Effects of a Low Glycemic Index in Obese Children

Effects of a Low Glycemic Index Diet on Body Composition and Metabolic Syndrome Risks in Obese Thai Children: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: low calorie/fat diet; Behavioral: Low glycaemic index diet

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Patumwan, Bangkok, Thailand, 10330
      • Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Behavioral: low calorie/fat diet; 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).
Experimental: 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).	Behavioral: Low glycaemic index diet; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in body composition measured by BIA and DEXA at month 6	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in metabolic syndrome risks at month 6	Metabolic syndrome risks are fasting blood sugar, insulin and lipid profiles.	6 months

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline in body weight, BMI z-score and waist circumference at month 6	6 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Sirinuch Chomtho, M.D., PhD., Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): January 30, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: LGI-01