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Stanford Healthy Goals Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 15 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for children ages 10–15 with obesity. It tests whether adding two short activities about thoughts and social experiences to a family-based group weight program works better than adding extra health lessons. The program lasts 6 months, with study measurements through 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Children ages 10–15.
  • Have obesity when assigned to a study group: a body mass index (BMI), a measure based on height and weight, at or above the 95th percentile on the CDC growth chart.
  • The child and at least one parent or guardian must agree to take part.

Who can't join

  • Have a health condition that affects growth.
  • Take medicine that affects growth.
  • Have a condition that limits taking part in study activities.
  • Have a condition that limits completing study measurements.
  • Cannot read, understand, or complete the study consent form in English or Spanish.
  • Other reasons the study team decides make someone unable to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 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 * Other exclusion as deemed by the investigators

Study sites (1)

CA