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

Pediatric Obesity Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976454
• Other study ID #: R40MC29452
• Status: Completed
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI percentile	Change in BMI percentile within and between study groups	6 months and 1 year
Primary	Difference in percentage of sessions that were attended	Difference in percentage of sessions that were attended between groups	6 months
Secondary	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
Secondary	Activity Support scale	Difference in parent support behaviors to encourage physical activity between groups	6 months
Secondary	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
Secondary	Dietary History Questionnaire II	Changes in child dietary behavior from baseline to post treatment	6 months
Secondary	Godin Physical Activity Scale	Changes in child physical activity level from baseline to post treatment	6 months
Secondary	Dietary Support scale (modified)	Difference in parent support behaviors to encourage healthy dietary behaviors between groups	6 months