Clinical trial NCT04179565: Healthy Children, Healthy Families: Parents Making A Difference
Official title: Healthy Children, Healthy Families: Parents Making A Difference: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity Prevention
Keywords: childhood obesity
parenting practices
food and physical activity
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 391
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The impacts of Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) on how low-income parents enrolled in the Expanded Food and Nutrition Education Program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed intervention control group.

Detailed description: The Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) curriculum is a Cornell curriculum for parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain. These behaviors include drinking water or milk instead of sweetened beverages, eating more vegetables and fruits, playing actively, eating fewer high-fat and high-sugar foods, limiting screen time, and having sensible serving sizes. The 8-session curriculum uses a learner-centered dialogue approach, hands-on activities and role plays. The study will include 300 participants with young children 3-5 years old in Head Start and childcare programs in New York City using a randomized control design. In period 1 (9 weeks), half the groups will receive HCHF education (immediate education, IE) and half will serve as controls, receiving no education (delayed education, DE). In period 2 (9 weeks), DE will receive education; IE will receive no education and be followed longitudinally for periods 2 and 3. In period 3 (16 weeks), neither group will receive education and both will be followed longitudinally. Data will be collected at each time point using validated measures, including the HCHF Checklist developed by the investigators and complementary measures that assess parenting feeding practices, food behavior in parents, food behavior in children, and parent self-efficacy around obesity prevention behaviors. It is hypothesized that change pre- to post- HCHF will be greater than control groups, and changes in behavior will be retained post-education.

Eligibility criteria: * Inclusion Criteria: Parents/caregivers with young children 3-5 years old
* Exclusion Criteria: Any person who does not have children who are 3-5 years old

Primary outcomes:
measure: Healthy Children, Healthy Families Checklist
timeFrame: up to 8 months
measure: Comprehensive Feeding Practices Questionnaire (CFPQ)
timeFrame: up to 8 months
Secondary outcomes:
measure: Parental self-efficacy
timeFrame: up to 8 months
measure: Food frequency of sugar sweetened beverages and foods
timeFrame: up to 8 months
measure: Parent food choice behaviors
timeFrame: up to 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Cornell University
name: Jamie S Dollahite
role: PRINCIPAL_INVESTIGATOR
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