NCT00215111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

September 15, 2005

Last Update Submit

February 4, 2015

Conditions

Childhood Obesity

Keywords

childhood obesityweight managementdietary interventionscardiovascular disease risk factors

Outcome Measures

Primary Outcomes (5)

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

    3 month

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

    6-month and 12-month

  • height,body mass index,waist circumference,percent body fat,

    baseline, 3-month, 6-month and 12-month

  • adipose mass,lean body mass,bone mineral density,fasting lipid profile,

    baseline, 3-month, 6-month and 12-month

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

    baseline, 3-month, 6-month and 12-month

Secondary Outcomes (6)

  • physical activity (3-day physical activity records and pedometer readings)

    3-month, 6-month and 12-month

  • compliance with behavioral intervention (frequency rewards were earned)

    weekly

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

    3-month, 6-month and 12-month

  • Sexual Maturity Rating

    baseline

  • Hunger/Satiety assessment (Three-Factor Eating Questionnaire)

    baseline, 3-month, 6-month and 12-month

  • +1 more secondary outcomes

Study Arms (1)

Low carbohydrate, reduced glycemic load, control diet

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

Interventions

Low carbohydrate, reduced glycemic load, and a control dietBEHAVIORAL
Low carbohydrate, reduced glycemic load, control diet

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shelley Kirk, Ph.D., R.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

US(1)