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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using a Guided Self-Help Treatment Model for Childhood Obesity Management in the Primary Care Setting

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: Guided Self-Help Obesity Treatment
* Behavioral: Family-based behavioral obesity treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Self-Help Obesity Treatment<br>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. | Behavioral: Guided Self-Help Obesity Treatment<br>* Guided Self-Help obesity treatment will be provided by a health coach in the clinic. The treatment involves 14 sessions: 1 one-hour session and 13 twenty-minute sessions with the health coach who will provide behavioral obesity treatment.<br>* Other names: Guided self-help;|
| Active Comparator: Family-based behavioral obesity treatment<br>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. | Behavioral: Family-based behavioral obesity treatment<br>* Traditional family-based, group-based behavioral weight control program. The treatment involves 20 hourly group-based sessions for parents and children separately, which occurs weekly for 16 weeks, then every other week for the last 2 months (4 session).<br>* Other names: FBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI percentile | Change in BMI percentile within and between study groups | 6 months and 1 year | 
| Difference in percentage of sessions that were attended | Difference in percentage of sessions that were attended between groups | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Societal cost for each 0.1 unit BMI z-score change | Cost-effectiveness from a societal perspective including cost of delivering intervention, parental costs, and primary care office costs | 6 months and 1 year | 
| Activity Support scale | Difference in parent support behaviors to encourage physical activity between groups | 6 months | 
| Parent self-efficacy for health related behaviors scale | Difference in parent self-efficacy to engage in weight loss between intervention parents and control parents | 6 months | 
| Dietary History Questionnaire II | Changes in child dietary behavior from baseline to post treatment | 6 months | 
| Godin Physical Activity Scale | Changes in child physical activity level from baseline to post treatment | 6 months | 
| Dietary Support scale (modified) | Difference in parent support behaviors to encourage healthy dietary behaviors between groups | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity treatment, Primary care, Guided Self-Help