NCT03429699

Brief Summary

Interventions that encompass behavioral modifications of dietary intake and physical activity dietary management are essential for the management of obese children. This study assessed the effectiveness of a stage-based lifestyle modification intervention for obese children. A total of 50 obese children (7-11 years) were randomized to intervention (n=25) or control (n=25) group. Data were collected at baseline, at follow-up (every month) and at six-month post-intervention. The intervention group (IG) received stage-based lifestyle modification intervention based on Nutrition Practice Guideline for the Management of Childhood Obesity, while the control group (CG) received standard treatment. Changes in body composition, physical activity, and dietary intake were examined in both intervention and control groups.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2014

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

February 4, 2018

Last Update Submit

February 9, 2018

Conditions

Childhood ObesityLife Style Modification

Outcome Measures

Primary Outcomes (3)

  • weight (kg)

    24 weeks

  • Height (cm)

    24 weeks

  • BMI-for-age Z score

    24 weeks

Secondary Outcomes (10)

  • waist circumference (cm)

    24 weeks

  • Mid-upper Arm Muscle Circumference (cm)

    24 weeks

  • Body fat (%)

    24 weeks

  • Energy (kcal)

    24 weeks

  • carbohydrate (g)

    24 weeks

  • +5 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity

Control group

OTHER
Behavioral: Existing practice for the management of childhood obesity

Interventions

Stage-based Lifestyle Modification Intervention for the Management of Childhood ObesityBEHAVIORAL

The participants will receive treatment based on nutrition clinical practice guideline for the management of childhood obesity. Participants in IG will be received a nutrition clinical practice guideline for the management of childhood obesity that comprised several activities, including nutrition counselling, aerobic sessions, a hands-on activity (healthy food preparation) and 'Sharing is Caring'. The Nutrition Practice Guideline for the Management of Childhood Obesity that comprised recommendations for assessment of nutritional status, determination of energy requirement, dietary prescriptions and physical activity modifications will be used. Participants' SOC for dietary and physical activity behaviors will be determined before any information was given to ensure that the selected educational topic will be tailored to the participant's current SOC.

Intervention group
Existing practice for the management of childhood obesityBEHAVIORAL

The participants will receive treatment based on the existing practice for the management of childhood obesity. Only nutritional counseling will be received by CG and standard treatment based on current practices by most dietitians in Malaysia for weight management of obese children will be used.

Control group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The participants will be included if they are:
  • Children aged 2 - 12 years old
  • Obese based on the WHO growth chart 2007 (BMI-for-age more than +2SD)

You may not qualify if:

  • The participants will be excluded if they are:
  • Diagnosed with diabetes mellitus, psychiatric disorder (e.g. schizophrenia, severe autism or
  • mental retardation or psychosis), or other serious medical conditions.
  • Receiving medications that would potentially promote weight gain or weight loss.
  • Involved in any weight management program
  • Overweight, normal weight and underweight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Md Yusop NB, Mohd Shariff Z, Hwu TT, Abd Talib R, Spurrier N. The effectiveness of a stage-based lifestyle modification intervention for obese children. BMC Public Health. 2018 Mar 1;18(1):299. doi: 10.1186/s12889-018-5206-2.

    PMID: 29490648DERIVED

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
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

February 4, 2018

First Posted

February 12, 2018

Study Start

February 2, 2012

Primary Completion

March 10, 2014

Study Completion

March 10, 2014

Last Updated

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share