Obesity, ChildhoodNCT07839832
Stanford Healthy Goals Study
A study of Obesity, Childhood, run by Stanford University at 1 site in United States.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Kay Kim, PhD, (650) 723-5895, kaywkim@stanford.edu
Thomas N Robinson, MD, MPH
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.
- Conditions
- Obesity, Childhood
- 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 group | Role | What they receive |
|---|---|---|
| Wise interventions plus behavioral Rx | Experimental | Wise 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 Rx | Active comparator | Health 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.
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.
- First posted24 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Robinson, Stanford University
- Investigators
- Thomas Robinson, MD, MPH, Principal investigator, Stanford University
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity
- ClinicalTrials.gov ID
- NCT07839832
- Acronym / sponsor ID
- 54341-1
- Conditions
- Obesity, Childhood
- Keywords
- obesity, children, adolescents, families, wise interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 24 Sep 2026 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wise interventions plus behavioral Rx | Experimental | Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatmentWise 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 comparator | Behavioral: Education plus usual care behavioral treatmentHealth education plus a family-based, group, usual care behavioral intervention for weight control |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatmentAddition 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 | Behavioural | Wise interventions plus behavioral Rx |
| Education plus usual care behavioral treatment6-month health education plus usual care behavioral intervention for weight control in children with obesity | Behavioural | Education plus behavioral Rx |
Primary outcome
Change in body mass index from baseline to 12 months
Time frame: Change from baseline to 12 months
body mass index = weight in kilograms divided by the squared height in meters
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
Thomas Robinson, MD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
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.