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Childhood ObesityKICOGNCT03022474

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

A study testing Healthy Lifestyles Intervention in people with Childhood Obesity, run by Guangzhou Women and Children's Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 6 years
Conditions the study is for
Childhood Obesity
What is being tested?
Healthy Lifestyles Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
984 participants
Where
No sites listed yet
Study dates
Jan 2012to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • None

About this study

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.

Read the 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.

Being tested
Healthy Lifestyles Intervention
Keywords
Childhood obesity
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Lifestyles InterventionBehavioural

    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.

Study groups in NCT03022474
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Behavioral: Healthy Lifestyles Intervention
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass index (BMI) change

    Measured: BMI was measured at baseline and one year after intervention

  2. BMI Z-score change

    Measured: BMI Z-score was measured and calculated at baseline and one year after intervention

Secondary outcomes (1)
  1. Feasibility and acceptability of the intervention

    Qualitatively describe

    Measured: During intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2017 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03022474
Sponsor's protocol ID
20121A011070
Acronym
KICOG
Status last verified
Mar 2017
First submitted
13 Jan 2017
Last updated
28 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Lifestyles Intervention in people with Childhood Obesity, run by Guangzhou Women and Children's Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index (BMI) change (time frame: BMI was measured at baseline and one year after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.

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