Clinical trial NCT03843424: Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
Official title: A Pragmatic Family-Centered Approach to Childhood Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Pediatric Obesity
Childhood Obesity
Adolescent Obesity
Overweight
Overweight and Obesity
Overweight or Obesity
Overweight Adolescents
Weight Gain
Overnutrition
Body Weight
Body Weight Changes
Nutrition Disorders
Keywords: Weight Management
Child
Intervention
Weight Loss
Behavior Therapy
Nutrition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Blue Cross and Blue Shield of Louisiana
name: American Academy of Pediatrics
name: Pennington Biomedical Research Center
name: Louisiana Healthcare Connections
name: Nationwide Children s Hospital in Columbus, Ohio
name: University of Rochester
First posted: 2019-02-18
Enrollment: 1460
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.

Detailed description: Note: our enrollment number includes two participants (one child and one parent) from each enrolled family.

Eligibility criteria: Inclusion Criteria for children include:

* have a BMI percentile ≥95th for age and sex;
* comfortable speaking English language;
* able to provide written or verbal (based on age) informed assent;
* willing to change diet, physical activity, and/or weight;
* patient of a participating clinic/practice; and
* able to participate in scheduled sessions.

Inclusion Criteria for parents include:

• comfortable speaking and reading English language.

Exclusion Criteria include:

* families who plan to no longer have the child be a patient of any participating clinic/practice during any point in the 18-month study period;
* children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation;
* families for whom the Primary Care Provider (PCP) or site PI thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties, if the PI/PCP believes these factors will interfere with study/intervention participation); and
* families in whom the parent or child exhibits eating disorder symptomatology.

Primary outcomes:
measure: Child percent overweight
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alton
country: United States
facility: Washington University School of Medicine
state: Illinois
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Cape Girardeau
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbia
country: United States
facility: University of Missouri School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: Washington University School of Medicine
name: Denise E. Wilfley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Stephen Cook, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: