Healthy Children, Healthy Families: Parents Making A Difference

Childhood Obesity Prevention Clinical Trial

Official title:

Healthy Children, Healthy Families: Parents Making A Difference: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179565
• Other study ID #: CornellU
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2022
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The impacts of Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) on how low-income parents enrolled in the Expanded Food and Nutrition Education Program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed intervention control group.

Description:

The Healthy Children, Healthy Families: Parents Making a Difference! (HCHF) curriculum is a Cornell curriculum for parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain. These behaviors include drinking water or milk instead of sweetened beverages, eating more vegetables and fruits, playing actively, eating fewer high-fat and high-sugar foods, limiting screen time, and having sensible serving sizes. The 8-session curriculum uses a learner-centered dialogue approach, hands-on activities and role plays. The study will include 300 participants with young children 3-5 years old in Head Start and childcare programs in New York City using a randomized control design. In period 1 (9 weeks), half the groups will receive HCHF education (immediate education, IE) and half will serve as controls, receiving no education (delayed education, DE). In period 2 (9 weeks), DE will receive education; IE will receive no education and be followed longitudinally for periods 2 and 3. In period 3 (16 weeks), neither group will receive education and both will be followed longitudinally. Data will be collected at each time point using validated measures, including the HCHF Checklist developed by the investigators and complementary measures that assess parenting feeding practices, food behavior in parents, food behavior in children, and parent self-efficacy around obesity prevention behaviors. It is hypothesized that change pre- to post- HCHF will be greater than control groups, and changes in behavior will be retained post-education.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: December 31, 2019
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

• Inclusion Criteria: Parents/caregivers with young children 3-5 years old

• Exclusion Criteria: Any person who does not have children who are 3-5 years old

Related Conditions & MeSH terms

• Childhood Obesity Prevention
• Pediatric Obesity

Intervention

Behavioral:
• Healthy Children Healthy Families
The Healthy Children, Healthy Families: Parents Making a Difference! intervention was developed by the investigators for low-income parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

References & Publications (87)

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* Note: There are 87 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthy Children, Healthy Families Checklist	The checklist is a 16-item instrument that assesses parents'/caregivers' parenting and personal practices around food and physical activity, as well as the target child's food and physical activity practices. The checklist asks parents to report frequency (per day/week/month) of practices on 5-point Likert-type scales. The constructs measure parent diet quality and physical activity, child diet quality and physical activity, and parenting practices. Each question on the instrument is converted to a numeric value, 1 for the least desirable to 5 for most desirable response. The values for the entire instrument are summed (range 1 - 80 - only those checklists with at least one response are included) and divided by the number of items with a response (0 - 16), resulting in a mean score range of 0 - 5. The questions within each sub-scale are handled in the same way, with a sub-scale range of 0 - 5.	up to 8 months
Primary	Comprehensive Feeding Practices Questionnaire (CFPQ)	Six sub-scales (24 items) aligned with the learning objectives of the intervention, were selected from the original CFPQ. The constructs assessed by the sub-scales include encouraging balance and variety, use of food as reward, parent allowing child to control eating, parental modeling, parental pressure for child to consume more food, and home environment. Response options for 6 items include frequency on a Likert-type scale (never to always) and for 18 items include a Likert scale (strongly disagree to strongly agree). Each response is converted to a numeric value, 1 for the least desirable to 5 for the most desirable option. These values are then summed (range 0 - 120) and divided by the number of items with a response, resulting in a mean scale score range of 0 - 5. The items within each sub-scale are handled in the same way, with the sub-scale ranges of 0 - 5.	up to 8 months
Secondary	Parental self-efficacy	Four items were selected assessing parental efficacy for influencing behaviors addressed in the interventions: child's physical activity; and fruit, vegetable, and sugar sweetened beverage intake. The item responses included a 5-point Likert-type scale (not sure to extremely sure). Each question is converted to a numeric value, 1 for the least to 5 for the most desirable. These values are summed (range 0 - 20) and divided by the number of items with a response (0 - 4), resulting in a mean scale score range of 0 - 5.	up to 8 months
Secondary	Food frequency of sugar sweetened beverages and foods	Five items were selected from a 10-item instrument; selected items specifically focus on sugar-sweetened beverages and foods with added sugars. Parents report the number of times per day the child consumes each. Based on initial responses, a scoring system was devised that assigned 7 for a response of zero intake (most desirable) to 1 for a response of >2.5 times per day (least desirable). The response values are then summed (range 0 - 35) and divided by 5, resulting in a mean scale score range of 0 - 7.	up to 8 months
Secondary	Parent food choice behaviors	Two scales are used from the Food Behavior Checklist to assess parents' self-reported food intake of fruits and vegetables (9 items) and overall diet quality (4 items). Nine items have Likert-type responses with 8 being never to always (scored 1 - 4), and one being poor to excellent (scored 1-5), with the higher score being most desirable in all cases. The responses to two items are no or yes, scored 1 or 5 respectively. Two items ask for number of servings consumed per day and are assigned the value provided. The fruit and vegetable 9-item scale response values are summed (range = 1 - (26+sum of 2 frequency responses). The diet quality 4-item scale response values are summed (range 1 - 17). The sum for each scale is divided by the number of items in the scale resulting in a mean scale score range of 0-7 for the 9-item scale and 0-4.25 for the 4-item scale.	up to 8 months