Happy Family, Healthy Kids Program

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183179
• Other study ID #: Grant #R-1904-144322
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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 exclusion criteria for both caregivers and preschoolers.

1. Preschoolers or caregivers who have medical conditions precluding participating in dietary changes.

2. 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).

3. Preschoolers who have diagnosed developmental disabilities (e.g., autism), or caregivers who have diagnosed psychiatric or mental health problems.

Related Conditions & MeSH terms

• Healthy Diet
• Intergenerational Relations
• Pediatric Obesity
• Stress

Intervention

Behavioral:
• Happy Family, Healthy Kids Program
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

Locations

Country	Name	City	State
United States	Betsie Valley Elementary	Thompsonville	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental knowledge of health eating	Parental knowledge of health eating will be assessed by the 10-item Parental Nutrition Knowledge Scale. This scale has been used with Head Start parents to assess their knowledge level. The sum of the 10 items, with a range from 0 to 10, will be calculated, with a higher sum score indicating greater knowledge on healthy eating and physical activity.	Change from baseline parental knowledge of health eating at 15 weeks
Other	Parental self-efficacy for supporting health eating	Parental self-efficacy for supporting health eating will be assessed with the 12-item Parental Eating Self-Efficacy Scale. The scale has shown to have a good internal consistency reliability of 0.94 with Head Start parents. The mean score of the 12 items, with a range from 0 to 10, will be calculated, with a higher mean score indicating greater self-efficacy.	Change from baseline parental self-efficacy for supporting health eating at 15 weeks
Other	Parental support for health eating	Parental support for health eating will be measured by the 7-item Parental Support Scale for Eating Habits. A prior study with Head Start parents showed that the scale had a Cronbach's alpha of 0.87. The mean score of the seven items, with a range from 1 to 6, will be calculated, with a higher mean score indicating greater parental support.	Change from baseline parental support for health eating at 15 weeks
Other	Parental feeding practice skill	Parental feeding practice skill will be assessed by the Child Feeding Questionnaire. The Child Feeding Questionnaire has seven factors: perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, restriction, pressure to eat, and monitoring with good Cronbach's alphas of 0.73, 0.80, 0.75, 0.73, 0.69, 0.65, and 0.82 among Head Start parents, respectively. The mean score of the items for each factor, with a range from 1 to 5, will be calculated, with a higher mean score indicating greater perceived responsibility, perceived caregiver weight, perceived child weight, concerns about child weight, pressure to eat, restriction, and monitoring, respectively.	Change from baseline parental feeding practice skill at 15 weeks
Other	Parental food resource management and food safety	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.	Change from baseline parental food resource management and food safety at 15 weeks
Other	Parental perceived stress	Parental perceived stress will be assessed by the 10-item Perceived Stress Scale (PSS). Literature has support that the 10-item PSS has better psychometric properties than the original 14-item PSS. It has five response choices from 0=never to 4=very often. The sum score of the 10 items will be calculated, with a higher sum score indicating a higher perceived stress level.	Change from baseline parental perceived stress at 15 weeks
Other	Parental coping strategies	Parental coping strategies will be assessed by the 28-item Brief COPE. The Brief COPE measures 14 coping strategies including self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. It has four response choices from "1=not at all" to "4=a lot". A sum score, range from 2 to 8, for each coping strategy will be calculated, with a higher sum score indicating a higher level of that coping strategy used.	Change from baseline parental coping strategies at 15 weeks
Other	Parent fruit/vegetable/fiber intake	Parent fruit/vegetable/fiber intake will be assessed by the 7-item Block Fruit/Vegetable/Fiber Screener. The screener had significant relationships with the 1995 Block 100-item Food Frequency Questionnaire (r=0.71 for fruit/vegetable intake and 0.62 for fiber intake). It has good Cronbach's alphas of 0.75-0.76 among Head Start parents. The survey has six response choices ranging from 0=less than one per week to 5=2 or more a day. Following the equations provided by the NutritionQuest, the number of fruit and vegetable servings per day will be calculated to describe parents' fruit and vegetable intake.	Change from baseline parent fruit/vegetable/fiber intake at 15 weeks
Other	Parental emotional eating	Parental emotional eating will be assessed by the Three-Factor Eating Questionnaire (TFEQ-R18). The TFEQ-R18 has three domains: uncontrolled eating, emotional eating, and cognitive restraint, with Cronbach's alpha coefficients of 0.84, 0.92, and 0.70, respectively, among U.S. healthy weight, overweight, and obese adults. Another study with tumor survivors aged 15-39 years old further supports the reliability and factor structure of the scale. It has four response choices ranging from 1="definitely false" to 4="definitely true". The mean score of each domain will be calculated, with a higher mean score indicating a higher level of uncontrolled eating, emotional eating, and cognitive restraint, respectively.	Change from baseline parental emotional eating at 15 weeks
Other	Home eating environment	Home eating environment will be assessed by the 10-item Family Nutrition Screening Tool, with good construct validity in young children. Evidence has shown that the healthier home eating environment is related to healthier BMI and lower odds of food insecurity. It has four response choices ranging from 1=never/almost never to 4=very often/always. The sum score of the 10 items, with a range from 10 to 40, will be calculated, with a higher sum score indicating a healthier home environment.	Change from baseline home eating environment at 15 weeks
Other	Food security status	Food security status in the past 12 months will be assessed by the 18-item U.S. Household Food Security Survey Module. It has two subscales: a 10-item Adult Food Security subscale and an 8-item Child Food Security subscale. Raw score, ranging from 0 to 18, will be calculated for the whole scale, adult subscale, and child subscale, respectively, with a higher raw score indicating a higher level of food insecurity. Household will be categorized as 0-2=food secure and 3-18=food insecure.	Change from baseline food security status at 15 weeks
Other	Parent proportion of overweight and obesity and body mass index	Body mass index will be calculated based on weight (kg)/height (m2). Data collection procedures for parents will be similar to those employed for preschoolers.	Change from baseline parent proportion of overweight and obesity and body mass index at 15 weeks
Primary	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.	Change from baseline child dietary intake at 15 weeks
Secondary	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.	Change from baseline child eating style at 15 weeks
Secondary	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.	Change from baseline proportion of overweight and obesity and body mass index z-score at 15 weeks
Secondary	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%.	Change from baseline blood pressure at 15 weeks
Secondary	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.	Baseline only