Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132132
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-08-17
Brief Title:
Study of Impact of Behavioral Intervention- Exercise Nutrition Education- on Body Mass Index BMI
Sponsor:
Steward St Elizabeths Medical Center of Boston Inc
Organization:
Steward St Elizabeths Medical Center of Boston Inc
Study Overview
Official Title:
Type 2 Diabetes and Obesity Pediatric Prevention Project
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BMIin 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 projectsgames
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
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 projectsgames
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None