Trial Outcomes & Findings for Happy Family, Healthy Kids Program (NCT NCT04183179)
NCT ID: NCT04183179
Last Updated: 2025-03-27
Results Overview
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.
COMPLETED
NA
214 participants
Change from baseline child dietary intake at 15 weeks
2025-03-27
Participant Flow
107 caregivers and 107 preschoolers were recruited.
Participant milestones
| Measure |
Program-Preschoolers
The 14-week healthy eating program activities including 2 components for preschoolers:
1. 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children
2. Weekly child letter to parents to connect child learning at the Head Start center with parental practices at home
|
Program-Caregivers
The 14-week healthy eating program activities including 2 components for caregivers:
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
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
107
|
|
Overall Study
COMPLETED
|
103
|
103
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The total sample of 214 include 107 preschoolers and 107 caregivers.
Baseline characteristics by cohort
| Measure |
Program
n=214 Participants
The 14-week healthy eating program activities including 4 components:
1. 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children
2. Weekly child letter to parents to connect child learning at the Head Start center with parental practices at home
3. 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
4. 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
|
|---|---|
|
Age, Continuous
Preschoolers
|
3.94 Years
STANDARD_DEVIATION 0.57 • n=107 Participants • The total sample of 214 include 107 preschoolers and 107 caregivers.
|
|
Age, Continuous
Caregivers
|
30.12 Years
STANDARD_DEVIATION 5.98 • n=107 Participants • The total sample of 214 include 107 preschoolers and 107 caregivers.
|
|
Sex: Female, Male
Preschoolers · Female
|
58 Participants
n=107 Participants • Total 214 participants including 107 preschoolers and 107 caregivers.
|
|
Sex: Female, Male
Preschoolers · Male
|
49 Participants
n=107 Participants • Total 214 participants including 107 preschoolers and 107 caregivers.
|
|
Sex: Female, Male
Caregivers · Female
|
102 Participants
n=107 Participants • Total 214 participants including 107 preschoolers and 107 caregivers.
|
|
Sex: Female, Male
Caregivers · Male
|
5 Participants
n=107 Participants • Total 214 participants including 107 preschoolers and 107 caregivers.
|
|
Ethnicity (NIH/OMB)
Preschooler · Hispanic or Latino
|
9 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Ethnicity (NIH/OMB)
Preschooler · Not Hispanic or Latino
|
98 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Ethnicity (NIH/OMB)
Preschooler · Unknown or Not Reported
|
0 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
7 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
100 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Preschoolers · American Indian or Alaska Native
|
1 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Preschoolers · Asian
|
0 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Preschoolers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Preschoolers · Black or African American
|
21 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Preschoolers · White
|
78 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Preschoolers · More than one race
|
7 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Preschoolers · Unknown or Not Reported
|
0 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
3 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
16 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Caregivers · White
|
79 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
8 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
1 Participants
n=107 Participants • Total 214 participants with 107 preschoolers and 107 caregivers.
|
|
Region of Enrollment
United States
|
214 participants
n=214 Participants
|
PRIMARY outcome
Timeframe: Change from baseline child dietary intake at 15 weeksPopulation: This outcome is for preschoolers only. Caregivers' outcomes were presented separately.
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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Child Dietary Fruit and Vegetable Intake
|
0.07 Cups per day
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Change from baseline to 15 weeksChild 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Child Emotional Overeating
|
0.05 Mean score
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Change from baseline body mass index z-score at 15 weeksHeight 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Child Body Mass Index Z-score
|
-0.06 BMI z score
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Change from baseline blood pressure at 15 weeksPopulation: 214 participants include 107 preschoolers and 107 caregivers.
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%.
Outcome measures
| Measure |
Program - Preschooler Participants
n=214 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Systolic and Diastolic Blood Pressure
Child SBP
|
1.02 mmHg
Standard Deviation 11.77
|
|
Systolic and Diastolic Blood Pressure
Child DBP
|
-1.60 mmHg
Standard Deviation 12.38
|
|
Systolic and Diastolic Blood Pressure
Caregiver SBP
|
-3.64 mmHg
Standard Deviation 11.96
|
|
Systolic and Diastolic Blood Pressure
Caregiver DBP
|
-2.10 mmHg
Standard Deviation 9.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parental knowledge of health eating at 15 weeksParental 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parental Knowledge of Health Eating
|
0.44 Sum score on a scale
Standard Deviation 1.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parental self-efficacy for supporting health eating at 15 weeksParental 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parental Self-efficacy for Supporting Health Eating
|
0.56 score on a scale
Standard Deviation 1.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parental support for health eating at 15 weeksParental 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parental Support for Health Eating
|
0.47 score on a scale
Standard Deviation 0.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parental feeding practice skill at 15 weeksParental 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parental Feeding Practice Skill
perceived responsibility
|
-0.05 score on a scale
Standard Deviation 0.45
|
|
Parental Feeding Practice Skill
perceived caregiver weight
|
0.003 score on a scale
Standard Deviation 0.37
|
|
Parental Feeding Practice Skill
perceived child weight
|
-0.03 score on a scale
Standard Deviation 0.30
|
|
Parental Feeding Practice Skill
concerns about child weight
|
0.02 score on a scale
Standard Deviation 0.44
|
|
Parental Feeding Practice Skill
restriction
|
-0.09 score on a scale
Standard Deviation 0.79
|
|
Parental Feeding Practice Skill
pressure to eat
|
-0.11 score on a scale
Standard Deviation 0.78
|
|
Parental Feeding Practice Skill
monitoring
|
0.04 score on a scale
Standard Deviation 1.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parental perceived stress at 15 weeksParental 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parental Perceived Stress
|
3.74 score on a scale
Standard Deviation 9.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parental coping strategies at 15 weeksParental 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parental Coping Strategies
Problem-focused coping
|
0.14 score on a scale
Standard Deviation 0.61
|
|
Parental Coping Strategies
Emotion-focused coping
|
-0.01 score on a scale
Standard Deviation 0.44
|
|
Parental Coping Strategies
Avoidant coping
|
0.01 score on a scale
Standard Deviation 0.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parent fruit/vegetable/fiber intake at 15 weeksParent 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parent Fruit/Vegetable/Fiber Intake
|
0.12 servings per day
Standard Deviation 1.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parental emotional eating at 15 weeksParental 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parental Emotional Eating
|
0.01 score on a scale
Standard Deviation 0.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline home eating environment at 15 weeksHome 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Home Eating Environment
|
0.87 score on a scale
Standard Deviation 3.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline food security status at 15 weeksFood 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.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Food Security Status
|
-0.01 score on a scale
Standard Deviation 0.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline parent proportion of overweight and obesity and body mass index at 15 weeksBody mass index will be calculated based on weight (kg)/height (m2). Data collection procedures for parents will be similar to those employed for preschoolers.
Outcome measures
| Measure |
Program - Preschooler Participants
n=107 Participants
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
Happy Family, Healthy Kids Program: 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
|
|---|---|
|
Parent Body Mass Index
|
-0.13 kg/m^2
Standard Deviation 3.40
|
Adverse Events
Program for Preschoolers
Program for Caregivers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place