NCT03329300

Brief Summary

We plan to examine whether child and parental cognitive/executive function predict body composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment (FBT), for pediatric obesity. Our objectives are to: (1) examine the effects of parent and child complex cognitive functions on treatment outcomes and adherence in a 6-month FBT program for obesity in a diverse group of children aged 8-12 (total of 16 child-parent pairs), and (2) examine the strength of the relationship between parent and child cognitive function. We hypothesize that children with poorer executive function, and those who have parents with poorer executive function, will have poorer body composition and adherence outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

October 25, 2017

Results QC Date

April 13, 2022

Last Update Submit

January 25, 2023

Conditions

Pediatric ObesityExecutive Function

Keywords

Pediatric ObesityExecutive FunctionBehavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline Child Body Fat Mass at 6 Months

    Dual-energy X-ray Absorptiometry (DXA)

    Baseline to 6 months

Secondary Outcomes (2)

  • Adherence to Treatment (Number of Contact Hours)

    Baseline to 6 months

  • Adherence to Treatment (Completed Days of Self-monitoring)

    Baseline to 6 months

Other Outcomes (9)

  • Child Height

    Baseline and 6 months

  • Child Weight

    Baseline and 6 months

  • Change in Child Body Mass Index

    Baseline to 6 months

  • +6 more other outcomes

Study Arms (1)

All participants

OTHER

Family-based Behavioral Treatment (FBT)

Behavioral: Family-based Behavioral Treatment (FBT)

Interventions

Family-based Behavioral Treatment (FBT)BEHAVIORAL

Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.

All participants

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Have a BMI ≥ 85th percentile
  • Are ≥8 and ≤12 years old at the beginning of treatment
  • Can read, write, and speak English, along with their parent
  • Plan to stay living within the local area during the study period
  • Have a consenting parent who can commit to all study procedures and provide reliable travel.

You may not qualify if:

  • Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight
  • Are currently participating in a formal weight management program beyond their usual medical care or have a parent participating in a formal weight management program
  • Have been diagnosed with an intellectual disability or traumatic brain injury
  • Have medical contraindications to physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Marissa Gowey, PhD
Organization
University of Alabama at Birmingham Department of Pediatrics
marissa.gowey.phd@gmail.com
2056386618

Study Officials

  • Marissa Gowey, PhD

    University of Alabama at Birmingham Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 1, 2017

Study Start

June 4, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

November 7, 2023

Results First Posted

November 7, 2023

Record last verified: 2023-01

Locations

US(1)