Clinical trial NCT06978270: Healthy Start: Family Childcare Providers and Parents
Official title: Healthy Start: An Innovative, Multi-level Intervention With Family Childcare Providers and Families to Improve the Dietary Behaviors of Pre-school Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Obesity
Nutrition, Healthy
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2025-05-18
Enrollment: 40
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: 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, 8-month 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 8-month 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.

Eligibility criteria: Providers:

Inclusion Criteria:

* 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

Exclusion Criteria:

* Participation in the prior Healthy Start Project

Parents:

Inclusion Criteria:

* 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

Exclusion Criteria:

* Not meeting above criteria.

Children:

Inclusion Criteria:

* 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).

Exclusion Criteria:

- Not meeting above criteria.

Primary outcomes:
measure: Feasibility Score
timeFrame: 9 Months
measure: Acceptability Score
timeFrame: 9 months
measure: Child diet at home
timeFrame: Baseline and 9 months
measure: Dietary Observation in Child Care
timeFrame: Baseline and 9 months
Secondary outcomes:
measure: Veggie Meter
timeFrame: Baseline and 9 months
measure: Environment and Policy Assessment and Observation Tool
timeFrame: Baseline and 9 months
measure: Child Weight
timeFrame: Baseline and 9 months
measure: Child Height
timeFrame: Baseline and 9 months
measure: Feeding Practices
timeFrame: Baseline and 9 months
measure: Beverage Intake Questionnaire (BEVQ-PS)
timeFrame: Baseline and 9 months
measure: Rapid Prime Diet Quality Score (rPDQS)
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Brown School of Public Health
name: Patricia M Risica, DrPH
role: PRINCIPAL_INVESTIGATOR
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: 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: Tovar 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.
citation: Ramirez 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.
citation: Jiang 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.
citation: Jiang 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.
citation: Jiang 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.