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USDA Healthy Caregivers/Healthy Children: A Childhood Obesity Prevention Program (HC2)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Childhood Obesity
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring childhood obesity, early childhood, nutrition

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers
Inclusion Criteria. Centers must have met the following criteria to be included: (1) have > 30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade County Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment. Studies were excluded if they did not meet these criteria.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment

    Control

    Arm Description

    The intervention centers' menus were modified to include more fresh fruit, fresh vegetables, low-fat (1%) or skim milk, water, less juice, and less simple carbohydrate snacks. The centers were also encouraged to incorporate fresh fruits and vegetables as often as possible for snack and meal time. Physical Activity. Physical activity was promoted for at least 60 minutes per day. TV viewing, watching movies and playing computer games were logged and limited to 30 minutes or less per day. Schools adopted "Best-Practice Policies".

    Those schools randomized to the control arm received a safety curriculum and some child care center locations received an attention control consisting of three visits from the University of Miami Safety Van which provided parents and teachers with home, car and child seat safety information. The control group received all the same pre-post measures as the intervention arms. They also received the same incentives as the intervention arms to foster involvement and ensure retention/reduce loss to follow up.

    Outcomes

    Primary Outcome Measures

    Maintenance of a Child's Body Mass Index as a result of the intervention
    Assessment of demographic variables, anthropometrics, food insecurity and parent perception were performed. Sociodemographic variables included age and gender of the children, country of birth of parent and child, years living in the US, and parental education (highest grade completed). Child Health Measures:Anthropometric Variables. Assessment of body composition included height (by stadiometer), weight (by digital scale), which was converted to BMI (weight in kilograms/height in meters squared) and then to a BMI age-and sex-adjusted BMI percentile. Participants were asked to remove shoes and any heavy outer clothing prior to measurement. Weight and height measurements were collected by trained staff based on US Department of Health and Human Services (HHS) guidelines for accurate anthropomorphic measurement. Research grade stadiometers and scales were used, and were brought from site to site by the staff.

    Secondary Outcome Measures

    A Parent's perception of his/her child's weight status
    Caregiver Measures. To assess parent perception of child weight status, the child's actual weight status (determined by BMI percentile group) was compared to the caregivers' response to the question "Do you consider your child to be overweight, underweight or about right weight for (his/her) age?" Food insecurity was measured by the short form of the USDA's Food Security Scale. This information was obtained by means of a structured parent interview or a self-administered survey. Caregiver BMI was obtained by self reported height and weight included on the caregivers survey. Parent acculturation was measured by items from the Stephenson Acculturation Scale.

    Full Information

    First Posted
    October 26, 2012
    Last Updated
    November 2, 2012
    Sponsor
    University of Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01722032
    Brief Title
    USDA Healthy Caregivers/Healthy Children: A Childhood Obesity Prevention Program
    Acronym
    HC2
    Official Title
    Healthy Caregivers/Healthy Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    September 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention intervention randomized trial in the child care setting. Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income, ethnically diverse child care centers located throughout Miami-Dade County, FL is currently being conducted over two years (2010-present) to test the efficacy of an intervention that poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy Children (HC2) program includes a curriculum focusing specifically on healthy food choices, increased exercise, and role modeling. The program targets food policy changes throughout the school, and via the child, caregiver, and teacher. Major outcome measures include child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, and amount of physical activity. Discussion: Although few attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation should inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting. (H1) A child care center-based obesity prevention intervention program that includes a teacher and parent nutritional gatekeeper and role modeling program will be more effective in maintaining BMI in 3-5 year olds compared to a control group. (H2) Role modeling (teacher and parent) will be identified as a significant mediator in preventing obesity among intervention children versus controls. (H3) A child care center-based multi-level obesity prevention intervention program will improve child nutrition (increased consumption of fruits and vegetables, decreased consumption of sweetened beverages) and increase physical activity level compared to a control group.
    Detailed Description
    Over one third of preschoolers were either overweight (18.4%) or obese (16.5%). The majority (92%) of caregivers of an overweight/obese child inaccurately perceived that their child was in a normal BMI category. Foreign-born caregivers were significantly more likely to inaccurately perceive their child's BMI percentile category, versus US-born caregivers (OR=0.65, 95% CI, 0.48-0.88). Specifically, those born in South America [OR=0.59. 95% CI, 0.36-0.98), Central America/Mexico (OR=0.59, 95% CI,0.41-0.85), and Caribbean Hispanic nations [OR=0.54, 95% CI 0.35-0.83) were significantly less likely to accurately perceive their child's BMI category, versus US-born caregivers. Conclusions: The results of this study suggest that foreign-born parents of preschool-age overweight/obese children in particular do not accurately perceive their child's BMI status. Pediatricians and other healthcare providers serving foreign-born caregivers may consider additional healthy weight counseling for these families.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity
    Keywords
    childhood obesity, early childhood, nutrition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    The intervention centers' menus were modified to include more fresh fruit, fresh vegetables, low-fat (1%) or skim milk, water, less juice, and less simple carbohydrate snacks. The centers were also encouraged to incorporate fresh fruits and vegetables as often as possible for snack and meal time. Physical Activity. Physical activity was promoted for at least 60 minutes per day. TV viewing, watching movies and playing computer games were logged and limited to 30 minutes or less per day. Schools adopted "Best-Practice Policies".
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Those schools randomized to the control arm received a safety curriculum and some child care center locations received an attention control consisting of three visits from the University of Miami Safety Van which provided parents and teachers with home, car and child seat safety information. The control group received all the same pre-post measures as the intervention arms. They also received the same incentives as the intervention arms to foster involvement and ensure retention/reduce loss to follow up.
    Intervention Type
    Other
    Intervention Name(s)
    Childhood Obesity
    Primary Outcome Measure Information:
    Title
    Maintenance of a Child's Body Mass Index as a result of the intervention
    Description
    Assessment of demographic variables, anthropometrics, food insecurity and parent perception were performed. Sociodemographic variables included age and gender of the children, country of birth of parent and child, years living in the US, and parental education (highest grade completed). Child Health Measures:Anthropometric Variables. Assessment of body composition included height (by stadiometer), weight (by digital scale), which was converted to BMI (weight in kilograms/height in meters squared) and then to a BMI age-and sex-adjusted BMI percentile. Participants were asked to remove shoes and any heavy outer clothing prior to measurement. Weight and height measurements were collected by trained staff based on US Department of Health and Human Services (HHS) guidelines for accurate anthropomorphic measurement. Research grade stadiometers and scales were used, and were brought from site to site by the staff.
    Time Frame
    up to two years
    Secondary Outcome Measure Information:
    Title
    A Parent's perception of his/her child's weight status
    Description
    Caregiver Measures. To assess parent perception of child weight status, the child's actual weight status (determined by BMI percentile group) was compared to the caregivers' response to the question "Do you consider your child to be overweight, underweight or about right weight for (his/her) age?" Food insecurity was measured by the short form of the USDA's Food Security Scale. This information was obtained by means of a structured parent interview or a self-administered survey. Caregiver BMI was obtained by self reported height and weight included on the caregivers survey. Parent acculturation was measured by items from the Stephenson Acculturation Scale.
    Time Frame
    up to two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria. Centers must have met the following criteria to be included: (1) have > 30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade County Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment. Studies were excluded if they did not meet these criteria.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ruby Natale, PhD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23356862
    Citation
    Natale R, Scott SH, Messiah SE, Schrack MM, Uhlhorn SB, Delamater A. Design and methods for evaluating an early childhood obesity prevention program in the childcare center setting. BMC Public Health. 2013 Jan 28;13:78. doi: 10.1186/1471-2458-13-78.
    Results Reference
    derived

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    USDA Healthy Caregivers/Healthy Children: A Childhood Obesity Prevention Program

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