NCT02228434

Brief Summary

The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. It probably raise the passion of obese children to control weight, form healthy life style, be effective in sustaining weight loss and early prevent adulthood diseases.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

2.6 years

First QC Date

August 27, 2014

Last Update Submit

August 27, 2014

Conditions

Keywords

Childhood obesity, intervention, effectiveness, comparison

Outcome Measures

Primary Outcomes (1)

  • Change in body mass index

    Baseline, 1-year post-intervention

Secondary Outcomes (4)

  • Change in obesity-related anthropometric measurements

    Baseline, 1-year post-intervention

  • Change of blood pressure

    Baseline, 1-year post-intervention

  • Change of biomarkers for disease risk

    Baseline, 1-year post-intervention

  • Change of attitude, knowledge, and behaviors on dietary and physical activity

    Baseline, 1-year post-intervention

Study Arms (4)

Tailored intervention group

EXPERIMENTAL

For the monitoring session, physical activity was assessed by accelerometer and dietary was assessed by diary. Based on the monitoring information, the individual tailored prescription, including the normative feedback and process feedback, were formed and delivered to children and parents. Children were encouraged to modify the behaviors according to the prescription. Then, next monitoring circle was followed. In total, 7 monitoring round were completed.

Behavioral: Monitoring and Tailored prescriptionBehavioral: General Health Education

Happy 10 exercise group

EXPERIMENTAL

All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day.

Behavioral: Happy 10 programBehavioral: General Health Education

Nutrition education group

EXPERIMENTAL

The nutrition intervention was mainly conducted based on the nutrition knowledge through health education lectures given by researchers. The lectures were given for eight times to students and twice to parents. Each lecture session lasted no less than 40 min.

Behavioral: Specified nutrition educationBehavioral: General Health Education

Control group

NO INTERVENTION

Receive no intervention

Interventions

Also known as: ZhiJi accelerometer UX-02 as physical activity monitor
Tailored intervention group
Also known as: happy 10 program developed by Center for Disease Control and Prevention, China
Happy 10 exercise group
Nutrition education group
Happy 10 exercise groupNutrition education groupTailored intervention group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Overweight and obese children from grade 1-5 primary schools

You may not qualify if:

  • Students with any contraindication or physical diseases (heart, Lung, liver, kidney, other vital organs, endocrine diseases and drug side effects et al.) and psychological illnesses that may prevent them from participating in physical activity and eating a normal diet were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insitute of Child and Adolescent Health, Peking University

Beijing, 100191, China

Location

Related Publications (1)

  • Wang JJ, Lau WC, Wang HJ, Ma J. Evaluation of a comprehensive intervention with a behavioural modification strategy for childhood obesity prevention: a nonrandomized cluster controlled trial. BMC Public Health. 2015 Dec 3;15:1206. doi: 10.1186/s12889-015-2535-2.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Institute of Child and Adolescent Health

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

May 1, 2009

Primary Completion

December 1, 2011

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations