Clinical trial NCT00132132: Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
Official title: Type 2 Diabetes and Obesity Pediatric Prevention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: BMI
obesity
behavioral intervention
longterm randomized controlled trial
exercise
empowerment
nutrition
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2005-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* Ages 10-20 years
* BMI\>85%

Exclusion Criteria:

* Endocrine disorder
* On psychotropic medications

Primary outcomes:
measure: Change in BMI (Body Mass Index)
timeFrame: Baseline, 12-15 months
measure: Percentage of Participants With BMI Reduction
timeFrame: Baseline, 12-15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Shirley Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References: