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

March 24, 2017 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

984

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body mass index (BMI) change
Time Frame: BMI was measured at baseline and one year after intervention
BMI was measured at baseline and one year after intervention
BMI Z-score change
Time Frame: BMI Z-score was measured and calculated at baseline and one year after intervention
BMI Z-score was measured and calculated at baseline and one year after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability of the intervention
Time Frame: During intervention
Qualitatively describe
During intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Xiu Qiu, Doctor, Guangzhou Women and Children's Medical Center, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 20121A011070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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