NCT04183179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

November 27, 2019

Results QC Date

June 5, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Obesity preventionEarly childhoodIntergenerationalHealthy eatingLife stress management

Outcome Measures

Primary Outcomes (1)

  • Child Dietary Fruit and Vegetable Intake

    Child dietary intake will be assessed by the 41-item Block Kids Food Screener. The Block Kids Food Screener is a food frequency questionnaire used to assess dietary intake of fruits, vegetables, dairy, whole grains, protein sources, saturated fat, and added sugars in youth aged 2-17 years old. It has been shown to have significant relationships (r=0.53-0.88) with Nutrition Data System for Research 24-h food recall data. The Block Kids Food Screener has acceptable Cronbach's alphas of 0.76-0.77 for the survey items assessing fruit and vegetable intake among Head Start preschoolers. The completed surveys will be processed and analyzed by NutritionQuest, and the number of cups of fruit and vegetable consumed per day will be used to describe children's fruit and vegetable intake, with a higher number indicating a healthier eating behavior.

    Change from baseline child dietary intake at 15 weeks

Secondary Outcomes (3)

  • Child Emotional Overeating

    Change from baseline to 15 weeks

  • Child Body Mass Index Z-score

    Change from baseline body mass index z-score at 15 weeks

  • Systolic and Diastolic Blood Pressure

    Change from baseline blood pressure at 15 weeks

Other Outcomes (11)

  • Parental Knowledge of Health Eating

    Change from baseline parental knowledge of health eating at 15 weeks

  • Parental Self-efficacy for Supporting Health Eating

    Change from baseline parental self-efficacy for supporting health eating at 15 weeks

  • Parental Support for Health Eating

    Change from baseline parental support for health eating at 15 weeks

  • +8 more other outcomes

Study Arms (1)

Program

EXPERIMENTAL

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

Behavioral: Happy Family, Healthy Kids Program

Interventions

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

Program

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betsie Valley Elementary

Thompsonville, Michigan, 49683, United States

Location

Related Publications (1)

  • Ling J, Chen S, Zhang N, Robbins LB, Kerver JM. Happy Family, Healthy Kids: A Healthy Eating and Stress Management Program in Low-Income Parent-Preschooler Dyads. Nurs Res. 2024 Jan-Feb 01;73(1):3-15. doi: 10.1097/NNR.0000000000000697. Epub 2023 Sep 23.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jiying Ling
Organization
Michigan State University College of Nursing

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 3, 2019

Study Start

August 20, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 27, 2025

Results First Posted

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

De-identified data including code book can be shared with other researchers upon request.

Locations