Effects of a Low Glycemic Index in Obese Children

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: low calorie/fat diet; Behavioral: Low glycaemic index diet

• Registration Number: NCT02049788
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Obese children aged 9-16 years from King Chulalongkorn Memorial Hospital were randomized to receive instruction either for a low-GI diet (intervention group) or a low-calorie, low-fat diet (control group). Both groups were followed-up every month for six months. The primary outcomes were body composition changes during the six-month period, measured by dual X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). Secondary outcomes were metabolic syndrome risk changes measured by fasting plasma glucose, insulin, and lipid profiles.

The adherence to the nutritional education and physical activity recommendation was evaluated by using three-day dietary records (two weekdays and one weekend day) and a physical activity questionnaire at each visit. All participants were examined and counseled about physical activity and life style modification strategies by a pediatrician at every visit.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-01
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Study First Posted: 2014-01-30
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low calorie/fat diet	low calorie/fat diet	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).
Low glycaemic index diet	Low glycaemic index diet	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).

Primary Outcome Measures

Name	Time	Method
Change from baseline in body composition measured by BIA and DEXA at month 6	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in metabolic syndrome risks at month 6	6 months	Metabolic syndrome risks are fasting blood sugar, insulin and lipid profiles.

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Patumwan, Bangkok, Thailand