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Happy Family, Healthy Kids Program

Primary Purpose

Healthy Diet, Stress, Pediatric Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Happy Family, Healthy Kids Program

About this trial

This is an interventional prevention trial for Healthy Diet focused on measuring Obesity prevention, Early childhood, Intergenerational, Healthy eating, Life stress management

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

There are ten inclusion criteria (five for preschoolers and five for caregivers).

Preschoolers must:

Have parental consent.
Have child assent if the child is 5 years old.
Be 3-5 years of age.
Be able to understand and speak English. The intervention will be delivered in English.
Be enrolled in the full-day or part-day Head Start program.

Caregivers must:

Provide consent.
Be the primary adult caregiver (≥ 18 years old) for the preschooler. Primary caregiver refers to the one person most responsible for providing care to the preschooler on a daily basis.
Be able to read, understand, and speak English. The intervention will be delivered in English.
Have at least weekly Internet access using a smartphone, tablet, or a computer. Each caregiver needs to have Internet access to access the study's Facebook group for participating in the Facebook-based program.
Be willing to use Facebook. Since the caregiver intervention component will be delivered via Facebook, caregivers need to be willing to use Facebook in the study.

Exclusion Criteria:

There are three exclusion criteria for both caregivers and preschoolers.

Preschoolers or caregivers who have medical conditions precluding participating in dietary changes.
Preschoolers or caregivers who have diagnosed health conditions known to impact weight (e.g., Prader-Willi Syndrome) or are taking weight-affecting medications (e.g., stimulants).
Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.

Sites / Locations

Betsie Valley Elementary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Program

Arm Description

The 14-week healthy eating program activities including four components: A 14-week parent Facebook-based program focusing on stress management and healthy eating to reduce emotional eating and increase parents' capacity to initiate healthy eating practices at home Three parent face-to-face or virtual meetings at Head Start centers to connect parents with each other in person, offer healthy cooking tools/classes, and discuss behavioral change strategies and challenges 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children Weekly child letter to parents to connect child learning at the Head Start center with parental practices at home

Outcomes

Primary Outcome Measures

Child dietary 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.

Secondary Outcome Measures

Child eating style

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 each factor will be calculated, with a higher mean factor score indicating a higher level of food responsiveness, emotional overeating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional undereating, and food fussiness, respectively.

Child proportion of overweight and obesity and 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 percentile and BMI z-score for age and sex will be determined via SAS program for CDC Growth Charts.

Systolic and diastolic blood pressure

Both systolic and diastolic blood pressure 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%.

Hair cortisol concentration

Hair cortisol concentration in pg/mg will be obtained from hair samples using the enzyme immunoassay approach analyzed by the Hormone Assay Core Laboratory at the University of Massachusetts Amherst.

Full Information

NCT ID

NCT04183179

First Posted

November 27, 2019

Last Updated

August 25, 2023

Sponsor

Michigan State University

1. Study Identification

Unique Protocol Identification Number

NCT04183179

Brief Title

Happy Family, Healthy Kids Program

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

August 20, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: A 14-week parent Facebook-based program focusing on stress management and healthy eating to reduce emotional eating and increase parents' capacity to initiate healthy eating practices at home Three parent face-to-face or virtual meetings at Head Start centers to connect parents with each other in person, offer healthy cooking tools/classes, and discuss behavioral change strategies and challenges 14-week child "Eat My ABCs" program at Head Start centers to provide an age-appropriate, healthy eating program to children Weekly child letter to parents to connect child learning at the Head Start center with parental practices at home In Project Year 2, the investigators will finalize the program based on the evaluation outcomes in Project Year 1, and work closely with the participating Head Start organizations to disseminate the healthy eating program to all the participating Head Start centers and classes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Diet, Stress, Pediatric Obesity, Intergenerational Relations

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The program will be evaluated with about 100 Head Start children, aged 3 to 5 years, and their parents (one parent per family) in four urban and three rural Head Start centers to compare the program outcomes between urban and rural settings.

Masking

None (Open Label)

Allocation

N/A

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Program

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Happy Family, Healthy Kids Program

Intervention Description

Primary Outcome Measure Information:

Title

Child dietary intake

Description

Time Frame

Change from baseline child dietary intake at 15 weeks

Secondary Outcome Measure Information:

Title

Child eating style

Description

Time Frame

Change from baseline child eating style at 15 weeks

Title

Child proportion of overweight and obesity and body mass index z-score

Description

Time Frame

Change from baseline proportion of overweight and obesity and body mass index z-score at 15 weeks

Title

Systolic and diastolic blood pressure

Description

Time Frame

Change from baseline blood pressure at 15 weeks

Title

Hair cortisol concentration

Description

Hair cortisol concentration in pg/mg will be obtained from hair samples using the enzyme immunoassay approach analyzed by the Hormone Assay Core Laboratory at the University of Massachusetts Amherst.

Time Frame

Baseline only

Other Pre-specified Outcome Measures:

Title

Parental knowledge of health eating

Description

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

Title

Parental self-efficacy for supporting health eating

Description

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

Title

Parental support for health eating

Description

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

Title

Parental feeding practice skill

Description

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

Title

Parental food resource management and food safety

Description

Parental food resource management and food safety will be assessed by the 9-item Expanded Food and Nutrition Education Program Checklist developed by the University of California Cooperative Extension. Each question has five response choices ranging from 0=no to 4=almost always. The sum score of the 9 items will be calculated, with a higher sum score indicating a better food management and safety behavior.

Time Frame

Change from baseline parental food resource management and food safety at 15 weeks

Title

Parental perceived stress

Description

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

Title

Parental coping strategies

Description

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

Title

Parent fruit/vegetable/fiber intake

Description

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

Title

Parental emotional eating

Description

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

Title

Home eating environment

Description

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

Title

Food security status

Description

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

Title

Parent proportion of overweight and obesity and body mass index

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: There are ten inclusion criteria (five for preschoolers and five for caregivers). Preschoolers must: Have parental consent. Have child assent if the child is 5 years old. Be 3-5 years of age. Be able to understand and speak English. The intervention will be delivered in English. Be enrolled in the full-day or part-day Head Start program. Caregivers must: Provide consent. Be the primary adult caregiver (≥ 18 years old) for the preschooler. Primary caregiver refers to the one person most responsible for providing care to the preschooler on a daily basis. Be able to read, understand, and speak English. The intervention will be delivered in English. Have at least weekly Internet access using a smartphone, tablet, or a computer. Each caregiver needs to have Internet access to access the study's Facebook group for participating in the Facebook-based program. Be willing to use Facebook. Since the caregiver intervention component will be delivered via Facebook, caregivers need to be willing to use Facebook in the study. Exclusion Criteria: There are three exclusion criteria for both caregivers and preschoolers. Preschoolers or caregivers who have medical conditions precluding participating in dietary changes. Preschoolers or caregivers who have diagnosed health conditions known to impact weight (e.g., Prader-Willi Syndrome) or are taking weight-affecting medications (e.g., stimulants). Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.

Facility Information:

Facility Name

Betsie Valley Elementary

City

Thompsonville

State/Province

Michigan

ZIP/Postal Code

49683

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

De-identified data including code book can be shared with other researchers upon request.

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Happy Family, Healthy Kids Program

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