Stanford Healthy Goals Study
Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity
2 other identifiers
interventional
200
1 country
1
Brief Summary
Past modest, transient and highly variable outcomes from many behavioral treatments for pediatric obesity may be, in part, because of the psychological barriers children with obesity face when trying to control their weight. The goal of this randomized controlled trial is to test whether adding two innovative, brief, social psychological activities (termed "wise" interventions) to a high quality, family-based, group behavioral weight control program, will produce better outcomes among participating children with obesity. The primary hypothesis is that children who receive the family-based, group, behavioral weight control program plus the wise social psychological interventions will have significantly less body mass index growth over 12 months than children who receive the family-based, group, behavioral weight control program plus additional educational content. Participants will be asked to do participate in the six month treatment program and complete measurements at the beginning of the study, after 3 months, after 6 months (the end of the behavioral treatment program), and after 12 months (6 months after completing the behavioral treatment program). This study has the potential to substantially improve the outcomes of pediatric weight control treatments and significantly reduce concurrent and future health, psychological and social harms from childhood obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2026
CompletedFirst Posted
Study publicly available on registry
September 24, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
Study Completion
Last participant's last visit for all outcomes
March 1, 2030
September 28, 2026
September 1, 2026
3.1 years
September 18, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body mass index from baseline to 12 months
body mass index = weight in kilograms divided by the squared height in meters
Change from baseline to 12 months
Study Arms (2)
Wise interventions plus behavioral Rx
EXPERIMENTALWise social psychological interventions (growth mindset and values self-affirmation) plus a usual care family-based, group, behavioral intervention for weight control.
Education plus behavioral Rx
ACTIVE COMPARATORHealth education plus a family-based, group, usual care behavioral intervention for weight control
Interventions
6-month health education plus usual care behavioral intervention for weight control in children with obesity
Addition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care behavioral intervention for weight control in children with obesity
Eligibility Criteria
You may qualify if:
- year old children
- Obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization.
- Child and at least one parent/guardian must agree to participate
You may not qualify if:
- Medical conditions affecting growth
- Medications affecting growth
- Conditions limiting participation in the interventions
- Conditions limiting participation in the assessments
- Unable to read, understand or complete informed consent in English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Robinson, MD, MPH
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 18, 2026
First Posted
September 24, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
September 28, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Limited access data will be shared within six months of the publication date for the primary outcome publication or within two years of the date that the database is locked for analysis, whichever occurs first.
- Access Criteria
- User registration will be required. Users must agree to the conditions of use governing access to the public release data (a data use agreement), including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
Data sharing will be based on the policy for data sharing issued by the NIH and consistent with HIPAA privacy standards and specific terms outlined in the consent forms. Our data management team will prepare de-identified public use data set from this study for deposition in a repository.