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Completed

NCT Number: NCT00132132

Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)

This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.

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Key information

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

About this study

This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI > 85%.

The intervention group will:

  • have baseline and follow up blood work (fasting insulin, glucose, lipid panel)
  • have baseline and follow up BMI, blood pressure measurements
  • see a dietician-minimum of three visits during study
  • attend monthly, four hour sessions. These sessions include:
  • registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power)
  • one hour of exercise (including strength training)
  • educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
  • projects/games
  • empowerment tools such as leading exercises and presenting food labels for discussion

The control group will have:

  • baseline and follow up blood work (fasting insulin, glucose, lipid panel)
  • baseline and follow up BMI and blood pressure measurements
  • visits to dietician (minimum of three visits during study)
  • standard education on nutrition and exercise given during office visit with primary care doctor

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ages 10-20 years
  • BMI>85%

Exclusion criteria

  • Endocrine disorder
  • On psychotropic medications

Treatment and study plan

Behavioral education program

Behavioral

Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives

Primary outcomes

  1. Change in BMI (Body Mass Index)

    Time frame: Baseline, 12-15 months

  2. Percentage of Participants With BMI Reduction

    Time frame: Baseline, 12-15 months

Sponsors and collaborators

Lead sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

Other

Registry information

Official study title

Type 2 Diabetes and Obesity Pediatric Prevention Project

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 19, 2005
Registry last updated
May 21, 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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