Pediatric ObesityGOTDocNCT02976454
Guided Self-Help Obesity Treatment in the Doctor's Office - GOT Doc
A study testing Guided Self-Help Obesity Treatment and Family-based behavioral obesity treatment in people with Pediatric Obesity, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Guided Self-Help Obesity Treatment and Family-based behavioral obesity treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- Guided Self-Help Obesity Treatment, Family-based behavioral obesity treatment
- Keywords
- Obesity treatment, Primary care, Guided Self-Help
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-Help Obesity TreatmentBehavioural
Also called Guided self-help
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 treatmentBehavioural
Also called FBT
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Family-based behavioral obesity treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI percentile
Change in BMI percentile within and between study groups
Measured: 6 months and 1 year
Difference in percentage of sessions that were attended
Difference in percentage of sessions that were attended between groups
Measured: 6 months
Secondary outcomes (6)
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
Measured: 6 months and 1 year
Activity Support scale
Difference in parent support behaviors to encourage physical activity between groups
Measured: 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
Measured: 6 months
Dietary History Questionnaire II
Changes in child dietary behavior from baseline to post treatment
Measured: 6 months
Godin Physical Activity Scale
Changes in child physical activity level from baseline to post treatment
Measured: 6 months
Dietary Support scale (modified)
Difference in parent support behaviors to encourage healthy dietary behaviors between groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start12 Dec 2016
- Primary completion30 Dec 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Responsible party
- Principal investigator, Kay Rhee, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976454
- Sponsor's protocol ID
- R40MC29452
- Acronym
- GOTDoc
- Status last verified
- Aug 2020
- First submitted
- 21 Nov 2016
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35712916
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Guided Self-Help Treatment Model for Childhood Obesity Management in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT02976454
- Acronym / sponsor ID
- GOTDoc / R40MC29452
- Conditions
- Pediatric Obesity
- Keywords
- Obesity treatment, Primary care, Guided Self-Help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Self-Help Obesity Treatment | Experimental | Behavioral: Guided Self-Help Obesity TreatmentGuided 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. |
| Family-based behavioral obesity treatment | Active comparator | Behavioral: Family-based behavioral obesity treatmentThe 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. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self-Help Obesity TreatmentAlso: Guided self-helpGuided 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. | Behavioural | Guided Self-Help Obesity Treatment |
| Family-based behavioral obesity treatmentAlso: FBTTraditional 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). | Behavioural | Family-based behavioral obesity treatment |
Primary outcome
Change in BMI percentile
Time frame: 6 months and 1 year
Change in BMI percentile within and between study groups
Difference in percentage of sessions that were attended
Time frame: 6 months
Difference in percentage of sessions that were attended between groups
6 secondary outcomes
Societal cost for each 0.1 unit BMI z-score change
Time frame: 6 months and 1 year
Activity Support scale
Time frame: 6 months
Parent self-efficacy for health related behaviors scale
Time frame: 6 months
Dietary History Questionnaire II
Time frame: 6 months
Godin Physical Activity Scale
Time frame: 6 months
Dietary Support scale (modified)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Derived from this study: PubMed 35712916Rhee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Help Obesity Treatment and Family-based behavioral obesity treatment in people with Pediatric Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI percentile (time frame: 6 months and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.