N/A
N=214
Happy Family, Healthy Kids Program
Healthy Diet · Stress · Pediatric Obesity · Intergenerational Relations
Bottom Line
View on ClinicalTrials.gov: NCT04183179 ↗Enrolled (actual)
214
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Child Dietary Fruit and Vegetable Intake — 0.07 Cups per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Happy Family, Healthy Kids Program (Behavioral)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Michigan State University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Dietary Fruit and Vegetable Intake |
0.07 | — |
| SECONDARY Child Emotional Overeating |
0.05 | — |
| SECONDARY Child Body Mass Index Z-score |
-0.06 | — |
| SECONDARY Systolic and Diastolic Blood Pressure |
1.02; -1.60; -3.64; -2.10 | — |
Summary
Happy Family, Healthy Kids program, funded by the Michigan Health Endowment Fund, is a 14-week healthy eating program aimed to foster "Happy Family & Healthy Kids." The program will target parental emotional eating through a life stress management component, and parents will be coached on making happy and healthy eating behavioral changes at home that will support their children to establish lifelong healthy eating habits. At the end of this project, the investigators expect to have an effective, comprehensive, and sustainable healthy eating program ready to expand to any Head Start center in an urban or rural setting.
Eligibility Criteria
Inclusion Criteria
There are ten inclusion criteria (five for preschoolers and five for caregivers).
Preschoolers must:
- Have parental consent.
- Have child assent if the child is 5 years old.
- Be 3-5 years of age.
- Be able to understand and speak English. The intervention will be delivered in English.
- Be enrolled in the full-day or part-day Head Start program.
Caregivers must:
- Provide consent.
- Be the primary adult caregiver (≥ 18 years old) for the preschooler. Primary caregiver refers to the one person most responsible for providing care to the preschooler on a daily basis.
- Be able to read, understand, and speak English. The intervention will be delivered in English.
- Have at least weekly Internet access using a smartphone, tablet, or a computer. Each caregiver needs to have Internet access to access the study's Facebook group for participating in the Facebook-based program.
- Be willing to use Facebook. Since the caregiver intervention component will be delivered via Facebook, caregivers need to be willing to use Facebook in the study.
Exclusion Criteria
There are three exclusion criteria for both caregivers and preschoolers.
- Preschoolers or caregivers who have medical conditions precluding participating in dietary changes.
- Preschoolers or caregivers who have diagnosed health conditions known to impact weight (e.g., Prader-Willi Syndrome) or are taking weight-affecting medications (e.g., stimulants).
- Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.
Data sourced from ClinicalTrials.gov (NCT04183179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.