Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT00132132
Brief Summary:
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.
Detailed Description:
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:
1. 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)
2. one hour of exercise (including strength training)
3. educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic
4. projects/games
5. empowerment tools such as leading exercises and presenting food labels for discussion
The control group will have:
1. baseline and follow up blood work (fasting insulin, glucose, lipid panel)
2. baseline and follow up BMI and blood pressure measurements
3. visits to dietician (minimum of three visits during study)
4. standard education on nutrition and exercise given during office visit with primary care doctor
Study:
NCT00132132
Study Brief:
Protocol Section:
NCT00132132