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Completed

NCT Number: NCT00215111

Role of Carbohydrate Modification in Weight Management Among Obese Children

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low carbohydrate, reduced glycemic load, and a control diet

Behavioral

Primary outcomes

  1. The outcomes listed below will be obtained at baseline,3-month,

    Time frame: 3 month

  2. 6-month and 12-month assessments unless otherwise noted,body weight,

    Time frame: 6-month and 12-month

  3. height,body mass index,waist circumference,percent body fat,

    Time frame: baseline, 3-month, 6-month and 12-month

  4. adipose mass,lean body mass,bone mineral density,fasting lipid profile,

    Time frame: baseline, 3-month, 6-month and 12-month

  5. fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),

    Time frame: baseline, 3-month, 6-month and 12-month

Secondary outcomes

  1. physical activity (3-day physical activity records and pedometer readings)

    Time frame: 3-month, 6-month and 12-month

  2. compliance with behavioral intervention (frequency rewards were earned)

    Time frame: weekly

  3. attendance at group and individual sessions during initial 3-month intervention

    Time frame: 3-month, 6-month and 12-month

  4. Sexual Maturity Rating

    Time frame: baseline

  5. Hunger/Satiety assessment (Three-Factor Eating Questionnaire)

    Time frame: baseline, 3-month, 6-month and 12-month

  6. Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Thrasher Research Fund

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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