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Happy Family, Healthy Kids Program

Happy Family, Healthy Kids: An Intergenerational Program to Promote Healthy Eating Habits

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04183179
Enrollment
214
Registered
2019-12-03
Start date
2021-08-20
Completion date
2022-12-31
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Diet, Intergenerational Relations, Pediatric Obesity, Stress

Keywords

Obesity prevention, Early childhood, Intergenerational, Healthy eating, Life stress management

Brief summary

Happy Family, Healthy Kids program, funded by the Michigan Health Endowment Fund, is a 14-week healthy eating program aimed to foster Happy Family & Healthy Kids. The program will target parental emotional eating through a life stress management component, and parents will be coached on making happy and healthy eating behavioral changes at home that will support their children to establish lifelong healthy eating habits. At the end of this project, the investigators expect to have an effective, comprehensive, and sustainable healthy eating program ready to expand to any Head Start center in an urban or rural setting.

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: 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 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.

Interventions

BEHAVIORALHappy 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

Sponsors

Michigan State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

There are ten inclusion criteria (five for preschoolers and five for caregivers). Preschoolers must: 1. Have parental consent. 2. Have child assent if the child is 5 years old. 3. Be 3-5 years of age. 4. Be able to understand and speak English. The intervention will be delivered in English. 5. Be enrolled in the full-day or part-day Head Start program. Caregivers must: 1. Provide consent. 2. 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. 3. Be able to read, understand, and speak English. The intervention will be delivered in English. 4. 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. 5. 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

Design outcomes

Primary

MeasureTime frameDescription
Child Dietary Fruit and Vegetable IntakeChange from baseline child dietary intake at 15 weeksChild 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.

Secondary

MeasureTime frameDescription
Child Emotional OvereatingChange 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.
Child Body Mass Index Z-scoreChange 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.
Systolic and Diastolic Blood PressureChange from baseline blood pressure at 15 weeksBoth 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%.

Other

MeasureTime frameDescription
Parental Perceived StressChange 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.
Parental Coping StrategiesChange 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.
Parent Fruit/Vegetable/Fiber IntakeChange 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.
Parental Knowledge of Health EatingChange 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.
Home Eating EnvironmentChange 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.
Food Security StatusChange 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.
Parent Body Mass IndexChange 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.
Parental Emotional EatingChange 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.
Parental Self-efficacy for Supporting Health EatingChange 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.
Parental Support for Health EatingChange 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.
Parental Feeding Practice SkillChange 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.

Countries

United States

Participant flow

Recruitment details

107 caregivers and 107 preschoolers were recruited.

Participants by arm

ArmCount
Program
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
214
Total214

Baseline characteristics

CharacteristicProgram
Age, Continuous
Caregivers
30.12 Years
STANDARD_DEVIATION 5.98
Age, Continuous
Preschoolers
3.94 Years
STANDARD_DEVIATION 0.57
Ethnicity (NIH/OMB)
Caregivers
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Caregivers
Not Hispanic or Latino
100 Participants
Ethnicity (NIH/OMB)
Caregivers
Unknown or Not Reported
0 Participants
Ethnicity (NIH/OMB)
Preschooler
Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Preschooler
Not Hispanic or Latino
98 Participants
Ethnicity (NIH/OMB)
Preschooler
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Caregivers
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Caregivers
Asian
0 Participants
Race (NIH/OMB)
Caregivers
Black or African American
16 Participants
Race (NIH/OMB)
Caregivers
More than one race
8 Participants
Race (NIH/OMB)
Caregivers
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Caregivers
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
Caregivers
White
79 Participants
Race (NIH/OMB)
Preschoolers
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Preschoolers
Asian
0 Participants
Race (NIH/OMB)
Preschoolers
Black or African American
21 Participants
Race (NIH/OMB)
Preschoolers
More than one race
7 Participants
Race (NIH/OMB)
Preschoolers
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Preschoolers
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Preschoolers
White
78 Participants
Region of Enrollment
United States
214 participants
Sex: Female, Male
Caregivers
Female
102 Participants
Sex: Female, Male
Caregivers
Male
5 Participants
Sex: Female, Male
Preschoolers
Female
58 Participants
Sex: Female, Male
Preschoolers
Male
49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1070 / 107
other
Total, other adverse events
0 / 1070 / 107
serious
Total, serious adverse events
0 / 1070 / 107

Outcome results

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.

Time frame: Change from baseline child dietary intake at 15 weeks

Population: This outcome is for preschoolers only. Caregivers' outcomes were presented separately.

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsChild Dietary Fruit and Vegetable Intake0.07 Cups per dayStandard Deviation 1.04
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.

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

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsChild Body Mass Index Z-score-0.06 BMI z scoreStandard Deviation 0.48
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.

Time frame: Change from baseline to 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsChild Emotional Overeating0.05 Mean scoreStandard Deviation 0.46
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%.

Time frame: Change from baseline blood pressure at 15 weeks

Population: 214 participants include 107 preschoolers and 107 caregivers.

ArmMeasureGroupValue (MEAN)Dispersion
Program - Preschooler ParticipantsSystolic and Diastolic Blood PressureChild SBP1.02 mmHgStandard Deviation 11.77
Program - Preschooler ParticipantsSystolic and Diastolic Blood PressureChild DBP-1.60 mmHgStandard Deviation 12.38
Program - Preschooler ParticipantsSystolic and Diastolic Blood PressureCaregiver SBP-3.64 mmHgStandard Deviation 11.96
Program - Preschooler ParticipantsSystolic and Diastolic Blood PressureCaregiver DBP-2.10 mmHgStandard Deviation 9.21
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.

Time frame: Change from baseline food security status at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsFood Security Status-0.01 score on a scaleStandard Deviation 0.87
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.

Time frame: Change from baseline home eating environment at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsHome Eating Environment0.87 score on a scaleStandard Deviation 3.65
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.

Time frame: Change from baseline parental coping strategies at 15 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Program - Preschooler ParticipantsParental Coping StrategiesProblem-focused coping0.14 score on a scaleStandard Deviation 0.61
Program - Preschooler ParticipantsParental Coping StrategiesEmotion-focused coping-0.01 score on a scaleStandard Deviation 0.44
Program - Preschooler ParticipantsParental Coping StrategiesAvoidant coping0.01 score on a scaleStandard Deviation 0.39
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.

Time frame: Change from baseline parental emotional eating at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsParental Emotional Eating0.01 score on a scaleStandard Deviation 0.67
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.

Time frame: Change from baseline parental feeding practice skill at 15 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Program - Preschooler ParticipantsParental Feeding Practice Skillperceived responsibility-0.05 score on a scaleStandard Deviation 0.45
Program - Preschooler ParticipantsParental Feeding Practice Skillperceived caregiver weight0.003 score on a scaleStandard Deviation 0.37
Program - Preschooler ParticipantsParental Feeding Practice Skillperceived child weight-0.03 score on a scaleStandard Deviation 0.3
Program - Preschooler ParticipantsParental Feeding Practice Skillconcerns about child weight0.02 score on a scaleStandard Deviation 0.44
Program - Preschooler ParticipantsParental Feeding Practice Skillrestriction-0.09 score on a scaleStandard Deviation 0.79
Program - Preschooler ParticipantsParental Feeding Practice Skillpressure to eat-0.11 score on a scaleStandard Deviation 0.78
Program - Preschooler ParticipantsParental Feeding Practice Skillmonitoring0.04 score on a scaleStandard Deviation 1.07
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.

Time frame: Change from baseline parental knowledge of health eating at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsParental Knowledge of Health Eating0.44 Sum score on a scaleStandard Deviation 1.21
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.

Time frame: Change from baseline parental perceived stress at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsParental Perceived Stress3.74 score on a scaleStandard Deviation 9.16
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.

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

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsParental Self-efficacy for Supporting Health Eating0.56 score on a scaleStandard Deviation 1.25
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.

Time frame: Change from baseline parental support for health eating at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsParental Support for Health Eating0.47 score on a scaleStandard Deviation 0.89
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.

Time frame: Change from baseline parent proportion of overweight and obesity and body mass index at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsParent Body Mass Index-0.13 kg/m^2Standard Deviation 3.4
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.

Time frame: Change from baseline parent fruit/vegetable/fiber intake at 15 weeks

ArmMeasureValue (MEAN)Dispersion
Program - Preschooler ParticipantsParent Fruit/Vegetable/Fiber Intake0.12 servings per dayStandard Deviation 1.53

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026