Guided Self-Help Obesity Treatment in the Doctor's Office - GOT Doc (GOTDoc)

University of California San Diego

Status: Completed

Conditions: Pediatric Obesity

Treatments: Behavioral: Guided Self-Help Obesity Treatment; Behavioral: Family-based behavioral obesity treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02976454

R40MC29452

Details and patient eligibility

About

One-third of our nations' children are overweight or obese (OW/OB). The cornerstone of obesity treatment involves intensive family-based behavioral therapy, yet these programs often exist in tertiary care academic settings that have long wait lists and are too far away for families to access. Primary care providers (PCP) have been called on by several organizations to be the front line of obesity management, yet they are limited by a lack of time, resources, and skills. Thus, if we are to offer effective obesity management in the healthcare setting, other care models need to be developed and tested. The goal of this proposal is to deliver Guided Self-Help (GSH) treatment of childhood obesity in the primary care setting. This program relies on classic behavioral therapy strategies, self-regulation theory, and provides the support needed for patient/family self-management of weight loss. Implementing this program in the primary care setting will increase our ability to deliver nutrition and weight-related counseling in the primary care office and serve patients closer to home, thereby increasing access to effective treatment, improving adherence to recommended changes, and meeting the goals of Healthy People 2020.

Full description

Currently 1/3 of our nation's children are overweight or obese. The goal of Healthy People 2020 is to reduce the proportion of children who are obese and increase the proportion of primary care visits that include nutrition and weight-related counseling. However, there are a lack of resources and providers that can offer effective weight-related counseling and treatment. Gold-standard family-based weight control programs for children are often provided at tertiary care academic centers and can be difficult to access. Furthermore, primary care providers (PCPs), who have been identified as key players in the treatment of childhood obesity, are not well-equipped to address this issue, engage in behavior modification/lifestyle counseling, or provide effective treatment in the primary care setting. As a result, new models of care are needed so that a greater proportion of overweight/obese (OW/OB) children and their parents can access care and receive quality treatment for obesity. The investigators propose to train health coaches in the primary care setting to deliver Guided Self-Help (GSH) treatment of childhood obesity. Implementing this program in the primary care setting will increase our ability to deliver nutrition and weight-related counseling in the primary care office and serve patients closer to home, thereby increasing access to effective treatment, improving adherence to recommended changes, and meeting the goals of Healthy People 2020.

The goal of this study is to conduct a pragmatic clinical trial in two large pediatric practices in San Diego County (n=200) where 38% and 39% of children are OW/OB. The intervention group will receive GSH (14 sessions over 6 months) delivered by a health coach in the clinic. The control group will receive usual care, i.e. PCP provides obesity management using decision support tools in the electronic health record and refers to a tertiary care program (20 sessions over 6 months) at the academic center.

Enrollment: 230 patients

Sex: All

Ages: 5 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• an OW/OB child (BMI ≥ 85th%ile for age and gender) in the family who is between the ages of 5 and 13 years old
• parent who is responsible for food preparation willing to participate
• parent who can read English or Spanish at a minimum of a 5th grade level
• family who is willing to commit to attendance at all assessment visits
• family not moving out of the San Diego area within the time frame of the study.

Exclusion criteria

• child who is taking medications that may impact weight
• child or parent with a psychiatric or behavioral illness that will impact their ability to participate in treatment
• child with physical difficulties that limit the ability to exercise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Guided Self-Help Obesity Treatment

Experimental group

Description:

Guided Self-Help obesity treatment will include 14 meetings over 6 months to mimic the structure of the proposed Medicare funding for obesity treatment for adults. These meetings will include a single one-hour meeting and 13 twenty-minute meetings that occur in the clinic. During this time, the health coach will assess patient/parent readiness to engage in behavior change, assess barriers and facilitators to behavior change, engage in behavior change and problem solving, and provide feedback and accountability.

Treatment:

Behavioral: Guided Self-Help Obesity Treatment

Family-based behavioral obesity treatment

Active Comparator group

Description:

The active control group will receive usual care, i.e. PCP provides obesity management using decision support tools in the electronic health record and refers to a tertiary care program at the academic center. This program is the traditional family-based behavioral weight control program which consists of 20 one-hour, group-based sessions over 6 months.

Treatment:

Behavioral: Family-based behavioral obesity treatment