Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers

NCT03843424 | Completed DMC

• 2 other identifiers: 201810158PCS-2017C2-7542
• Study Type: interventional
• Target: 1,460
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

• Child percent overweight

  1 year

Study Arms (2)

Enhanced Standard of Care (eSOC)

ACTIVE COMPARATOR

This group will receive the eSOC program. A minimum of 6 visits to 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.

Behavioral: eSOC program

Family-Based Behavioral Treatment (FBT + eSOC)

ACTIVE COMPARATOR

This group will receive eSOC plus the FBT program. Family-based behavioral treatment (FBT), an effective treatment that targets both child and parents meeting regularly with a health coach for healthy eating, activity, positive parenting strategies, and managing environmental cues.

Behavioral: eSOC program; Behavioral: FBT program

Interventions

eSOC program BEHAVIORAL

American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling

Enhanced Standard of Care (eSOC); Family-Based Behavioral Treatment (FBT + eSOC)

FBT program BEHAVIORAL

An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.

Family-Based Behavioral Treatment (FBT + eSOC)

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• comfortable speaking and reading English language.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Blue Cross and Blue Shield of Louisiana: collaborator
• American Academy of Pediatrics: collaborator
• Pennington Biomedical Research Center: collaborator
• Louisiana Healthcare Connections: collaborator
• Nationwide Children s Hospital in Columbus, Ohio: collaborator
• University of Rochester: collaborator

Study Sites (7)

Washington University School of Medicine

Alton, Illinois, 62002, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Pennington Biomedical Research Center

New Orleans, Louisiana, 70121, United States

Location

Washington University School of Medicine

Cape Girardeau, Missouri, 63703, United States

Location

University of Missouri School of Medicine

Columbia, Missouri, 65201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Staiano AE, Button AM, Baker A, Beyl R, Conn AM, Lima A, Lindros J, Newton RL Jr, Stein RI, Welch RR, Cook S, Wilfley DE; TEAM UP Research Group. A pragmatic trial of a family-centered approach to childhood obesity treatment: Rationale and study design. Contemp Clin Trials. 2024 Mar;138:107459. doi: 10.1016/j.cct.2024.107459. Epub 2024 Jan 24.

  PMID: 38278478 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity; Weight Gain; Overnutrition; Body Weight; Body Weight Changes; Nutrition Disorders; Weight Loss

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise E. Wilfley, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Stephen Cook, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: September 12, 2019
• Primary Completion: June 26, 2024
• Study Completion: July 26, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (7)