PO: Parent-Based Treatment for Pediatric Overweight

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT00807560
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 77
• Locations: 2
• Arms: 2
• Duration (Months): 57
• Patients Per Site: 38.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Behavioral: FBT-PO; Behavioral: NEC	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Parent-Based Treatment for Pediatric Overweight
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FBT-PO Family Based Therapy for Pediatric Overweight.	Behavioral: 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.; Other Names: Family Based Therapy for Pediatric Overweight
Active Comparator: NEC-control Nutritional Educational Control Condition (NEC).	Behavioral: NEC; Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.; Other Names: Nutritional Educational Control Condition

Outcome Measures

Primary Outcome Measures

1. 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).

2. BMI Z Score [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)

Secondary Outcome Measures

1. Percent Completion [at 44 weeks]

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

2. Waist Measurement [baseline]

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

3. Waist Measurement [up to 44 weeks]

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

4. Hip Measurement [baseline]

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

5. Hip Measurement [up to 44 weeks]

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

6. Height [Baseline]

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

7. Height [up to 44 weeks]

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

8. Weight [baseline]

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

9. Weight [up to 44 weeks]

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

10. BMI [baseline]

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

11. BMI [up to 44 weeks]

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

12. BMI Percentile [baseline]

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

13. BMI Percentile [up to 44 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago	Chicago	Illinois	United States	60637
2	Icahn School of Medicine at Mount Sinai	NY	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Katherine L Loeb, PH.D., Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT00807560
• Other Study ID Numbers: GCO 07-0216; 1R21HD057394-01
• First Posted: Dec 12, 2008
• Last Update Posted: Jan 8, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Icahn School of Medicine at Mount Sinai: Overweight; Obesity; Adolescents; Family Therapy
• Additional relevant MeSH terms: Overweight

Study Results

Participant Flow

Arm/Group Title	FBT-PO	NEC- Control
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	38	39
COMPLETED	38	39
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	FBT-PO	NEC-control	Total
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition	Total of all reporting groups
Overall Participants	38	39	77
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.0 (1.52)	15.2 (1.6)	15.1 (1.56)
Sex: Female, Male (Count of Participants)
Female	25 65.8%	27 69.2%	52 67.5%
Male	13 34.2%	12 30.8%	25 32.5%
Region of Enrollment (participants) [Number]
United States	38 100%	39 100%	77 100%

Outcome Measures

1. Secondary Outcome

Title	Percent Completion
Description	Percent of participants who completed the trial to assess feasibility and retention in the trial
Time Frame	at 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Number [percentage of participants]	34.2 90%	28.2 72.3%

2. Secondary Outcome

Title	Waist Measurement
Description	Waist measurement in inches. This is not a primary outcome variable.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Mean (Standard Deviation) [inches]	42.0 (3.5)	44.5 (4.6)

3. Secondary Outcome

Title	Waist Measurement
Description	Waist measurement in inches. This is not a primary outcome variable.
Time Frame	up to 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	8	9
Mean (Standard Deviation) [inches]	41.7 (3.6)	45.3 (3.9)

4. Secondary Outcome

Title	Hip Measurement
Description	Hip measurement in inches. This is not a primary outcome variable.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Mean (Standard Deviation) [inches]	47.1 (10.4)	49.6 (4.8)

5. Secondary Outcome

Title	Hip Measurement
Description	Hip measurement in inches. This is not a primary outcome variable.
Time Frame	up to 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	8	9
Mean (Standard Deviation) [inches]	47.3 (11.0)	50.3 (4.5)

6. Secondary Outcome

Title	Height
Description	This variable informs the calculation of the outcome variable of BMI Z score.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Mean (Standard Deviation) [inches]	65.7 (3.0)	64.7 (2.79)

7. Primary Outcome

Title	BMI Z Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Mean (Standard Deviation) [Z-score]	2.3 (.41)	2.4 (.25)

8. Secondary Outcome

Title	Height
Description	This variable informs the calculation of the outcome variable of BMI Z score.
Time Frame	up to 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	13	11
Mean (Standard Deviation) [inches]	66.1 (2.7)	64.8 (2.9)

9. Secondary Outcome

Title	Weight
Description	This variable informs the calculation for the outcome variable of BMI Z score.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Mean (Standard Deviation) [pounds]	213.1 (31.9)	227.8 (63.8)

10. Secondary Outcome

Title	Weight
Description	This variable informs the calculation of the outcome variable of BMI z score.
Time Frame	up to 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	13	11
Mean (Standard Deviation) [pounds]	213.3 (33.2)	233.0 (64.1)

11. Secondary Outcome

Title	BMI
Description	Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Mean (Standard Deviation) [kg/m^2]	35.3 (5.5)	36.6 (6.6)

12. Secondary Outcome

Title	BMI
Description	Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.
Time Frame	up to 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	13	11
Mean (Standard Deviation) [kg/m^2]	34.5 (5.2)	38.7 (9.0)

13. Secondary Outcome

Title	BMI Percentile
Description	Body Mass Index percentile. This is not a primary outcome variable.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	38	39
Mean (Standard Deviation) [percentile]	98.0 (2.4)	99.0 (1.1)

14. Primary Outcome

Title	BMI Z Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	13	9
Mean (Standard Deviation) [Z-score]	2.2 (0.4)	2.4 (.12)

15. Secondary Outcome

Title	BMI Percentile
Description	Body Mass Index percentile. This is not a primary outcome variable.
Time Frame	up to 44 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FBT-PO	NEC-control
Arm/Group Description	Family Based Therapy for Pediatric Overweight	Nutritional Educational Control Condition
Measure Participants	13	9
Mean (Standard Deviation) [percentile]	98.3 (2.2)	99.2 (0.3)

Adverse Events

Arm/Group Title	FBT-PO		NEC- Control
Arm/Group Description	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.		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.
All Cause Mortality
	FBT-PO		NEC- Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	FBT-PO		NEC- Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	FBT-PO		NEC- Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.