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Obesity, ChildhoodNCT07839832

Stanford Healthy Goals Study

A study of Obesity, Childhood, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 15 years
Conditions the study is for
Obesity, Childhood
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Jan 2027to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 10 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 10-15 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

Who cannot join

  • 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
  • Other exclusion as deemed by the investigators

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas Robinson, MD, MPH contact

650-723-5895

tom.robinson@stanford.edu

United States1 site, 1 recruiting
  • Stanford University

    Stanford, California, 94305

    Kay Kim, PhD, (650) 723-5895, kaywkim@stanford.edu

    Thomas N Robinson, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

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.

Read more

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.

Read the detailed description

The investigators propose a 2-arm, parallel group, randomized controlled trial to test the efficacy of adding two innovative "wise" social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care family-based, group behavioral intervention for weight control in children with obesity, to reduce body mass index trajectory over 12 months, compared to the usual care behavioral intervention alone.

A total of 200 10-15-year-old children with obesity (BMI ≥ 95th percentile) will participate. All children will participate with their parents in a usual care six-month, family-based, group, behavioral weight control program. In addition, families randomized to the wise intervention condition will receive two, innovative social psychological interventions-growth mindset and self-affirmation-strategically selected and timed to enhance the behavioral intervention.

There remains a great need for innovative approaches to increase and sustain weight loss among children with obesity. The investigators propose that existing weight control interventions are limited in their success with many children in part because of the many psychological barriers and threats they face when attempting to manage their weight. One novel and potentially effective and efficient way to enhance the success of behavioral treatments may be to focus on changing the mindsets and preparedness of the participant.

Measures will be collected at baseline, 3 months, 6 months (end of the behavioral treatment), and 12 months (follow-up 6 months after the end of treatment) from children and parents. Body mass index (BMI) trajectory over the entire 12 months is the primary outcome measure. Secondary outcome measures and potential moderating and/or mediating variables include waist circumference and triceps skinfold thickness, parent weight outcomes, physical activity (accelerometery), energy intake (24-hour dietary recalls), screen time, and hypothesized mediators of the behavioral intervention and the two social psychological interventions. The investigators propose highly rigorous and transparent RCT methods.

Primary Hypothesis: Compared to children randomized to receive the usual care family-based, group behavioral weight control program alone, children randomized to receive the usual care family-based, group behavioral weight control program plus the wise social psychological interventions will have a significantly attenuated BMI trajectory over 12 months.

Secondary Analysis: The investigators will examine the effects of the intervention on secondary outcome measures and explore possible moderators and mediators of intervention responsiveness. Sex will be examined as a biological variable, and risk factor/targeting and process/delivery of intervention analyses will be performed.

Innovation: This research is particularly exciting because it: 1. tests a novel theory and paradigm for pediatric weight control, one that emphasizes how precisely changing perceptions of oneself and one's environment can unleash one's ability to benefit from available resources and behavioral strategies, 2. introduces a new theory of change for weight control, involving small changes in perceptions triggering recursive feedback loops that domino into large changes in weight over time, 3. applies methods from educational research, to a new domain of weight control, and 4. involves a truly transdisciplinary effort between social psychology and health creating a fundamentally new, integrated approach to health behavior change.

Being tested
Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment, Education plus usual care behavioral treatment
Keywords
obesity, children, adolescents, families, wise interventions
Medical subject headings
Pediatric Obesity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 treatmentBehavioural

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

Study groups in NCT07839832
Study groupRoleWhat they receive
Wise interventions plus behavioral RxExperimentalWise social psychological interventions (growth mindset and values self-affirmation) plus a usual care family-based, group, behavioral intervention for weight control.
Receives: Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment
Education plus behavioral RxActive comparatorHealth education plus a family-based, group, usual care behavioral intervention for weight control
Receives: Behavioral: Education plus usual care behavioral treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body mass index from baseline to 12 months

    body mass index = weight in kilograms divided by the squared height in meters

    Measured: Change from baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionFeb 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

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
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07839832
Sponsor's protocol ID
54341-1
Other IDs
R01DK123286
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study of Obesity, Childhood, run by Stanford University 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas Robinson, MD, MPH (650-723-5895, tom.robinson@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body mass index from baseline to 12 months (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Sep 2026.

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