Clinical trial NCT04183179: Happy Family, Healthy Kids Program
Official title: Happy Family, Healthy Kids: An Intergenerational Program to Promote Healthy Eating Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Diet
Stress
Pediatric Obesity
Intergenerational Relations
Keywords: Obesity prevention
Early childhood
Intergenerational
Healthy eating
Life stress management
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 214
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The program will be evaluated with about 100 Head Start children, aged 3 to 5 years, and their parents (one parent per family) in four urban and three rural Head Start centers to compare the program outcomes between urban and rural settings.
Primary purpose: PREVENTION

Brief 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.

Detailed description: In Project Year 1, the program will be evaluated with about 100 Head Start children, aged 3 to 5 years, and their parents (one parent per family) in four urban and four rural Head Start centers. The investigators will compare the program outcomes between urban and rural settings. All involved Head Start centers will support MSU staff to conduct data collection activities (e.g., online survey completed by parents; height, weight, and blood pressure measures; hair samples collected from both children and parents). MSU staff, along with Head Start staff, will implement the 14-week healthy eating program activities including four components:

1. A 14-week parent Facebook-based program focusing on stress management and healthy eating to reduce emotional eating and increase parents' capacity to initiate healthy eating practices at home
2. Three parent face-to-face or virtual meetings at Head Start centers to connect parents with each other in person, offer healthy cooking tools/classes, and discuss behavioral change strategies and challenges
3. 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children
4. Weekly child letter to parents to connect child learning at the Head Start center with parental practices at home

In Project Year 2, the investigators will finalize the program based on the evaluation outcomes in Project Year 1, and work closely with the participating Head Start organizations to disseminate the healthy eating program to all the participating Head Start centers and classes.

Eligibility criteria: Inclusion Criteria:

There are ten inclusion criteria (five for preschoolers and five for caregivers).

Preschoolers must:

1. Have parental consent.
2. Have child assent if the child is 5 years old.
3. Be 3-5 years of age.
4. Be able to understand and speak English. The intervention will be delivered in English.
5. Be enrolled in the full-day or part-day Head Start program.

Caregivers must:

1. Provide consent.
2. 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.
3. Be able to read, understand, and speak English. The intervention will be delivered in English.
4. 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.
5. 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.

1. Preschoolers or caregivers who have medical conditions precluding participating in dietary changes.
2. 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).
3. Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.

Primary outcomes:
measure: Child Dietary Fruit and Vegetable Intake
timeFrame: Change from baseline child dietary intake at 15 weeks
Secondary outcomes:
measure: Child Emotional Overeating
timeFrame: Change from baseline to 15 weeks
measure: Child Body Mass Index Z-score
timeFrame: Change from baseline body mass index z-score at 15 weeks
measure: Systolic and Diastolic Blood Pressure
timeFrame: Change from baseline blood pressure at 15 weeks
Other outcomes:
measure: Parental Knowledge of Health Eating
timeFrame: Change from baseline parental knowledge of health eating at 15 weeks
measure: Parental Self-efficacy for Supporting Health Eating
timeFrame: Change from baseline parental self-efficacy for supporting health eating at 15 weeks
measure: Parental Support for Health Eating
timeFrame: Change from baseline parental support for health eating at 15 weeks
measure: Parental Feeding Practice Skill
timeFrame: Change from baseline parental feeding practice skill at 15 weeks
measure: Parental Perceived Stress
timeFrame: Change from baseline parental perceived stress at 15 weeks
measure: Parental Coping Strategies
timeFrame: Change from baseline parental coping strategies at 15 weeks
measure: Parent Fruit/Vegetable/Fiber Intake
timeFrame: Change from baseline parent fruit/vegetable/fiber intake at 15 weeks
measure: Parental Emotional Eating
timeFrame: Change from baseline parental emotional eating at 15 weeks
measure: Home Eating Environment
timeFrame: Change from baseline home eating environment at 15 weeks
measure: Food Security Status
timeFrame: Change from baseline food security status at 15 weeks
measure: Parent Body Mass Index
timeFrame: Change from baseline parent proportion of overweight and obesity and body mass index at 15 weeks
Locations:
city: Thompsonville
country: United States
facility: Betsie Valley Elementary
state: Michigan
Study officials:
References: