- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183179
Happy Family, Healthy Kids Program
Happy Family, Healthy Kids: An Intergenerational Program to Promote Healthy Eating Habits
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Michigan
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Thompsonville, Michigan, United States, 49683
- Betsie Valley Elementary
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Program
The 14-week healthy eating program activities including four components:
|
The 14-week healthy eating program activities including four components:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Change from baseline child dietary intake at 15 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Emotional Overeating
Time Frame: Change from baseline to 15 weeks
|
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.
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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
|
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.
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Change from baseline body mass index z-score at 15 weeks
|
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Systolic and Diastolic Blood Pressure
Time Frame: Change from baseline blood pressure at 15 weeks
|
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%.
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Change from baseline blood pressure at 15 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Knowledge of Health Eating
Time Frame: Change from baseline parental knowledge of health eating at 15 weeks
|
Parental knowledge of health eating will be assessed by the 10-item Parental Nutrition Knowledge Scale.
This scale has been used with Head Start parents to assess their knowledge level.
The sum of the 10 items, with a range from 0 to 10, will be calculated, with a higher sum score indicating greater knowledge on healthy eating and physical activity.
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Change from baseline parental knowledge of health eating at 15 weeks
|
|
Parental Self-efficacy for Supporting Health Eating
Time Frame: Change from baseline parental self-efficacy for supporting health eating at 15 weeks
|
Parental self-efficacy for supporting health eating will be assessed with the 12-item Parental Eating Self-Efficacy Scale.
The scale has shown to have a good internal consistency reliability of 0.94 with Head Start parents.
The mean score of the 12 items, with a range from 0 to 10, will be calculated, with a higher mean score indicating greater self-efficacy.
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Change from baseline parental self-efficacy for supporting health eating at 15 weeks
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Parental Support for Health Eating
Time Frame: Change from baseline parental support for health eating at 15 weeks
|
Parental support for health eating will be measured by the 7-item Parental Support Scale for Eating Habits.
A prior study with Head Start parents showed that the scale had a Cronbach's alpha of 0.87.
The mean score of the seven items, with a range from 1 to 6, will be calculated, with a higher mean score indicating greater parental support.
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Change from baseline parental support for health eating at 15 weeks
|
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Parental Feeding Practice Skill
Time Frame: Change from baseline parental feeding practice skill at 15 weeks
|
Parental feeding practice skill will be assessed by the Child Feeding Questionnaire.
The Child Feeding Questionnaire has seven factors: perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, restriction, pressure to eat, and monitoring with good Cronbach's alphas of 0.73, 0.80, 0.75, 0.73, 0.69, 0.65, and 0.82 among Head Start parents, respectively.
The mean score of the items for each factor, with a range from 1 to 5, will be calculated, with a higher mean score indicating greater perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, pressure to eat, restriction, and monitoring, respectively.
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Change from baseline parental feeding practice skill at 15 weeks
|
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Parental Perceived Stress
Time Frame: Change from baseline parental perceived stress at 15 weeks
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Parental perceived stress will be assessed by the 10-item Perceived Stress Scale (PSS).
Literature has support that the 10-item PSS has better psychometric properties than the original 14-item PSS.
It has five response choices from 0=never to 4=very often.
The sum score of the 10 items will be calculated, with a higher sum score indicating a higher perceived stress level.
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Change from baseline parental perceived stress at 15 weeks
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Parental Coping Strategies
Time Frame: Change from baseline parental coping strategies at 15 weeks
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Parental coping strategies will be assessed by the 28-item Brief COPE.
The Brief COPE measures 14 coping strategies including self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame.
It has four response choices from "1=not at all" to "4=a lot".
A sum score, range from 2 to 8, for each coping strategy will be calculated, with a higher sum score indicating a higher level of that coping strategy used.
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Change from baseline parental coping strategies at 15 weeks
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Parent Fruit/Vegetable/Fiber Intake
Time Frame: Change from baseline parent fruit/vegetable/fiber intake at 15 weeks
|
Parent fruit/vegetable/fiber intake will be assessed by the 7-item Block Fruit/Vegetable/Fiber Screener.
The screener had significant relationships with the 1995 Block 100-item Food Frequency Questionnaire (r=0.71 for fruit/vegetable intake and 0.62 for fiber intake).
It has good Cronbach's alphas of 0.75-0.76
among Head Start parents.
The survey has six response choices ranging from 0=less than one per week to 5=2 or more a day.
Following the equations provided by the NutritionQuest, the number of fruit and vegetable servings per day will be calculated to describe parents' fruit and vegetable intake.
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Change from baseline parent fruit/vegetable/fiber intake at 15 weeks
|
|
Parental Emotional Eating
Time Frame: Change from baseline parental emotional eating at 15 weeks
|
Parental emotional eating will be assessed by the Three-Factor Eating Questionnaire (TFEQ-R18).
The TFEQ-R18 has three domains: uncontrolled eating, emotional eating, and cognitive restraint, with Cronbach's alpha coefficients of 0.84, 0.92, and 0.70, respectively, among U.S. healthy weight, overweight, and obese adults.
Another study with tumor survivors aged 15-39 years old further supports the reliability and factor structure of the scale.
It has four response choices ranging from 1="definitely false" to 4="definitely true".
The mean score of each domain will be calculated, with a higher mean score indicating a higher level of uncontrolled eating, emotional eating, and cognitive restraint, respectively.
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Change from baseline parental emotional eating at 15 weeks
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Home Eating Environment
Time Frame: Change from baseline home eating environment at 15 weeks
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Home eating environment will be assessed by the 10-item Family Nutrition Screening Tool, with good construct validity in young children.
Evidence has shown that the healthier home eating environment is related to healthier BMI and lower odds of food insecurity.
It has four response choices ranging from 1=never/almost never to 4=very often/always.
The sum score of the 10 items, with a range from 10 to 40, will be calculated, with a higher sum score indicating a healthier home environment.
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Change from baseline home eating environment at 15 weeks
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Food Security Status
Time Frame: Change from baseline food security status at 15 weeks
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Food security status in the past 12 months will be assessed by the 18-item U.S. Household Food Security Survey Module.
It has two subscales: a 10-item Adult Food Security subscale and an 8-item Child Food Security subscale.
Raw score, ranging from 0 to 18, will be calculated for the whole scale, adult subscale, and child subscale, respectively, with a higher raw score indicating a higher level of food insecurity.
Household will be categorized as 0-2=food secure and 3-18=food insecure.
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Change from baseline food security status at 15 weeks
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Parent Body Mass Index
Time Frame: Change from baseline parent proportion of overweight and obesity and body mass index at 15 weeks
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Body mass index will be calculated based on weight (kg)/height (m2).
Data collection procedures for parents will be similar to those employed for preschoolers.
|
Change from baseline parent proportion of overweight and obesity and body mass index at 15 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Grant #R-1904-144322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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