NCT02049788

Brief Summary

The objective of this study is to compare the effectiveness of a low-GI diet program and a standard counseling program in the treatment of obese Thai children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable obesity

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

January 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

January 28, 2014

Last Update Submit

January 28, 2014

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in body composition measured by BIA and DEXA at month 6

    6 months

Secondary Outcomes (1)

  • Change from baseline in metabolic syndrome risks at month 6

    6 months

Other Outcomes (1)

  • Change from baseline in body weight, BMI z-score and waist circumference at month 6

    6 months

Study Arms (2)

low calorie/fat diet

ACTIVE COMPARATOR

The low calorie/fat diet group, obese children aged 9-16, received conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).

Behavioral: low calorie/fat diet

Low glycaemic index diet

EXPERIMENTAL

Low glycaemic index diet group, obese children of both sexes aged 9-16, received experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).

Behavioral: Low glycaemic index diet

Interventions

low calorie/fat dietBEHAVIORAL

Conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).

low calorie/fat diet
Low glycaemic index dietBEHAVIORAL

Experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).

Low glycaemic index diet

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between nine to sixteen years old
  • BMI higher than the International Obesity Task Force cut-off

You may not qualify if:

  • psychological problems
  • underlying diseases that might affect a weight management program
  • used drugs associated with weight increment or reduction
  • attended other weight management programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Patumwan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sirinuch Chomtho, M.D., PhD.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

TH(1)