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OpenTrials
Completed

NCT Number: NCT00409422

Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children

To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

About this study

Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 8-16 years old
  • BMI >95th percentile for age/gender based on CDC
  • Both primary caregiver/parent and child must agree to participate in the nutrition classes

Exclusion criteria

  • endocrinopathies, including hypothyroidism and diabetes
  • Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
  • Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
  • Any use of medication (steroids, for ex.) that contributes to excess adiposity.
  • Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
  • Any concurrent membership in a weight management program.
  • Inability or unwillingness of parent to accompany the child to nutrition classes.
  • Pregnancy

Treatment and study plan

Weight management program

Behavioral

Primary outcomes

  1. weight

    Time frame: 6 months and 1 year

  2. body mass index

    Time frame: 6 months and 1 year

  3. % body fat

    Time frame: 6 months and 1 year

  4. lipids

    Time frame: 6 months and 1 year

  5. blood pressure

    Time frame: 6 months and 1 year

  6. glucose

    Time frame: 6 months and 1 year

  7. insulin

    Time frame: 6 months and 1 year

  8. HOMA index

    Time frame: 6 months and 1 year

Secondary outcomes

  1. planned to compare dieting with non-dieting approach in weight management group

    Time frame: 6 months and 1 year

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Dec 8, 2006
Registry last updated
Jun 24, 2008

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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