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Kindergarten-based Intervention for Childhood Obesity in Guangzhou(KICOG) (KICOG)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy Lifestyles Intervention
Sponsored by
Guangzhou Women and Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Childhood obesity

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(i) run by the government (public kindergarten); (ii) located in the central area of the district; (iii) had no less than 100 students; (iv)had no less than two school doctors.

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Body mass index (BMI) change
    BMI Z-score change

    Secondary Outcome Measures

    Feasibility and acceptability of the intervention
    Qualitatively describe

    Full Information

    First Posted
    January 13, 2017
    Last Updated
    March 24, 2017
    Sponsor
    Guangzhou Women and Children's Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03022474
    Brief Title
    Kindergarten-based Intervention for Childhood Obesity in Guangzhou(KICOG)
    Acronym
    KICOG
    Official Title
    Kindergarten-based Intervention for Childhood Obesity in Guangzhou(KICOG)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangzhou Women and Children's Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Early life interventions for childhood obesity may provide substantial benefits. Most existing studies aimed at school children have reported limited effectiveness, however few have targeted preschool children. This study aimed to pilot procedures for a multifaceted, culturally appropriate intervention for preschool children and to provide a preliminary assessment of effectiveness of the intervention.
    Detailed Description
    The intervention protocol was developed by an expert group from the National Children Obesity Intervention Team, comprising pediatricians, children healthcare doctors, preschool teachers, and nutritionists, and included three integrated components: Component 1 - training of kindergarten staff: Before the start of the program, two members of the intervention team (a dietitian and a physician) delivered eight 40-min sessions (twice a week for a month) on dietary management in children and daily food purchasing for school doctors and kitchen staff. During the trial, two health education doctors gave lectures every two months on general knowledge in nutrition to all preschool staff, focusing on the promotion of healthy food and restriction of unhealthy food. To assess the effectiveness of these lectures, we administered a questionnaire on the material covered. We also trained the kitchen staff to use the dietary software to plan menu with balanced nutrition for preschool children. Component 2 - a curriculum promoting healthy diet and lifestyle: We designed a health education curriculum and associated picture books for the children. Children in the intervention group received a 20-minute health education lesson every week, where they had learning activities and games covering healthy food choice, appropriate portion sizes and eating pace, and reduction of sedentary behaviours. Learning aids such as colourful picture books or cards, food models, nursery rhymes and stories were used. Two elements were introduce to increase children's activity such as lunchtime activity and daily dance at less than 10 minutes during break. Component 3 - collaboration between families and kindergartens: We organized lectures designed for parents every two months during the intervention period. Topics covered included the cause and harms of childhood obesity, advice on healthy diet (increasing consumption of vegetables and fruits, reducing consumption of meat, snacks, fast foods, and eating out, and avoiding sugary drinks), body mass index (BMI) reference for preschool-age children, and how to use growth curves. We produced a handbook for communication between families and schools, to be handed out to every family weekly, in which children's health behaviours were documented and reviewed by teachers and parents. Finally, parents were notified of their children's anthropometric measurements every three months, so that they could plot and interpret their children's growth curves.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    984 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Lifestyles Intervention
    Intervention Description
    The program included three major components. The first component consists of live lectures to kindergarten staff about basic nutrition and food concepts that attempted to correct false beliefs. The second component was a health curriculum for children that focused on promoting healthy nutrition habits and a healthy living style. Preschools were required to ensure that children received a health education lesson every two weeks. The third component was aimed at educating parents and consisted of lectures every two months, preschool-home communication every week and child growth monitoring every three months.
    Primary Outcome Measure Information:
    Title
    Body mass index (BMI) change
    Time Frame
    BMI was measured at baseline and one year after intervention
    Title
    BMI Z-score change
    Time Frame
    BMI Z-score was measured and calculated at baseline and one year after intervention
    Secondary Outcome Measure Information:
    Title
    Feasibility and acceptability of the intervention
    Description
    Qualitatively describe
    Time Frame
    During intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (i) run by the government (public kindergarten); (ii) located in the central area of the district; (iii) had no less than 100 students; (iv)had no less than two school doctors. Exclusion Criteria: None
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiu Qiu, Doctor
    Organizational Affiliation
    Guangzhou Women and Children's Medical Center, China
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Kindergarten-based Intervention for Childhood Obesity in Guangzhou(KICOG)

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