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Healthy Children, Healthy Families: Parents Making A Difference

Primary Purpose

Childhood Obesity Prevention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy Children Healthy Families
Sponsored by
Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity Prevention focused on measuring childhood obesity, parenting practices, food and physical activity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Immediate intervention

    Delayed intervention

    Arm Description

    The immediate education (IE) group will receive the intervention, Healthy Children, Healthy Families: Parents Making a Difference! in period 1. In period 2, IE will receive no education and will be followed longitudinally for periods 2 and 3.

    The delayed education (DE) group will serve as controls in period 1, receiving no intervention. In period 2, the treatments will cross over, so DE will receive the Healthy Children, Healthy Families: Parents Making a Difference! intervention.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    September 7, 2018
    Last Updated
    March 8, 2022
    Sponsor
    Cornell University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04179565
    Brief Title
    Healthy Children, Healthy Families: Parents Making A Difference
    Official Title
    Healthy Children, Healthy Families: Parents Making A Difference: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    August 30, 2018 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cornell University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity Prevention
    Keywords
    childhood obesity, parenting practices, food and physical activity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    391 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate intervention
    Arm Type
    Active Comparator
    Arm Description
    The immediate education (IE) group will receive the intervention, Healthy Children, Healthy Families: Parents Making a Difference! in period 1. In period 2, IE will receive no education and will be followed longitudinally for periods 2 and 3.
    Arm Title
    Delayed intervention
    Arm Type
    Active Comparator
    Arm Description
    The delayed education (DE) group will serve as controls in period 1, receiving no intervention. In period 2, the treatments will cross over, so DE will receive the Healthy Children, Healthy Families: Parents Making a Difference! intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Children Healthy Families
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Healthy Children, Healthy Families Checklist
    Description
    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.
    Time Frame
    up to 8 months
    Title
    Comprehensive Feeding Practices Questionnaire (CFPQ)
    Description
    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.
    Time Frame
    up to 8 months
    Secondary Outcome Measure Information:
    Title
    Parental self-efficacy
    Description
    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.
    Time Frame
    up to 8 months
    Title
    Food frequency of sugar sweetened beverages and foods
    Description
    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.
    Time Frame
    up to 8 months
    Title
    Parent food choice behaviors
    Description
    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.
    Time Frame
    up to 8 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jamie S Dollahite
    Organizational Affiliation
    Cornell University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified individual participant data for all primary and secondary outcome measures will be made available.
    IPD Sharing Time Frame
    2020
    IPD Sharing Access Criteria
    Data access requests will be reviewed by investigators within the Division of Nutritional Sciences at Cornell who were not involved in the study. Requestors will be required to sign a data access agreement.
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