Stanford Healthy Goals Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-15
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Medical conditions affecting growth

Medications affecting growth

Conditions limiting participation in the interventions

Conditions limiting participation in the assessments

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    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

    Behavioral

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Wise interventions plus behavioral RxExperimental treatment 1 intervention
Group B: Education plus behavioral RxActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in body mass index from baseline to 12 months

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

Time frame
Change from baseline to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator