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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program | Experimental | The 14-week healthy eating program activities including four components:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Happy Family, Healthy Kids Program | Behavioral | The 14-week healthy eating program activities including four components:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Knowledge of Health Eating | 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. | Change from baseline parental knowledge of health eating at 15 weeks |
Inclusion Criteria:
There are ten inclusion criteria (five for preschoolers and five for caregivers).
Preschoolers must:
Caregivers must:
Exclusion Criteria:
There are three exclusion criteria for both caregivers and preschoolers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Betsie Valley Elementary | Thompsonville | Michigan | 49683 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37768980 | Derived | 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. |
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De-identified data including code book can be shared with other researchers upon request.
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107 caregivers and 107 preschoolers were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Program-Preschoolers | The 14-week healthy eating program activities including 2 components for preschoolers:
|
| FG001 | Program-Caregivers | The 14-week healthy eating program activities including 2 components for caregivers:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
107 preschoolers and 107 caregivers
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| ID | Title | Description |
|---|---|---|
| BG000 | Program | The 14-week healthy eating program activities including 4 components:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The total sample of 214 include 107 preschoolers and 107 caregivers. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This outcome is for preschoolers only. Caregivers' outcomes were presented separately. | Posted | Mean | Standard Deviation | Cups per day | Change from baseline child dietary intake at 15 weeks |
|
Adverse events were assessed and collected throughout the entire study during baseline data collection, intervention implementation, and post-intervention data collection lasting for about 1 year and 4 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Program for Preschoolers | The 14-week healthy eating program activities including 2 components for preschoolers:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiying Ling | Michigan State University College of Nursing | 5173538591 | lingjiyi@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2022 | Mar 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2022 | Mar 26, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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.
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|
| 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. | 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%. | Change from baseline blood pressure at 15 weeks |
| Parental Self-efficacy for Supporting Health Eating | 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. | Change from baseline parental self-efficacy for supporting health eating at 15 weeks |
| Parental Support for Health Eating | 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. | Change from baseline parental support for health eating at 15 weeks |
| Parental Feeding Practice Skill | 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. | Change from baseline parental feeding practice skill at 15 weeks |
| Parental Perceived Stress | 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. | Change from baseline parental perceived stress at 15 weeks |
| Parental Coping Strategies | 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. | Change from baseline parental coping strategies at 15 weeks |
| Parent Fruit/Vegetable/Fiber Intake | 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. | Change from baseline parent fruit/vegetable/fiber intake at 15 weeks |
| Parental Emotional Eating | 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. | Change from baseline parental emotional eating at 15 weeks |
| Home Eating Environment | 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. | Change from baseline home eating environment at 15 weeks |
| Food Security Status | 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. | Change from baseline food security status at 15 weeks |
| Parent Body Mass Index | 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 |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Total 214 participants including 107 preschoolers and 107 caregivers. | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Total 214 participants with 107 preschoolers and 107 caregivers. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Total 214 participants with 107 preschoolers and 107 caregivers. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Program - Preschooler Participants | The 14-week healthy eating program activities including four components:
Happy Family, Healthy Kids Program: The 14-week healthy eating program activities including four components:
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Mean score | Change from baseline to 15 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | BMI z score | Change from baseline body mass index z-score at 15 weeks |
|
|
|
| Secondary | 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%. | 214 participants include 107 preschoolers and 107 caregivers. | Posted | Mean | Standard Deviation | mmHg | Change from baseline blood pressure at 15 weeks |
|
|
|
| Other Pre-specified | Parental Knowledge of Health Eating | 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. | Posted | Mean | Standard Deviation | Sum score on a scale | Change from baseline parental knowledge of health eating at 15 weeks |
|
|
|
| Other Pre-specified | Parental Self-efficacy for Supporting Health Eating | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline parental self-efficacy for supporting health eating at 15 weeks |
|
|
|
| Other Pre-specified | Parental Support for Health Eating | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline parental support for health eating at 15 weeks |
|
|
|
| Other Pre-specified | Parental Feeding Practice Skill | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline parental feeding practice skill at 15 weeks |
|
|
|
| Other Pre-specified | Parental Perceived Stress | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline parental perceived stress at 15 weeks |
|
|
|
| Other Pre-specified | Parental Coping Strategies | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline parental coping strategies at 15 weeks |
|
|
|
| Other Pre-specified | Parent Fruit/Vegetable/Fiber Intake | 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. | Posted | Mean | Standard Deviation | servings per day | Change from baseline parent fruit/vegetable/fiber intake at 15 weeks |
|
|
|
| Other Pre-specified | Parental Emotional Eating | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline parental emotional eating at 15 weeks |
|
|
|
| Other Pre-specified | Home Eating Environment | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline home eating environment at 15 weeks |
|
|
|
| Other Pre-specified | Food Security Status | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline food security status at 15 weeks |
|
|
|
| Other Pre-specified | Parent Body Mass Index | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Change from baseline parent proportion of overweight and obesity and body mass index at 15 weeks |
|
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| 0 |
| 107 |
| EG001 | Program for Caregivers | The 14-week healthy eating program activities including 2 components for caregivers:
| 0 | 107 | 0 | 107 | 0 | 107 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Caregiver SBP |
|
|
| Caregiver DBP |
|
|
| Title | Measurements |
|---|---|
|
| concerns about child weight |
|
| restriction |
|
| pressure to eat |
|
| monitoring |
|
| Title | Measurements |
|---|---|
|