search
Back to results

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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Self-Help Obesity Treatment
Family-based behavioral obesity treatment
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Obesity treatment, Primary care, Guided Self-Help

Eligibility Criteria

5 Years - 13 Years (Child)All SexesAccepts 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

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided Self-Help Obesity Treatment

Family-based behavioral obesity treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in BMI percentile
Change in BMI percentile within and between study groups
Difference in percentage of sessions that were attended
Difference in percentage of sessions that were attended between groups

Secondary Outcome Measures

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
Activity Support scale
Difference in parent support behaviors to encourage physical activity between groups
Parent self-efficacy for health related behaviors scale
Difference in parent self-efficacy to engage in weight loss between intervention parents and control parents
Dietary History Questionnaire II
Changes in child dietary behavior from baseline to post treatment
Godin Physical Activity Scale
Changes in child physical activity level from baseline to post treatment
Dietary Support scale (modified)
Difference in parent support behaviors to encourage healthy dietary behaviors between groups

Full Information

First Posted
November 21, 2016
Last Updated
August 19, 2020
Sponsor
University of California, San Diego
Collaborators
HRSA/Maternal and Child Health Bureau
search

1. Study Identification

Unique Protocol Identification Number
NCT02976454
Brief Title
Guided Self-Help Obesity Treatment in the Doctor's Office - GOT Doc
Acronym
GOTDoc
Official Title
Using a Guided Self-Help Treatment Model for Childhood Obesity Management in the Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Obesity treatment, Primary care, Guided Self-Help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Self-Help Obesity Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Family-based behavioral obesity treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Help Obesity Treatment
Other Intervention Name(s)
Guided self-help
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family-based behavioral obesity treatment
Other Intervention Name(s)
FBT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in BMI percentile
Description
Change in BMI percentile within and between study groups
Time Frame
6 months and 1 year
Title
Difference in percentage of sessions that were attended
Description
Difference in percentage of sessions that were attended between groups
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Societal cost for each 0.1 unit BMI z-score change
Description
Cost-effectiveness from a societal perspective including cost of delivering intervention, parental costs, and primary care office costs
Time Frame
6 months and 1 year
Title
Activity Support scale
Description
Difference in parent support behaviors to encourage physical activity between groups
Time Frame
6 months
Title
Parent self-efficacy for health related behaviors scale
Description
Difference in parent self-efficacy to engage in weight loss between intervention parents and control parents
Time Frame
6 months
Title
Dietary History Questionnaire II
Description
Changes in child dietary behavior from baseline to post treatment
Time Frame
6 months
Title
Godin Physical Activity Scale
Description
Changes in child physical activity level from baseline to post treatment
Time Frame
6 months
Title
Dietary Support scale (modified)
Description
Difference in parent support behaviors to encourage healthy dietary behaviors between groups
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35712916
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs