Trial Outcomes & Findings for Parent-Based Treatment for Pediatric Overweight (NCT NCT00807560)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

77 participants

Primary outcome timeframe

baseline

Results posted on

2016-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	38	39
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parent-Based Treatment for Pediatric Overweight

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition	Total n=77 Participants Total of all reporting groups
Age, Continuous	15.0 years STANDARD_DEVIATION 1.52 • n=5 Participants	15.2 years STANDARD_DEVIATION 1.6 • n=7 Participants	15.1 years STANDARD_DEVIATION 1.56 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	39 participants n=7 Participants	77 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
BMI Z Score	2.3 Z-score Standard Deviation .41	2.4 Z-score Standard Deviation .25

PRIMARY outcome

Timeframe: up to 44 weeks

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)

Outcome measures

Outcome measures
Measure	FBT-PO n=13 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=9 Participants Nutritional Educational Control Condition
BMI Z Score	2.2 Z-score Standard Deviation 0.4	2.4 Z-score Standard Deviation .12

SECONDARY outcome

Timeframe: at 44 weeks

Percent of participants who completed the trial to assess feasibility and retention in the trial

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
Percent Completion	34.2 percentage of participants	28.2 percentage of participants

SECONDARY outcome

Timeframe: baseline

Waist measurement in inches. This is not a primary outcome variable.

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
Waist Measurement	42.0 inches Standard Deviation 3.5	44.5 inches Standard Deviation 4.6

SECONDARY outcome

Timeframe: up to 44 weeks

Waist measurement in inches. This is not a primary outcome variable.

Outcome measures

Outcome measures
Measure	FBT-PO n=8 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=9 Participants Nutritional Educational Control Condition
Waist Measurement	41.7 inches Standard Deviation 3.6	45.3 inches Standard Deviation 3.9

SECONDARY outcome

Timeframe: baseline

Hip measurement in inches. This is not a primary outcome variable.

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
Hip Measurement	47.1 inches Standard Deviation 10.4	49.6 inches Standard Deviation 4.8

SECONDARY outcome

Timeframe: up to 44 weeks

Hip measurement in inches. This is not a primary outcome variable.

Outcome measures

Outcome measures
Measure	FBT-PO n=8 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=9 Participants Nutritional Educational Control Condition
Hip Measurement	47.3 inches Standard Deviation 11.0	50.3 inches Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline

This variable informs the calculation of the outcome variable of BMI Z score.

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
Height	65.7 inches Standard Deviation 3.0	64.7 inches Standard Deviation 2.79

SECONDARY outcome

Timeframe: up to 44 weeks

This variable informs the calculation of the outcome variable of BMI Z score.

Outcome measures

Outcome measures
Measure	FBT-PO n=13 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=11 Participants Nutritional Educational Control Condition
Height	66.1 inches Standard Deviation 2.7	64.8 inches Standard Deviation 2.9

SECONDARY outcome

Timeframe: baseline

This variable informs the calculation for the outcome variable of BMI Z score.

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
Weight	213.1 pounds Standard Deviation 31.9	227.8 pounds Standard Deviation 63.8

SECONDARY outcome

Timeframe: up to 44 weeks

This variable informs the calculation of the outcome variable of BMI z score.

Outcome measures

Outcome measures
Measure	FBT-PO n=13 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=11 Participants Nutritional Educational Control Condition
Weight	213.3 pounds Standard Deviation 33.2	233.0 pounds Standard Deviation 64.1

SECONDARY outcome

Timeframe: baseline

Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
BMI	35.3 kg/m^2 Standard Deviation 5.5	36.6 kg/m^2 Standard Deviation 6.6

SECONDARY outcome

Timeframe: up to 44 weeks

Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.

Outcome measures

Outcome measures
Measure	FBT-PO n=13 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=11 Participants Nutritional Educational Control Condition
BMI	34.5 kg/m^2 Standard Deviation 5.2	38.7 kg/m^2 Standard Deviation 9.0

SECONDARY outcome

Timeframe: baseline

Body Mass Index percentile. This is not a primary outcome variable.

Outcome measures

Outcome measures
Measure	FBT-PO n=38 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=39 Participants Nutritional Educational Control Condition
BMI Percentile	98.0 percentile Standard Deviation 2.4	99.0 percentile Standard Deviation 1.1

SECONDARY outcome

Timeframe: up to 44 weeks

Body Mass Index percentile. This is not a primary outcome variable.

Outcome measures

Outcome measures
Measure	FBT-PO n=13 Participants Family Based Therapy for Pediatric Overweight	NEC-control n=9 Participants Nutritional Educational Control Condition
BMI Percentile	98.3 percentile Standard Deviation 2.2	99.2 percentile Standard Deviation 0.3

Adverse Events

FBT-PO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NEC- Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katharine Loeb, PhD

Icahn School of Medicine at Mount Sinai

Phone: 212-659-8724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place