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

NCT02976454 | Completed

• 1 other identifier: R40MC29452
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Obesity treatment; Primary care; Guided Self-Help

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Societal cost for each 0.1 unit BMI z-score change

  6 months and 1 year

• Activity Support scale

  6 months

• Parent self-efficacy for health related behaviors scale

  6 months

• Dietary History Questionnaire II

  6 months

• Godin Physical Activity Scale

  6 months

Study Arms (2)

Guided Self-Help Obesity Treatment

EXPERIMENTAL

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

Family-based behavioral obesity treatment

ACTIVE COMPARATOR

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

Interventions

Guided Self-Help Obesity Treatment BEHAVIORAL

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.

Also known as: Guided self-help

Guided Self-Help Obesity Treatment

Family-based behavioral obesity treatment BEHAVIORAL

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).

Also known as: FBT

Family-based behavioral obesity treatment

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• 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.

  PMID: 35712916 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: December 12, 2016
• Primary Completion: December 30, 2019
• Study Completion: July 30, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

US (1)