NCT03022474

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
984

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

January 13, 2017

Last Update Submit

March 24, 2017

Conditions

Keywords

Childhood obesity

Outcome Measures

Primary Outcomes (2)

  • Body mass index (BMI) change

    BMI was measured at baseline and one year after intervention

  • BMI Z-score change

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

Secondary Outcomes (1)

  • Feasibility and acceptability of the intervention

    During intervention

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Healthy Lifestyles Intervention

Control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xiu Qiu, Doctor

    Guangzhou Women and Children's Medical Center, China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Healthcare Department Director

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 16, 2017

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share