Role of Carbohydrate Modification in Weight Management Among Obese Children

Childhood Obesity Clinical Trial

Official title:

Role of Carbohydrate Modification in Weight Management Among Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215111
• Other study ID #: 02819-8
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: February 4, 2015
• Start date: March 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12. In addition this study is also designed to test the safety of diets with modified carbohydrate content as compared to a conventional weight management diet among younger overweight children.

Description:

The treatment of pediatric obesity supported by the medical community is a moderate restriction in calories by modifying intake of fat and simple sugars, along with an increase in energy expenditure through more physical activity. However, this approach is associated with only limited success. As a result, overweight children and adolescents are seeking alternative approaches to weight management, such as diets that modify the type and amount of carbohydrates. However, at this time there is limited data on the safety and efficacy of these diets, particularly with younger children. This study is a controlled clinical trial that compares the safety and efficacy of a low carbohydrate and reduced glycemic load diets to a more standard dietary intervention for the management of pediatric obesity (i.e. portion-controlled, moderate fat, high carbohydrate diet). This study will involve 150 overweight children (ages 7 to 12) who will be randomly assigned to one of the three diet groups for 12 months. The effects of each diet will be determined by measuring changes in anthropometric measures (body weight, height, body mass index, waist circumference, body composition), other cardiovascular risk factors (blood pressure, fasting lipid profile, fasting glucose and insulin, and inflammatory markers of cardiovascular disease), and measures of psychological well-being and mental status. The results of this study will provide needed information to the public in their quest for safe, effective, and health-promoting weight management strategies for obese children. Such information is vital if we are to address the obesity epidemic in the United States.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age 7-12 years

• Body mass index >95th percentile and BMI z-score no greater than 2.65

• Normal fasting blood glucose of less than 100 mg/dL

• Age-appropriate cognitive and behavioral skills

• Absence of developmental or physical disabilities

• Capability to function independently in group exercise sessions

• Commitment of parent/guardian to attend scheduled meetings for 12-month period

Exclusion Criteria:

• Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia

• Chronic infections

• Uncompensated or labile mental illness

• Chronic or intermittent use of corticosteroids

• Specific medications that may alter lipid, glucose, bone metabolism or appetite

Study Design

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

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Low carbohydrate, reduced glycemic load, and a control diet

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcomes listed below will be obtained at baseline,3-month,		3 month	No
Primary	6-month and 12-month assessments unless otherwise noted,body weight,		6-month and 12-month	No
Primary	height,body mass index,waist circumference,percent body fat,		baseline, 3-month, 6-month and 12-month	No
Primary	adipose mass,lean body mass,bone mineral density,fasting lipid profile,		baseline, 3-month, 6-month and 12-month	No
Primary	fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),		baseline, 3-month, 6-month and 12-month	No
Secondary	physical activity (3-day physical activity records and pedometer readings)		3-month, 6-month and 12-month	No
Secondary	compliance with behavioral intervention (frequency rewards were earned)		weekly	No
Secondary	attendance at group and individual sessions during initial 3-month intervention		3-month, 6-month and 12-month	No
Secondary	Sexual Maturity Rating		baseline	No
Secondary	Hunger/Satiety assessment (Three-Factor Eating Questionnaire)		baseline, 3-month, 6-month and 12-month	No
Secondary	Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group		baseline	No