Obesity, Overweight
Conditions
Keywords
Overweight, Obesity, Adolescents, Family Therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFBT-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.
BEHAVIORALNEC
Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Ages 13-17 * Male and female * Living with at least one parent or guardian who is willing to participate in treatment * A BMI percentile \>85% for gender and age (e.g., overweight or at risk for overweight)
Exclusion criteria
* Current psychotic illness * Current alcohol/drug dependence * Active suicidality * Eating disorders (e.g., binge eating disorder) * History of bariatric surgery * Medication associated with significant weight changes (e.g., antipsychotics) * Serious medical or physical conditions resulting in significant weight changes (e.g., pregnancy, genetic disorders). * Complications of obesity that contraindicate moderate physical activity (e.g. orthopedic disorders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI Z Score | baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Measurement | baseline | Waist measurement in inches. This is not a primary outcome variable. |
| Hip Measurement | baseline | Hip measurement in inches. This is not a primary outcome variable. |
| Height | Baseline | This variable informs the calculation of the outcome variable of BMI Z score. |
| Percent Completion | at 44 weeks | Percent of participants who completed the trial to assess feasibility and retention in the trial |
| BMI | baseline | Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score. |
| BMI Percentile | baseline | Body Mass Index percentile. This is not a primary outcome variable. |
| Weight | baseline | This variable informs the calculation for the outcome variable of BMI Z score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FBT-PO Family Based Therapy for Pediatric Overweight | 38 |
| NEC-control Nutritional Educational Control Condition | 39 |
| Total | 77 |
Baseline characteristics
| Characteristic | Total | FBT-PO | NEC-control |
|---|---|---|---|
| Age, Continuous | 15.1 years STANDARD_DEVIATION 1.56 | 15.0 years STANDARD_DEVIATION 1.52 | 15.2 years STANDARD_DEVIATION 1.6 |
| Region of Enrollment United States | 77 participants | 38 participants | 39 participants |
| Sex: Female, Male Female | 52 Participants | 25 Participants | 27 Participants |
| Sex: Female, Male Male | 25 Participants | 13 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 |
Outcome results
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).
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | BMI Z Score | 2.3 Z-score | Standard Deviation 0.41 |
| NEC-control | BMI Z Score | 2.4 Z-score | Standard Deviation 0.25 |
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)
Time frame: up to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | BMI Z Score | 2.2 Z-score | Standard Deviation 0.4 |
| NEC-control | BMI Z Score | 2.4 Z-score | Standard Deviation 0.12 |
Secondary
BMI
Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | BMI | 35.3 kg/m^2 | Standard Deviation 5.5 |
| NEC-control | BMI | 36.6 kg/m^2 | Standard Deviation 6.6 |
Secondary
BMI
Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.
Time frame: up to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | BMI | 34.5 kg/m^2 | Standard Deviation 5.2 |
| NEC-control | BMI | 38.7 kg/m^2 | Standard Deviation 9 |
Secondary
BMI Percentile
Body Mass Index percentile. This is not a primary outcome variable.
Time frame: up to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | BMI Percentile | 98.3 percentile | Standard Deviation 2.2 |
| NEC-control | BMI Percentile | 99.2 percentile | Standard Deviation 0.3 |
Secondary
BMI Percentile
Body Mass Index percentile. This is not a primary outcome variable.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | BMI Percentile | 98.0 percentile | Standard Deviation 2.4 |
| NEC-control | BMI Percentile | 99.0 percentile | Standard Deviation 1.1 |
Secondary
Height
This variable informs the calculation of the outcome variable of BMI Z score.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Height | 65.7 inches | Standard Deviation 3 |
| NEC-control | Height | 64.7 inches | Standard Deviation 2.79 |
Secondary
Height
This variable informs the calculation of the outcome variable of BMI Z score.
Time frame: up to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Height | 66.1 inches | Standard Deviation 2.7 |
| NEC-control | Height | 64.8 inches | Standard Deviation 2.9 |
Secondary
Hip Measurement
Hip measurement in inches. This is not a primary outcome variable.
Time frame: up to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Hip Measurement | 47.3 inches | Standard Deviation 11 |
| NEC-control | Hip Measurement | 50.3 inches | Standard Deviation 4.5 |
Secondary
Hip Measurement
Hip measurement in inches. This is not a primary outcome variable.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Hip Measurement | 47.1 inches | Standard Deviation 10.4 |
| NEC-control | Hip Measurement | 49.6 inches | Standard Deviation 4.8 |
Secondary
Percent Completion
Percent of participants who completed the trial to assess feasibility and retention in the trial
Time frame: at 44 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FBT-PO | Percent Completion | 34.2 percentage of participants |
| NEC-control | Percent Completion | 28.2 percentage of participants |
Secondary
Waist Measurement
Waist measurement in inches. This is not a primary outcome variable.
Time frame: up to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Waist Measurement | 41.7 inches | Standard Deviation 3.6 |
| NEC-control | Waist Measurement | 45.3 inches | Standard Deviation 3.9 |
Secondary
Waist Measurement
Waist measurement in inches. This is not a primary outcome variable.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Waist Measurement | 42.0 inches | Standard Deviation 3.5 |
| NEC-control | Waist Measurement | 44.5 inches | Standard Deviation 4.6 |
Secondary
Weight
This variable informs the calculation of the outcome variable of BMI z score.
Time frame: up to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Weight | 213.3 pounds | Standard Deviation 33.2 |
| NEC-control | Weight | 233.0 pounds | Standard Deviation 64.1 |
Secondary
Weight
This variable informs the calculation for the outcome variable of BMI Z score.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FBT-PO | Weight | 213.1 pounds | Standard Deviation 31.9 |
| NEC-control | Weight | 227.8 pounds | Standard Deviation 63.8 |