Healthy Start: Family Childcare Providers and Parents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Participation in the prior Healthy Start Project
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
Trial design
Design model
Parallel
Treatments tested in this trial
Healthy Eating: Provider and Parent Components
BehavioralHealthy 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 Materials
BehavioralReading 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Healthy Start: Healthy Eating in Childcare and Home SettingsExperimental treatment 1 intervention
Group B: Healthy Start: Reading Readiness in Childcare and at HomeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility Score
Feasibility Score Recruitment and retention success will be measured and scored. Higher scores will indicate higher recruitment and retention.
Time frame
9 Months2
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.
Time frame
9 months3
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.
Time frame
Baseline and 9 months4
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
Time frame
Baseline and 9 monthsSecondary outcomes
1
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.
Time frame
Baseline and 9 months2
Environment and Policy Assessment and Observation Tool
EPAO Score Measures childcare nutrition environments and practices over a full-day.
Time frame
Baseline and 9 months3
Child Weight
Weight (kg) Investigators will use standard techniques for measuring child weight in kilograms
Time frame
Baseline and 9 months4
Child Height
Height (cm) Investigators will use standard techniques for measuring child height in cm.
Time frame
Baseline and 9 monthsLocations
Sponsors and contacts
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Brown University
Lead sponsor
University of Connecticut
Collaborator
Source ClinicalTrials.gov
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