M Risica, DrPH, Principal investigator, Brown School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978270
- Sponsor's protocol ID
- DK131940-01
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30999881Tovar A, Risica PM, Ramirez A, Mena N, Lofgren IE, Cooksey Stowers K, Gans KM. Exploring the Provider-Level Socio-Demographic Determinants of Diet Quality of Preschool-Aged Children Attending Family Childcare Homes. Nutrients. 2020 May 11;12(5):1368. doi: 10.3390/nu12051368.
PubMed 32403299Ramirez A, Vadiveloo M, Risica PM, Gans KM, Greaney ML, Mena NZ, Cooksey Stowers K, Tovar A. Dietary Contributors to Food Group Intake in Preschool Children Attending Family Childcare Homes: Differences between Latino and Non-Latino Providers. Nutrients. 2020 Nov 29;12(12):3686. doi: 10.3390/nu12123686.
PubMed 33260442Jiang Q, Risica PM, Tovar A, Stowers KC, Schwartz MB, Lombardi C, Gans KM. Mediation of the Association between Social Environmental Characteristics of Family Childcare Home and Weight Status in Children by Diet Quality. Res Sq [Preprint]. 2023 Aug 16:rs.3.rs-3147729. doi: 10.21203/rs.3.rs-3147729/v1.
PubMed 37645722Jiang Q, Risica PM, Tovar A, Stowers KC, Schwartz MB, Lombardi C, Alhassan S, Gans KM. Effect of Applying Best Practices for Physical Activity and Screen Time to Family Childcare Homes. Prev Chronic Dis. 2023 Jul 13;20:E60. doi: 10.5888/pcd20.220325.
PubMed 37441753Jiang Q, Tovar A, Risica PM, Cooksey Stowers K, Schwartz M, Lombardi C, Kang A, Mena NZ, Gans KM. Ethnic Differences in Family Childcare Providers' Nutrition- and Activity-Related Attitudes and Barriers. J Obes. 2021 Oct 7;2021:6697006. doi: 10.1155/2021/6697006. eCollection 2021.
PubMed 34659829Gans 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 35428298
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Start: An Innovative, Multi-level Intervention With Family Childcare Providers and Families to Improve the Dietary Behaviors of Pre-school Children
- ClinicalTrials.gov ID
- NCT06978270
- Acronym / sponsor ID
- DK131940-01
- Conditions
- Child Obesity, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 18 May 2025 (actual)
- 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.
The preschool years are a critical time for shaping food preferences and eating behaviors, which affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease, and other chronic conditions. Unfortunately, many US children, especially low-income and ethnic minorities, have dietary patterns associated with obesity and increased morbidity. Thus, to improve child diet quality, it is essential to develop effective targeted interventions in settings where children (especially higher-risk children) spend time. The investigators build upon our efficacious Healthy Start intervention with family childcare home (FCCH) providers (FCCP) to pilot a novel, 8-month multilevel tailored intervention to reach families through FCCH. This would be the first study to incorporate family-based intervention components into FCCH. The 8-month intervention will include an adapted version of the Healthy Start intervention as well as FCCP training to deliver nutrition messages to parents using an existing childcare App, complemented with FCCH environmental cues and tailored print and videos for parents. In sum, feasible and effective interventions to improve young children's diets are urgently needed. The FCCH is a novel and untapped setting to intervene with both FCCP and parents simultaneously to affect children's diets in both childcare and home settings, which has the potential to more fully impact the child's overall diet and weight status.
Detailed description
The preschool years are a critical time for shaping food preferences and eating behaviors which, in turn, affect dietary behaviors in adults and life-long risks for obesity, diabetes, cardiovascular disease and other chronic conditions. Unfortunately, many US children, especially low-income and ethnic minorities, have dietary patterns associated with obesity and increased morbidity. Thus, to improve child diet quality, it is essential to develop effective targeted interventions in settings where children (especially higher risk children) spend time. There is a national call for dietary interventions that span multiple settings including the childcare and home environments. In response to PAS-20-160, the investigators build upon our efficacious Healthy Start intervention with family childcare home (FCCH) providers (FCCP) to pilot a novel, multilevel tailored intervention to reach families through FCCH. This would be the first study to incorporate family-based intervention components into FCCH. FCCH are a promising intervention setting as parents trust FCCPs as extended family members and FCCP feel comfortable talking to parents about children's diet, but want more training to do so effectively. The intervention will include an adapted version of the Healthy Start intervention for English and Spanish-speaking FCCP as well as FCCP training to deliver nutrition messages to parents using an existing childcare App, complemented with FCCH environmental cues and tailored print and videos for parents. Specific Aims are to: SA.1. Conduct formative research with FCCP and parents to inform refinement of the multi-level intervention. SA.2. Conduct a pilot trial with 40 FCCP and 80 parents with 18-54-month-old children to evaluate feasibility and acceptability of intervention and study protocols, and preliminary efficacy of the nutrition intervention compared to an attention-matched control on: a). children's dietary quality at FCCH and home, b). social/physical FCCH and home food environments, c). children's dermal carotenoid levels and z-BMI scores. SA3. Conduct post qualitative interviews with parents, FCCP, coaches, staff \& partners to assess the intervention's acceptability and suggestions for improvement. In sum, feasible and effective interventions to improve young children's diets are urgently needed. The FCCH is a novel and untapped setting to intervene with both FCCP and parents simultaneously to affect children's diets in both the childcare and home settings, which has the potential to more fully impact the child's overall diet and weight status. This pilot feasibility research of a novel, multi-level intervention will inform a future full-scale cluster RCT, which will fill important research gaps and move the frontier of nutrition research forward.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Start: Healthy Eating in Childcare and Home Settings | Experimental | Behavioral: Healthy Eating: Provider and Parent Components1) Adapted version of Healthy Start nutrition intervention (peer coach using brief MI online, tailored materials, coach-led online support groups for FCCP and children's tableware and food toys for the FCCH); 2) Brief training from coach on using and scheduling healthy eating messages within the Classtag App; 3) Posters for the FCCH; 4) Tailored health eating packets (newsletters, videos and tableware/food toys) for parents. |
| Healthy Start: Reading Readiness in Childcare and at Home | Active comparator | Behavioral: Healthy Start: Reading Readiness Childcare Proiver and Parent MaterialsAn attention-matched intervention re. reading readiness and literacy promotion based on the dialogic reading technique to be delivered with a similar dose and intensity including reading readiness-focused Tailored feedback reports, monthly support coach calls, Classtag App, and tailored packets (with FCCP and parent materials) distributed monthly and online peer support groups. The FCCP will select which of the reading readiness-related and early literacy skills topics they want to work on monthly. FCCP and parents in this group will receive a set of books. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- English and/or Spanish-speaking and reading
- State licensed family childcare providers (FCCP)
- FCCP that care for 18-54 month-old children,
- Plan for FCCH to be in operation for the next year
- Willing to be randomized to either study arm,
Key exclusion criteria (5 listed)
- Participation in the prior Healthy Start Project
- Not meeting above criteria.
- Not meeting above criteria.
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 Eating: Provider and Parent ComponentsHealthy Eating intervention for child care providers: Peer coaching using brief MI online, tailored materials, coach-led online support groups for FCCP and children's tableware and food toys; 2) Brief training on using and scheduling messages within the Classtag App; 3) Posters for the FCCH. Also for parents, healthy eating encoragement and communication from childcare providers including via the Classtag App, newsletters, videos and tableware/food toys focused on child diet at home. | Behavioural | Healthy Start: Healthy Eating in Childcare and Home Settings |
| Healthy Start: Reading Readiness Childcare Proiver and Parent MaterialsReading readiness intervention for child care providers: Peer coaching using brief MI online, tailored materials, coach-led online support groups for FCCP and children's books; 2) Brief training on using and scheduling messages within the Classtag App; 3) Posters for the FCCH. Also for parents, reading readiness encoragement and communication from childcare providers including via the Classtag App, newsletters, books focused for use at home. | Behavioural | Healthy Start: Reading Readiness in Childcare and at Home |
Primary outcome
Feasibility Score
Time frame: 9 Months
Feasibility Score Recruitment and retention success will be measured and scored. Higher scores will indicate higher recruitment and retention.
Acceptability Score
Time frame: 9 months
Acceptability Score Participant providers and parents rate the intervention as acceptable, which will be coded as a score. Higher score will indicate higher acceptability of the intervention.
Child diet at home
Time frame: Baseline and 9 months
HEI Score - Diet Quality at Home Parents will be called on two randomly selected days (at least one weekend day) and asked to recall child's food intake in previous 24-hours using gold standard multiple-pass method. Parents will report child's foods and beverage intake on the previous day (excluding child intake while outside their care) using established methods as in our Healthy Start diversity supplement. Data will be entered into the NDSR program, which will be used to average data across both days and then calculate HEI-2015 score using same methods as for childcare.
Dietary Observation in Child Care
Time frame: Baseline and 9 months
HEI Score - Diet Quality in Childcare Dietary Observation for Childcare (DOCC) is a validated visual observation technique that minimizes observer intrusion, so children don't know intake is being observed. Observers visually estimate and record amount /type of foods/beverages served to children in meals/snacks. Foods not easily discerned will be clarified with FCCP (e.g. food prep, brand names). Amount of food wasted (e.g. dropped, spilled, traded) and remaining will be recorded and amount of food consumed will be estimated as amount served - amount remaining. -Both days of observation data will be entered into NDSR, and averaged to estimate daily nutrient and food data. -Nutrient content, HEI-2015 total and component scores will be derived
7 secondary outcomes
Veggie Meter
Time frame: Baseline and 9 months
Environment and Policy Assessment and Observation Tool
Time frame: Baseline and 9 months
Child Weight
Time frame: Baseline and 9 months
Child Height
Time frame: Baseline and 9 months
Feeding Practices
Time frame: Baseline and 9 months
Beverage Intake Questionnaire (BEVQ-PS)
Time frame: Baseline and 9 months
Rapid Prime Diet Quality Score (rPDQS)
Time frame: Baseline and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: 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.
- Background: PubMed 32403299Tovar A, Risica PM, Ramirez A, Mena N, Lofgren IE, Cooksey Stowers K, Gans KM. Exploring the Provider-Level Socio-Demographic Determinants of Diet Quality of Preschool-Aged Children Attending Family Childcare Homes. Nutrients. 2020 May 11;12(5):1368. doi: 10.3390/nu12051368.
- Background: PubMed 33260442Ramirez A, Vadiveloo M, Risica PM, Gans KM, Greaney ML, Mena NZ, Cooksey Stowers K, Tovar A. Dietary Contributors to Food Group Intake in Preschool Children Attending Family Childcare Homes: Differences between Latino and Non-Latino Providers. Nutrients. 2020 Nov 29;12(12):3686. doi: 10.3390/nu12123686.
- Background: PubMed 37645722Jiang Q, Risica PM, Tovar A, Stowers KC, Schwartz MB, Lombardi C, Gans KM. Mediation of the Association between Social Environmental Characteristics of Family Childcare Home and Weight Status in Children by Diet Quality. Res Sq [Preprint]. 2023 Aug 16:rs.3.rs-3147729. doi: 10.21203/rs.3.rs-3147729/v1.
- Background: PubMed 37441753Jiang Q, Risica PM, Tovar A, Stowers KC, Schwartz MB, Lombardi C, Alhassan S, Gans KM. Effect of Applying Best Practices for Physical Activity and Screen Time to Family Childcare Homes. Prev Chronic Dis. 2023 Jul 13;20:E60. doi: 10.5888/pcd20.220325.
- Background: PubMed 34659829Jiang Q, Tovar A, Risica PM, Cooksey Stowers K, Schwartz M, Lombardi C, Kang A, Mena NZ, Gans KM. Ethnic Differences in Family Childcare Providers' Nutrition- and Activity-Related Attitudes and Barriers. J Obes. 2021 Oct 7;2021:6697006. doi: 10.1155/2021/6697006. eCollection 2021.
- Results publication: 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.
- Individual participant dataSharing planned: Yes
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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.
Patricia M Risica, DrPH principal investigator
Brown School of Public Health
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 Eating: Provider and Parent Components and Healthy Start: Reading Readiness Childcare Proiver and Parent Materials in people with Child Obesity and Nutrition, Healthy, 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 16 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Score (time frame: 9 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 NCT06978270, which also lists 7 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 31 Jul 2026.