Effects of a Low Glycemic Index in Obese Children

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049788
• Other study ID #: LGI-01
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: January 28, 2014
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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).
• 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).

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Patumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in body weight, BMI z-score and waist circumference at month 6		6 months	No
Primary	Change from baseline in body composition measured by BIA and DEXA at month 6		6 months	No
Secondary	Change from baseline in metabolic syndrome risks at month 6	Metabolic syndrome risks are fasting blood sugar, insulin and lipid profiles.	6 months	No