Healthy DietNCT04183179
Happy Family, Healthy Kids Program
A study testing Happy Family, Healthy Kids Program in people with Healthy Diet and Stress, run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Stress, Pediatric Obesity
- What is being tested?
- Happy Family, Healthy Kids Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Betsie Valley Elementary
Thompsonville, Michigan, 49683
About this study
Official title: Happy Family, Healthy Kids: An Intergenerational Program to Promote Healthy Eating Habits
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.
Read the 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:
- 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
- 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
- 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children
- 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.
- Conditions
- Healthy Diet, Stress, Pediatric Obesity, Intergenerational Relations
- Being tested
- Happy Family, Healthy Kids Program
- Keywords
- Obesity prevention, Early childhood, Intergenerational, Healthy eating, Life stress management
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy Family, Healthy Kids ProgramBehavioural
The 14-week healthy eating program activities including four components:
- 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
- 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
- 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children
- Weekly child letter to parents to connect child learning at the Head Start center with parental practices at home
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Happy Family, Healthy Kids Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline child dietary intake at 15 weeks
Secondary outcomes (3)
Child Emotional Overeating
Child eating style will be assessed by the 35-item Child Eating Behavior Questionnaire. It has five response choices ranging from 1=never to 5=always. The Child Eating Behavior Questionnaire has eight factors including food responsiveness, emotional overeating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional undereating, and food fussiness with good reliability and validity among preschoolers. A mean score (min-max: 1-5) for the emotional overeating factor will be calculated, with a higher mean factor score indicating a higher level of emotional overeating.
Measured: Change from baseline to 15 weeks
Child Body Mass Index Z-score
Height and weight will be measured to the nearest 0.1 cm with a ShorrBoard stadiometer and to the nearest 0.1 kg with a Seca model 874 portable electronic weight scale, respectively. All measurements will occur in a private room with participants removing their shoes, jackets, or heavy clothes. BMI z-score for age and sex will be determined via SAS program for CDC Growth Charts. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. A negative change in Z-scores indicates a favorable outcome.
Measured: Change from baseline body mass index z-score at 15 weeks
Systolic and Diastolic Blood Pressure
Both systolic (SBP) and diastolic blood pressure (DBP) will be measured using the Omron HEM-705-CP digital blood pressure monitor in the right arm of each relaxed (rest at least 15 minutes) and seated participant. The Omron HEM-705-CP can provide accurate estimation of blood pressure in both children and adults with a sensitivity of 82% and specificity of 98%.
Measured: Change from baseline blood pressure at 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start20 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiying Ling, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183179
- Sponsor's protocol ID
- Grant #R-1904-144322
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2019
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data including code book can be shared with other researchers upon request.
Publications
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.
PubMed 37768980
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Happy Family, Healthy Kids: An Intergenerational Program to Promote Healthy Eating Habits
- ClinicalTrials.gov ID
- NCT04183179
- Acronym / sponsor ID
- Grant #R-1904-144322
- Conditions
- Healthy Diet, Stress, Pediatric Obesity, Intergenerational Relations
- Keywords
- Obesity prevention, Early childhood, Intergenerational, Healthy eating, Life stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Program | Experimental | Behavioral: Happy Family, Healthy Kids ProgramThe 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 |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- There are ten inclusion criteria (five for preschoolers and five for caregivers).
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happy Family, Healthy Kids ProgramThe 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 | Behavioural | Program |
Primary outcome
Child Dietary Fruit and Vegetable Intake
Time frame: Change from baseline child dietary intake at 15 weeks
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.
3 secondary outcomes
Child Emotional Overeating
Time frame: Change from baseline to 15 weeks
Child Body Mass Index Z-score
Time frame: Change from baseline body mass index z-score at 15 weeks
Systolic and Diastolic Blood Pressure
Time frame: Change from baseline blood pressure at 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37768980Ling 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.
- Individual participant dataSharing planned: No. De-identified data including code book can be shared with other researchers upon request.
Related trials for Healthy Diet
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Recruiting
Training, Coaching and Marketing Program for Vegetable and Fruit Vendors in Markets to Improve Food Safety Practices and Vegetable and Fruit Intake Among Women 20-49 yr Old in Quezon City, Philippines
Intake of Fruit, Intake of Vegetables
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Not yet recruiting
Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets for Pediatric Cancer Survivors and Their Families
Pediatric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happy Family, Healthy Kids Program in people with Healthy Diet and Stress, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Dietary Fruit and Vegetable Intake (time frame: Change from baseline child dietary intake at 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.