Clinical trial NCT04364282: Stay In Treatment for Pediatric Weight Management
Official title: War of Attrition: Predicting Dropout From Pediatric Weight Management
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pediatric Obesity
Attrition
Family Research
Weight Loss
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Boston Children's Hospital
name: Children's Mercy Hospital Kansas City
name: Nationwide Children's Hospital
First posted: 2020-04-28
Enrollment: 1100
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment will be through existing pediatric weight management clinics. A total of 100 child-parent dyads at each site over 2 years (300 dyads across all three sites; total of 600 participants) will be recruited. An additional 50 dyads across sites (150 dyads total; 300 total participants) will be recruited in year 3 for temporal validation and a 4th site will also be added for external validation (100 dyads, 200 total participants). Children ages 7-18 years, and a legal parent/guardian referred to a participating pediatric weight management program, are eligible.

Brief summary: Attrition from pediatric weight management programs is unacceptably high, with dropout ranging from 27-73%. This project will utilize a model that predicts dropout from treatment, increasing its power and accuracy through a multi-site observational study. This will result in a powerful tool that will be used to decrease attrition from pediatric weight management, with the potential for widespread dissemination to improve treatment outcomes.

Detailed description: The obesity epidemic is one of the foremost threats to the health of children and adults in the U.S today. Multidisciplinary pediatric weight management programs have been deemed effective, with increased access to these programs strongly advocated. However, the effectiveness of these programs is limited by attrition, with dropout ranging from 27-73%, limiting health benefits to children and inefficiently utilizing already scarce resources. In addition to better understanding the drivers of attrition, being able to predict or forecast dropout holds great potential to improve adherence and outcomes, and modify treatment approaches to best serve the needs of families. Using a model that isolates variables associated with attrition from pediatric weight management to forecast participant dropout, this prospective, longitudinal observational study will collect comprehensive data on child and family-, obesity-, and treatment-related variables In Stage 1, investigators will install an attrition forecasting model, the Outcomes Forecasting System (OFS), in 3 pediatric weight management programs, and build its precision and calibration using a conceptual model of adherence. In Stage 2, we will establish external validation, installing the OFS in a fourth weight management program, and temporal validation through continued use of the OFS within the 3 original sites. The overall goal of this project is to increase the accuracy and power of an attrition prediction model through its installation in weight management programs and to demonstrate its internal, external, and temporal validity. A greater understanding of patient, family, and disease-specific factors that predict dropout from pediatric weight management can be utilized to prevent attrition. By identifying the most pertinent factors driving attrition across weight management sites, new avenues for treatment and prevention will be identified. This project will result in a valuable tool, available for dissemination across a diverse array of clinical programs to improve adherence, decrease costs, and improve outcomes.

Eligibility criteria: Inclusion Criteria:

* Child is 7-18 years of age
* Participating child has been referred to one of the participating weight management programs, and the family (child-parent dyad) has chosen to participate in said program.
* Participating child is obese (BMI ≥95th percentile for age and sex).
* Participating child provides assent to participation in the research study.
* At least one parent/guardian consents to participate (and consent to child participation).

The parent should be the primary parent accompanying the child to treatment, and the child's primary residence must be with that parent.

- Both members of the parent-child dyad must speak either English or Spanish.

Exclusion Criteria:

* Participating child cannot complete measures and study activities (non-verbal, significant developmental and behavioral challenges).
* Participating child has a chronic illness that impacts weight (i.e. cancer).
* Participating child with a genetic condition (i.e. Prader-Willi) that is associated with excessive weight.
* One member of the parent-child dyad refuses to participate in the study or does not wish to complete 6 months of treatment.
* One member of the parent-child dyad is unable to participate in 6 month follow-up data collection.

Primary outcomes:
measure: Attrition from weight management
timeFrame: 6 months
Secondary outcomes:
measure: Body mass index (BMI) z score
timeFrame: 6 months
measure: Percent of the 95th percentile BMI
timeFrame: 6 months
measure: Body weight
timeFrame: 6 months
measure: Family Health Habits
timeFrame: 6 months
measure: General and psychosocial health (Parent)
timeFrame: 6 months
measure: General and psychosocial health (Child)
timeFrame: 6 months
measure: Family function (Parent report)
timeFrame: 6 months
measure: Family function (Child report)
timeFrame: 6 months
measure: Household environment (Parent report)
timeFrame: 6 months
measure: Household environment (Child report)
timeFrame: 6 months
measure: Stress (Parent report)
timeFrame: 6 months
measure: Stress (Child report)
timeFrame: 6 months
measure: Motivation/self-efficacy
timeFrame: 6 months
measure: Health Literacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Winston-Salem
country: United States
facility: Brenner Children's Hospital
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph A Skelton, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berry DC, Rhodes ET, Hampl S, Young CB, Cohen G, Eneli I, Fleischman A, Ip E, Sweeney B, Houle TT, Skelton J. Stay in treatment: Predicting dropout from pediatric weight management study protocol. Contemp Clin Trials Commun. 2021 Jun 9;22:100799. doi: 10.1016/j.conctc.2021.100799. eCollection 2021 Jun.