Stay In Treatment for Pediatric Weight Management (SIT)

Wake Forest University (WFU)

Status: Completed

Conditions: Weight Loss; Family Research; Pediatric Obesity; Attrition

Treatments: Other: Care team informed; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04364282

IRB00062191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,216 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,216 participants in 2 patient groups, including a placebo group

Care team informed

Active Comparator group

Description:

Participants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will be informed of the family's risk profile for attrition.

Treatment:

Other: Care team informed

Control

Placebo Comparator group

Description:

Participants in this study will be children and their parents taking part in existing pediatric weight-management programs at participating sites. In this group, members of the weight-management care team will not be informed of the family's risk profile for attrition.

Treatment:

Other: Control