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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.
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:
The control group will have:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention is a Behavioral education program which meets monthly for 4 hour session and includes exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose). |
|
| Standard of Care/Control | No Intervention | Education on physical activity and nutrition in a primary care office setting |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral education program | Behavioral | Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI (Body Mass Index) | Baseline, 12-15 months | |
| Percentage of Participants With BMI Reduction | Baseline, 12-15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Gonzalez, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Program | This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose). |
| FG001 | Standard of Care/Control | Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Program | This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in BMI (Body Mass Index) | Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment | Posted | Mean | 95% Confidence Interval | kg/m^2 | Baseline, 12-15 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Program | This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose). |
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A limitation of the study is the lost to follow up. However, our rate of lost to follow up is comparable to rates seen in similar studies in this field
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shirley Gonzalez | SEMC | 617-926-0114 | shirley.gonzalez@steward.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| BG001 | Standard of Care/Control | Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Percentage of Participants With BMI Reduction | Per protocol | Posted | Number | percentage of participants | Baseline, 12-15 months |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Standard of Care/Control | Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist | 0 | 15 | 0 | 15 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |