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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: Guided Self-Help Obesity Treatment; Behavioral: Family-based behavioral obesity treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Self-Help Obesity Treatment; 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; 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.; Other Names: Guided self-help
Active Comparator: Family-based behavioral obesity treatment; 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; 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).; Other Names: FBT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: HRSA/Maternal and Child Health Bureau

Publications and helpful links

General Publications

• Rhee KE, Herrera L, Strong D, Kang-Sim E, Shi Y, Boutelle KN. Guided Self-Help for Pediatric Obesity in Primary Care: A Randomized Clinical Trial. Pediatrics. 2022 Jul 1;150(1):e2021055366. doi: 10.1542/peds.2021-055366.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Primary care; Guided Self-Help; Obesity treatment
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: R40MC29452