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NCT07839832NARecruiting

Stanford Healthy Goals Study

Stanford University

Start Date

1/1/2027

Completion Date

3/1/2030

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. 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.

Eligibility Criteria

Age Range: 10 years to 15 years

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

Interventions

BEHAVIORAL

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

BEHAVIORAL

Education plus usual care behavioral treatment

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Conditions

Obesity, Childhood

Locations

Stanford University

Stanford, California 94305

United States