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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD057394-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.
Rates of pediatric overweight (PO) among Americans are increasing and associated with significant psychological, social, quality of life, and health related outcomes. Because of the broad mental and physical health implications of PO and the difficulty in sustaining weight loss as an adult, it is of interest to find successful methods of weight loss and/or prevention of weight gain for obese children and adolescents. The family unit is a logical and empirically supported point of intervention for PO. Interventions on this level have shown good long term efficacy in young children, but there is very little research on adolescent family intervention. Within the eating disorder literature, there is growing support for the efficacy of family-based interventions (FBI) for adolescents. Given its trans-developmental applicability, focus on family as the unit of intervention, and utility in creating a healthy eating environment, FBI is a logical candidate for adaptation to intervention for PO and intervention for at-risk for overweight youth (FBI-PO). The core of the current project is to test the feasibility and efficacy of an adapted FBI manual for adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders clinic and compare this modality to a minimal nutritional educational control (NEC) condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FBT-PO | Experimental | Family Based Therapy for Pediatric Overweight. |
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| NEC-control | Active Comparator | Nutritional Educational Control Condition (NEC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FBT-PO | Behavioral | The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI Z Score | Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html). | baseline |
| BMI Z Score | Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html) | up to 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Completion | Percent of participants who completed the trial to assess feasibility and retention in the trial | at 44 weeks |
| Waist Measurement | Waist measurement in inches. This is not a primary outcome variable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine L Loeb, PH.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Icahn School of Medicine at Mount Sinai |
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| ID | Title | Description |
|---|---|---|
| FG000 | FBT-PO | Family Based Therapy for Pediatric Overweight. FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases. |
| FG001 | NEC- Control | Nutritional Educational Control Condition (NEC). NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FBT-PO | Family Based Therapy for Pediatric Overweight |
| BG001 | NEC-control | Nutritional Educational Control Condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percent Completion | Percent of participants who completed the trial to assess feasibility and retention in the trial | Posted | Number | percentage of participants | at 44 weeks |
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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 | FBT-PO | Family Based Therapy for Pediatric Overweight. FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katharine Loeb, PhD | Icahn School of Medicine at Mount Sinai | 212-659-8724 | Katharine.Loeb@mssm.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| NEC | Behavioral | Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks. |
|
|
| baseline |
| Waist Measurement | Waist measurement in inches. This is not a primary outcome variable. | up to 44 weeks |
| Hip Measurement | Hip measurement in inches. This is not a primary outcome variable. | baseline |
| Hip Measurement | Hip measurement in inches. This is not a primary outcome variable. | up to 44 weeks |
| Height | This variable informs the calculation of the outcome variable of BMI Z score. | Baseline |
| Height | This variable informs the calculation of the outcome variable of BMI Z score. | up to 44 weeks |
| Weight | This variable informs the calculation for the outcome variable of BMI Z score. | baseline |
| Weight | This variable informs the calculation of the outcome variable of BMI z score. | up to 44 weeks |
| BMI | Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score. | baseline |
| BMI | Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score. | up to 44 weeks |
| BMI Percentile | Body Mass Index percentile. This is not a primary outcome variable. | baseline |
| BMI Percentile | Body Mass Index percentile. This is not a primary outcome variable. | up to 44 weeks |
| New York |
| New York |
| 10029 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Secondary | Waist Measurement | Waist measurement in inches. This is not a primary outcome variable. | Posted | Mean | Standard Deviation | inches | baseline |
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|
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| Secondary | Waist Measurement | Waist measurement in inches. This is not a primary outcome variable. | Posted | Mean | Standard Deviation | inches | up to 44 weeks |
|
|
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| Secondary | Hip Measurement | Hip measurement in inches. This is not a primary outcome variable. | Posted | Mean | Standard Deviation | inches | baseline |
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|
|
| Secondary | Hip Measurement | Hip measurement in inches. This is not a primary outcome variable. | Posted | Mean | Standard Deviation | inches | up to 44 weeks |
|
|
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| Secondary | Height | This variable informs the calculation of the outcome variable of BMI Z score. | Posted | Mean | Standard Deviation | inches | Baseline |
|
|
|
| Primary | BMI Z Score | Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html). | Posted | Mean | Standard Deviation | Z-score | baseline |
|
|
|
| Secondary | Height | This variable informs the calculation of the outcome variable of BMI Z score. | Posted | Mean | Standard Deviation | inches | up to 44 weeks |
|
|
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| Secondary | Weight | This variable informs the calculation for the outcome variable of BMI Z score. | Posted | Mean | Standard Deviation | pounds | baseline |
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|
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| Secondary | Weight | This variable informs the calculation of the outcome variable of BMI z score. | Posted | Mean | Standard Deviation | pounds | up to 44 weeks |
|
|
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| Secondary | BMI | Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score. | Posted | Mean | Standard Deviation | kg/m^2 | baseline |
|
|
|
| Secondary | BMI | Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score. | Posted | Mean | Standard Deviation | kg/m^2 | up to 44 weeks |
|
|
|
| Secondary | BMI Percentile | Body Mass Index percentile. This is not a primary outcome variable. | Posted | Mean | Standard Deviation | percentile | baseline |
|
|
|
| Primary | BMI Z Score | Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html) | Posted | Mean | Standard Deviation | Z-score | up to 44 weeks |
|
|
|
| Secondary | BMI Percentile | Body Mass Index percentile. This is not a primary outcome variable. | Posted | Mean | Standard Deviation | percentile | up to 44 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | NEC- Control | Nutritional Educational Control Condition (NEC). NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks. | 0 | 39 | 0 | 39 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |