An interventional study of Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment and Education plus usual care behavioral treatment in Obesity, Childhood, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
A 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body mass index (BMI) trajectories over 6 months between 10-16-year-old children with obesity randomized to receive the wise social psychological interventions plus a usual care behavioral intervention for weight management compared to children randomized to receive additional education plus a usual care behavioral intervention.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 2 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone
Conditions limiting participation in the interventions - e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason
Conditions limiting participation in the assessments - child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language
Unable to read, understand or complete informed consent in English or Spanish
Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control.
Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment
Health education plus a usual care behavioral intervention for weight control
Behavioral: Education 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
6-month health education plus usual care behavioral intervention for weight control in children with obesity
Change in Body Mass Index From Baseline to 6 Months
body mass index = weight in kilograms divided by the squared height in meters
Time frame: Change from baseline to 6 months
To enter the study, the child and at least one parent/guardian must have agreed to participate, and both child and adult were considered to be enrolled.
| Milestone | Wise Interventions Plus Behavioral Rx | Education Plus Behavioral Rx |
|---|---|---|
| Started | 0 | 2 |
| Completed | 0 | 0 |
| Not completed | 0 | 2 |
body mass index = weight in kilograms divided by the squared height in meters
No measurements were reported for this outcome.
Collected over Up to 2.5 months, when participation ended.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education Plus Behavioral Rx | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Education Plus Behavioral Rx |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Education Plus Behavioral Rx |
|---|---|
| Female | 2 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Education Plus Behavioral Rx |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Education Plus Behavioral Rx |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Education Plus Behavioral Rx |
|---|---|
| United States | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data sharing will be based on the policy for data sharing issued by the NIH and consistent with HIPAA privacy standards. Our data management team will prepare de-identified public use data set from this study for deposition in a repository.
Supporting information: Study protocol, Sap, Icf
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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