Recruiting

Behavioral Program with Wise Interventions

Sponsor:

Stanford University

Code:

NCT07839832

Conditions

Obesity, Childhood

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Not accepted

Interventions

Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment

Education plus usual care behavioral treatment

Study Details

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.

Conditions

Obesity, Childhood

Study ID

NCT07839832

Start date

Jan, 2027

Status verified date

Sep, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- 10-15 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. - Participation in a behavioral weight control program. Standard behavioral weight control program eligibility criteria will apply: Child and at least one parent/guardian must agree to participate

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Wise interventions plus behavioral Rx

Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care family-based, group, behavioral intervention for weight control.

active comparator: Education plus behavioral Rx

Health education plus a family-based, group, usual care behavioral intervention for weight control

Interventions

Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment

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

Education plus usual care behavioral treatment

6-month health education plus usual care behavioral intervention for weight control in children with obesity

Primary outcome measure

  • Change in body mass index from baseline to 12 months [ Time Frame: Change from baseline to 12 months ]

Central Contacts and Locations

Central contacts

Thomas Robinson, MD, MPH

650-723-5895tom.robinson@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Kay Kim, PhD

(650) 723-5895kaywkim@stanford.edu

Principal Investigator:

Thomas N Robinson, MD, MPH

More Information

Sponsor

Stanford University

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • obesity
  • children
  • adolescents
  • families
  • wise interventions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Stanford University on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.